Due Diligence of course...
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BIO updates Thursday February 7, 2013
Eli Lilly and Company (NYSE: LLY) announced it will discontinue the Phase 3 rheumatoid arthritis (RA) program for tabalumab, an anti-BAFF (B cell activating factor) monoclonal antibody, due to lack of efficacy. The decision was not based on safety concerns. The tabalumab Phase 3 program for systemic lupus erythematosus, ILLUMINATE, is ongoing and will continue as planned.
In December 2012, Lilly discontinued the Phase 3 RA registration study FLEX-M for lack of treatment effect. FLEX-M was investigating tabalumab in patients with moderate-to-severe RA who had an inadequate response to methotrexate therapy.
Based on FLEX-M findings, an interim futility analysis was conducted of the FLEX-V study, which was investigating tabalumab for the treatment of patients with moderate-to-severe RA who had an inadequate response to one or more tumor necrosis factor (TNF) inhibitors.
Based on the outcomes of these two separate interim futility analyses, Lilly has decided to discontinue development of tabalumab in the current RA program. All ongoing Phase 2 and Phase 3 RA studies will be stopped.
"While we are obviously disappointed by these results in rheumatoid arthritis, we continue to believe that tabalumab could have significant potential for patients in other disease areas," said Eiry Roberts, M.D., vice president of autoimmune product development at Lilly. "Autoimmune disorders are highly individualized. We believe that targeting BAFF with a molecule such as tabalumab may still represent an important advance for patients, and therefore we will continue the ongoing Phase 3 tabalumab lupus program."
The decision to stop the current RA program for tabalumab is expected to result in a first-quarter charge to research and development expense of approximately $50 million. The company's previously issued financial guidance for 2013 remains unchanged.
Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) announced it has successfully completed the first of a two-stage pharmacokinetic study with AVP-786, a drug product containing a deuterium modified form of dextromethorphan. Based on interim data, Avanir believes that it has identified a formulation of AVP-786 with a comparable pharmacokinetic, safety and tolerability profile to AVP-923 (dextromethorphan hydrobromide and quinidine sulfate). The company has requested a meeting with the FDA to discuss the full development path for AVP-786.
"The results of this study are very encouraging," said Joao Siffert, MD, chief scientific officer for Avanir. "We were able to successfully replicate the steady-state plasma levels of AVP-923, but with a substantially lower dose of quinidine. Given these results, we believe that AVP-786 would be an ideal candidate to test in one or more of our ongoing clinical programs."
Avanir also announced today that the company intends to modify the enrollment target of its ongoing phase II clinical study of AVP-923 in central neuropathic pain in multiple sclerosis to 200 patients.
"With the encouraging pharmacokinetic results in hand, we have made the decision to accelerate the completion of the PRIME study, as we believe AVP-786 has the potential to be a preferable development compound," said Joao Siffert, MD. "We plan to use the data from the PRIME study to guide the further development of AVP-786."
As a result of this change, the company now expects to have data from the PRIME study in the fourth calendar quarter of 2013.
Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced it will present at the 15th Annual BIO CEO & Investor Conference on February 11th at 9:30am EST in the Basildon room at the Waldorf=Astoria in New York City.
Allergan, Inc. (NYSE: AGN) (“Allergan”) and MAP Pharmaceuticals, Inc. (NASDAQ: MAPP) (“MAP”) today announced that the Federal Trade Commission has granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”), with respect to the tender offer for all of the outstanding shares of common stock of MAP by Groundhog Acquisition, Inc. (“Purchaser”), a wholly-owned subsidiary of Allergan.
Amgen (NASDAQ: AMGN) today outlined the company's long-term strategy during a Business Review meeting with analysts and investors in New York City.
Anthera Pharmaceuticals, Inc.(Nasdaq: ANTH) a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, today announced Paul F. Truex, Anthera's President and Chief Executive Officer, will present at the 2013 Leerink Global Healthcare Conference in New York, NY on Thursday, February 14, 2013 at approximately 8:00 am Eastern Time.
ArQule, Inc. (Nasdaq: ARQL) today announced that the Company will present at the Leerink Swann Global Healthcare Conference on Thursday, February 14, 2013 at 1:30 p.m.
CEL-SCI Corporation (NYSE MKT: CVM) announced that Geert Kersten, Chief Executive Officer, will be presenting at the 2013 BIO CEO & Investor Conference on Monday, February 11, 2013 at 11:00 a.m.
China Cord Blood Corporation (NYSE: CO) ("CCBC" or the "Company"), the first and largest cord blood banking operator in China, today announced the completion of the previously announced transaction with Cordlife Services (S) Pte. Ltd., a subsidiary of the Company's strategic affiliate, Cordlife Limited (CBB.AU) ("Cordlife"), a cord blood and tissue banking services provider listed on the Australian Securities Exchange.
CorMedix Inc. (NYSE MKT: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiorenal disease, announces the receipt of notice on February 1, 2013 from the NYSE MKT LLC (the “NYSE MKT”) that the NYSE MKT granted it an extension until April 15, 2013 to regain compliance with the continued listing standards of the NYSE MKT.
Digirad Corporation (NASDAQ: DRAD) announced today R. King Nelson, former Chairman, and Gerhard F. Burbach have tendered their resignations from the Board of Directors after more than a decade of service to the Board and management team at Digirad.
EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced results from its randomized ReCharge Pivotal Trial of VBLOC® vagal blocking therapy for the treatment of obesity.
ERBA Diagnostics, Inc. (NYSE MKT: ERB), a fully integrated in vitro diagnostics company, has appointed Mohan Gopalkrishnan as Vice President - Operations.
GTx, Inc. (NASDAQ: GTXI) today announced that it will host a conference call and webcast to provide a corporate update and discuss the Company's fourth quarter and full year 2012 financial results on Thursday, February 21, at 9:00 a.m. Eastern Time.
iCAD, Inc. (Nasdaq: ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, today announced that the Company will release financial results for the three and twelve months ended December 31, 2012, following the close of the market on Tuesday, February 19, 2013.
Ingen Technologies, Inc. (PINKSHEETS: IGNT), an emerging medical device manufacturer with patented proprietary medical technology for the growing $55 Billion US home healthcare industry, is pleased to announce that Charles Vorwaller, a consultant with Ingen, has introduced Thomas Childers to the company and has agreed to help create sales of the Smart Nasal Cannula and Oxyview oxygen flow meter to his government clientele.
Insulet Corporation (NASDAQ: PODD), the leader in tubeless insulin pump technology with its OmniPod® Insulin Management System, announced plans to release its financial results for the fourth quarter and full year 2012 on February 27, 2013 after the close of the financial markets.
KaloBios Pharmaceuticals, Inc. (NASDAQ: KBIO) today announced the completion of its initial public offering of 8,750,000 shares of common stock at $8.00 per share.
LiveWire Ergogenics, Inc. (OTCQB: LVVV) has provided a corporate update of the company's activities and accomplishments in 2012 during which LiveWire completed the transition from a private company to a fully reporting public company with audited financials.
MeadWestvaco Corporation (NYSE: MWV), a global leader in packaging and packaging solutions, announced today the expansion of its pharmaceutical manufacturing Centre of Excellence, based in Hemer, Germany.
MiMedx Group, Inc. (OTC: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that its results for the fourth quarter ended December 31, 2012, will be released before the opening of the market on Thursday, March 7, 2013.
Novadaq® Technologies Inc. (TSX:NDQ) (NASDAQ:NVDQ), a developer of clinically-relevant fluorescence imaging solutions for use in surgical procedures, today announced financial results for its fourth quarter and full year ended December 31, 2012.
Omeros Corporation (NASDAQ: OMER) today announced data from toxicology studies evaluating OMS721, the lead human monoclonal antibody in Omeros' mannan-binding lectin associated serine protease-2 (MASP-2) program.
Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) today announced that it will report financial results for the fourth quarter and full year 2012 ended December 31, 2012 after market closes on Thursday, February 21, 2013.
Opexa Therapeutics, Inc. (NASDAQ:OPXA) a company developing Tcelna™ (imilecleucel-T), a novel T-cell therapy for multiple sclerosis (MS), today announced it has priced an offering of shares of its common stock and warrants to purchase common stock in a private registered offering of 1,083,334 units at a price of $3.00 per unit, for gross proceeds of $3,250,000.
Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) today announced it will report fourth quarter and fiscal year 2012 financial results after the NASDAQ Global Market closes on February 28.
Oramed Pharmaceuticals Inc. (OTCQB: ORMPD), a developer of oral drug delivery systems, announced today that NASDAQ has approved the company's application to list its shares of common stock on the NASDAQ Capital Market.
Orexigen® Therapeutics, Inc. (Nasdaq: OREX) today announced that management will be presenting at two upcoming investor conferences.
Parametric Sound Corporation (NASDAQ: PAMT), a leading innovator of audio technology and solutions, today announced financial results for its first fiscal quarter ended December 31, 2012.
Palatin Technologies, Inc. (NYSE MKT: PTN) announced that it will be presenting at the 15th Annual BIO CEO & Investor Conference.
RTI Biologics Inc. (RTI) (Nasdaq:RTIX), a leading provider of orthopedic and other biologic implants, reported operating results for the fourth quarter and full year of 2012.
SurePure, Inc. (OTCBB: SURP) a global leader in liquid photopurification, announced that Sigma Alimentos, a major Mexican food producer, would purchase at least three of its SurePure ultraviolet (UVC) photopurification systems.
Venaxis, Inc. (Nasdaq: APPY), an in vitro diagnostic company focused on obtaining FDA clearance and commercializing its blood-based appendicitis test, APPY1, today announced it has signed its first European commercial development agreement with Netherlands-based EMELCA Bioscience for the initial phase of Venaxis' EU launch.
YM BioSciences Inc. (NYSE MKT: YMI) (TSX: YM), today reported operational and financial results for the second quarter of fiscal 2013, ended December 31, 2012.
BIO updates Wednesday January 30, 2013
Shares of Celsion (NASDAQ: CLSN) were halted in after-hours trading on Wednesday. The company said it would hold a conference call Thursday morning at 8 am to discuss the top-line results from its Phase III HEAT Study with ThermoDox.
The HEAT Study had received a Fast Track designation from the FDA and Orphan Drug status.
Isis Pharmaceuticals (NASDAQ: ISIS) is up big on Wednesday on the approval of KYNAMRO by the FDA.
On Tuesday, the Carlsbad, California firm announced FDA approval of this cholesterol-fighting drug. Specifically, the drug is used to treat homozygous familial hypercholesterolemia (HoFH), a rare condition that prevents patients from being able to remove LDL or “bad” cholesterol from the blood. And “rare” is not an overstatement, as literally one in a million Americans develops this condition, which often results in heart attacks and death before the age of 30.
One-in-a-Million Drug Earns Isis $25 million--Investors may wonder why the approval of a drug that will only benefit one-millionth of the population has caused this stock to spike. The answer lies in the company's partnership with Genzyme, a Sanofi company (NYSE: SNY).
With the approval of KYNAMRO, Genzyme will pay ISIS $25 million. That's more than double ISIS's total third quarter revenues. Accordingly, the stock has risen substantially in trading on Wednesday.
Market Reaction--The FDA approval of KYNAMRO has sent Isis skyward in trading on Wednesday.
After bottoming out below $8 in November, Isis gradually climbed back into double-digits by late December. It continued to increase into January, as well.
Now, after hovering in the $13-14 range over the past three weeks, Isis is above $15 as of this writing. It currently rests at its highest point since mid-September of 2012.
Align Technology, Inc. (NASDAQ: ALGN) today announced that Kenneth B. Arola will step down as vice president, finance and chief financial officer effective March 4, 2013 and will remain an employee of the Company through June 28, 2013.
Align Technology, Inc. (NASDAQ: ALGN) today reported financial results for the fourth quarter and fiscal year ended December 31, 2012.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, and collaborators announced today the publication of complete study results from a Phase I trial with ALN-VSP, a systemically delivered RNAi therapeutic for the treatment of advanced solid tumors with liver involvement.
Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH) today announced that it has completed the previously announced underwritten public offering of 60,606,061 shares of its common stock, offered at a price of $0.66 per share.
Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL), a specialty biopharmaceutical company ("Auxilium"), today announced the closing of its previously announced offering of 1.50% Convertible Senior Notes due 2018 (the "Convertible Notes").
Dendreon Corporation (Nasdaq: DNDN) today announced that management will host a conference call on Monday, February 25, 2012, at 9:00 a.m. ET to review fourth quarter and full year 2012 financial results.
Generex Biotechnology Corporation (OTCBB: GNBT) today provided an overview on the early breast cancer competitive status of the lead cancer immunotherapy product, AE37, under development at its wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com).
IEC Electronics Corp. (NYSE MKT: IEC) announces that the replay of today's annual meeting is now available. Listeners may access the annual meeting webcast and presentation by registering through the Company's webcast link on its home page, www.iec-electronics.com.
Life Technologies Corporation (NASDAQ: LIFE) today announced it will provide a complete laboratory solution to identify an estimated 20,000 human remains found in various mass graves in Libya following the uprising of 2011 and to address missing persons cases from the 42-year regime of Muammar Gaddafi.
LifeMap Sciences, Inc., a subsidiary of BioTime, Inc. (NYSE MKT: BTX), announced today the publication of a paper authored by a research group under the supervision of Prof. Doron Lancet from the Department of Molecular Genetics at the Weizmann Institute of Science describing the analysis and display of a non-redundant compendium of human non-coding RNA genes, which was made available as part of GeneCards® Version 3.09, released November 18, 2012.
LipoScience, Inc. (NASDAQ: LPDX) today announced it has closed its previously announced initial public offering of 5,000,000 shares of common stock at a price to the public of $9.00 per share.
Masimo (NASDAQ: MASI) announced today that it will release fourth quarter and full year 2012 financial results for the period ended December 29, 2012, after the market closes on Thursday, February 14, 2013.
Mauna Kea Technologies (NYSE Euronext: MKEA), leader in the optical biopsy market and developer of Cellvizio®, the fastest way to see cancer, reported its first Cellvizio system sales in Japan, the world's second largest healthcare market.
mPhase Technologies, Inc. (OTCBB: XDSL) reported today that it has been issued patent number 8,344,543 from the U.S. Patent & Trademark Office (USPTO) for a Reserve Battery System.
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today that it has priced an underwritten sale of common stock in a transaction led by J.P. Morgan Asset Management and involving one other institutional investor.
NeuroMetrix, Inc. (Nasdaq: NURO), www.neurometrix.com, a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes, announced that is has launched a website (www.neurometrix.com/sensus) for the SENSUS Pain Management System.
NewLink Genetics Corporation (NASDAQ: NLNK), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced the pricing of an underwritten public offering of 4,000,000 shares of its common stock at a price to the public of $11.40 per share, which was the previous day's closing price.
Novus International Inc., a leading manufacturer of animal nutrition and health products and Verenium Corporation (Nasdaq: VRNM), a leading industrial biotechnology company focused on the development and commercialization of high-performance enzymes, today announced significant steps forward in their collaboration's progress toward commercializing its suite of next-generation animal nutrition enzymes.
Obagi Medical Products, Inc. (Nasdaq:OMPI), a leader in topical aesthetic and therapeutic skin-health systems, and Suneva Medical, Inc., a rapidly growing aesthetics company, jointly announce a partnership to co-distribute ReGenica Facial Rejuvenation Complex.
Organovo Holdings, Inc. (OTCQX: ONVO) ("Organovo"), a creator and manufacturer of functional, three-dimensional human tissues for medical research and therapeutic applications, and the Knight Cancer Institute at Oregon Health & Science University (OHSU), a national leader in translational oncology research, have formed a collaboration to develop more clinically predictive in vitro three dimensional cancer models which will ultimately advance discovery of novel cancer therapeutics.
Oxygen Biotherapeutics, Inc. ("Oxygen") (NASDAQ:OXBT) announced today the Company will be presenting at the 15th Annual BIO CEO & Investor Conference to be held at the Waldorf Astoria Hotel in New York City, February 11-12. Michael Jebsen, President and Chief Financial Officer of Oxygen, will present a corporate overview and update on Monday, February 11 at 9 am EST.
PDL BioPharma, Inc. (PDL) (NASDAQ: PDLI) today announced that Caroline Krumel resigned her position as vice president of finance and principal accounting officer effective immediately on January 25th.
RBC Life Sciences, Inc. (OTCQB: RBCL) (the "Company"), has been granted US Patent 8357422, which protects its unique dietary supplement formulation that nutritionally supports cognitive function, learning and remembering.
Rite Aid (NYSE: RAD) is taking on heart disease this February by offering customers basic healthy lifestyle support backed by expert pharmacist counseling and 12-page, full-color Heart Health guides available for free online and at pharmacy counters.
RXi Pharmaceuticals Corporation (OTC: RXII), a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using RNA-targeted technologies, today announced that its second Phase 1 study with their anti-scarring drug, RXI-109, for the management of surgical and hypertrophic scars and keloids, has been fully enrolled.
Sangamo BioSciences, Inc. (Nasdaq: SGMO) today announced that the company will release its fourth quarter and full year 2012 financial results on Wednesday, February 6, 2013, after the market closes.
SpectraScience, Inc. (OTCQB: SCIE), a San Diego based medical device company, today announced that in continuation of its distribution and sales efforts in Europe and the Middle East it is demonstrating its WavSTAT4 Optical Biopsy System at the 38th Annual Arab Health 2013 Exhibition and Congress.
Targeted Medical Pharma, Inc. (OTCQB: TRGM) (OTCBB: TRGM), a biotechnology company that develops and distributes prescription medical foods to physicians and pharmacies, today announced it has received an Issue Notification from the United States Patent and Trademark Office (USPTO) regarding projected patent number 8370172, which relates to a system and method for submitting claims for a dispensed medication to a patient by point-of-care physicians.
Tengion, Inc. (OTCQB: TNGN), a leader in regenerative medicine, today announced advances for its two lead programs, the Neo-Urinary Conduit™ and Neo-Kidney Augment™.
Verisante Technology, Inc. (TSX VENTURE:VRS) (OTCQX:VRSEF) (FRANKFURT:V3T) (the "Company" or "Verisante"), a leader in cancer detection technology, announced today that the Company has received purchase orders for Verisante Aura™ from the Company's exclusive distributors in Canada and Europe.
Walgreens (NYSE: WAG) (Nasdaq: WAG) subsidiary Take Care Health Systems and Indianapolis-based Community Health Network today announced a clinical collaboration that will facilitate more coordinated health care services, and improve patient access to high-quality, convenient and affordable care throughout Central Indiana.
WuXi PharmaTech (NYSE: WX), a leading pharmaceutical, biotechnology, and medical device research and development outsourcing company with operations in China and the United States, announced the winners of its 6th annual WuXi PharmaTech Life Science and Chemistry Awards at a ceremony held on January 20, 2013.
BIO updates Tuesday January 29, 2013
Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) announced that the INCIVEK® (telaprevir) label in the United States has been updated to include a Boxed Warning stating that fatal and non-fatal serious skin reactions have been reported in patients taking INCIVEK combination treatment. Fatal cases of serious skin reactions have been reported in patients with progressive rash and systemic symptoms who continued to receive INCIVEK combination treatment after a serious skin reaction was identified.
Rash and serious skin reactions are known adverse events associated with INCIVEK combination treatment and were previously included in the warnings and precautions section of the label. Given the severity of the events reported in the post-marketing setting, and the importance of discontinuing INCIVEK combination treatment in the event of one of these reactions, the information has been given greater prominence through a boxed warning.
The safety of people taking our medicines is our first priority, and we are committed to ensuring that patients and physicians are aware of the label update to help them use INCIVEK properly, said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer at Vertex. We will continue to educate physicians to follow the rash management plan developed while INCIVEK was in clinical trials and the information contained in the updated label.
In Phase 3 clinical trials, less than 1 percent of people who received INCIVEK combination treatment experienced a serious skin reaction. These serious skin reactions required hospitalization and all patients recovered. For serious skin reactions, INCIVEK combination treatment must be discontinued immediately, and patients should be promptly referred for urgent medical care.
The INCIVEK label was also updated to include additional information on the time to onset and management of anemia.
Anacor Pharmaceuticals (ANAC) today announced positive preliminary results from the first of two Phase 3 trials of tavaborole, its topical anti-fungal for onychomycosis, a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States. Tavaborole achieved a high degree of statistical significance on all primary and secondary endpoints.
In this first Phase 3 study (known as Study 301), 6.5% of patients treated with tavaborole met the primary endpoint of complete cure vs. 0.5% of patients treated with vehicle (p=0.001) at week 52. Complete cure is a composite endpoint that requires both a mycological cure and a completely clear nail.
Among the secondary endpoints, 26.1% of patients treated with tavaborole achieved a completely clear or almost clear (d10% clinical involvement) nail vs. 9.3% in the vehicle-treated arm (p<0.001) at week 52. 31.1% of patients treated with tavaborole achieved mycological cure vs. 7.2% in the vehicle-treated arm (p<0.001) at week 52. Mycological cure is the absence of fungus as determined by a negative potassium hydroxide (KOH) examination and a negative fungal culture. 15.3% of patients treated with tavaborole achieved completely clear or almost clear nail with mycological cure vs. 1.5% in the vehicle-treated arm (p<0.001) at week 52.
In addition to the primary and secondary endpoints noted above, 87.0% of patients treated with tavaborole had a negative fungal culture vs. 47.9% in the vehicle-treated arm (p<0.001) at week 52, and 24.6% of patients treated with tavaborole achieved completely clear or almost clear nail and negative culture vs. 5.7% in the vehicle-treated arm (p<0.001) at week 52.
We are pleased that tavaborole met all of the parameters outlined in our Special Protocol Assessment with the FDA with a high degree of statistical significance in this first Phase 3 trial. With its high rates of completely clear or almost clear nails, high negative culture rates, demonstrated safety and ease of use, we believe tavaborole could offer significant advantages over currently approved treatments for onychomycosis, said David Perry, Chief Executive Officer of Anacor.
Patients and physicians have been waiting for a safe and effective treatment for onychomycosis. Millions of patients are treated several times a year with debridement because it is the safest option to improve the appearance of the nail and minimize discomfort, even though debridement doesnt actually eliminate the fungus. Tavaborole has the potential to offer these patients an effective, safe and convenient therapy to treat this difficult infection and prevent it from spreading to other toes and skin, said Max Weisfeld, DPM.
Tavaborole belongs to a novel class of drugs, known as oxaboroles, and should be an exciting addition to dermatologists treatment options for patients who suffer from onychomycosis, said Boni Elewski, MD, Professor of Dermatology, University of Alabama. It is a challenging and frustrating disease, but tavaborole could be a safe and effective alternative for patients who are embarrassed by the appearance of their yellow, thickened nails and are either unwilling or unable to take oral medications to treat this condition.
Tavaborole Phase 3 Study 301 Design--Study 301 enrolled 594 patients in the United States and Mexico with distal subungual onychomycosis, randomized two-to-one to receive either tavaborole, 5% solution, or vehicle. Eligible patients were at least 18 years of age (with no upper age limit) with a clinical diagnosis of distal subungual onychomycosis involving 20% - 60% of the total area of the target great toenail, at least 3mm of clear nail from the proximal nail fold to the most proximal visible mycotic border and positive mycology. Patients were instructed to apply tavaborole solution or vehicle to the target great toenail once daily for 48 weeks.
Overall, tavaborole was safe and well-tolerated across study subjects. There were no serious adverse events related to study drug. The rate of discontinuations as a result of adverse events was low (2.8% for tavaborole and 1.6% for vehicle).
Study 301 is the first of two Phase 3 clinical trials of tavaborole in onychomycosis. Anacor received a Special Protocol Assessment from the FDA on all major parameters of the studies, including endpoints. Data from the second Phase 3 clinical trial (known as Study 302) are expected in March of this year. Study 302 is identical in design to Study 301 with sites in the United States and Canada. Subject to the results of Study 302, Anacor plans to file an NDA for tavaborole in the middle of this year.
Afraxis, Inc. today announced that it has entered into a global licensing agreement with Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), to develop compounds for an undisclosed novel target.
AirWare Labs Corp. (OTCQB: AIRW) today announced it will expand its sales and promotional marketing efforts of the AIR® Allergy product in addition to the Sleep/Snore product as part of its continued commitment to a national rollout at Walgreens 7500 stores.
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, announced that Catherine M. Burzik has been elected to its Board of Directors.
BIOLASE, Inc. (NASDAQ: BIOL), the world's leading dental laser manufacturer and distributor, announced today two key appointments to its senior management team.
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that company management will present at investor conferences during February to discuss the company’s business activities, financial outlook, and current news.
Generex Biotechnology Corporation (OTCBB: GNBT) previously announced that Company management has scheduled an investor conference call for Thursday, January 31, 2013.
IEC Electronics Corp. (NYSE MKT: IEC) announced that it will host a conference call on Tuesday, February 5, 2013 at 10:00 a.m. Eastern Time, to discuss its financial results for the first quarter ended December 31, 2012.
Life Technologies Corporation (NASDAQ: LIFE) today announced the establishment of the Global Influenza Network, a partnership including scientists at a number of the world's leading government public health organizations, veterinary agencies and research institutes in a collaborative effort to increase the speed and efficiency of influenza monitoring and vaccine development.
Medifocus Inc. (Medifocusor the Company) (TSX VENTURE:MFS)(OTCQX:MDFZF) has agreed, subject to regulatory approval, to issue an aggregate of 1,090,000 common shares at a deemed price of $0.25 per common share to settle an aggregate of $272,500 of debt representing unpaid salary ($210,000) and amounts due to service providers ($62,500).
Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for cancer, announced today that Dr. Marnix Bosch, the Company's Chief Technical Officer, will be presenting at the Phacilitate Cell And Gene Therapy Forum 2013, today at 3:30 pm in a session entitled Clinical Development Updates: Oncology.
OvaScienceSM, (OTC: OVSC), a life sciences company focused on the discovery, development and commercialization of new treatments for infertility, announced today that Michelle Dipp, M.D., Ph.D., Chief Executive Officer of OvaScience, will present at several upcoming conferences in February.
ServiceSource® (NASDAQ: SREV), the global leader in recurring revenue management, today announced an extension of its partnership with Affymetrix®, Inc., a pioneer of microarray technology used in groundbreaking genetic discoveries.
Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today that its OrbeShieldTM (oral beclomethasone 17,21-dipropionate or oral BDP) development program for the treatment of GI ARS has received "Fast Track" designation from the U.S. Food and Drug Administration (FDA).
Therapeutic Solutions International, Inc. (OTCQB: TSOI) announced today the signing of a distribution agreement with Dentorient Fuss Ltd., a dental supply company headquartered in Tel Aviv, Israel.
Verisante Technology, Inc. (TSX VENTURE:VRS)(OTCQX:VRSEF)(FRANKFURT:V3T) (the "Company" or "Verisante"), a leader in cancer detection technology, today announced that it has retained Crescendo Communications, LLC ("Crescendo") to help increase investor awareness throughout North America.
Gonna try and post a few...
ANX initiates pivital Phase 3 study of ANX-188
ANX 0.5934
Adventrx Pharmaceuticals announced that it has initiated patient recruitment in its pivotal phase 3 clinical study of ANX-188 in sickle cell disease.
SNGX -Wonder if people have noticed this board has been posting updates on this company since the end of last year:) and beyond
A company I have been following for awhile which could benefit me and my daughter...
http://investorshub.advfn.com/boards/msgsearchbyboard.aspx?boardID=16112&srchyr=2012&SearchStr=sngx
Soligenix is a development stage biopharmaceutical company developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17,21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec®), as well as developing its novel innate defense regulator (IDR) technology SGX942 for the treatment of oral Mucositis.
Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government's Strategic National Stockpile. Soligenix's lead biodefense products in development are a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax™, a vaccine against anthrax exposure. RiVax™ has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax™ and VeloThrax™ are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix's new vaccine heat stabilization technology known as ThermoVax™. Soligenix is also developing OrbeShield™ for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a $600,000 NIAID Small Business Innovation Research (SBIR) grant. OrbeShieldTM has previously demonstrated statistically significant preclinical survival results in two separate canine GI ARS studies funded by the NIH.
For further information regarding Soligenix, Inc., please visit the Company's website at http://www.soligenix.com.
BIO updates for Monday January 28, 2013
Medtronic, Inc. (NYSE: MDT) announced the start of PROMISE, a Prospective, Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant Low Back Pain. This is the first-ever, large-scale study comparing the effectiveness of Medtronic neurostimulation therapy with Specify® 5-6-5 multicolumn surgical leads plus optimal medical management (OMM) to the administration of OMM alone in patients with failed back surgery syndrome (FBSS) and predominant low back pain.
"Chronic pain is a clinically challenging and often debilitating condition for which oral medications may provide insufficient relief," said Bart Edmiston, M.D., principal investigator for the PROMISE study at The Neuroscience Center in Ocean Springs, Mississippi, which enrolled the study's first patient on January 8. "The PROMISE study will add to the growing body of evidence supporting Medtronic neurostimulation therapy, a well-established therapeutic approach, for the patients worldwide who continue to experience low back pain following back surgery."
It is estimated that more than 100 million U.S. adults1 and one in five European adults2 live with chronic pain. Back pain is the most prevalent type of chronic pain, affecting approximately 10 percent of the U.S. population alone.3 FBSS is defined as persistent or recurring pain in the back or legs following one or more spine surgeries. The majority of FBSS patients receive physical rehabilitation and/or oral medications to help manage their pain, but studies and clinical experience find that many of these patients will not sufficiently improve and will require additional interventions.4
Medtronic neurostimulation therapy (also known as spinal cord stimulation, or SCS) is a widely established treatment option for chronic back and/or leg pain that has been used to treat more than 250,000 people worldwide. It uses a medical device to deliver mild electrical impulses to the spinal cord to block pain signals from reaching the brain.
PROMISE is a prospective, randomized, open-label, parallel-group, clinical study enrolling up to 300 individuals suffering from predominant chronic low back pain due to FBSS at 30 centers in the United States , Canada and Europe (Belgium, France, Germany, Spain, The Netherlands and The United Kingdom). It is the first large-scale, randomized, controlled clinical trial designed to assess the value of SCS for predominant low back pain with leg pain using a surgical lead, in contrast to previous studies of this technology, which have focused on predominant leg pain.
"Spinal cord stimulation has become an increasingly valued treatment approach in chronic pain, and we look forward to participating in the latest study," said Philippe Rigoard, M.D., the study's global principal investigator, who started enrolling patients January 14 at Poitiers University Hospital in Poitiers, France. "If the PROMISE results are positive, they will provide critically needed relief for those patients suffering from chronic low back pain associated with FBSS."
PROMISE participants will be randomized 1:1 to receive treatment with either SCS with OMM or OMM only. After a six-month observational phase, the study will compare the proportion of participants in the SCS group who report more than 50 percent reduction in low back-pain intensity, as measured by the Numeric Pain Rating Scale, with those in the OMM-only group. Health care utilization data collected will be used to develop cost analysis models for potential use in future studies evaluating the long-term economic impact of SCS.
"Medtronic is committed to advancing the understanding of its neurostimulation therapy in patients with low back pain resulting from FBSS," said Julie Foster, general manager and vice president, Pain Stimulation and Targeted Drug Delivery in the Neuromodulation business of Medtronic, Inc. "PROMISE provides the opportunity to assess not only the degree of pain relief provided by SCS plus OMM compared to OMM alone in failed back surgery patients, but also to evaluate the economic and quality of life impact of this treatment by looking at such important measures as sleep, ability to work and changes in pain medication."
Repros Therapeutics Inc.® (Nasdaq: RPRX) earlier provided a revised date for expected clinical results from the first pivotal study, ZA-301, of Androxal® in the treatment of secondary hypogonadism. The Company now plans to provide the data in Q3 2013 instead of Q2 2013.
During the ongoing review of the data it was determined that one site's patient population was markedly different from the other 16 sites from the standpoint of baseline sperm counts. The site in question had enrolled 40 subjects into the 151 subject trial. Though the subjects at the site meet the strict entry criteria for the trial, the clear difference from the other sites begs the question of whether or not this site represents the general population to be treated or is, in fact, a special population. To that end, the Company felt it would be prudent to remove the site from the efficacy studies and replace the subjects with those enrolled at other sites. Preliminary blinded analysis of reported subjects from the identified site indicates these subjects have responded as well or better than the other sites from the standpoints of improved testosterone and maintenance of sperm concentration.
Fortunately, the Company is enrolling subjects into the identical pivotal trial ZA-302. The current plan, pending regulatory approval, is to move already enrolled subjects from sites in ZA-302 to ZA-301 to make up the shortfall. Since many of these subjects have recently been enrolled, it will extend the time before the data base from the first study can be locked and analyzed. The Company believes it can have the data available for top line release in Q3 of this year.
The Company is attempting to schedule a meeting with the FDA to advise the Agency of Repros' plan. Repros believes this outcome will not affect the timing of the NDA submission currently targeted for mid-2014.
Conference Call Details: Time: Monday, January 28, 2013 – 8AM Eastern Participant Dial In Number: 877-407-0782 International callers: 201-689-8567 Participant Title: Repros Therapeutics Teleconference Replay will be available until February 4, 2013. Replay Number: 877-660-6853, Conference ID#: 408375
Actinium Pharmaceuticals, (OTCBB: CTVN), a biopharmaceutical company that develops innovative targeted payload immunotherapeutics, reported today that the program of the EMIT: Targeted Radiotherapy conference will feature three presentations devoted to Actinium Pharmaceuticals' clinical programs and technology platform.
ALR Technologies (OTCBB: ALRT), a medical device company providing remote monitoring and care facilitation for patients with chronic diseases, today announced that Kent Stoneking, Pharm. D., CDE, has been appointed Director, Diabetes Care Facilitation, effective February 1, 2013.
Amarantus BioScience, Inc. (OTCQB: AMBS), a biotechnology company discovering and developing treatments and diagnostics for diseases associated with the neurodegeneration and apoptosis centered around its patented therapeutic protein MANF, today announced the launch of the Company's new website at www.amarantus.com.
Atossa Genetics, Inc. (NASDAQ: ATOS), The Breast Health Company™, announced today that Dr. Steven C. Quay, M.D., Ph.D., FCAP, Chairman, CEO and President, will present the Company's products and services at the 15th Annual BIO CEO and Investor Conference at the Waldorf Astoria Hotel in New York City, on Monday, February 11, 2013, at 1:00 pm Eastern Time (10:00 am Pacific Time).
Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) ("Auxilium") and Xstelos Holdings, Inc. (OTCQB: XTLS) ("Xstelos") announced today that they filed a lawsuit against Upsher-Smith Laboratories, Inc. ("USL") for infringement of ten U.S. patents covering Testim, 1% testosterone gel, that are listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. Food and Drug Administration ("FDA").
Bio-Rad Laboratories, Inc. (NYSE: BIO) and (NYSE: BIO.B), a multinational manufacturer and distributor of life science research and clinical diagnostic products, will report financial results for the fourth quarter and full year 2012 on Tuesday, February 26, 2013, after the close of the market.
BrainStorm Cell Therapeutics (OTC.QB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that it has appointed Mr. Alon Natanson as its new Chief Executive Officer (CEO).
CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, announced that an in vivo trial investigating aldoxorubicin, its tumor-targeting conjugate of the widely used chemotherapeutic agent doxorubicin, in combination with unconjugated doxorubicin, demonstrated positive results and provided the basis for the Company’s current evaluation of the combination therapy in cancer patients with advanced solid tumors in a Phase 1b clinical trial.
Galectin Therapeutics (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that the American Chemical Society (ACS), as part of its ACS Symposium Series, has published online the proceedings from the galectin-focused symposium hosted by Galectin Therapeutics, Galectins and Disease Implications for Targeted Therapeutics.
Genzyme, a Sanofi Company (EURONEXT: SAN and NYSE: SNY), announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s supplemental Biologics License Application (sBLA) file seeking approval of LEMTRADA (alemtuzumab) for the treatment of relapsing multiple sclerosis (RMS).
Hadasit Bio-Holdings Ltd. (TASE: HDST, OTC: HADSY) and its portfolio companies ProtAb Ltd. ("ProtAb") and KAHR Medical Ltd. ("KAHR") announced today that they will receive additional funding of NIS 10.7 million (over $2.8 million USD) by the Israeli Ministry of Industry and Commerce, Office of the Chief Scientist (OCS) to support product development and advance clinical trials.
Hanover Portfolio Acquisitions (OTCQB: HVPA) will be presenting its investment opportunity to an audience of principals and key decision makers of broker/dealers and financial firms at the FSX Investment Conference to be held in Dallas, Texas from February 7th to 9th, 2013.
IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has submitted an additional abbreviated new drug application (ANDA) to the US FDA, which brings the company’s total number of submissions to nine.
Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) today announced successful top-line results from the long-term Phase 3 study of Zerenex™ (ferric citrate), the Company's ferric iron-based phosphate binder drug candidate, for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis.
Medicago Inc. (TSX: MDG) (OTCQX: MDCGF), a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced the execution of a collaboration agreement with Mitsubishi Chemical Holdings Corporation ("MCHC") to develop a next generation technology for plant production.
Medicure Inc. (TSX VENTURE:MPH) (PINKSHEETS:MCUJF), a specialty pharmaceutical company, today reported its results from operations for the quarter ended November 30, 2012.
MMRGlobal, Inc. (OTCQB: MMRF) ("MMR") today announced that the Japan Patent Office has allowed Patent Application No. 2008-529977 directed toward a Method and System for Providing Online Medical Records.
Novation Holdings (OTCBB:NOHO) today announced that it has acquired a controlling interest in Alternative Energy Partners, Inc., a mining and energy holding company whose common shares are traded on the OTC BB under the symbol AEGY.
Oncolytics Biotech Inc. (TSX:ONC, NASDAQ: ONCY) today announced a poster presentation covering positive preliminary results from a Phase I study examining the intravenous administration of REOLYSIN in combination with FOLFIRI in patients with metastatic colorectal cancer (REO 022).
Pernix Therapeutics Holdings, Inc. (NASDAQ: PTX), a specialty pharmaceutical company, today announced that it is scheduled to ring The NASDAQ Stock Market Opening Bell at 9:30 am EST on Monday, January 28, 2013 to celebrate the Company's listing on the NASDAQ Global Market.
Questcor Pharmaceuticals, Inc. (NASDAQ: QCOR) today announced the appointment of Michael Aldridge to the new position of Senior Vice President, Corporate Strategic Development.
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced safety findings from the pivotal, registrational Phase 2 BELIEF trial of belinostat, a pan-histone deacetylase (HDAC) inhibitor.
WaferGen Bio-systems, Inc. (OTCBB: WGBS) today announced the results of a successful study of lncRNA markers associated with prostate cancer in the lab of Dr. Arul Chinnaiyan at the University of Michigan Cancer Center.
Waters Corporation (NYSE: WAT) today reinforced its commitment to advancing biotherapeutic characterization technology at the Well Characterized Biotechnology Pharmaceuticals 2013 Symposium (WCBP 2013).
I am home and resting, things went well and will be back soon:) thank you for the prayers and great thoughts
Diva
muchly appreciated:) tc and gb
ty sweety:)
hey PW, been recovery from surgery... have another on Monday but I check in. thank you for your post on SNGX :) looks awesome imo
IMGN Announces Conference Call to Discuss its Second Quarter Fiscal Year 2013 Financial Results
Symbol Price Change
IMGN 15.36
WALTHAM, Mass.--(BUSINESS WIRE)--
ImmunoGen, Inc. (IMGN), a biotechnology company that develops anticancer products using its Targeted Antibody Payload (TAP) technology and antibody expertise, today announced that the Company will host a conference call at 8:00 a.m. ET on Friday, January 25, 2013, to discuss ImmunoGen's financial results for the three-month period ended December 31, 2012 – the second quarter of the Company’s 2013 fiscal year.
To access the live call by phone, dial 913-312-0721. Passcode: 8098402. The call also may be accessed through the Investor Information section of the Company's website, www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location through February 8, 2013.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics using its TAP technology together with the Company’s expertise in monoclonal antibodies and tumor biology. A TAP compound uses a tumor-targeting monoclonal antibody to deliver one of ImmunoGen's purpose-developed cancer-killing agents specifically to tumor cells. Ten TAP compounds are now in clinical testing, of which three are wholly owned by the Company. Marketing applications for trastuzumab emtansine (T-DM1), the most advanced compound using ImmunoGen's TAP technology, are under review in the US and Europe. Roche is developing this compound globally under an agreement between ImmunoGen and Genentech, a member of the Roche Group. More information about ImmunoGen can be found at www.immunogen.com.
Contact:
For Investors:
ImmunoGen, Inc.
Carol Hausner, 781-895-0600
Executive Director, Investor Relations and Corporate Communications
info@immunogen.com
or
For Media:
The Yates Network
Barbara Yates, 781-258-6153
YMI Plan of Arrangement with Gilead Sciences, Inc. Endorsed by Leading Independent Proxy Advisors ISS and Glass Lewis
Symbol Price Change
YMI 2.92
- U.S. Federal Trade Commission and Canadian Competition Bureau also Clear Plan of Arrangement -
MISSISSAUGA, ON, Jan. 18, 2013 /PRNewswire/ - YM BioSciences Inc. (NYSE MKT: YMI, TSX: YM), today reported that leading proxy advisory firms Institutional Investor Services ("ISS") and Glass, Lewis & Co. ("Glass Lewis") have recommended that shareholders of YM BioSciences Inc. ("YM" or the "Company") vote in favor of the previously announced plan of arrangement under which a wholly owned subsidiary of Gilead Sciences, Inc. will acquire YM for U.S.$2.95 per share in cash.
In addition, the initial waiting period under the United States Hart-Scott-Rodino Antitrust Improvements Act of 1976 has expired without any action by the Federal Trade Commission or the Antitrust Division of the United States Department of Justice. The Canadian Competition Bureau has also issued a letter stating that it does not, at this time, intend to challenge the completion of the transaction and waived the parties' obligation to submit a notification.
ISS noted that a vote FOR is warranted. The all-cash consideration offers a satisfactory premium. In addition, it noted that market reaction has been favorable, no alternative offers had been made and there are no significant governance concerns.
Glass Lewis commented that the YM board of directors conducted a reasonable review of strategic alternatives available to the Company prior to entering into the proposed agreement. The agreement is in the interests of the Company and shareholders in light of the lengthy strategic review conducted by the YM board of directors and the value of the proposed consideration.
ISS and Glass Lewis are leading independent international corporate governance analysis and proxy voting firms. Their recommendations assist shareholders to make their decisions regarding proxy voting.
Completion of the transaction remains contingent on the approval of YM shareholders at a special meeting of shareholders, as well as court approval. The special meeting will be held on Thursday, January 31, 2013 at 10:00am (EST) at the offices of Gowling Lafleur Henderson LLP, Suite 1600, 1 First Canadian Place, 100 King Street West, Toronto, Ontario. The transaction is expected to close in the first quarter of calendar 2013.
Permission to quote from the ISS and Glass Lewis reports was neither sought nor obtained.
Attention YM BioSciences shareholders.
Be sure to vote your proxy before Tuesday January 29, 2013 at 10:00 AM (EST)
For information or assistance in voting your proxy, please contact Kingsdale Shareholder Services Inc. at 1-866-229-8263 or 416.867.2272, or by email at contactus@kingsdaleshareholder.com.
About YM BioSciences
YM BioSciences Inc. is a drug development company primarily focused on advancing CYT387, an orally administered inhibitor of both the JAK1 and JAK2 kinases, which have been implicated in a number of hematological and immune cell disorders including myeloproliferative neoplasms and inflammatory diseases as well as certain cancers. Positive results have been reported from a Phase I/II trial of CYT387 in 166 patients with myelofibrosis.
This press release may contain forward-looking statements, which reflect YM's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, shareholder approval of the proposed arrangement; YM's ability to obtain court and other approvals in connection with the proposed arrangement; uncertainties as to the timing of the arrangement; the satisfaction of the conditions precedent to the completion of the arrangement; changing market conditions; the successful and timely completion of clinical studies; the establishment of corporate alliances; the impact of competitive products and pricing; new product development; uncertainties related to the regulatory approval process or the ability to obtain drug product in sufficient quantity or at standards acceptable to health regulatory authorities to complete clinical trials or to meet commercial demand; and other risks detailed from time to time in YM's ongoing quarterly and annual reporting. Except as required by applicable securities laws, YM undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
APDN to Provide Unique DNA Mark to Forward Components, Inc. for DNA-Marking of Microcircuits
Symbol Price Change
APDN 0.213
STONY BROOK, NY--(Marketwire - Jan 17, 2013) - Applied DNA Sciences, Inc. ( OTCBB : APDN ), (Twitter: @APDN), a provider of DNA-based anti-counterfeiting technology and product authentication solutions, announced today that Forward Components, Inc. (Forward Components Engineering, or FCE), based in Foothill Ranch, CA, has requested a unique DNA mark from APDN for DNA-marking for FSC 5962 microcircuits in accordance with the mandate issued by the U.S. Defense Logistics Agency (DLA). The mandate requires use of APDN's SigNature® DNA marking on a certain class of microcircuits, FSC 5962.
FCE will be required to undergo an in-house inspection and training prior to receiving the unique DNA mark to determine if they will qualify to mark in-house or will require third party marking initially. Quality control testing is an ongoing requirement to ensure that all parts continue to be marked correctly for as long as FCE marks parts with a unique APDN DNA marker.
FCE is an authorized distributor and assembly/test facility for the military and aerospace hi-rel industries. The company will apply their SigNature DNA Provenance mark to electronic parts which have traceable documentation as well as parts known as non-trace legacy components. The latter, which comprise only about 5% of the business of FCE, are parts which lack traceability documentation, but which are subject to rigorous test and inspection methods at the FCE facility. These parts, sometimes called "obsolete," can be vital to many military applications due to the long life of much military equipment.
FCE owner and President Scott Wilkosz stated, "Forward Components is pleased to offer DNA-marking on their 5962 components as a value-added service. This technology fits well with our core philosophy of strong quality control and 'best-practice' solutions for our hi-rel customers. Outside of DLA, we invite other customers to request DNA-marked parts from us, knowing that they will essentially be procuring an added layer of forensic protection for their supply-chain."
The Provenance mark to be used by FCE is one of two forms of APDN's SigNature DNA mark: the SigNature Authenticity mark, which is intended to authenticate original products manufactured by OCMs, and the SigNature Provenance mark for distributed products that are marked after manufacture.
The majority of materials FCE distributes are fully traceable; however, when a customer, such as DLA, requests an obsolete legacy component that does not have traceability, the on-staff engineering team at FCE screens these parts using test and inspection methods outlined in the recently approved SAE standard AS6081. Only after these parts are subjected to the test and inspection methods, and are shown to meet AS6081 criteria, will FCE then apply their SigNature DNA Provenance mark.
Bob MacDowell, Senior Account Representative at APDN, commented: "This DNA Provenance Mark will be unique to FCE, and is a testimony to their commitment to quality and best practices for the hi-rel component business."
Dr. James A. Hayward, President and CEO of Applied DNA Sciences, stated: "We are pleased to welcome FCE as another partner in the effort to protect the military supply chain and bring additional value to their businesses. As the DLA-mandated program for DNA marking and authentication grows and develops, we continue to widen the options for electronics companies wishing to join the program and gain its benefits."
About Forward Components Engineering
FCE is an authorized distributor and assembly/test facility for the military and aerospace hi-rel industries. With an on-site engineering staff and a technical sales team, Forward is able to utilize first-class quality systems and in-depth product to offer customers solution-based programs, including distribution and logistics services, cable and harness assembly, through-hole board assembly, and military compliant/RFID packaging. FCE offers extensive test capabilities for AC, DC, and functional testing for a wide array of devices in support of current and legacy programs. Parts inspections are compliant with IDEA-STD-1010 and the appropriate MIL-STD-883 standards. FCE is an ISO 9001:2008 certified company and has successfully contracted with various branches of the Armed Forces and Primes in support of the MV22, Blue Force Tracker, F/A-18 and many other vital programs critical to the success of the American Warfighter. For more information please contact us at info@forwardcomponents.com.
About Applied DNA Sciences
APDN is a provider of botanical-DNA based security and authentication solutions that can help protect products, brands and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion. SigNature® DNA and smartDNA™, our principal anti-counterfeiting and product authentication solutions that essentially cannot be copied, provide a forensic chain of evidence and can be used to prosecute perpetrators.
The statements made by APDN may be forward-looking in nature. Forward-looking statements describe APDN's future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of APDN. Actual results could differ materially from those projected due to our short operating history, limited financial resources, limited market acceptance, market competition and various other factors detailed from time to time in APDN's SEC reports and filings, including our Annual Report on Form 10-K, filed on December 20, 2012 and our subsequent quarterly reports on Form 10-Q. APDN undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events.
Contact:
MEDIA CONTACT:
Mitchell Miller
646-543-3373
fax: 631-444-8848
INVESTOR CONTACT:
Debbie Bailey
631-444-8090
fax: 631-444-8848
FCMN
Email Contact
PROGRAM CONTACT:
Janice Meraglia
631-444-6293
Web site: http://www.adnas.com
Twitter: @APDN, @APDNInvestor
Astex Pharmaceuticals (ASTX) announced that collaborators Cancer Research UK and its commercial arm Cancer Research Technology are launching a trial of an experimental drug shown to simultaneously block many enzymes that control cancer cell growth and death. The 'master-switch' experimental drug, owned by Astex Pharmaceuticals, is being studied in a range of cancer types.
ALIM -Alimera Sciences' ILUVIEN receives marketing authorization in Spain for the treatment of chronic diabetic macular edema (ALIM) 1.71 : Co and pSivida (PSDV) announced the Spanish Agency of Drugs and Medical Devices has granted marketing authorization to ILUVIEN for the treatment of vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to available therapies. Alimera reported "With our European management team now on board, we are looking forward to the initial commercial launch of ILUVIEN in Germany, expected during the first quarter of 2013. In addition, we continue to work closely with the Italian regulatory authorities to secure marketing authorization in Italy."
SPPI Announces Extension of FUSILEV® (levoleucovorin) for Injection Patent Until 2022
FUSILEV patent No. 6,500,829 extended from December 31, 2019 to March 7, 2022
Having penetrated around one-third of the folate analog market, Spectrum believes FUSILEV has more room to grow in the coming years
Spectrum is focused on reaching additional physicians – roughly, 50% – who have not yet been contacted by sales team
Spectrum augmented its senior sales and marketing leadership earlier this month following 1) strategic commercial team realignment and 2) expansion of FUSILEV manufacturing capacity, both initiatives having been implemented in November 2012
Symbol Price Change
SPPI 12.05
HENDERSON, Nev.--(BUSINESS WIRE)--
Spectrum Pharmaceuticals (SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that the United States Patent and Trademark Office (USPTO) has extended by more than two years U.S. Patent No. 6,500,829, which covers FUSILEV® (levoleucovorin) for injection. The extension was granted through the Hatch-Waxman Act and extends the original December 31, 2019 expiration date to March 7, 2022.
“The extension of the FUSILEV patent is an important development for Spectrum, adding more than two years of exclusive commercial rights for our top-selling oncology product,” stated Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. “We estimate that 50% of physicians treating colorectal cancer patients have not yet been contacted by a Spectrum sales representative. Through the expansion and realignment of our sales organization, we are able to contact more of these clinicians and expect to see further growth in the coming years.”
About FUSILEV® (levoleucovorin) for injection
FUSILEV, a novel folate analog, is approved as a ready-to-use solution (FUSILEV® Injection), and as freeze-dried powder (FUSILEV for Injection). FUSILEV is indicated for use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer. FUSILEV is also indicated for rescue after high-dose methotrexate therapy in osteosarcoma. FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. FUSILEV, under various trade names, is marketed outside the United States by Pfizer, Sanofi-Aventis, and Takeda.
Important FUSILEV® (levoleucovorin) Safety Considerations
FUSILEV is dosed at one-half the usual dose of racemic d,l-leucovorin. FUSILEV is contraindicated for patients who have had previous allergic reactions attributed to folic acid or folinic acid. Due to calcium content, no more than 16-mL (160-mg) of levoleucovorin solution should be injected intravenously per minute. FUSILEV enhances the toxicity of fluorouracil. Concomitant use of d,l-leucovorin with trimethoprim-sulfamethoxazole for pneumocystis carinii pneumonia in HIV patients was associated with increased rates of treatment failure in a placebo-controlled study. Allergic reactions were reported in patients receiving FUSILEV. Vomiting (38%), stomatitis (38%) and nausea (19%) were reported in patients receiving FUSILEV as rescue after high dose methotrexate therapy. The most common adverse reactions ( > 50%) in patients with advanced colorectal cancer receiving FUSILEV in combination with 5-fluorouracil were diarrhea, nausea and stomatitis. FUSILEV may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone, and increase the frequency of seizures in susceptible patients.
Full prescribing information can be found at www.FUSILEV.com.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in oncology and hematology. Spectrum and its affiliates market three oncology drugs - FUSILEV® (levoleucovorin) for Injection in the U.S.; FOLOTYN® (pralatrexate injection), also marketed in the U.S.; and ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use, for which the Company has worldwide marketing rights. Spectrum's strong track record in in-licensing and acquiring differentiated drugs, and expertise in clinical development have generated a robust, diversified, and growing pipeline of product candidates in advanced-stage Phase 2 and Phase 3 studies. More information on Spectrum is available at www.sppirx.com.
Forward-looking statement — This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements are based on management's current beliefs and expectations. These statements include, but are not limited to, statements that relate to our business and its future, including certain company milestones, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, leveraging the expertise of partners and employees around the world to assist us in the execution of our strategy, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates may not prove safe or effective, the possibility that our existing and new applications to the FDA and other regulatory agencies may not receive approval in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of sustained revenue history, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC.®, FUSILEV®, FOLOTYN®, and ZEVALIN® are registered trademarks of Spectrum Pharmaceuticals, Inc and its affiliates. REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
© 2013 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Contact:
Spectrum Pharmaceuticals, Inc.
Shiv Kapoor, 702-835-6300
Vice President, Strategic Planning & Investor Relations
InvestorRelations@sppirx.com
EBS Initiates Phase 2 Clinical Trial for Next Generation Anthrax Vaccine NuThrax
Symbol Price Change
EBS 16.57
ROCKVILLE, Md.--(BUSINESS WIRE)--
Emergent BioSolutions Inc. (EBS) today announced the initiation of a Phase 2 clinical trial for NuThraxTM (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant), also known as AV7909, with the dosing of the first subject. NuThrax, a next generation vaccine being developed as part of Emergent's anthrax franchise, consists of Anthrax Vaccine Adsorbed in combination with a novel immunostimulatory adjuvant, CPG 7909.
“Emergent is pleased to initiate this Phase 2 clinical trial of NuThrax, which supports the near-term goal and priority of the U.S. Department of Health and Human Services (HHS) to develop next generation anthrax vaccines with advanced characteristics such as requiring fewer doses and generating an enhanced immune response,” said Adam Havey, EVP and president of the biodefense division at Emergent BioSolutions. “We thank HHS for their continued trust and partnership as we work together to accomplish elements of its Public Health Emergency Medical Countermeasures Enterprise Implementation Plan set forth to strengthen the nation’s biodefense capabilities.”
The Phase 2 clinical trial, a randomized, parallel-group, active-controlled, double-blind study, is designed to evaluate the safety and immunogenicity of NuThrax for post-exposure prophylaxis of anthrax infection using two and three dose immunization schedules and two dose levels. The study is being conducted in multiple sites within the U.S. and plans to enroll 168 healthy adult volunteers. Preliminary data from this study are expected in the fourth quarter of 2013.
Emergent has submitted to the U.S. Food and Drug Administration the Clinical Study Report for the Phase 1 study, which evaluated the safety and immunogenicity of NuThrax for post-exposure prophylaxis of anthrax infection using a two dose immunization schedule and four formulations.
This Phase 2 clinical trial is being conducted with support from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) of HHS, under development contract number HHSN272201000035C. The Phase 1 trial was conducted with support from a development contract jointly administered under contract number HHSN272200800051C by NIAID and the Office of the Biomedical Advanced Research and Development Authority (BARDA), a component of the Office of the Assistant Secretary for Preparedness and Response (ASPR), HHS.
About Emergent BioSolutions
Emergent BioSolutions is a specialty pharmaceutical company seeking to protect and enhance life by offering specialized products to healthcare providers and governments to address medical needs and emerging health threats. Additional information may be found at www.emergentbiosolutions.com. Follow us on twitter: @emergentbiosolu.
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, prospects, plans and objectives of management, and any other statements containing the words “believes”, “expects”, “anticipates”, “intends”, “plans”, “estimates” and similar expressions, are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.
There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including the success of our ongoing and planned preclinical studies and clinical trials; the rate and degree of market acceptance and clinical utility of our products; the success of our ongoing and planned development programs; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.
Contact:
Emergent BioSolutions Inc.
Investor Contact
Robert G. Burrows
Vice President, Investor Relations
301-795-1877
BurrowsR@ebsi.com
or
Media Contact:
Tracey Schmitt
Vice President, Corporate Communications
301-795-1800
SchmittT@ebsi.com
DSCO Receives New US Patent for Pulmonary Surfactant Formulations
DSCO 2.28
WARRINGTON, Pa., Jan. 17, 2013 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (DSCO) today announced it has received a patent issued by the United States Patent and Trademark Office (USPTO) entitled "Pulmonary Surfactant Formulations." The claims of the patent (U.S. Patent Number 8,337,815) provide coverage for synthetic pulmonary surfactant compositions comprising a combination of a proprietary synthetic peptide and various lipids. The patent term expires in December 2028.
"The Company's strategy is to seek broad patent protection in the field of synthetic surfactants," said John G. Cooper, President and Chief Executive Officer at Discovery Labs. "This patent, together with our existing KL4 formulation patents covering SURFAXIN(R) and combinations of pulmonary surfactant with protease inhibitors, as well as our patents covering methods of use and manufacture, provides a strong foundation for our continued leadership in the development of synthetic surfactants."
This patent provides exclusivity for new formulations of KL4 surfactant and is separate and distinct from the patent portfolios covering SURFAXIN, the Company's lead KL4 surfactant product, and AEROSURF(R), the Company's lead KL4 surfactant development program.
Discovery Laboratories, Inc. is a specialty biotechnology company with one focus -- to advance a new standard in respiratory critical care. Discovery Labs' novel proprietary KL4 surfactant technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant and is being developed in liquid, lyophilized, and aerosolized dosage forms. Discovery Labs is also developing its proprietary drug delivery technologies to enable efficient delivery of aerosolized KL4 surfactant and other inhaled therapies. Discovery Labs believes that its proprietary technologies make it possible, for the first time, to develop a significant pipeline of products to address a variety of respiratory diseases for which there frequently are few or no approved therapies.
Discovery Labs' strategy is initially focused on the development of its technologies to improve the management of respiratory distress syndrome (RDS) in premature infants. Discovery Labs believes that its RDS product portfolio has the potential to become the new standard of care for RDS and, over time, to significantly expand the current worldwide RDS market.
For more information, please visit our website at www.Discoverylabs.com.
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Examples of such risks and uncertainties are described in Discovery Labs' filings with the Securities and Exchange Commission, including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto. Any forward-looking statement in this release speaks only as of the date on which it is made. Discovery Labs assumes no obligation to update or revise any forward-looking statements.
Contact:
Media Relations:
Michael Parks, Pitch360 - 484.356.7105
or Michael@pitch360inc.com
Investor Relations:
Michael Rice, LifeSci Advisors - 646.597.6979
John Tattory, Vice President of Finance,
Discovery Labs - 215.488.9418
HPTX Notified That FDA Will Not Meet the PDUFA Action Date for Ravicti(TM)
HPTX 12.00
SOUTH SAN FRANCISCO, Calif., Jan. 16, 2013 (GLOBE NEWSWIRE) -- Hyperion Therapeutics, Inc. (HPTX) said that the U.S. Food and Drug Administration (FDA) has advised the Company not to expect a final action by the Prescription Drug User Fee Act (PDUFA) action date of January 23, 2013. The agency explained it is continuing to work on label and post-marketing requirements in connection with Hyperion's New Drug Application (NDA) for Ravicti(TM) (glycerol phenylbutyrate) for the treatment of Urea Cycle Disorders (UCD).
About Ravicti(TM) (glycerol phenylbutyrate)
Ravicti, an investigational drug, is a pre-pro-drug of phenylacetic acid, the active moiety of BUPHENYL(R), the only branded therapy currently FDA-approved as adjunctive therapy for the chronic management of patients with the most prevalent urea cycle disorders. Ravicti holds orphan product designations in the US and Europe for the maintenance treatment of patients with urea cycle disorders and in the US for the intermittent or chronic treatment of patients with cirrhosis and any grade of hepatic encephalopathy.
About Hyperion Therapeutics
Hyperion Therapeutics is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat disorders in the areas of orphan diseases and hepatology. Hyperion Therapeutics is developing Ravicti(TM) (glycerol phenylbutyrate) for two orphan indications: urea cycle disorders and hepatic encephalopathy.
Forward-Looking Statement
To the extent that statements contained in this press release are not descriptions of historical facts regarding Hyperion, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements contained in this press release include statements regarding expectations about the timing of any FDA action as well as the content, nature and extent of any label or post-marketing requirements. Hyperion undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties relating to the business of the company in general, see Hyperion's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 7 and any subsequent filings with the Securities and Exchange Commission.
BUPHENYL(R) is a registered trademark of Ucyclyd Pharma, Inc.
Contact:
Shari Annes, Investor Relations
Cell: 650 888 0902
OXGN Regains Nasdaq Closing Bid Price Compliance
Symbol Price Change
OXGN 4.45
SOUTH SAN FRANCISCO, Calif., Jan. 16, 2013 (GLOBE NEWSWIRE) -- OXiGENE, Inc. (OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, today announced that on January 14, 2013, Nasdaq notified the Company that it regained compliance with the minimum $1.00 per share closing bid price requirement for continued listing. As a result of satisfying the minimum bid price requirement, this matter is now closed.
As previously announced, the Company received notice from Nasdaq on June 25, 2012 that the Company did not meet the minimum bid price rule required for continued listing on The Nasdaq Capital Market. On December 26, 2012, Nasdaq provided the Company until June 24, 2013 to achieve compliance with this requirement.
About OXiGENE
OXiGENE is a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer. The Company's major focus is developing vascular disrupting agents (VDAs) that selectively disrupt abnormal blood vessels associated with solid tumor progression. OXiGENE is dedicated to leveraging its intellectual property and therapeutic development expertise to bring life-extending and life-enhancing medicines to patients.
The OXiGENE, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=4969
Safe Harbor Statement
This news release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Any or all of the forward-looking statements in this press release, including those pertaining to OXiGENE's ongoing listing status with The Nasdaq Capital Market, may turn out to be wrong. Forward-looking statements can be affected by inaccurate assumptions OXiGENE might make or by known or unknown risks and uncertainties, including, but not limited to, the Company's inability to obtain additional financing or maintain its listing on the Nasdaq Capital Market. Additional information concerning factors that could cause actual results to materially differ from those in the forward-looking statements is contained in OXiGENE's reports to the Securities and Exchange Commission, including OXiGENE's reports on Form 10-K, 10-Q and 8-K. However, OXiGENE undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise. Please refer to our Annual Report on Form 10-K for the fiscal year ended December 31, 2011.
Contact:
Investor and Media Contact:
ir@oxigene.com
650-635-7000
CXM listing compliance plan accepted by NYSE MKT - Yahoo! Finance http://finance.yahoo.com/news/cardium-therapeutics-listing-compliance-plan-140109768.html via @YahooFinance
AMBS Announces Publication of Independent Peer-Reviewed Data for Receptor and Secretion Pathways related to MANF
Symbol Price Change
AMBS 0.10
SUNNYVALE, Calif., Jan. 16, 2013 /PRNewswire/ -- Amarantus BioScience, Inc. (AMBS), a biotechnology company discovering and developing treatments and diagnostics for diseases associated with protein misfolding and apoptosis centered around its patented therapeutic protein Mesencephalic Astrocyte-derived Neurotrophic Factor (MANF), today announced that an independent peer-reviewed research paper entitled Mesencephalic astrocyte-derived neurotrophic factor (MANF) secretion and cell surface binding are modulated by KDEL receptors was published in the Journal of Biological Chemistry. The research paper concludes "These findings provide insight into the mechanisms of MANF neuroprotection, and may be applicable to understanding its functions in other secretory tissues."
The endoplasmic reticulum (ER) is the part of the cell where unfolded proteins are properly folded and then exported into different parts of the cell, or secreted out of the cell, so that they can perform their normal biological functions. When the ER becomes stressed, protein folding is compromised, and cells can become dysfunctional. Apoptosis, also known as Programmed Cell Death, is one of the main side effects of protein misfolding due to ER stress, and several independent peer-reviewed research papers have demonstrated that MANF plays a critical role in reducing protein misfolding and apoptosis. MANF has been shown to be upregulated inside the cell, and subsequently secreted out of the cell, with data demonstrating that MANF ultimately reduces apoptosis in the cells in which it originates, the cells it interacts with once secreted out of the cell, as well as when manufactured MANF is administered to various parts of the body undergoing ER stress. Amarantus is seeking to administer manufactured MANF to areas in the body where ER-stress occurs due to injury or disease, giving the body additional quantities of MANF during times of stress in order to reduce apoptosis and improve cellular function. The Company believes that if cellular function can be improved, overall system recovery is likely in many therapeutic indications. ER-stress and protein misfolding appear to be a key component of Parkinson's disease biology. Amarantus' Chief Scientist originally discovered MANF, and the Company was awarded composition of matter patents on MANF in Europe in 2010 and in the United States in 2011. The Company also recently won a court challenge to its composition of matter patents in Europe. The Company also owns worldwide patent applications covering various methods of using MANF as it relates to neurological conditions.
In this research paper, the authors describe the process by which MANF's intracellular activity (autocrine) may be regulated through MANF binding to the canonical ER-specific retention receptors with the amino acid sequence 'KDEL', known as 'KDELRs' (KDEL Receptors). Researchers expressed, or blocked, a key amino acid sequence on the MANF molecule known as 'RTDL,' which is a highly-conserved amino acid sequence that was shown in this research paper to be required for retention of MANF in the ER, or for secretion of MANF out of the ER, with signal activation through the KDELRs. Further, the research paper goes on to suggest that certain KDELRs are resident on the cell surface membrane, and that MANF's extracellular activity (paracrine) is regulated, at least in part, via cell-surface KDELRs. Interestingly, the paper suggests that following ER stress, there is an increase in expression of KDELRs on the cell surface membrane, opening the possibility that MANF's paracrine activity may be more potent or broad in times of ER stress.
"This publication provides further insight into the biological profile of MANF and the proteins it interacts with in both an autocrine and paracrine fashion," said Gerald E. Commissiong, President & CEO of Amarantus. "As we learn more about its biological functions, we believe the Company is likely to find additional avenues to commercially exploit MANF's breakthrough biology, and bring new meaningful treatments to patients in a variety of indications, including orphan indications."
About Mesencephalic-Astrocyte-derived Neurotrophic Factor (MANF)
MANF (Mesencephalic-Astrocyte-derived Neurotrophic Factor) is a protein that corrects protein misfolding, one of the major causes of apoptosis (Programmed Cell Death). Mesencephalic-Astrocyte-derived Neurotrophic Factor (MANF) is believed to have broad potential because it is a naturally-occurring protein produced by the body for the purpose of reducing and preventing apoptosis (in response to injury or disease), via the unfolded protein response. By manufacturing MANF and administering it to the body, Amarantus is seeking to use a regenerative medicine approach to assist the body with higher quantities of MANF when needed. Amarantus is the front-runner and primary holder of intellectual property (IP) around MANF, and is initially focusing on the development of MANF-based protein therapeutics. MANF's current lead indication is Parkinson's disease with additional focus on Traumatic Brain Injury (TBI. Future indications may include myocardial infarction and certain rare and ultra-rare orphan diseases where MANF is currently being evaluated.
The Company also owns an inventory of 88 cell lines referred to as "PhenoGuard Cell Lines." MANF was the first therapeutic protein discovered from a PhenoGuard Cell Line, and it is anticipated that additional therapeutic proteins useful for various therapeutic approaches to the Central Nervous System will be identified from the Company's inventory of PhenoGuard Cell Lines.
About Amarantus BioScience, Inc.
Amarantus BioScience, Inc. is a development-stage biotechnology company founded in January 2008. The Company has a focus on developing certain biologics surrounding the intellectual property and proprietary technologies it owns to treat and/or diagnose Parkinson's disease, Traumatic Brain Injury and other human diseases. The Company owns the intellectual property rights to a therapeutic protein known as Mesencephalic-Astrocyte-derived Neurotrophic Factor ("MANF") and is developing MANF-based products as treatments for brain disorders. The Company also is a Founding Member of the Coalition for Concussion Treatment (#C4CT), a movement initiated in collaboration with Brewer Sports International seeking to raise awareness of new treatments in development for concussions and nervous-system disorders. For further information please visit www.Amarantus.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the possible benefits of MANF therapeutic applications and/or advantages presented by Amarantus' PhenoGuard technology, as well as statements about expectations, plans and prospects of the development of Amarantus' new product candidates. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including the risks that the anticipated benefits of the therapeutic drug candidates or discovery platforms, as well as the risks, uncertainties and assumptions relating to the development of Amarantus' new product candidates, including those identified under "Risk Factors" in Amarantus' most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q and in other filings Amarantus periodically makes with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements Amarantus does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this presentation.
MEDIA CONTACTS
Amarantus Bioscience, Inc.
(408) 737-2734
pr@amarantus.com
Investor/Media Contact:
IR Sense, LLC
Remy Bernarda
415-203-6386
remy@irsense.com
I am trying to stay active, Go back under the knife Monday. Complications have knocked me on my touch again...
hugz to all
Diva
BIO updates Tuesday January 15, 2013
Luminex Corporation (NASDAQ: LMNX) announced it has received FDA clearance for its xTAG Gastrointestinal Pathogen Panel (GPP), the first comprehensive molecular diagnostic assay that tests for greater than 90% of bacterial, viral, and parasitic causes of infectious gastroenteritis in a single assay. The xTAG GPP assay can be an important clinical tool in the management of gastrointestinal infections, and is now available in the United States.
Diarrheal disease strikes more than two billion times globally each year and is a leading cause of child morbidity and mortality worldwide(1). In the United States alone, 99 million cases of GI infection occur annually, leading to over 250,000 hospitalizations(2) and 17,000 deaths(3), inflicting a significant toll on the healthcare system. Diagnosis of some causes of infectious gastroenteritis has traditionally required multiple tests across the microbiology, virology, and molecular laboratories for which results may not be available for several days.
Eli Lilly and Company (NYSE: LLY) and Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Lilly, announced Amyvid (Florbetapir F 18 Injection) has received marketing authorization from the European Commission as a diagnostic radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of beta-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive impairment. Amyvid should be used in conjunction with a clinical evaluation.
Alzheimer's Disease is one of many possible causes of cognitive impairment, which can make diagnosis challenging. Alzheimer's Disease and other causes of cognitive impairment share many overlapping symptoms, including deficiencies in memory, visuospatial ability, executive function, behavior, and language. It is estimated that up to one in five patients clinically diagnosed with probable Alzheimer's Disease during life do not exhibit Alzheimer's Disease pathology upon autopsy.
"We believe that Amyvid fills an unmet need in the medical community, providing physicians with important information about the presence or absence of beta-amyloid plaques that can help identify the cause of their patients' cognitive symptoms," said Diane Bakaysa, Amyvid global brand development leader. "This is important because, if, based on negative Amyvid findings and clinical assessment, it is determined that Alzheimer's Disease is not the cause of cognitive impairment, a physician can avoid unnecessary or potentially harmful treatments associated with a misdiagnosis of Alzheimer's Disease."
Beginning in Q2 2013, Amyvid will be available in select areas within the European Union.
Advanced BioMedical Technologies Inc. (OTCQB:ABMT), developer and manufacturer of orthopaedic internal fixation devices, is delighted to announce that the Company's Quality Management System (QMS) has been credited with ISO 13485:2003 certification.
AxoGen, Inc. (OTCBB: AXGN) a leader in the science and commercialization of surgical solutions for peripheral nerve repair, today announced that it will be presenting at Noble Financial Capital Markets' Ninth Annual Equity Conference to be held at the Hard Rock Hotel in Hollywood, Florida.
CorMedix Inc. (NYSE MKT: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiorenal disease, announced today that it has signed a commercial agreement with MKM Co-Pharma GmbH (http://mkm-europe.com/en/), a European sales, marketing and advertising company with extensive experience in the launch of cardiorenal products.
Covidien (NYSE:COV), a leading global provider of healthcare products, today announced the completion of enrollment in its DEFINITIVE AR (Anti-Restenosis) study.
Forest Laboratories, Inc. (NYSE: FRX), an international pharmaceutical manufacturer and marketer, today reported a GAAP loss per share of $0.58 in the third quarter of fiscal 2013 compared with income of $1.04 in the third quarter of fiscal 2012.
Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced the appointment of Rex Horton as Executive Director of Regulatory Affairs and Quality Assurance.
GE Healthcare (NYSE:GE) today announced that it has filed a supplemental new drug application (sNDA) that will allow the company to manufacture Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), within its own facility.
Given Imaging (NASDAQ: GIVN) today announced that it is ending its previously announced exploration of a possible sale or merger transaction as part of its evaluation of strategic options in order to maximize growth and enhance shareholder value.
Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today announced it will exhibit its Magellan™ Robotic System at the 25th Annual International Symposium on Endovascular Therapy (ISET), from January 19-23 at the Fontainebleau Miami Beach Hotel in Miami, FL.
Illumina, Inc. (NASDAQ:ILMN) today announced that it will issue results for fourth quarter and fiscal year 2012 following the close of market on Monday, January 28, 2013.
Illumina, Inc. (NASDAQ: ILMN) today announced two new grant recipients of its Agricultural Greater Good Initiative at the 21st International Plant and Animal Genome Conference. The recipients, International Crops Research Institute for the Semi-Arid Tropics (ICRISAT) and Biosciences Eastern and Central Africa – International Livestock Research Institute Hub (BecA-ILRI Hub), are pioneering applications of Illumina technologies to increase crop yields and reduce poverty and hunger.
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) today provided an update on its fourth quarter 2012 and recent business activities.
Luminex Corporation (NASDAQ: LMNX) announced today that it has received FDA clearance for its xTAG Gastrointestinal Pathogen Panel (GPP), the first comprehensive molecular diagnostic assay that tests for greater than 90% of bacterial, viral, and parasitic causes of infectious gastroenteritis in a single assay.
NanoViricides, Inc. (OTC BB: NNVC) (the "Company") provides an update on its influenza program. The Company states that in a highly lethal animal model against an H3N2 Influenza virus strain, very similar to the current dominant influenza strain, the Company’s oral anti-influenza drug candidate has shown significantly superior efficacy to Tamiflu® (oseltamivir).
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced the completion of a study of its novel radiopharmaceutical NAV4694 as a biomarker for visual detection and quantification of cerebral ß-amyloid in diagnosing Alzheimer’s disease (AD).
Neptune Technologies & Bioresources (NASDAQ: NEPT) announced they will hold a conference call on Thursday, January 17th at 4:30 EST.
Nu Skin Enterprises, Inc. (NYSE: NUS) today announced that Chief Financial Officer, Ritch Wood, will present at the ICR XChange Conference in Miami on Thursday, Jan. 17, 2013.
Omnicell, Inc. (NASDAQ: OMCL), a leading provider of medication and supply management solutions and analytics software for healthcare facilities, today announced that Springhill Medical Center selected Omnicell as its exclusive provider for medication management solutions throughout its 252-bed hospital in Mobile, AL.
Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) today announced an underwritten public offering of 4,400,000 shares of its common stock.
Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company developing Tcelna™, a novel T-cell therapy for multiple sclerosis (MS), today announced that it has received a letter from The NASDAQ Stock Market LLC notifying the Company that it has regained full compliance with the NASDAQ Capital Market's minimum bid price continued listing requirement.
PuraMed BioScience®, Inc, (OTCBB: PMBS) announces that its over-the-counter, homeopathic migraine pain reliever formulation, LipiGesic®M, has received a Notice of Allowance for its patent application from the United States Patent and Trademark Office.
Quture International, Inc. (OTCQB: QUTR) announced today that they will conduct a shareholder conference call on Wednesday, January 23, 2013, at 4:15 p.m. Eastern Standard Time to provide a management update and strategic marketing and sales plan for 2013.
ReliaBrand Inc. (OTCBB:RLIA) announced today the introduction of the "NxGen® Medi-Nurser™", the newest innovation from their Adiri® brand of infant feeding products.
Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of simulation and modeling software for pharmaceutical discovery and development, today reported financial results for its first quarter of fiscal year 2013 ended November 30, 2012 (1QFY13).
Stellar Biotechnologies, Inc. (OTCQB: SBOTF) (TSX VENTURE: KLH), the world leader in sustainable manufacture of GMP-grade Keyhole Limpet Hemocyanin (KLH), is very pleased to announce that it was listed for trading in U.S. yesterday on the OTCQB Market under the symbol SBOTF.
WPCS International Incorporated (NASDAQ: WPCS), a leader in design-build engineering services for communications infrastructure, has announced that it has received approximately $4 million in new projects.
it choked me up when i first saw it linked here:) ty
I use it tons now, maybe im not needed lol
BIO updates Friday January 11, 2013
In a published report, Aegis Capital Corp. reiterated its Buy rating on China Biologic Products (NASDAQ: CBPO), and raised its price target to $22.00 price target. Aegis Capital noted, “Recently, China's National Development and Reform Commission (NDRC) announced a new round of maximum retail price adjustment for drugs in the categories of respiratory, antipyretic, analgesic and specialty medications, with average price reduction of 15%, effective on Feb 1st, 2013. Interestingly, price ceilings for plasma-based products were raised. Notably, prices for various doses of human albumin would see an increase of approximately 5%. We note that the price ceiling of 10g/50ml human albumin, which is used as a representative by NDRC, was set at ¥330 in 2000 and reduced to ¥259 in 2006. However, it was raised to ¥360 in 2007 to balance the short supply and strong demand, with imported human albumin being allowed to charge 5% more. The current price of ¥378 essentially lets domestic manufacturers charge the same price as their foreign counterparts in China. Human albumin represents 54.5% and 45.3% of China Biologic's 2011 and 9-month 2012 total revenue, respectively.”
China Biologic Products closed on Thursday at $18.90.
Transcept Pharmaceuticals (NASDAQ:TSPT) gets a big boost from U.S. regulators after the FDA declined to lower the recommended dose of it's Intermezzo prescription sleep aid because the drug's label already recommends a lower dosage for women than men because of their smaller average size. The agency said it believes the bedtime dose of Ambien, Edluar and Zolpimist should be reduced from 10 milligrams to 5 milligrams because the drugs can impair alertness and driving ability in some people the next morning.
Daiichi Sankyo Company, Limited (TSE 4568) and ArQule, Inc. (Nasdaq: ARQL) today announced the top-line results of a randomized Phase 2 signal generation trial of tivantinib (ARQ 197) used in combination with irinotecan and cetuximab in patients with refractory or relapsed colorectal cancer (CRC). Although the trial did not meet its primary endpoint of Progression-Free Survival (PFS), the analysis of the patients enrolled (n=122) showed that median PFS was 8.3 months in the experimental arm (patients treated with irinotecan and cetuximab plus tivantinib), compared with 7.3 months in the control arm (patients treated with irinotecan and cetuximab plus placebo) (hazard ratio = 0.85, 95% CI: 0.55, 1.33).
Endeavor Power Corporation (“Endeavor Power” or the “Company”) (OTCQB: EDVP) is announcing that it has changed the name of its wholly owned operating subsidiary Parallax Diagnostics, Inc. and moved its corporate headquarters.
Generex Biotechnology Corporation (OTCBB: GNBT) today announced that Company management has scheduled an investor conference call for Thursday, January 31, 2013.
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the company is taking steps to suspend the availability of TREDAPTIVE™ (extended-release niacin/laropiprant) tablets worldwide. TREDAPTIVE is not approved for use in the United States.
Rapid Fire Marketing (PINKSHEETS: RFMK), a leading maker of vaporizers as well as the only publicly-traded company for vaporizers, announced today that the affiliate program for the sales of Rapid Fire Marketing's Vapor Inhalers is now open at TheCANNAcig.com.
SurgiCount Medical, Inc. (the wholly-owned operating subsidiary of Patient Safety Technologies, Inc. (OTCBB: PSTX, OTCQB: PSTX) today announced that it is joining a list of Committed Partners in sponsoring the inaugural Patient Safety, Science & Technology Summit.
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced the promotion of Joseph Turgeon to Senior Vice President and Chief Commercial Officer (CCO).
BIO updates Thursday January 10, 2013
BioTime, Inc. (NYSE: BTX), a biotechnology company which develops and markets products in the field of regenerative medicine, announced it has submitted a Clinical Investigation Protocol (CIP) to European regulatory authorities for approval to initiate studies for its Renevia" stem cell delivery platform. The Principal Investigator for the studies will be Ramon Llull, MD, and the planned trials will be conducted at the Stem Center, Palma de Mallorca, Spain (www.stem-center.com). The Stem Center is operated by the GID Group, Inc., of Louisville, Colorado. BioTime (BTIM-RETIRED) is currently completing the production of clinical materials according to current Good Manufacturing Practice regulations. The initiation of human clinical studies is expected in Q2 of this year upon approval of the CIP.
Renevia™, a member of the Companys HyStem® family of hydrogels, is a proprietary formulation that mimics the human extracellular matrix, a web of molecules surrounding cells that is essential to cellular function. Renevia" is designed to be a liquid injectable matrix capable of safely polymerizing in the body into a three-dimensional tissue-like scaffold in combination with transplanted cells. Anchoring the transplanted cells in such a biocompatible matrix generally increases the percentage of viable cell engraftment. HyStem® hydrogels are currently being used by researchers at a number of leading medical schools in laboratory studies to investigate a broad array of stem cell therapies, including wound healing, treatment of ischemic stroke, brain cancer, vocal fold scarring, and cardiac infarct.
This is an important step forward in our commercialization efforts and brings us closer to delivering this much-needed matrix technology for the emerging field of regenerative medicine, stated William P. Tew, PhD, Chief Commercialization Officer of BioTime, Inc. The technology forms a foundation for the delivery of cell-based therapeutic products in both the adult and embryonic stem cell marketplace. Current preclinical studies at leading medical institutions have shown that HyStem® hydrogels are compatible with a wide variety of tissue types including brain, bone, skin, nerve, cartilage, and heart.
In the clinical application described in this CIP, Renevia" will be used as a delivery matrix for autologous adipose cells in order to restore subcutaneous tissue lost as a result of injury, oncologic resection, or congenital defects. Restoration of the normal skin contour is an important quality-of-life issue, not only in elective cosmetic procedures, but also in reconstructive surgeries needed to repair deformities and traumatic injuries to the face and upper extremities. BioTimes plan is to bring Renevia" to the medical market first in the European Union, where the regulatory pathway will allow for faster approval. Once the use of Renevia" is established in Europe, BioTime plans to address an even larger potential market in the United States.
Eli Lilly and Co. (NYSE:LLY) has settled a lawsuit brought by four sisters who contended their breast cancer was caused by a drug their mother took during pregnancy in the 1950s, a move some believe could trigger financial settlements in scores of other claims brought by women around the country.
A total of 51 women, including the Melnick sisters, filed lawsuits in Boston against more than a dozen companies that made or marketed a synthetic estrogen known as DES.
The Melnick sisters' case was the first to go to trial. The settlement was announced Wednesday on the second day of testimony.
DES, or diethylstilbestrol, was prescribed to millions of pregnant women over three decades to prevent miscarriages, premature births and other problems. It was taken off the market in the early 1970s after it was linked to a rare vaginal cancer in women whose mothers used it. Studies later showed the drug didn't prevent miscarriages.
Attorney Aaron Levine, representing the Melnick sisters, told the jury during opening statements that Eli Lilly failed to test the drug's effect on fetuses before promoting it as a way to prevent miscarriages.
Lawyer James Dillon, for Indianapolis-based Eli Lilly, told the jury that there was no evidence the drug causes breast cancer in the daughters of women who took it.
Dillon also said that no medical records show that the mother of the Melnick sisters took DES or that, if she did take it, it was made by Eli Lilly. Leading researchers at the time recommended that DES be used for pregnant women who had consecutive miscarriages, he said.
DES was not patented and was made by many companies.
Boston attorney Andrew Meyer, who's handled numerous medical malpractice cases, said the settlement in this case could signal settlements in other cases.
"When one settles a case, they recognize they can lose it," he said. "The reason they can lose it is because there's enough evidence for the plaintiffs to be able to win it. So it's not just optics, it isn't."
Columbus, Ohio, resident Irene Sawyer also is suing Eli Lilly, alleging that her prenatal exposure to DES caused her breast cancer. She called the settlement "a huge victory" for DES daughters.
"The bottom line is that this company put out a drug without testing, without knowing the consequences of this drug," she said.
It's wonderful, she said, that drug companies "are starting to realize this is not right, that there are consequences."
The Melnick sisters, who grew up in Tresckow, Pa., said they all developed breast cancer in their 40s.
Levine told the jury that their mother did not take DES while pregnant with a fifth sister and that sister has not developed breast cancer.
The four Melnick sisters also had miscarriages, fertility problems or other reproductive tract problems long suspected of being caused by prenatal exposure to DES. They were diagnosed with breast cancer between 1997 and 2003 and had treatments ranging from lump-removal surgery to a full mastectomy, radiation and chemotherapy.
Thousands of lawsuits have been filed alleging links between DES and vaginal cancer, cervical cancer and fertility problems. Many of those cases were settled.
Amarantus BioScience, Inc. (OTCQB: AMBS), a biotechnology company discovering and developing treatments and diagnostics for diseases associated with protein misfolding and apoptosis centered around its patented therapeutic protein Mesencephalic Astrocyte-derived Neurotrophic Factor (MANF), today announced that a corporate presentation made by President & CEO Gerald E. Commissiong on Wednesday January 9, 2013 at Biotech Showcase 2013 is now available online at http://www.media-server.com/m/p/g4dhucqq.
American Diversified Holdings Corporation (PINKSHEETS: ADHC) has refocused its corporate direction and is in the processing of creating a secure mobile application platform in the mHealth arena specifically designed for the Apple® iPhone™ , iPod touch™, iPad™ and other mobile platforms including the Android™ platform developed by Google®.
BioClinica®, Inc. (NASDAQ: BIOC), a global provider of clinical trial management solutions, today announced that members of its team will attend, participate in and lead discussions at several upcoming industry conferences in January, February, and March.
Bio-Rad Laboratories, Inc. (NYSE: BIO) and (NYSE: BIO.B), a multinational manufacturer and distributor of life science research and clinical diagnostic products, today announced that it has purchased AbD Serotec, a division of MorphoSys AG, for approximately 53 million euros in cash.
BioTime, Inc. (NYSE MKT: BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, today announced it has submitted a Clinical Investigation Protocol (CIP) to European regulatory authorities for approval to initiate studies for its Renevia™ stem cell delivery platform.
BrainStorm Cell Therapeutics (OTC.QB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced that it has successfully completed a 12-week repeat dose toxicity study with its NurOwn cells in mice.
CONMED Corporation (NASDAQ: CNMD), a medical technology company specializing in medical devices for surgical markets, announced today that the Company will participate in the 15th Annual Needham Growth Conference, on Thursday, January 17, 2013 at 1:30 PM Eastern time.
GeoVax Labs, Inc.(OTCQB: GOVX), an Atlanta-based biopharmaceutical firm developing vaccines to prevent and treat HIV/AIDS, announced it has completed enrollment in a nine-patient Phase 1/2 clinical trial testing the safety, immunogenicity and ability of its DNA/MVA vaccine to elicit protective immune responses in HIV-infected individuals.
Ingen Technologies, Inc. (PINKSHEETS: IGNT), an emerging medical device manufacturer with patented proprietary medical technology for the growing $55 Billion US home healthcare industry, is pleased to announce that its Quebec-Canada export distributor, MMT Inc., has given Ingen verbal commitments of approximately $3 Million in product purchases.
InSite Vision Incorporated (OTCBB: INSV) today announced that the last patient has completed dosing and evaluation in the Phase 3 clinical trial of BromSite™ (ISV-303) for the reduction of pain and inflammation after cataract surgery.
Noninvasive and continuous total hemoglobin (SpHb) monitoring technology from Masimo (NASDAQ: MASI) helps clinicians reduce intra-operative red blood cell (RBC) transfusions during high blood-loss surgery, speeds time to transfusion when indicated, and saves significant costs, according to a new study unveiled at the Society for Technology in Anesthesia (STA) annual meeting.
PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, today announced that its Chairman and CEO, Josef von Rickenbach, has been named 2013 chairman of the Association of Clinical Research Organizations (ACRO).
PharmAthene, Inc. (NYSE MKT: PIP) announced that the Delaware Supreme Court heard oral arguments today related to both parties' appeal in the Company's on-going litigation against SIGA Technologies.
Proteonomix, Inc. (the "Company") (OTC Pink: PROT), a biotechnology company (the "Company") focused on developing therapeutics based upon the use of human cells and their derivatives, announced today that upon its name change to StromaCel, Inc., presently scheduled for January 18, 2013, all shareholders will be required to submit their stock certificates to our transfer agent, VStock Transfer, in order to obtain their new share certificates in the Company.
Proteo, Inc. (OTCQB: PTEO) and its wholly-owned subsidiary Proteo Biotech AG announced today: The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Elafin for the treatment of pulmonary arterial hypertension.
BIO updates Wednesday January 9, 2013
Teva Pharmaceutical Industries Ltd, (NYSE:TEVA) which makes the market-leading multiple sclerosis drug Copaxone, has filed a petition with the U.S. FDA that could, if granted, delay entry to the market of a rival drug developed by Biogen Idec Inc (NASDAQ:BIIB).
Teva's petition asks that the FDA not approve any new multiple sclerosis drug until its safety has been evaluated by a panel of outside advisors, and said it had uncovered "troubling information" on a publicly accessible website about the safety of Biogen's drug, BG-12.
Israel-based Teva said the information showed that kidney changes were observed after repeated administration of BG-12 in mice, rats, dogs and monkeys. The company suggested that as a result, "there is a substantial probability the risk is applicable to humans as well."
Biogen spokeswoman Kate Niazi-Sai, echoing comments made by company chief executive, George Scangos, at the J.P. Morgan Healthcare Conference earlier this week, said the company is "confident" in BG-12's safety data.
Niazi-Sai said the incidence of kidney problems was similar between patients taking BG-12 and those taking a placebo, she said. A late-stage clinical trial showed that 21 percent of patients taking the placebo experienced kidney problems, compared with 22 percent of patients taking BG-12 twice a day and 25 percent of patients taking BG-12 three times a day.
Teva asked the FDA not to approve any new MS drug unless or until it has convened a panel of outside advisors and listened to the panel's recommendations. And it said its motives were to protect patients.
"Teva filed the petition, on behalf of the more than 300,000 patients with relapsing remitting multiple sclerosis in the U.S.," Denise Bradley, a spokeswoman for Teva, said in an emailed statement. She said the company wants to "ensure that appropriate safeguards are implemented to maintain an acceptable risk-benefit profile."
So far the agency has not scheduled such a meeting for BG-12, though it could do so at any time. An advisory committee meeting would delay BG-12's entry to the market.
The FDA is scheduled to rule on whether to approve BG-12 by the end of March, three months later than the original decision date. Biogen has said the agency did not require additional information, just more time to review application.
Brian Abrahams, an analyst at Wells Fargo Securities, said he doubts Teva's petition will cause the FDA to delay BG-12's approval, "though one cannot rule out the possibility of a minor process-related delay as FDA necessarily evaluates/responds" to the petition.
Bayer HealthCare Pharmaceuticals Inc. (NYSE:MOH) announced the U.S. FDA approved Skyla™ (levonorgestrel-releasing intrauterine system) 13.5 mg, a new hormone-releasing system that is placed in the uterus for the prevention of pregnancy for up to three years.[1]
"Research shows that nearly 50 percent of pregnancies in the U.S. are unintended,2 which emphasizes the need for increased education and access to effective birth control options," said Anita L. Nelson , M.D., Professor of Obstetrics and Gynecology at Harbor-UCLA Medical Center, Torrance, CA. "Skyla is more than 99 percent effective at preventing pregnancy and may be appropriate for women who want a birth control method that they do not have to take daily. Further, Skyla may be used by women whether or not they have ever had a child, representing an important new choice for women who don't want to become pregnant for up to three years."
Skyla is a small, flexible plastic T-shaped device containing 13.5 mg of a progestin hormone called levonorgestrel. The size of the Skyla T-body is 28mm x 30mm and the outer diameter of the placement tube is 3.8mm. Because Skyla slowly releases levonorgestrel into the uterus, only small amounts of the hormone enter the blood. During the first three to six months of using Skyla, women may experience irregular periods and an increase in the number of bleeding days. Women may also have frequent spotting or light bleeding. Some women may have heavy bleeding during this time. After using Skyla for a while, the number of bleeding and spotting days is likely to lessen, and there is a small chance that periods may stop altogether.1,3
Women can have Skyla placed by a healthcare provider during an in-office visit. Skyla is intended for long-term use for up to three years but may be removed by a healthcare provider at any time. Women could become pregnant as soon as Skyla is removed, so they should use another method of birth control if they do not want to become pregnant. About 77% of women who want to become pregnant will become pregnant sometime in the first year after Skyla is removed.3
"The approval of Skyla expands Bayer's IUD portfolio and highlights our continued commitment to empower women with a variety of birth control options at different reproductive stages of their lives," said Pamela A. Cyrus , M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. "We are pleased to bring the first new IUD to market in the U.S. in 12 years, and to provide women who are seeking contraception with an important new and effective option to consider with their healthcare providers."
Skyla (levonorgestrel-releasing intrauterine system) 13.5 mg will be available by prescription the week of February 11.
BrainStorm Cell Therapeutics (OTCQB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that it has achieved a new breakthrough for commercialization of its stem cell therapy candidate, NurOwn.
CONMED Corporation (NASDAQ: CNMD) announced today that it expects to report fourth quarter 2012 financial results before the market opens on Thursday, February 14, 2013, and will also hold a conference call live over the Internet at 10:00 a.m. Eastern Time that same day.
CytoSorbents Corporation (OTCBB: CTSO), a critical care focused company using blood purification to treat life-threatening illnesses, issued the following letter to shareholders.
Endeavor Power Corporation (OTCQB: EDVP) provides an outline of its new target market in the Point-of-Care In Vitro diagnostics market.
Foster Wheeler AG (Nasdaq: FWLT) announced today that it has acquired Yonkers Industries, Inc., a 30-year-old US-based firm that specializes in the management of construction and commissioning of pharmaceutical and biotech facilities, with capabilities to also manage the full EPCm (Engineering, Procurement and Construction Management) of such facilities.
Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) and its development partner VGX International, Inc. (KSE: 011000) will move Inovio's hepatitis C (HCV) DNA vaccine into a phase I/IIa clinical trial by the end of 2013.
Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH) today announced the recent accreditation of its Biorepository by the College of American Pathologists (CAP). CAP’s inaugural accreditation program was developed to establish internationally-recognized best practices and quality standards for the collection, storage and future analysis of biospecimens.
MediSwipe Inc. (www.MediSwipe.com) (OTCQB: MWIP), a patient security solutions and financial products company for the health care industry, announced today that the Company has launched "GetRx" Mobile in cooperation with 800 Commerce Inc.
MMRGlobal, Inc. (OTCQB: MMRF) ("MMR") today announced that it has received two additional patents adding 57 additional claims to the Company's patent portfolio to expand the scope of the Company's patent protection to include insurance, legal, accounting, mortgage and other types of important documents when combined with a Personal Health Record (PHR).
NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today preliminary unaudited revenue results for the full year ended December 31, 2012.
Orthofix International N.V., (NASDAQ:OFIX) (the Company) announced today the launch of the CONSTRUX® Mini PEEK Titanium Composite™ (PTC) Spacer System through its spine distribution network.
PerkinElmer, Inc. (NYSE: PKI) and Verinata Health, Inc., today announced a strategic agreement for expanding access to Verinata’s verifi® test, the most comprehensive non-invasive prenatal test (NIPT) currently available for high-risk pregnancies.
Rand Capital Corporation ("Rand") (NASDAQ: RAND), a business development company (BDC) founded in 1969, and its subsidiary, Rand Capital SBIC, Inc. announced that in 2012 its portfolio investment activity exceeded $6 million and represented the largest single investment period in the 40+ years of the fund.
Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, today announced that data from a study assessing the differences between cancer of unknown primary (CUP) and metastatic solid tumors of known primary metastases (KPM) by profiling microRNA expression were recently published in Clinical Experimental Metastasis, in an article entitled "Global microRNA profiling in favorable prognosis subgroups of cancer of unknown primary (CUP) demonstrates no significant expression differences with metastases of matched known primary tumors."
SmartMetric, Inc. (OTCQB: SMME) Speaking today, the President and CEO of SmartMetric, Inc., Ms. Chaya C. Hendrick, said, "SmartMetric, Inc. to start selling soon direct to the public in the United States, its Electronic Medical Records device."
VolitionRx Limited (OTC: VNRX), a life sciences company focused on developing blood-based diagnostic tests, announces that it will commence a large internal clinical study for its Nucleosomics® diagnostic products this month.
Im home, kinda back...will post when I feel better, hugz all
TGTX Initiates First-In-Human, Phase I Clinical Trial for Its Novel, Highly Specific PI3K-Delta Inhibitor, TGR-1202, in Patients With Hematologic Malignancies
Symbol Price Change
TGTX 4.80
NEW YORK, Jan. 8, 2013 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (TGTX) today announced that it has initiated a Phase I, open label, multi-center, first-in-human clinical trial of its novel PI3K delta inhibitor, TGR-1202, in patients with hematologic malignancies.
The study, entitled "A Phase I Dose Escalation Study Evaluating the Safety and Efficacy of TGR-1202 in Patients with Relapsed or Refractory Hematologic Malignancies," is being run in collaboration with the Sarah Cannon Research Institute in Nashville, TN, and will enroll approximately 30 patients during the initial dose escalation phase, followed by up to an additional 30 patients in an expansion phase once the optimal dose has been determined. Enrollment is open to patients with relapsed or refractory Non-Hodgkin's Lymphoma ("NHL"), Chronic Lymphocytic Leukemia ("CLL"), and Peripheral T-Cell Lymphoma ("PTCL"). Michael R. Savona, MD, Director of Leukemic Research, Sarah Cannon Research Institute, will act as Study Chair for the Phase I study.
"Having received FDA clearance of our IND only last week, the launch of this first-in-human Phase I study of TGR-1202 demonstrates our team's commitment to rapidly initiating and executing our clinical programs," stated Michael S. Weiss, Executive Chairman and Interim CEO of TG Therapeutics. "Inhibition of PI3K delta has demonstrated remarkable potential as a therapeutic strategy for the treatment of patients with hematologic malignancies and we are excited to begin working with Dr. Savona and the research team at Sarah Cannon and other centers across the United States to begin assessing the clinical potential of TGR-1202."
The commencement of this Phase I study of TGR-1202 marks the third clinical trial for TG Therapeutics, following the initiation of two Phase I/II clinical trials last year for TG-1101 (ublituximab), the Company's novel anti-CD20 monoclonal antibody, also under development for hematologic malignancies.
ABOUT TGR-1202
TGR-1202 is a highly specific, orally available, PI3K delta inhibitor, targeting the delta isoform with nanomolar potency and several fold selectivity over the alpha, beta, and gamma isoforms of PI3K. Inhibition of PI3K delta signaling with TGR-1202 has demonstrated activity in numerous pre-clinical models and primary cells from patients with hematologic malignancies. TG Therapeutics, Inc. and Rhizen Pharmaceuticals, SA are jointly developing TGR-1202 on a worldwide basis, excluding India.
ABOUT TG THERAPEUTICS, INC.
TG Therapeutics is an innovative, clinical-stage biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of cancer and other underserved therapeutic needs. Currently, the company is developing two advanced therapies targeting hematological malignancies. TG-1101 (ublituximab) is a novel, third generation monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, a highly specific, orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B-lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies. TG Therapeutics is headquartered in New York City.
The TG Therapeutics logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=11857
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for TG-1101 and TGR-1202 and may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete pre-clinical and clinical trials for TG-1101 and TGR-1202; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data analyses from prior pre-clinical and clinical trials; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
TGTX - G
Contact:
Jenna Bosco
Director - Investor Relations
TG Therapeutics, Inc.
Telephone: 212.554.4484
Email: ir@tgtxinc.com
IMMU Announces U.S. Patent for Hexavalent DOCK-AND-LOCK(TM) Complexes
Symbol Price Change
IMMU 3.04
MORRIS PLAINS, N.J., Jan. 8, 2013 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (IMMU), a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, announced that IBC Pharmaceuticals, Inc. (IBC), a majority-owned subsidiary, has received notice that its patent application for "Multiple signaling pathways induced by hexavalent, monospecific and bispecific antibodies for enhanced toxicity to B-cell lymphomas and other diseases," will issue as U.S. patent no. 8,349,332 today.
This patent, which provides coverage until 2026, concerns methods of use of hexavalent DOCK-AND-LOCK(TM) (DNL(TM)) constructs, comprising antibodies and/or antigen-binding antibody fragments tethered together using the Company's patented platform technology. The allowed claims cover bispecific antibodies that bind to CD20 and CD22 antigens on B cells. The DNL(TM) complexes are of use for the treatment of B-cell malignancies or B-cell-related autoimmune diseases.
At the 2012 Annual Meeting of the American Society of Hematology, the Company reported potent anti-tumor activity of a new class of hexavalent bispecific antibodies targeting CD20 and CD22 in an animal model of human non-Hodgkin lymphoma. These DNL(TM) complexes extended the median survival time of animals in a statistically significant manner. (Please refer to the Company's press release at www.immunomedics.com/pdfs/news/2012/pr12122012.pdf for more information).
"We are pleased to receive this patent. These hexavalent bispecific antibodies are more effective in killing of B cells, even in the absence of cross-linking antibodies, by inducing multiple signaling pathways in the target cell," commented Cynthia L. Sullivan, President and Chief Executive Officer. "We believe that these next-generation bispecific antibodies may contain the therapeutic properties of both CD20 and CD22 antibodies in a single construct, thus avoiding administration and costs of two antibodies that appear to show complementary and enhanced activity when combined," Ms. Sullivan further remarked.
About Immunomedics
Immunomedics is a New Jersey-based biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases. We have developed a number of advanced proprietary technologies that allow us to create humanized antibodies that can be used either alone in unlabeled or "naked" form, or conjugated with radioactive isotopes, chemotherapeutics, cytokines or toxins, in each case to create highly targeted agents. Using these technologies, we have built a pipeline of therapeutic product candidates that utilize several different mechanisms of action. We also have a majority ownership in IBC Pharmaceuticals, Inc., which is developing a novel DOCK-AND-LOCK(TM) (DNL(TM)) method with us for making fusion proteins and multifunctional antibodies, and a new method of delivering imaging and therapeutic agents selectively to disease, especially different solid cancers (colorectal, lung, pancreas, etc.), by proprietary, antibody-based, pretargeting methods. We believe that our portfolio of intellectual property, which includes approximately 215 active patents in the United States and more than 400 foreign patents, protects our product candidates and technologies. For additional information on us, please visit our website at www.immunomedics.com. The information on our website does not, however, form a part of this press release.
This release, in addition to historical information, may contain forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements, including statements regarding clinical trials, out-licensing arrangements (including the timing and amount of contingent payments), forecasts of future operating results, potential collaborations, and capital raising activities, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. Factors that could cause such differences include, but are not limited to, risks associated with any cash payment that the Company might receive in connection with a sublicense involving a third party and UCB, which is not within the Company's control, new product development (including clinical trials outcome and regulatory requirements/actions), our dependence on our licensing partners for the further development of epratuzumab and veltuzumab for non-cancer indications, competitive risks to marketed products and availability of required financing and other sources of funds on acceptable terms, if at all, as well as the risks discussed in the Company's filings with the Securities and Exchange Commission. The Company is not under any obligation, and the Company expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact:
Dr. Chau Cheng
Senior Director, Investor Relations & Grant Management
(973) 605-8200, extension 123
ccheng@immunomedics.com
QMDT Quick-Med Announces First Commercial Sale of Advanced Dressings With NIMBUS(R) Technology
Viridis BioPharma Launches Microfoam(TM) Advanced Wound Care Dressings in India
Symbol Price Change
QMDT 0.035
GAINESVILLE, FL --(Marketwire - January 08, 2013) - Quick-Med Technologies, Inc. (QMDT), a life sciences company that is developing innovative technologies for the healthcare and consumer markets, announced today that Viridis BioPharma Pvt. Ltd. has begun selling and shipping Microfoam™ dressings to customers. Microfoam is the first advanced wound care dressing to utilize Quick-Med's proprietary non-leaching NIMBUS® technology. Viridis received approval by the Food and Drug Administration of India in September 2011 to manufacture and market Microfoam wound dressings incorporating NIMBUS antimicrobial technology.
NIMBUS represents a next generation in wound care. This unique technology offers surgeons, wound care clinicians, infection control experts and primary care doctors an important new weapon against the transmission of such virulent bacteria as Methicillin-resistant Staphylococcus aureus (MRSA). It is the first non-leaching antimicrobial available in a wound dressing.
"It's exciting that this unique technology is now available in an advanced wound dressing format, in an emerging market," said Bernd Liesenfeld, Quick-Med's president. "India's large population, increasing investments in health care and fast growing wound care market represents a significant opportunity for Viridis to provide patients and caregivers with great a product, and to drive sales with our unique, value-added NIMBUS antimicrobial feature."
The NIMBUS technology is designed to prevent bacteria developing resistance, and avoid releasing toxic material into the wound, so there is no impeding the wound healing process. It is a novel antimicrobial technology: non-leaching and effective even in high concentrations of body fluids. NIMBUS technology is easy for the caregiver to implement as part of prophylactic care for patients at risk for infections.
As part of its commercialization efforts, Viridis BioPharma has sponsored clinical trials to demonstrate the efficacy of Microfoam dressings. "India tops the diabetes sufferers list as per World Health Organization (WHO) figures and consequently chronic diabetic wounds and ulcers. Quick-Med's NIMBUS Technology applied through Microfoam dressing shows remarkable relief in burn and wound cases and particularly in diabetic chronic wounds, as well as in venous and pressure ulcers, in an Indian clinical trial," commented Dr. Dilip Mehta, CEO of Viridis BioPharma Pvt. Ltd.
About NIMBUS
Quick-Med's patented technology, NIMBUS, is a cutting-edge antimicrobial technology that has been custom designed for wound care and other medical applications. NIMBUS received De Novo FDA clearance in 2009 and has been commercialized in traditional wound care applications. It is the only non-leaching antimicrobial dressing which, by design, poses no risk of bacteria developing resistance. NIMBUS technology is protected by twelve U.S. patents and patents pending and 24 foreign counterparts. Additional applications under development include advanced wound dressings, medical adhesives, catheters, and contact lenses.
About Viridis BioPharma Pvt. Ltd.
Through strategic associations with international pharmaceutical and biopharma companies, Viridis BioPharma Pvt. Ltd. commercializes products with therapeutic efficacy and growth potential in the Indian subcontinent and delivers a range of clinically-proven products to enable people to live better and more active lives. Viridis currently manufactures and markets a number of medical devices for companies, manufactured under license for B. Braun, American BioTech Labs, and Bhabha Atomic Research Center (BARC). For more information, see: www.viridisbiopharma.com
About Quick-Med Technologies, Inc.
Quick-Med Technologies, Inc. is a life sciences company that is developing proprietary, broad-based technologies for infection prevention and control in the consumer and healthcare markets. In addition to NIMBUS, Quick-Med's Stay Fresh® technology provides highly durable antimicrobial protection for laundered apparel and other textile applications and its NimbuDerm™ technology is being developed as a long-lasting hand sanitizer. For more information, see: www.quickmedtech.com.
© 2013 Quick-Med Technologies, Inc. All rights reserved. NIMBUS® and Stay Fresh® are registered trademarks and NimbuDerm™ is a trademark of Quick-Med Technologies, Inc. Microfoam™ is a trademark of Viridis BioPharma Pvt. Ltd.
Forward-looking statements (statements which are not historical facts) in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained in this release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "expect," "plan," "believe," "anticipate," "intend," "could," "would," "estimate," and/or "continue" or the negative or other variations thereof or comparable terminology are intended to identify forward-looking statements involve risks and uncertainties, including those risks that are discussed in the Company's filings with the Securities and Exchange Commission ("SEC"), which may be accessed at the SEC's Edgar System at www.sec.gov.
Contact:
CONTACT:
Quick-Med Technologies
Bernd Liesenfeld
President
(888) 835.2211 Ext 103
bliesenfeld@quickmedtech.com
PACB 100K Pathogen Genome Project Selects PacBio SMRT(R) DNA Sequencing to Generate High-Quality, Finished Genomes
PacBio Long Sequence Reads Provide Ability to Close Genomes; SMRT Kinetic Information Enables Epigenetic Characterization
Symbol Price Change
PACB 1.80
MENLO PARK, Calif., Jan. 8, 2013 (GLOBE NEWSWIRE) -- Pacific Biosciences of California, Inc. (PACB) provider of the PacBio(R)RS High Resolution Genetic Analyzer, and the University of California, Davis (UC Davis) today announced a partnership for the 100K Pathogen Genome Project. As part of the project, Pacific Biosciences' Single Molecule, Real-Time (SMRT(R)) technology will be used to sequence the genomes from at least 1,000 foodborne pathogen samples to completion, and to elucidate their epigenomes. These bacteria represent major illness-causing pathogens, including Salmonella, Campylobacter, E. coli, Vibrio, and Listeria.
The 100K Genome Project was founded by the U.S. Food & Drug Administration, Agilent Technologies, and the laboratory of Dr. Bart Weimer at UC Davis to create a consortium of partners from around the world that will sequence 100,000 foodborne pathogens using next-generation sequencing. This initiative addresses a significant shortage of bacterial pathogen information for use in designing molecular diagnostics, creates a resource to expand our understanding of infection mechanisms, and constructs a public repository for new insights into bacterial evolution by using large-scale genomics.
Pacific Biosciences' SMRT sequencing technology generates sequence reads an order of magnitude longer than other leading DNA sequencing technologies, thereby facilitating efficient de novo microbial genome assemblies. Long reads are critical for resolving genetic complexity in the assembly and finishing of genomes. The use of SMRT sequencing for the automated finishing of microbial genomes has been demonstrated in multiple recent publications, including for the genetic analysis of the Haitian cholera and German E. coli outbreaks.
The kinetic information acquired during SMRT sequencing can be used to elucidate the epigenome of bacteria. Epigenetic DNA base modifications, such as methylation, play an important role in the phenotypic variation, adaptability and pathogenicity of many bacteria, but they have been difficult to study due to the lack of a sequencing method to detect them. As part of the 100K Genome Project, the epigenomes of the pathogenic strains subjected to SMRT sequencing will be characterized, adding an important dataset to public database repositories.
"SMRT sequencing has been shown to be a powerful technology for the comprehensive determination of microbial genomes and epigenomes," said Dr. Jonas Korlach, Chief Scientific Officer of Pacific Biosciences. "Through the combination of long reads, high consensus accuracy, and the lack of sequencing bias to GC content or sequence contexts, SMRT sequencing harbors the necessary requirements to construct finished genomes in an unbiased, hypothesis-free manner. The ability to detect methylation as part of the sequencing process is unique to SMRT sequencing, and will provide an invaluable resource to illuminate the epigenetic components controlling bacterial pathogenicity."
"We are very pleased to utilize SMRT sequencing as part of the 100K Genome Project," said Bart Weimer, Professor and Director of the 100K Genome Project, "SMRT technology will enable production of complete genomes that will contribute great value toward databases for biological insight, new biomarker discovery, and reference genomes for food pathogen detection. A project of this scale is needed since microbial genome variations, including structural variations, the acquisition and loss of mobile elements, and phages or plasmids, are very difficult or impossible to detect without a de novo sequencing and genome assembly approach, yet they have a significant impact on food safety."
The partnership will entail the sequencing of at least 1,000 samples by the 100K consortium member labs with access to the PacBio RS instrumentation, including pipeline constructions for high-throughput pathogen sequencing, de novo genome assemblies, epigenome determination, and data curation and deposition. Pacific Biosciences will provide technical guidance and training to support these activities, and interface closely with the involved laboratories to assist in the efficient construction of these pipelines.
For more information, please visit http://100kgenome.vetmed.ucdavis.edu/index.cfm and www.pacb.com.
About Pacific Biosciences
Pacific Biosciences of California, Inc. (PACB) offers the PacBio(R)RS High Resolution Genetic Analyzer to help scientists solve genetically complex problems. Based on its novel Single Molecule, Real-Time (SMRT(R)) technology, the company's products enable: targeted sequencing to more comprehensively characterize genetic variations; de novo genome assembly to more fully identify, annotate and decipher genomic structures; and DNA base modification identification to help characterize epigenetic regulation and DNA damage. By providing access to information that was previously inaccessible, Pacific Biosciences enables scientists to increase their understanding of biological systems.
About The 100K Genome Project
Established in March 2012 by UC Davis, Agilent Technologies and the U.S. Food and Drug Administration, the 100K Genome Project is a landmark consortium that addresses the persistent food safety concerns by engaging world-wide partners to create a publicly available genetic database of the most common foodborne disease-causing microbes. By sequencing 100,000 pathogen genomes, the project will bring a new paradigm to public health to empower precise and robust molecular testing in the food chain -- from the farm to the kitchen table. For more information, visit http://100kgenome.vetmed.ucdavis.edu.
About UC Davis
For more than 100 years, UC Davis has engaged in teaching, research and public service that matter to California and transform the world. Located close to the state capital, UC Davis has more than 33,000 students, more than 2,500 faculty and more than 21,000 staff, an annual research budget of nearly $750 million, a comprehensive health system and 13 specialized research centers. The university offers interdisciplinary graduate study and more than 100 undergraduate majors in four colleges -- Agricultural and Environmental Sciences, Biological Sciences, Engineering, and Letters and Science. It also houses six professional schools -- Education, Law, Management, Medicine, Veterinary Medicine and the Betty Irene Moore School of Nursing.
Contact:
For Pacific Biosciences:
Media:
Maurissa Messier
For Pacific Biosciences
760.539.7417
maurissa@bioscribe.com
Investors:
Trevin Rard
Pacific Biosciences
650.521.8450
ir@pacificbiosciences.com
For UC Davis:
Media:
Patricia Bailey
Science/Agriculture writer
UC Davis News Service
(530) 752-9843 office
(530) 219-9640 cell
pjbailey@ucdavis.edu
Scientific:
Dr. Bart Weimer
Professor, School of Veterinary Medicine
Director, 100K Genome Project
Director, BGI@UCDavis
(530) 754-0109
bcweimer@ucdavis.edu
GTXI Announces FDA’s Grant of Fast Track Designation to Enobosarm For the Prevention and Treatment of Muscle Wasting in patients with Non-Small Cell Lung Cancer
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GTXI 4.75
MEMPHIS, Tenn.--(BUSINESS WIRE)--
GTx, Inc. (GTXI) today announced that the U.S. Food and Drug Administration (FDA) has designated enobosarm (GTx-024) for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer as a Fast Track development program. Fast Track status is a process designed by FDA to facilitate the development and expedite the review of new drug candidates that are intended to treat serious diseases and have the potential to fill an unmet medical need. With a Fast Track designation, there is an increased possibility for a priority review of a new drug application (NDA) filed for the drug candidate and more opportunity for more frequent interactions with the FDA both prior to and following the filing of a NDA.
GTx is assessing the ability of enobosarm to prevent and treat muscle wasting in non-small cell lung cancer patients in two pivotal Phase III clinical trials, POWER 1 and POWER 2. In each of the placebo-controlled, double-blind clinical trials, approximately 300 patients with Stage III or IV non-small cell lung cancer have been randomized to oral daily doses of placebo or enobosarm 3 mg at the time they began first line standard platinum doublet chemotherapy. The studies are evaluating as co-primary endpoints at three months of treatment the responder rates of enobosarm versus placebo on maintaining or improving total lean body mass (muscle) assessed by dual x-ray absorptiometry and improving physical function measured by the Stair Climb Test. Durability of the drug effect is being evaluated as a secondary endpoint at five months of treatment.
“We are very pleased that FDA has recognized enobosarm as a drug candidate with the potential to address the serious and unmet medical need of preventing and treating muscle wasting in non-small cell lung cancer patients,” said Mitchell Steiner, MD, CEO of GTx. “With approximately 650 patients fully enrolled in our two definitive Phase III clinical studies of enobosarm, we expect to receive top line data from these studies this summer. Assuming the data supports our ability to do so, we will move quickly to meet with FDA to discuss the filing of a new drug application for enobosarm.”
About GTx
GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery, development, and commercialization of small molecules for the treatment of cancer, cancer supportive care, and other serious medical conditions.
Forward-Looking Information is Subject to Risk and Uncertainty
This press release contains forward-looking statements based upon GTx’s current expectations. Forward-looking statements involve risks and uncertainties, and include, but are not limited to, statements relating to GTx’s clinical trials for enobosarm (also known as Ostarine® or GTx-024). GTx’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risks (i) that GTx will not be able to commercialize its product candidates if clinical trials do not demonstrate safety and efficacy in humans; (ii) that GTx may not be able to obtain required regulatory approvals to commercialize its product candidates in a timely manner or at all; (iii) that clinical trials being conducted by GTx may not be completed on schedule, or at all, or may otherwise be suspended or terminated; or (iv) that GTx could utilize its available cash resources sooner than it currently expects and may be unable to raise capital when needed, which would force GTx to delay, reduce or eliminate its product candidate development programs or commercialization efforts. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release. GTx’s quarterly report on Form 10-Q filed with the Securities and Exchange Commission on November 8, 2012 contains under the heading, "Risk Factors", a more comprehensive description of these and other risks to which GTx is subject. GTx expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
Contact:
GTx, Inc.
Marc Hanover, President and Chief Operating Officer, 901-523-9700
BSTC Announces XIAFLEX® Progress in Two Pipeline Indications
- Auxilium Exercises Option to Expand XIAFLEX License to Include Additional Indication for Potential Treatment of Cellulite -
- FDA Accepts Supplemental Biologics License Application Filing for Treatment of Peyronie's Disease -
Symbol Price Change
BSTC 14.77
LYNBROOK, N.Y., Jan. 7, 2013 /PRNewswire/ -- BioSpecifics Technologies Corp. (BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX in the U.S. and XIAPEX® in Europe and Eurasia, today announced progress for XIAFLEX in two pipeline indications. BioSpecifics' strategic partner Auxilium Pharmaceuticals, Inc. (Auxilium) has exercised its exclusive option under the Second Amended and Restated Development and License Agreement ("The Agreement"), dated as of August 31, 2011, to expand the field of its license for injectable collagenase to include the potential treatment of adult patients with edematous fibrosclerotic panniculopathy, commonly known as cellulite. As a result, BioSpecifics will receive a license fee payment of $500,000 from Auxilium. In addition, on December 27, 2012, the U.S. Food and Drug Administration (FDA) accepted for filing Auxilium's supplemental Biologics License Application (sBLA) for XIAFLEX for the potential treatment of Peyronie's disease. As a result, BioSpecifics will also receive a modest milestone payment from Auxilium. The filing was granted standard review status and, under the Prescription Drug User Fee Act (PDUFA), the FDA is expected to take action on the application by September 6, 2013.
"We are very pleased to announce these two significant milestones for the XIAFLEX pipeline, which support the continued expansion of the very promising XIAFLEX franchise," commented Thomas L. Wegman, President of BioSpecifics. "We believe both of these indications represent significant opportunities for XIAFLEX and we look forward to updating you on the clinical and regulatory progress this year."
Auxilium's exclusive, worldwide license has now been expanded, subject to the terms of The Agreement, to include all research, development, use, commercialization, marketing, sales and distribution rights for injectable collagenase for the potential treatment of cellulite. Auxilium plans to initiate a Phase IIa trial for this indication in the second half of 2013. The initial clinical trial utilizing injectable collagenase for the treatment of cellulite was conducted by BioSpecifics and showed promising Phase I results in the reduction of the appearance of cellulite.
Auxilium's sBLA submission for XIAFLEX as a potential treatment for Peyronie's disease is based on data from the Company's IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) Phase III clinical program and other controlled and uncontrolled clinical studies, in which over 1,000 Peyronie's disease patients were enrolled and received over 7,400 injections of XIAFLEX. For more details on the IMPRESS clinical program and data from the two Phase III studies, please refer to Auxilium's press release issued on December 27, 2012.
About Cellulite
Cellulite, also known medically as edematous fibrosclerotic panniculopathy (EFP), describes a condition, in which lobules of subcutaneous adipose tissue extend into the dermal layer. Cellulite can involve the loss of elasticity or shrinking of collagen cords, called septae, that attach the skin to lower layers of muscle. When fat in cellulite prone areas swells and expands, the septae tether the skin, which causes surface dimpling characteristic of cellulite. These changes can visibly affect the shape of the epidermis and resemble an orange peel-like dimpling of the skin.1 XIAFLEX treatment is intended to target and lyse, or break, those collagen tethers with the goal of releasing the skin dimpling and potentially resulting in smoothing of the skin.
1. Avram, Cellulite: a review of its physiology and treatment, Journal of Cosmetic Laser Therapy 2004; 6: 181–185
About Peyronie's Disease
Peyronie's disease is characterized by the presence of inelastic collagen on the shaft of the penis, which can cause the penis to curve during erection, and may make sexual intercourse difficult or impossible in advanced cases. Significant psychological distress is common among sexually active patients with Peyronie's disease. Currently, there are no FDA-approved pharmaceutical therapies for this condition.
About BioSpecifics Technologies Corp.
BioSpecifics Technologies Corp. is a biopharmaceutical company that has developed injectable collagenase for twelve clinical indications. Injectable collagenase is currently marketed as XIAFLEX® in the U.S. for the treatment of adult Dupuytren's contracture patients with a palpable cord by Auxilium Pharmaceuticals, Inc. (Auxilium) and is approved for Dupuytren's contracture in the European Union, Switzerland and Canada. XIAFLEX is also in clinical development for the treatment of several additional promising indications: Auxilium recently submitted a supplemental Biologics License Application (sBLA) to the FDA for XIAFLEX for the potential treatment of Peyronie's disease based on positive results reported from its two Phase III clinical studies. Auxilium is also testing XIAFLEX for frozen shoulder syndrome (adhesive capsulitis) and cellulite in Phase IIa and Phase Ib clinical trials, respectively. BioSpecifics is currently managing the clinical development of XIAFLEX for the treatment of human lipoma and canine lipoma, which are both in Phase II clinical trials. Auxilium is currently partnered with Asahi Kasei Pharma Corporation for the development and commercialization of injectable collagenase for Dupuytren's contracture and Peyronie's disease in Japan and with Actelion Pharmaceuticals Ltd. for these same indications in Canada, Australia, Brazil and Mexico. Pfizer Inc. has marketing rights to XIAPEX® (the EU trade name for XIAFLEX) for Dupuytren's contracture in 46 countries in Eurasia through April 24, 2013. For more information, please visit www.biospecifics.com.
Forward Looking Statements
This release includes "forward-looking statements" within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are "forward-looking statements." The forward-looking statements include statements concerning, among other things, the receipt of payments from Auxilium; the opportunities for XIAFLEX as a treatment for Peyronie's disease and cellulite and the clinical and regulatory progress of such indications; and the timing for Auxilium initiating a Phase IIa clinical trial in cellulite. In some cases, these statements can be identified by forward-looking words such as "believe," "expect," "anticipate," "plan," "estimate," "likely," "may," "will," "could," "continue," "project," "predict," "goal," the negative or plural of these words, and other similar expressions. These forward-looking statements are predictions based on BioSpecifics' current expectations and its projections about future events. There are a number of important factors that could cause BioSpecifics' actual results to differ materially from those indicated by such forward-looking statements, including the ability of BioSpecifics' partner, Auxilium, and its partners, Asahi Kasei Pharma Corporation and Actelion Pharmaceuticals Canada Inc., to achieve their objectives for XIAFLEX in their applicable territories; the market for XIAFLEX in, and initiation and outcome of clinical trials for, additional indications including frozen shoulder, human lipoma and canine lipoma, all of which will determine the amount of milestone, royalty and sublicense income BioSpecifics may receive; the potential of XIAFLEX to be used in additional indications; the timing of results of any clinical trials; the timing of regulatory filings and action; the receipt of any applicable milestone payments from Auxilium; whether royalty payments BioSpecifics is entitled to receive will exceed set-offs; and other risk factors identified in BioSpecifics' Annual Report on Form 10-K for the year ended December 31, 2011, its Quarterly Reports on Form 10-Q for the first, second, and third quarters of 2012, and its Current Reports on Form 8-K filed with the Securities and Exchange Commission. All forward-looking statements included in this release are made as of the date hereof, and BioSpecifics assumes no obligation to update these forward-looking statements.
OPTR Reports Preliminary 2012 Gross Product Sales of $74.4 Million
4th Quarter 2012 Gross DIFICID® Sales of $21.3 Million, Up 74.7% Over 4th Quarter 2011 and 14.4% Above the 3rd Quarter of 2012
Optimer Launches DIFICID Co-Pay Assistance Program and Announces Price Increase
Symbol Price Change
OPTR 9.25
JERSEY CITY, N.J., Jan. 7, 2013 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (OPTR) today provided an update on 2012 sales for DIFICID (fidaxomicin) tablets, an antibacterial drug launched in July 2011 for the treatment of Clostridium difficile-associated diarrhea (CDAD) in adults 18 years of age or older in the United States. Preliminary 2012 gross product sales in the United States and Canada totaled $74.4 million. Preliminary gross product sales for the fourth quarter of 2012 were $21.3 million in the United States and Canada.
(Logo: http://photos.prnewswire.com/prnh/20090413/LA97352LOGO)
"We ended 2012 experiencing solid growth in fourth quarter DIFICID sales after introducing strategic initiatives to increase patient access to DIFICID and accelerate product adoption. Treatments shipped increased by over 14% from the third quarter," said Pedro Lichtinger, President and CEO of Optimer. "We believe the early response to our new strategy is very encouraging. Hospital contracting, among other efforts, appears to be having a positive impact. We are particularly encouraged by increased DIFICID use in hospitals that our sales force is targeting, and by the number of hospitals that are initiating a review of DIFICID's formulary position."
Preliminary 2012 DIFICID Commercial Results
Optimer estimates DIFICID gross sales in the United States and Canada for the three months ended December 31, 2012 were $21.3 million, an increase of over 14.4% versus the prior quarter. For the twelve months ended December 31, 2012, preliminary gross sales increased to $74.4 million from $24.4 million in 2011. Preliminary gross-to-net for the fourth quarter of 2012 is anticipated to be in the 21.0% to 21.5% range. Inventory levels at wholesalers remain within the range of 14 to 28 days of demand.
DIFICID Co-Pay Assistance Program
Optimer today announced that it is launching a Co-Pay Assistance Program for commercially insured patients.
Provides up to $200 toward a patient's out of pocket cost for one prescription of up to 20 tablets per calendar year. Restrictions and conditions apply, including:
Does not cover refills
Patients that have any part of their prescription paid by any state of federally funded programs, including but not limited to, Medicare, Medicaid, Medigap, Veterans Affairs, Department of Defense, TriCare, or where otherwise prohibited by law, are not eligible
DIFICID Price Increase
Optimer also announced today that it has increased the Wholesale Acquisition Cost of DIFICID effective January 3, 2013 by approximately 5.6%. However, for acute care inpatient hospitals the price increase will be offset through an additional discount, keeping the net price the same. "It is important to note that the announced 25% discount, as well as the additional offsetting discount, is exclusive to acute care inpatient hospitals and is not available to other classes of trade," Mr. Lichtinger continued.
Important Safety Information for DIFICID
DIFICID is contraindicated in patients with hypersensitivity to fidaxomicin or to any of the excipients in the formulation. DIFICID should not be used for systemic infections. Only use DIFICID for infection proven or strongly suspected to be caused by C. difficile. Prescribing DIFICID in the absence of a proven or strongly suspected C. difficile infection is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria. The most common adverse reactions are nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia (2%) and neutropenia (2%).
Please visit www.DIFICID.com or call 855-DIFICID (343-4243) for full prescribing information for DIFICID.
About Optimer Pharmaceuticals
Optimer Pharmaceuticals, Inc. is a global biopharmaceutical company focused on developing and commercializing innovative hospital specialty products that have a positive impact on society. Optimer developed DIFICID® (fidaxomicin) tablets, an FDA-approved macrolide antibacterial drug for the treatment of Clostridium difficile-associated diarrhea (CDAD) in adults 18 years of age and older and is commercializing DIFICID in the US and Canada. Optimer also received marketing authorization for fidaxomicin tablets in the European Union where its partner, Astellas Pharma Europe, is commercializing fidaxomicin under the trade name DIFICLIR™. The Company is exploring marketing authorization in other parts of the world where C. difficile has emerged as a serious health problem, including Asia. Additional information can be found at http://www.optimerpharma.com.
Forward-Looking Statements
Statements included in this press release that are not a description of historical facts are forward-looking statements, including without limitation statements related to the implementation and impact of Optimer's commercialization strategy, expansion and acceleration of DIFICID market penetration, DIFICID sales or market potential, the hospital formulary and patient access status of DIFICID. Words such as "believes," "would," "anticipates," "plans," "expects," "may," "intend," "will" and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Optimer that any of its plans will be achieved. These forward-looking statements are based on management's expectations on the date of this release. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Optimer's business including, without limitation, risks relating to: Optimer's ability to continue driving adoption and use of DIFICID, whether healthcare professionals will prescribe DIFICID, whether DIFICID will receive or continue to receive reimbursement coverage from healthcare payers and government agencies, the extent to which DIFICID will be accepted on hospital formularies and potential delays in formulary decisions, Optimer's ability to successfully coordinate commercialization efforts with Cubist Pharmaceuticals under its co-promotion agreement, whether Optimer will be able to realize expected benefits under its co-promotion agreement with Cubist, the fact that past results may not be predictive of future results of performance, the possibility of alternative means of preventing or treating CDAD impacting adoption and sales of DIFICID, Optimer's ability, though its third party manufacturers and logistics providers, to maintain a sufficient supply of DIFICID to meet demand and other risks detailed in Optimer's filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date of this release, and Optimer undertakes no obligation to update or revise these statements, except as may be required by law.
Contacts
Optimer Pharmaceuticals, Inc.
David Walsey, Vice President, Investor Relations and Corporate Communications
(858) 964-3418
Canale Communications, Inc.
Jason I. Spark, Senior Vice President
(619) 849-6005
NBS -NeoStem's Subsidiary, Progenitor Cell Therapy, and Hackensack University Medical Center Enter Into a Cell Processing and Storage Services Agreement
Press Release: NeoStem Inc. – 30 minutes ago
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NBS 0.6575
ALLENDALE, N.J. and HACKENSACK, N.J., Jan. 7, 2013 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) and its subsidiary, Progenitor Cell Therapy, LLC ("PCT"), an internationally recognized contract development and manufacturing organization (CDMO), and Hackensack University Medical Center ("HackensackUMC"), part of the Hackensack University Health Network and a hub of healthcare for the Northern New Jersey and New York metropolitan areas, announced today that HackensackUMC has renewed its engagement of PCT's services for processing and storage of a variety of cell types used therapeutically by the hospital.
HackensackUMC will use the services of PCT for processing and storage services for peripheral blood progenitor cells, donor leukocytes, bone marrow and cord blood, as well as for further assays, storage, retrieval and transportation. HackensackUMC was recently voted one of the best hospitals by U.S. News and World Report 2012-2013, placing it fourth out of the 184 hospitals in the New York Metropolitan Area and number 1 in New Jersey. HackensackUMC has grown to be a preeminent cancer treatment facility with one of the largest blood and bone marrow transplant programs in the world.
"We are very excited to continue our relationship with HackensackUMC, whose engagement of PCT began in 1999, thirteen years ago," said Robert A. Preti, PhD, President and Chief Scientific Officer of PCT. "Our agreement with HackensackUMC enables us to continue to play a vital part in patient care for cancers and other hematologic disorders, and to continue to provide cell products to our entire client base. Since its founding, PCT has provided cell therapy products for infusion into over 6,000 patients."
"Our agreement with PCT provides us with a high quality and cost-effective solution to our cell processing and storage needs and supports a range of cell therapy based research and development programs," said Robert C. Garrett, President and Chief Executive Officer of HackensackUMC. Dr. Andre Goy, Chairman and Director of the John Theurer Cancer Center at HackensackUMC, added, "PCT's platform, which is designed under strict cGMP ("Current Good Manufacturing Practices") guidelines, ensures that our research activities will be conducted using the gold standard of our industry. PCT's recognized competencies in cell and tissue processing and storage, as well as cell transportation, make it an ideally suited partner for HackensackUMC."
Dr. Robin L. Smith, NeoStem's Chairman and Chief Executive Officer, stated that, "Our continued partnership with an institution of the calibre of HackensackUMC is a validation of our entire company's focus and commitment to the support and development of the emerging cell therapy industry, as we bring innovative therapies to patients suffering from cancers, autoimmune conditions and other disorders. PCT has shown strong revenue growth in 2012 with an increase of over 90% from the year prior. PCT's exceptional client retention rate validates the management's commitment to Quality and Services as we look forward to future growth with our clients outside of the United States."
About Hackensack University Medical Center
HackensackUMC, a non-profit teaching and research hospital located in Bergen County, New Jersey, is the largest provider of inpatient and outpatient services in the state, and home to the only Level II Trauma Center in the county. This 775-bed facility has gone beyond traditional thinking by creating an entire campus of care, including: the Heart & Vascular Hospital, the John Theurer Cancer Center, the Joseph M. Sanzari Children's Hospital, and the Donna A. Sanzari Women's Hospital. As a result of using science and creativity to push medicine further, HackensackUMC was listed as the number one hospital in New Jersey and one of the top four New York metro area hospitals by the U.S. News & World Report, and has received nine national rankings in: Cancer; Cardiology & Heart Surgery; Ear, Nose & Throat; Gastroenterology; Geriatrics; Neurology & Neurosurgery; Orthopedics; Urology; and the Joseph M. Sanzari Children's Hospital ranked as one of the Top 25 Best Children's Hospitals for Neurology and Neurosurgery in the 2012-13 Best Children's Hospitals list. The medical center has also been named one of the Truven Health Analytics 100 Top Hospitals(R) and one of America's 50 Best Hospitals by HealthGrades(R). It is listed among the Leapfrog Top Hospitals List, received 19 Gold Seals of Approval(TM) by the Joint Commission, and is listed as one of the 50 Best Hospitals in America by Becker's Hospital Review. It was the first hospital in New Jersey and second in the nation to become a Magnet(R) recognized hospital for nursing excellence. The medical center is the Hometown Hospital of the New York Giants and the New York Red Bulls, and remains committed to its community through fundraising and community events. To learn more about one of the nation's 50 best hospitals, visit: www.HackensackUMC.org.
About NeoStem, Inc.
NeoStem continues to develop and build on its core capabilities in cell therapy, capitalizing on the paradigm shift occurring in medicine. We anticipate that cell therapy will have a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. We are emerging as a technology and market leading company in this fast developing cell therapy industry. Our multi-faceted business strategy combines a state-of-the-art contract development and manufacturing subsidiary, PCT, with a medically important cell therapy product development program, enabling near and long-term revenue growth opportunities. We believe that, with our expertise and research capabilities and collaborations, we will achieve our mission of becoming a premier cell therapy company.
Our contract development and manufacturing service business supports the development of proprietary cell therapy products. NeoStem's most clinically advanced therapeutic, AMR-001, is being developed at Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011. Amorcyte is developing a cell therapy for the treatment of cardiovascular disease and is enrolling patients in a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. Athelos Corporation ("Athelos"), which is 80%-owned by our subsidiary, PCT, is collaborating with Becton-Dickinson in the early clinical exploration of a T-cell therapy for autoimmune conditions. In addition, pre-clinical assets include our VSEL(TM) Technology platform as well as our mesenchymal stem cell product candidate for regenerative medicine. Our service business and pipeline of proprietary cell therapy products work in concert to create a competitive advantage that we believe is unique to the biotechnology and pharmaceutical industries. Supported by an experienced scientific and business management team and a substantial intellectual property estate, we are well positioned to succeed.
For more information on NeoStem, please visit www.neostem.com.
Forward-Looking Statements for NeoStem, Inc.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company's business strategy, including with respect to the Company's or its partners' successful development of AMR-001 and other cell therapeutics, the size of the market for such products, its competitive position in such markets, the Company's ability to successfully penetrate such markets and the market for its contract development and manufacturing business, and the efficacy of protection from its patent portfolio, as well as the future of the cell therapeutics industry in general, including the rate at which such industry may grow. The Company's actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors, including but not limited to matters described under the "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 20, 2012 and in the Company's other periodic filings with the Securities and Exchange Commission, all of which are available on its website. The Company does not undertake to update its forward-looking statements. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.
Contact:
For HackensackUMC press relations, please contact:
Sheri Hensley
551-996-3586
SHensley@HackensackUMC.org
For NeoStem press relations, please contact:
Trout Group
Lauren Kwiecinski, Senior Associate
Phone: +1-646-378-2934
Email: lkwiecinski@troutgroup.com
PBTH Receives Notice of Allowance for New U.S. Patent Covering Broad Applications of its CTP Platform for Long Acting Therapeutic Proteins
Press Release: PROLOR Biotech, Inc. – 29 minutes ago
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PBTH 4.86
NES-ZIONA, Israel, Jan. 7, 2013 /PRNewswire/ -- PROLOR Biotech, Inc. (NYSE MKT: PBTH) today announced that it received a notice of allowance from the U.S. Patent and Trademark Office for a patent application covering the company's CTP platform, which has the potential to extend the duration of activity of therapeutic proteins. The allowed claims cover manufacturing methods for CTP-modified compositions of a wide array of classes of therapeutic proteins, including hormones, high affinity protein ligands, proteins that induce or regulate an immune response, proteins involved with autocrine and paracrine activities, and mimetics of these therapeutic proteins, as well as other types of proteins.
This new U.S. patent is expected to be issued in the next few months.
"Upon issuance, this new patent is expected to further strengthen PROLOR's expanding intellectual property portfolio covering the CTP platform, as well as the new products we are developing using this versatile technology," said Shai Novik, president of PROLOR.
About PROLOR's CTP Technology
PROLOR's CTP technology is based on the naturally-occurring human carboxyl terminal peptide (CTP). When attached to a therapeutic protein, CTP significantly extends the length of time the protein remains active in the body. Clinical and preclinical studies have shown that the CTP technology appears to be safe and effective in extending the duration of all proteins tested to date. CTP's safety and efficacy have also been validated by the marketing approval of Merck's long-acting CTP-enhanced fertility drug Elonva® (FSH-CTP). A single Elonva injection replaces a regimen of seven daily FSH injections. Results from a Phase II trial of PROLOR's CTP-modified human growth hormone (hGH-CTP) in growth hormone deficient adults showed that a single weekly injection of hGH-CTP has the potential to replace seven consecutive daily injections of currently marketed human growth hormone. CTP was identified by researchers at Washington University in St. Louis and is exclusively licensed to PROLOR for all proteins and peptides, except for four endocrine proteins that are licensed to Merck. CTP is manufactured using standard industrial biotech processes.
ABOUT PROLOR
PROLOR Biotech, Inc. is a clinical stage biopharmaceutical company applying unique technologies, including patented CTP technology, primarily to develop longer-acting proprietary versions of already approved therapeutic proteins that currently generate billions of dollars in annual global sales. The CTP technology is applicable to virtually all proteins. PROLOR is currently developing a long-acting version of human growth hormone, which successfully completed a Phase II clinical trial. It also is developing long-acting versions of Factor VIIa and Factor IX for hemophilia and a GLP-1/Glucagon dual receptor agonist peptide for diabetes and obesity, all of which are in preclinical development. For more information, visit http://www.prolor-biotech.com.
Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "would", "intends," "estimates," "suggests," "has the potential to" and other words of similar meaning, including statements regarding the results of current clinical studies and preclinical experiments and the effectiveness of PROLOR's long-acting protein programs, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect PROLOR's business and prospects, including the risks that PROLOR may not succeed in generating any revenues or developing any commercial products, including any long-acting versions of human growth hormone, erythropoietin, interferon beta, GLP-1 and other products; that the long-acting products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; that the actual dollar amount of any grants from Israel's Office of the Chief Scientist is uncertain and is subject to policy changes of the Israeli government, and that such grants may be insufficient to assist with product development; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the CTP platform technology could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in PROLOR's filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law.
PROLOR CONTACT:
MEDIA CONTACT:
Shai Novik, President
Barbara Lindheim
PROLOR Biotech, Inc.
BLL Partners, LLC
Tel: +1 866 644-7811
+1 212 584-2276
Email: shai@prolor-biotech.com
blindheim@bllbiopartners.com