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Investor 100
VRTX:Vertex hepatitis C drug revenues plummet
PPS:$46.39
http://www.bizjournals.com/boston/blog/bioflash/2013/01/vertex-hepatitis-c-drug-revenues-plummet.html?ana=yfcpc&page=2
Vertex Pharmaceuticals (Nasdaq: VRTX) saw sales of its hepatitis C drug, Incivek, drop off precipitously in the fourth quarter, year over year. The fast decline in Incivek sales, less than two years after its U.S. Food and Drug Administration approval in May of 2011, underscores the fast-moving competitive landscape for hepatitis C.
Cambridge, Mass.-based Vertex and several other competitors are locked in battle to try to come up with an all-oral drug cocktail that would eliminate the need for interferon injections, which would improve patients’ quality of life. In the meantime, some patients are putting off treatment or joining clinical trials rather than starting Incivek or other already-approved medicines.
Vertex booked revenues of $334 million for the most recent quarter, down from $563 million for the corresponding quarter in 2011, driven by the drop in Incivek revenues. Incivek brought in $222.8 million in the fourth quarter of 2012, less than half the $456.8 million in sales for the year-ago period. The dip was slightly offset by cystic fibrosis drug Kalydeco’s revenues of $58.5 million for the fourth quarter of 2012. Kalydeco was approved in January of 2012.
Vertex posted a net loss of $76.1 million for the fourth quarter of 2012, down from net income of $188.1 during the corresponding period last year.
For the full year, the company booked revenue of $1.3 billion, up from $950.9 million for 2011, boosted by stronger Incivek sales earlier in the year. The company reported a net loss of $51.1 million for 2012, versus profits of $41.2 million in 2011
“Entering 2013, we are committed to advancing key development programs and to maintaining financial strength to position the company for sustainable long-term growth,” Dr. Jeffrey Leiden, Vertex's CEO, said in a statement. “Over the coming year, we expect to generate a significant amount of data from our key development programs in cystic fibrosis, hepatitis C and autoimmune diseases and to initiate important studies designed to bring additional transformative medicines to people with serious diseases, with a focus on specialty markets.”
Vertex ended 2012 with $1.32 billion in cash on hand.
The company gave full-year guidance for 2013 that it would book total revenues of between $1.1 billion and $1.25 billion, including Kalydeco revenues of between $280 million and $320 million. The company said the growth in Kalydeco revenues would depend on securing insurance reimbursement for the drug, which costs nearly $300,000 per year, in countries outside the U.S.
The company’s shares were up slightly after market at $46.39, Tuesday, having closed trading at $45.92.
Investor 100
ABIO:New Adaptive Phase 3 Trial Planned for GencaroTM in Atrial Fibrillation
Took a starter postion.
PPS:.69 (AH)
http://finance.yahoo.com/news/adaptive-phase-3-trial-planned-220000121.html
BROOMFIELD, Colo.--(BUSINESS WIRE)--
ARCA biopharma, Inc. (ABIO), a biopharmaceutical company developing genetically-targeted therapies for atrial fibrillation, heart failure and other cardiovascular diseases, today provided an update on a proposed, genetically-targeted clinical trial in atrial fibrillation (“AF”) of the Company’s lead developmental drug, Gencaro (bucindolol hydrochloride). The Company also announced that Medtronic, Inc., a leader in medical technologies to improve the treatment of chronic diseases, including cardiac rhythm disorders, has signed a non-binding Letter of Intent to collaborate on the initial, Phase 2B portion of the proposed trial.
The Proposed GENETIC-AF Phase 3 Adaptive Design Clinical Trial
The trial, known as GENETIC-AF, is projected to be a 620-patient, Phase 3 study comparing Gencaro to metoprolol CR/XL for prevention of AF in patients with heart failure and left ventricular dysfunction ("HFREF"). The Trial is planned to be genetically enriched by enrolling only those patients who possess the cardiac beta-1 adrenergic receptor genotype 389 arginine homozygous, which in the Beta Blocker Evaluation of Survival Trial ("BEST") was associated with an enhanced response to Gencaro in preventing atrial fibrillation. The Company estimates that this genotype is present in about 50% of the U.S. population. The primary endpoint of GENETIC-AF is planned to be the combination endpoint of recurrent symptomatic AF and all-cause mortality, over 24 weeks post electrical cardioversion for persistent AF. Commencement of the GENETIC-AF is conditional on receipt of the necessary funding, which ARCA intends to secure through equity financing or a strategic partnership.
ARCA has created an adaptive design for GENETIC-AF, under which the Company plans to initiate a Phase 2B study in approximately 200 HFREF patients. Depending on the results of the Phase 2B portion, the trial could then be expanded to a Phase 3 study by enrolling an estimated additional 420 patients. A secondary endpoint of the proposed Phase 2B portion of the trial will be AF burden, defined as a patient’s actual time in AF, regardless of symptoms. Under the Company’s proposed design, all 200 patients in the Phase 2B portion of the trial will have AF burden measured by continuous monitoring, either by previously implanted cardiac resynchronization or defibrillation devices, or newly or previously inserted implantable loop recorders. At the end of enrollment of the first 200 patients, the primary endpoint of recurrent symptomatic AF and all-cause mortality, and the secondary endpoint of AF burden will be evaluated by the trial’s Data and Safety Monitoring Board for evidence of an efficacy signal. If a sufficient efficacy signal is detected and acceptable safety is observed, the trial would then proceed to the Phase 3 portion and full enrollment.
ARCA believes that Gencaro has potential as a treatment for AF, based on placebo-controlled data from the Phase 3 heart failure BEST study. A retrospective analysis of data from the BEST Trial shows that patients with the genotype that ARCA plans to enroll in GENETIC-AF had a 74% reduction in the risk of AF compared to placebo (p = 0.0003). These same patients experienced a 38% reduction in the risk of all cause mortality (p < 0.05) and statistically significant improvements on other major clinical efficacy endpoints.
AF is considered an epidemic cardiovascular disease with an estimated prevalence of at least 2.7 million Americans in 2010. In HFREF patients, the approved therapies for the treatment or prevention of AF have disadvantages, such as toxic or cardiovascular adverse effects, and most of the approved drugs are contra-indicated or have warnings in their prescribing information. ARCA believes there is an unmet medical need for new AF treatments that are safe and more effective in the HFREF population at risk for AF.
ARCA has received guidance from the Food and Drug administration (“FDA”) regarding a Phase 3 clinical study comparing Gencaro to metoprolol for the prevention of AF in approximately 600 HFREF patients, with a design similar to GENETIC-AF, but without an adaptive feature. Based on this FDA guidance, the Company believes that a successful Phase 3 clinical study similar to GENETIC-AF, with a p-value of less than 0.01, could be sufficient evidence of efficacy upon which to base a New Drug Application (“NDA”) for the approval of Gencaro for an AF indication in HFREF patients. ARCA plans to obtain further guidance from the FDA, which may affect the trial’s design.
The proposed collaboration with Medtronic involves a substudy of the Phase 2B portion of GENETIC-AF that will measure the AF burden data by means of the continuous monitoring devices. Under the proposed collaboration, Medtronic would provide support associated with the AF burden substudy and with collection and analysis of the substudy data.
Dr. Michael Bristow, MD, PhD., President and Chief Executive Officer of ARCA, said, “We at ARCA are excited about the new adaptive design for GENETIC-AF and the potential to use AF burden measured by previously implanted devices as well as by newly inserted implantable loop recorders, which we believe represent the next generation of diagnosis and treatment options for patients at risk for AF. AF is a serious disorder that increases the risk of stroke and mortality, and in HFREF patients often heralds the worsening of heart failure. There is a need for new treatment options, particularly for patients with HFREF. The GENETIC-AF trial has the potential to result in an approvable new therapy that is safe and effective for HFREF patients at high risk for AF. We believe that the use of continuous monitoring devices including implantable loop recorders to monitor AF burden in the Phase 2B substudy will result in many more clinically-relevant events, which will potentially increase the power and usefulness of the data. We believe that AF burden used in conjunction with drug therapy will become an increasingly important tool in the diagnosis and treatment of AF.”
About ARCA biopharma
ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases. The Company's lead product candidate, GencaroTM (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for atrial fibrillation. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically-targeted atrial fibrillation prevention treatment. ARCA has a collaboration with the Laboratory Corporation of America (LabCorp), under which LabCorp has developed a companion genetic test for Gencaro. For more information please visit www.arcabiopharma.com.
Investor 100
Future Link
http://www.finviz.com/futures.ashx
Investor 100
PFE:Pfizer Earnings Top Estimates; Aided by Stronger Sales
http://www.cnbc.com/id/100413694
Pfizer reported fourth-quarter earnings on Tuesday that outpaced Wall Street's expectations, aided by strong sales in emerging markets and lower acquisition-related charges.
Following the announcement, the pharmaceutical giant's shares traded slightly higher before the opening bell. (Click here to get real-time quotes for Pfizer.)
Pfizer said it earned $6.32 billion, or 85 cents a share, in the latest quarter, up from earnings of $1.44 billion, or 19 cents a share, in the year-earlier period.
Net income included a gain from the upcoming sale of a nutrition business as well as restructuring and acquisition-related charges. Earnings these items, Pfizer said it earned 47 cents per share in the latest period, topping average analyst estimates of 44 cents a share reported by Thomson Reuters.
Revenue fell 9 percent to $15.07 billion from $16.75 billion during the same period last year.
Analysts had expected Pfizer to earn 44 cents a share on revenue of $14.38 billion, according to consensus estimates from Thomson Reuters.
Investors will watch to see how the pharmaceutical giant fares amid the "patent cliff," a loss of exclusivity on key blockbuster drugs that have affected other major drug makers such as Eli Lilly. Lower sales in Pfizer's latest quarter reflected the loss of exclusivity of drugs such as Lipitor, a treatment for high cholesterol, and Geodon, a treatment for bipolar disorder.
For the full year, Pfizer expects to earn between $2.20 a share and $2.30 a share on revenue of $56.2 billion to $58.2 billion. Analysts polled by Thomson Reuters expected Pfizer to earn $2.29 a share on revenue of $57.56 billion.
Investor 100
ONCY:Oncolytics Biotech® Inc. Announces Positive REOLSYIN® Clinical Trial Data Presented at ASCO Gastrointestinal Cancers Symposium
PPS:$3.39
http://finance.yahoo.com/news/oncolytics-biotech-inc-announces-positive-113000222.html
CALGARY , Jan. 28, 2013 /CNW/ - Oncolytics Biotech Inc. ("Oncolytics") (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). The results were presented at the ASCO Gastrointestinal Cancers Symposium in San Francisco , CA, which took place from January 24-26, 2013.
The poster presentation, titled: "A Multicenter Phase I Study of Intravenous Administration of REOLYSIN in combination with Irinotecan/Fluorouracil/Leucovorin (FOLFIRI) in Patients (pts) with Oxaliplatin-Refractory/Intolerant KRAS-Mutant Metastatic Colorectal Cancer (mCRC)," was authored by Ocean et al. Twenty-one patients were enrolled in the study, including nine that were FOLFIRI-naïve. Of the 18 patients evaluable for response there was one partial response and nine had stable disease. The combined overall progression free survival (PFS) of FOLFIRI-naïve and FOLFIRI-failed patients was 7.4 months. The authors concluded that the combination of REOLYSIN and FOLFIRI was safe and well tolerated and resulted in disease control in the majority of evaluable patients, including patients that had previously progressed on Irinotecan.
"These results are intriguing, particularly with respect to patients who have failed prior FOLFIRI treatment," said Dr. Brad Thompson , President and CEO of Oncolytics. "This study, in conjunction with an earlier study examining REOLYSIN monotherapy in metastatic colorectal patients (REO 013), formed the basis for our decision to proceed into a randomized study in colorectal cancer (IND 211), which is now enrolling."
The trial was a 21-patient, single arm dose escalation study designed to determine a maximum tolerated dose and dose-limiting toxicities for the combination of REOLYSIN and FOLFIRI. Eligible patients included those with histologically confirmed cancer of the colon or rectum with Kras mutation and measurable disease. They must have progressed on or within 190 after the last dose of an oxaliplatin regimen in the metastatic setting, or be intolerant to oxaliplatin.
About Oncolytics Biotech Inc.
Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics. Oncolytics' clinical program includes a variety of human trials including a Phase III trial in head and neck cancers using REOLYSIN®, its proprietary formulation of the human reovirus. For further information about Oncolytics, please visit: www.oncolyticsbiotech.com.
AXN:Aoxing Pharmaceutical Company, Inc. Announces Receipt Of Production License For Pholcodine
PPS:.30
http://finance.yahoo.com/news/aoxing-pharmaceutical-company-inc-announces-130000090.html
JERSEY CITY, N.J., Jan. 28, 2013 /PRNewswire/ -- Aoxing Pharmaceutical Company, Inc. (NYSE MKT: AXN) ("Aoxing Pharma"), a specialty pharmaceutical company focusing on research, development, manufacturing, and distribution of narcotic, pain-management, and addiction treatment pharmaceuticals, today announced that its Chinese subsidiary has received from the State Food and Drug Administration of China ("SFDA") a license to produce the active pharmaceutical ingredient ("API") in Pholcodine. The company has commenced preparation for the government's Good Manufacturing Practices (GMP) inspection, which is the last regulatory hurdle before the company can take the product to market in China.
Mrs. Guirong Zhou, Vice President for R&D, commented: "Our receipt of this license is evidence of the quality of our research and development team. We currently have a number of other products that have completed clinical trials and are in the process of applying for the SFDA production license. Our success in obtaining a production license for the Pholcodine API bodes well for success in our future applications."
About Aoxing Pharmaceutical Company, Inc.
Aoxing Pharmaceutical Company, Inc. is a US incorporated specialty pharmaceutical company with its operations in China, specializing in research, development, manufacturing and distribution of a variety of narcotics and pain-management products. Headquartered in Shijiazhuang City, outside Beijing, Aoxing has the largest and most advanced manufacturing facility in China for highly regulated narcotic medicines. Its facility is one of the few GMP facilities licensed for the manufacture of narcotic medicines by the China State Food and Drug Administration (SFDA). It has a joint venture collaboration with Johnson Matthey Plc to produce and market narcotics and neurological drugs in China. For more information, please visit: www.aoxingpharma.com.
Investor 100
IDIX:Idenix Pharmaceuticals Announces Collaboration With Janssen to Initiate Phase II All-Oral Combination Studies Including IDX719, Simeprevir (TMC435) and TMC647055 for the Treatment of Hepatitis C Virus (HCV)
PPS:$5.00
http://finance.yahoo.com/news/idenix-pharmaceuticals-announces-collaboration-janssen-120000219.html
CAMBRIDGE, Mass., Jan. 28, 2013 (GLOBE NEWSWIRE) -- Idenix Pharmaceuticals, Inc. (IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced a non-exclusive collaboration with Janssen Pharmaceuticals, Inc. for the clinical development of all-oral direct-acting antiviral (DAA) HCV combination therapies. The collaboration will evaluate combinations including IDX719, Idenix's once-daily pan-genotypic NS5A inhibitor, simeprevir (TMC435), a once-daily protease inhibitor jointly developed by Janssen and Medivir AB, and TMC647055, a once-daily non-nucleoside polymerase inhibitor, boosted with low dose ritonavir, being developed by Janssen.
Clinical development plans include an initial drug-drug interaction study to begin in the first quarter of 2013, followed by phase II studies as agreed between the companies, and pending approval from regulatory authorities. The phase II program is expected to first evaluate the two-DAA combination of IDX719 and simeprevir plus ribavirin for 12 weeks in treatment-naive HCV-infected patients. Subsequently, the companies plan to evaluate a three-DAA combination of IDX719, simeprevir and TMC647055/r, with and without ribavirin. The clinical trials will be conducted by Idenix. Both companies retain all rights to their respective compounds under this agreement.
"We are very pleased to be working with Janssen and look forward to initiating a phase II study in the first quarter of this year," said Ron Renaud, Idenix's President and Chief Executive Officer. "This will allow us to achieve a key goal of ours for 2013, which is to advance the development of IDX719 as part of all-oral HCV combinations in two- and three-drug regimens."
ABOUT IDX719
IDX719 is an NS5A inhibitor with low picomolar, pan-genotypic antiviral activity in vitro. To date, IDX719 has been safe and well tolerated after single and multiple doses of up to 100 mg in healthy volunteers (n=36; up to 7 days duration) and HCV-infected patients (n=69; up to 3 days duration). There have been no treatment-emergent serious adverse events reported in the program. IDX719 has demonstrated potent pan-genotypic antiviral activity in HCV-infected patients with mean maximal viral load reductions up to approximately 4.0 log10 IU/mL across HCV genotypes 1-4 in a proof-of-concept, three-day monotherapy study.
ABOUT SIMEPREVIR (TMC435)
Simeprevir is a once-daily potent investigational hepatitis C protease inhibitor in late Phase 3 clinical development being jointly developed by Janssen R&D Ireland and Medivir AB to treat chronic hepatitis C virus infections. Simeprevir is being investigated in combination with PegIFN/RBV in Phase 3 trials and is also being evaluated with Direct-acting Antiviral (DAA) agents in three other Phase 2 interferon-free combinations both with and without ribavirin (RBV). For further details please visit http://www.medivir.com.
ABOUT TMC647055
TMC647055 is a potent non-nucleoside hepatitis C polymerase inhibitor with broad genotypic coverage. TMC647055 is in Phase 2 clinical development and is developed by Janssen R&D Ireland to treat chronic hepatitis C virus infections. TMC647055 is being investigated in combination with other DAA agents in all oral interferon-free regimens. There have been no treatment-emergent serious adverse events reported in the program.
ABOUT HEPATITIS C
Hepatitis C virus is a common blood-borne pathogen infecting three to four million people worldwide annually. The World Health Organization (WHO) estimates that more than 170 million people worldwide are chronically infected with HCV, representing a nearly 5-fold greater prevalence than human immunodeficiency virus.
ABOUT IDENIX
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical Company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of patients with hepatitis C infection. For further information about Idenix, please refer to www.idenix.com.
Investor 100
CTYTR:CytRx Announces Positive Results from Animal Trial with Combination Aldoxorubicin and Doxorubicin Therapy
Produces rationale for Company’s ongoing Phase 1b clinical trial of the combination therapy in cancer patients with advanced solid tumors
Results published in the peer-reviewed International Journal of Pharmaceutics
PPS:$2.09
http://finance.yahoo.com/news/cytrx-announces-positive-results-animal-133000322.html
LOS ANGELES--(BUSINESS WIRE)--
CytRx Corporation (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.
The trial compared the antitumor efficacy and tolerability of weekly intravenous treatments with saline or doxorubicin compared with three dosing regimens of either aldoxorubicin alone or combination aldoxorubicin and doxorubicin in a xenograft model of human pancreatic cancer. As single agents, doxorubicin and aldoxorubicin were administered at their maximum tolerated doses (MTD), while each agent was given at 50% of their MTD when combined. Doxorubicin alone produced only modest tumor inhibition. Aldoxorubicin alone and each combination therapy arm induced both complete and partial remissions, with antitumor efficacy within all arms essentially identical. Importantly, the trial data showed better tolerability for the combination therapy at these low dose levels compared with single agent aldoxorubicin.
The study, “Evaluation of combination therapy schedules of doxorubicin and an acid-sensitive albumin-binding prodrug of doxorubicin in the MIA PaCa-2 pancreatic xenograft model,” Kratz, F., et al., was published in the peer-reviewed International Journal of Pharmaceutics, 441 (2013) pages 499-506.
“The data from this trial are particularly encouraging as pancreatic cancer typically responds poorly to chemotherapy,” said CytRx Executive Vice President and Chief Medical Officer Daniel Levitt, M.D., Ph.D. “The ability of a combined therapy with aldoxorubicin and doxorubicin to demonstrate efficacy in this cancer at doses that were well-tolerated indicates its potential for the treatment of other chemotherapeutic-resistant tumors such as chondrosarcoma and chordomas. The design and rationale behind this trial produced valuable information and we are currently testing this combination in a phase 1b clinical trial in patients with solid tumors. A study abstract has been submitted for presentation at the American Society for Clinical Oncology (ASCO) meeting later this year.”
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. The CytRx oncology pipeline includes two programs in clinical development for cancer indications: aldoxorubicin (formerly known as INNO-206) and tamibarotene. With its tumor-targeted doxorubicin conjugate aldoxorubicin, CytRx has initiated an international Phase 2b clinical trial as a treatment for soft tissue sarcomas, has completed its Phase 1b/2 clinical trial primarily in the same indication, and has initiated a Phase 1b pharmacokinetics clinical trial in patients with metastatic solid tumors, a Phase 2 trial for patients with advanced pancreatic ductal adenocarcinomas and a Phase 1b study of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors. The Company has held a positive meeting with the FDA to discuss a potential Phase 3 pivotal trial with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy, and is planning to submit a special protocol assessment related to this trial. Tamibarotene is being tested in a double-blind, placebo-controlled, international Phase 2b clinical trial in patients with non-small-cell lung cancer. The Company completed its evaluation of a third drug candidate, bafetinib, in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL), and plans to seek a partner for further development of bafetinib. For more information about CytRx Corporation, visit www.cytrx.com.
Investor 100
Future Link
http://www.finviz.com/futures.ashx
Investor 100
APPA @ Stockcharts
PPS:.734
http://openinsider.com/search?q=appa
http://investors.morningstar.com/ownership/shareholders-overview.html?t=appa
GLTA
Investor 100
PFE @ Stockcharts
PPS: $27 (Watch-List)
Tuesday earnings!
http://finance.yahoo.com/news/pfizer-declares-first-quarter-2013-154400550.html
Investor 100
Took a starter position @ DARA (.98)
Solid "DD" Sheff!
GLTA
Investor 100
ARIA:ARIAD Announces Proposed Public Offering of Common Stock
Financing to support global commercialization of Iclusig™ (ponatinib) and additional clinical development of its investigational targeted cancer medicines
http://finance.yahoo.com/news/ariad-announces-proposed-public-offering-210500441.html
Investor 100
AMRN:Amarin Announces First Notification of U.S. Patent Allowance Based on ANCHOR Clinical Trial Results
Key 12/815,569 Patent Application Related to Patient Population With Mixed Dyslipidemia
http://finance.yahoo.com/news/amarin-announces-first-notification-u-162811200.html
Investor 100
AMRN:Amarin Announces Publication of Additional Inflammatory Marker Data From MARINE and ANCHOR Phase 3 Clinical Trials in the American Journal of Cardiovascular Drugs
Reductions in Several Inflammatory Markers Shown in Hypertriglyceridemic Patients
PPS:$8.47
http://finance.yahoo.com/news/amarin-announces-publication-additional-inflammatory-123000620.html
Investor 100
CLSN:Celsion Corporation and Zhejiang Hisun Pharmaceutical Company Enter Into Technology Development Agreement for ThermoDox® for the Greater China Territory
Companies Also Anticipate 60-Day Exclusive Option Period for Commercial License for ThermoDox® for China Market
PPS:7.00
http://finance.yahoo.com/news/celsion-corporation-zhejiang-hisun-pharmaceutical-130000033.html
Investor 100
Future Link
http://www.finviz.com/futures.ashx
Investor 100
Welcome rentier to The Sheff Station!
Investor 100
Welcome NKJOE to the Sheff Station!
Investsor 100
Future Link
http://www.finviz.com/futures.ashx
Investor 100
BAC-C-BBT-KEY @ Stockcharts
Banks reporting next week include BAC & C however other opportunities to watch are BBT & Key Bank
It's a Good Time to Buy Into Bank Stocks: Analyst
http://www.cnbc.com/id/100371117
BAC:$11.63 (Holding since $7.10)
Earnings: Thursday-January 17th,2013
BBT:$30.31 (Watchlist)
http://www.fool.com/investing/general/2013/01/06/the-year-that-was-2012-for-bbt.aspx
C:$42.34 (Holding since $29)
Earnings: Thursday-January 17th,2013
KEY:$8.84 (Watchlist)
http://online.barrons.com/article/SB50001424052748703596604578229842100945054.html?ru=yahoo&mod=yahoobarrons#articleTabs_article%3D1
Investor 100
TELK @ Stockcharts
1 for 30 RS split April 2,2013 has come to life!
PPS:$2.98
Telik Announces Orphan Designation Of Telintra® For Treatment Of Myelodysplastic Syndrome
http://finance.yahoo.com/news/telik-announces-orphan-designation-telintra-002300483.html
Investor 100
ECTE @ Stockcharts
Starter postion $1.20
PPS: $1.27
http://www.bizjournals.com/philadelphia/news/2013/01/07/echo-therapeutics-seeking-partnership.html?ana=yfcpc
Investor 100
AMRN:Amarin Announces Notification of Patent Allowance for U.S. Application 13/610,217 Related to Vascepa(R) and FDA Approved MARINE Indication
Strengthens Positioning of Vascepa for Exclusivity Into 2030
PPS:$8.60
http://finance.yahoo.com/news/amarin-announces-notification-patent-allowance-123000032.html
BEDMINSTER, N.J., and DUBLIN, Ireland, Jan. 11, 2013 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that the United States Patent and Trademark Office (USPTO) has published notification of Notice of Allowance for U.S. Patent Application Serial Number 13/610,217. This application includes claims intended to protect the Vascepa(R) (icosapent ethyl) indication approved by the U.S. Food and Drug Administration (FDA) based on Amarin's MARINE clinical trial results.
A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application. The issued patent would have a term that expires no earlier than in 2030. After issuance, Amarin plans to list this patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.
The claims in this allowed application cover a method of use relating to Vascepa's MARINE indication. Specifically, the allowed independent claim covers use of highly pure icosapent ethyl, or EPA, including Vascepa, in lowering triglycerides through the daily administration of about 4 capsules, each containing about 900 mg to about 1000 mg of EPA, regardless of EPA purity.
"The claims in this allowed application cover the administration of capsules containing EPA within a significant range of EPA concentrations," stated Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin. "The issuance of this Notice of Allowance represents yet another significant step toward Amarin's goal of protecting the commercial potential of Vascepa to beyond 2030 through patent protection, regulatory exclusivity and trade secrets and by taking advantage of manufacturing barriers to entry."
This application is part of an expanding patent portfolio for Amarin with 12 patent applications now either issued or allowed with the USPTO and over 30 additional applications pending in the United States. Amarin is also pursuing patent applications related to Vascepa in multiple jurisdictions outside the United States.
About Amarin
Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin's product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. Vascepa(R) (icosapent ethyl), Amarin's first FDA approved product, is a patented, ultra pure omega-3 fatty acid product comprising not less than 96% EPA. For more information about Vascepa visit www.vascepa.com. For more information about Amarin visit www.amarincorp.com.
The Amarin Corporation plc logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=13817
Forward-looking statements
This press release contains forward-looking statements, including statements about whether the subject patent would be issued and adequately protect Vascepa against competition, the expiration date of the pending patent, Amarin's plan to list the patent, when issued, in FDA's Orange Book, Amarin's plan to protect the commercial potential of Vascepa, and the future status of pending patent applications. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: events that could interfere with the issuance of a patent, or once issued, the continued validity or enforceability of a patent; Amarin's ability generally to maintain adequate patent protection and successfully enforce patent claims against third parties; commercializing Vascepa without violating the intellectual property rights of others; and uncertainties associated generally with research and development, clinical trials and related regulatory approvals. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including its most recent Quarterly Report on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
Contact:
Stephen D. Schultz
Investor Relations and Corporate Communications
Amarin Corporation
In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com
Investor 100
OCLS:Oculus Innovative Sciences, Inc. Announces Plan to Spin Off Biotechnology Business
Oculus Management Conference Call Begins at 4:30 p.m. (ET) Today
PPS:$.72
http://finance.yahoo.com/news/oculus-innovative-sciences-inc-announces-130800845.html
PETALUMA, Calif., Jan. 10, 2013 (GLOBE NEWSWIRE) -- Oculus Innovative Sciences, Inc. (OCLS) today announced that its board of directors has unanimously approved a spin-off of its novel biotechnology business, Ruthigen, Inc.
Oculus management is currently working with securities counsel and bankers on a plan to provide equity in Ruthigen to Oculus shareholders. Oculus expects the spinoff to be a tax-free stock distribution and ultimately anticipates Ruthigen to become an independent NASDAQ-traded company. Oculus has retained bankers and financial advisors for the spinoff, and expects the spinoff to be completed in 2013. Execution of the transaction requires further work relative to structure, governance and other significant matters and risks.
Upon completion of the spinoff, Hoji Alimi, founder and current chief executive officer of Oculus, will remain on the board of directors at Oculus and serve as chairman and chief executive officer of Ruthigen, Inc. Jim Schutz, the current chief operating officer and director of Oculus, will assume the role of chief executive officer of Oculus, with a new board chair to be elected shortly. Each company will operate with independent management teams and boards of directors to establish separate governance and financials as required by accounting rules. Additional details regarding structure will be determined and disclosed at a later time.
Oculus will retain all Microcyn drug and device indications while Ruthigen will focus on RUT58-60, a drug candidate intended for the prevention of infection in trauma and surgical procedures. RUT58-60 is a new unique chemical formulation containing twice the concentration of hypochlorous acid, along with magnesium and no sodium hypochlorite.
Alimi said: "By separating these unique businesses into two companies, we believe each company will benefit from greater strategic and managerial focus and be better positioned to capitalize on future market opportunities. Under the plan currently under consideration, Oculus shareholders will receive shares of Ruthigen. Ultimately, we are seeking to create additional value for current and future shareholders of both Oculus and Ruthigen.
"Our Microcyn business will continue as it has over the past seven years providing life saving products for patients without the additional burden of drug development costs. Oculus has a foundation of strong fundamentals, including sustainable revenues from several key markets and a solid plan for new sources of revenue growth over the next several years."
Oculus' intent is to secure additional FDA and CE regulatory approvals and to expand medical device offerings over the next 12 months. This will provide current partners with new products and a growing platform of products for new partners. While Oculus will continue promoting Microcyn-based products for topical use, Ruthigen intends to focus on use of its uniquely differentiated drug for internal use targeting organ exposure. Ruthigen intends to identify a partner for its European drug indication as well as file an S-1 registration statement to fund its pivotal drug program in the United States. Upon completion of a public offering, the entities will operate as independent entities.
"The spin-off of Ruthigen should be attractive to shareholders who are interested in companies that are addressing the critical issue of surgical infection," said Alimi. "Initially, we intend to leverage our previous phase two drug data for use in regulatory approvals relative to the prevention of infection in surgeries."
The completion of the proposed spinoff is subject to certain customary conditions, including final approval by Oculus' board of directors, the filing and effectiveness of appropriate filings with the U.S. Securities and Exchange Commission including a registration statement on form S-1, and any necessary third-party consents, as well as certain other matters relating to the spinoff, receipt of legal opinions, execution of intercompany agreements, and final approval of the transactions contemplated by the spinoff, as may be required under Delaware law. Oculus notes that there can be no assurance that any separation transaction will ultimately occur, or, if one does occur, its terms or timing.
Management Conference Call
Oculus management will hold a conference call today to discuss the spin-off and to answer questions, beginning at 4:30 p.m. ET. Individuals interested in participating in the conference call may do so by dialing (877) 303-7607 for domestic callers or (973) 638-3203 for international callers. Those interested in listening to the conference call live via the Internet may do so at http://ir.oculusis.com/events.cfm. Log on approximately 30 minutes prior to the presentation in order to register and download the appropriate software. Please note that those listening via the web do not have the ability to pose questions.
A telephone replay will be available for seven days following the conclusion of the call by dialing (855) 859-2056 for domestic callers, or (404) 537-3406 for international callers, and entering conference code 87524998. A webcast replay will be available on the site at http://ir.oculusis.com/events.cfm for one year following the call.
About Oculus Innovative Sciences
Oculus Innovative Sciences is a healthcare company that designs, produces and markets innovative, safe and effective anti-infective products and medical devices while also developing multiple drug candidates for various indications including treatment of acne and surgical suite use. Oculus is pioneering innovative solutions in multiple markets for the dermatology, surgical, wound care, and animal healthcare markets, and has commercialized products in the United States, Europe, India, China, Mexico and select Middle East countries. The company's headquarters are in Petaluma, California, with manufacturing operations in the United States and Latin America. More information can be found at www.oculusis.com.
Investor 100
ROSG:Rosetta Genomics Reports Study Comparing microRNA Profiles of Cancer of Unknown Primary and Metastases of Known Primary Tumors Published in Clinical Experimental Metastasis
PPS:$4.60
http://finance.yahoo.com/news/rosetta-genomics-reports-study-comparing-133000638.html
PHILADELPHIA and REHOVOT, Israel, Jan. 9, 2013 /PRNewswire/ -- Rosetta Genomics Ltd. (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." The article can be viewed online at http://www.ncbi.nlm.nih.gov/pubmed/23124598.
The study assessed microRNA differences between CUP metastases with favorable prognosis and metastases of known primary tumors in order to screen for an aggressive, pro-metastatic, CUP-specific biologic signature.
The study consisted of two stages. In the first stage, metastases obtained from CUP cases were assigned to a primary tissue of origin using Rosetta's miRview® mets2 microarray assay and compared to pathological and clinical presentation. In the second stage, the expression of 733 microRNAs was examined in CUP tumors classified as breast, serous ovarian and upper squamous cancers and compared to that of matched KPMs.
The study evaluated approximately 100 CUP and KPM tumors and found no unique microRNA signature differentiating CUP presentation from that of metastases of known primaries. This supports current gold standard treatment for patients with favorable prognosis CUP, who are managed similarly to those with equivalent metastatic tumors of known primary. This study was a sub-set of a larger retrospective study assessing the performance of the miRview mets2 assay in a cohort of real CUP patients. The results of that study demonstrated that miRview mets2 assay showed agreement with pathological and clinical information in 92% of cases. Those data have been presented at medical conferences and are expected to be published in a separate peer-reviewed journal article.
Study author, George Pentheroudakis, M.D., Department of Medical Oncology at the University of Ioannina Medical School in Ioannina, Greece, noted, "This research is the first look for microRNA characteristics of CUP tumors. Study results confirmed epidemiologic evidence suggesting that patients with favorable prognosis CUP have a presentation, response to therapy and outcome no different from metastatic tumors of matched primaries."
"This publication demonstrates the utility of microRNA profiling in understanding the biology of CUP and may have important implications for the prognosis and treatment of CUP patients," stated Kenneth A. Berlin, President and CEO of Rosetta Genomics. "We look forward to the publication of the full data set which we believe continues to underscore the clinical value of our miRview mets2 assay in identifying the primary tumor type in CUP patients in order to optimize treatment protocols and potentially improve clinical outcomes."
About Cancer of Unknown Primary Origin
According to the American Cancer Society, an estimated 2 to 5 percent of all cancer patients have metastatic (secondary) tumors for which routine testing cannot locate the primary site. This is called cancer of unknown primary origin. Patients may be diagnosed with cancer of unknown primary origin if the primary tumor is too small to be identified with routine imaging tests, it regresses (disappears) before a secondary tumor arises or the secondary tumor has several possible primary sites. Cancer of unknown primary origin can appear anywhere in the body, but is most commonly found in the lymph nodes, liver, lungs, bones or skin.
The miRview mets2 assay measures the expression level of 64 microRNA biomarkers, which are then processed by an algorithm composed of two classifiers and a decision-maker that can accurately identify the origin of the patients' tumor for 42 different cancer tissue types, with 85 percent sensitivity and 99 percent specificity. Clinicians use Rosetta Genomics' assay to better diagnose CUP patients and get them on more optimal treatment plans.
About miRview®Products
miRview® are a series of microRNA-based diagnostic products offered by Rosetta Genomics. miRview® mets² accurately identifies the primary tumor type in primary and metastatic cancer including CUP. miRview® meso diagnoses mesothelioma, a cancer connected to asbestos exposure. miRview® lung accurately identifies the four main subtypes of lung cancer using small amounts of tumor cells. miRview® kidney accurately classifies the four most common kidney tumors: clear cell renal cell carcinoma (RCC), papillary RCC, chromophobe RCC and oncocytoma. miRview® tests are designed to provide objective diagnostic data; it is the treating physician's responsibility to diagnose and administer the appropriate treatment. In the U.S. alone, Rosetta Genomics estimates that 200,000 patients a year may benefit from the miRview® mets² test, 60,000 from miRview® meso, 54,000 from miRview® kidney and 226,000 patients from miRview® lung. The Company's assays are offered directly by Rosetta Genomics in the U.S., and through distributors around the world. For more information, please visit www.mirviewdx.com. Parties interested in ordering the test can contact Rosetta Genomics at (215) 382-9000 ext. 309.
About Rosetta Genomics
Rosetta develops and commercializes a full range of microRNA-based molecular diagnostics. Founded in 2000 Rosetta's integrative research platform combining bioinformatics and state-of-the-art laboratory processes has led to the discovery of hundreds of biologically validated novel human microRNAs. Building on its strong patent position and proprietary platform technologies, Rosetta is working on the application of these technologies in the development and commercialization of a full range of microRNA-based diagnostic tools. Rosetta's miRview® product line is commercially available through its Philadelphia-based CAP-accredited, CLIA-certified lab. Frost & Sullivan recognized Rosetta Genomics with the 2012 North American Next Generation Diagnostics Entrepreneurial Company of the Year Award.
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INO:Inovio Pharmaceuticals to Initiate Clinical Trial for its Hepatitis C Therapeutic Vaccine (INO-8000) Later this Year
Phase I/IIa Trial Follows Preclinical Study Demonstrating for First Time that a Multi-Antigen HCV Vaccine Can Generate Potent T-Cell Response in Liver
PPS:.62
http://finance.yahoo.com/news/inovio-pharmaceuticals-initiate-clinical-trial-090000907.html
BLUE BELL, Pa., Jan. 9, 2013 /PRNewswire/ -- 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. This advancement is based on outstanding results of a preclinical study which demonstrated for the first time that a multi-antigen SynCon® HCV vaccine can generate robust T-cell responses not only in the blood but, more importantly, in the liver, an organ known to supress T-cell activity. VGX International is funding all preclinical and clinical development.
In preparation for entering clinical trials with its HCV vaccine (INO-8000), Inovio has completed manufacturing of its multi-antigen HCV vaccine and is performing IND (Investigational New Drug application)-enabling toxicity testing in animals. INO-8000 is a SynCon HCV therapeutic vaccine targeting NS3/4A, NS4B, and NS5A proteins of HCV. INO-8000 was designed with Inovio's SynCon process to broadly cover HCV genotypes 1a and 1b, the types that have been most difficult to treat with drug therapies.
It is estimated that more than 5 million people in the United States are infected with hepatitis C, and perhaps as many as 200 million around the world. This makes HCV one of the greatest public health threats of this century.
HCV vaccine research to date has mostly focused on one area of the virus (the NS3/4A proteins) to induce T-cell responses; however, there has been little research aimed at elucidating whether vaccines targeting proteins other than NS3/4A can induce potent T-cell responses within the liver. In this study, Inovio and its collaborators developed SynCon antigen constructs that targeted three other areas of the HCV virus (NS4B, NS5A and NS5B) and then demonstrated that each vaccine construct expressed its respective protein and that all three constructs induced potent HCV-specific T-cells in mice.
Prior research has also identified that a successful HCV vaccine must be able to induce not only strong HCV-specific T-cell responses that target several components of the virus but that these cells must migrate to the liver and remain activated. In this study, Inovio researchers observed in the liver not only NS4B-, NS5A- and NS5B-specific CD4+ and CD8+ (or killer T-cell) responses, but also a large pool of vaccine-specific T-cells. This pool of vaccine-specific T-cells was shown to be fully functional in an environment in which T-cell activity is usually suppressed. In fact, using a transient HCV infection model in mice, therapeutic immunization with INO-8000 was able to clear HCV antigens from the liver, demonstrating the therapeutic potential of this vaccine.
The pioneering preclinical research appears in the peer-reviewed journal Plos One in an article entitled: "Induction of Intrahepatic HCV NS4B, NS5A and NS5B Specific Cellular Immune Responses following Peripheral Immunization."
In addition to moving forward with INO-8000, Inovio has a long-standing partnership with ChronTech Pharma, which is developing its NS3/4A-based HCV DNA vaccine using Inovio's proprietary delivery technology. Interim results of ChronTech's open-label, randomized phase II trial are expected later in the first quarter of this year.
Dr. J. Joseph Kim, Inovio's President and CEO, said, "Inovio is a leader in developing therapeutic vaccines for HCV and HBV. The major hurdle to developing therapeutic vaccines for these ailments has been the inability to generate a functional T-cell response in the liver. The fact that our preclinical model demonstrated functional T-cells in the liver in this published study suggests that INO-8000 has the capacity to clear that hurdle. There have been important recent drug therapy advances for HCV; however, a safe and effective therapeutic vaccine could play a vital role in enhancing the potency of HCV treatments, especially for genotype 1, while achieving the desired goal of eliminating the use of interferon/ribavirin and their undesirable side effects."
About Hepatitis C and Inovio's SynCon® Vaccines
Hepatitis C is an infectious disease affecting primarily the liver, caused by the hepatitis C virus (HCV). The infection is often asymptomatic, but chronic infection can lead to liver failure or liver cancer. Approximately 80% of people who become infected with hepatitis C virus develop chronic infection.
The major obstacle to HCV vaccine development has been the extensive genetic variation between different strains and genotypes, and even the significant antigenic variation among virus within individual patients. In addition, the absence of a clearly defined protective immune response after natural infection has historically complicated the prospects of developing a vaccine against HCV infection.
However, unlike traditional vaccines constrained by the paradigm of matching a preventive or therapeutic vaccine to a single pathogen strain or strains, Inovio's SynCon vaccines are based on genetic code for a specific antigen from multiple strains of the target pathogen. Thus, while the SynCon antigens may not be perfectly (100%) matched to the pathogenic strains, they are designed to protect against multiple existing strains as well as changing strains of a virus. Extensive preclinical data has validated their ability to protect against many strains of a disease; initial human data for our influenza vaccine has also provided evidence of this capability.
About Inovio Pharmaceuticals, Inc.
Inovio is revolutionizing vaccines to prevent and treat today's cancers and challenging infectious diseases. Its SynCon vaccines are designed to provide universal cross-strain protection against known as well as newly emergent unmatched strains of pathogens such as influenza. These synthetic vaccines, in combination with Inovio's proprietary electroporation delivery, have been shown in humans to generate best-in-class immune responses with a favorable safety profile. Inovio's clinical programs include phase II studies for cervical dysplasia, leukemia and hepatitis C virus and phase I studies for influenza and HIV. Partners and collaborators include the University of Pennsylvania, Merck, ChronTech, National Cancer Institute, U.S. Military HIV Research Program, NIH, HIV Vaccines Trial Network, University of Southampton, US Dept. of Homeland Security, University of Manitoba and PATH Malaria Vaccine Initiative. More information is available at www.inovio.com.
This press release contains certain forward-looking statements relating to our business, including our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines and our capital resources. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials and product development programs (including, but not limited to, the fact that pre-clinical and clinical results referenced in this release may not be indicative of results achievable in other trials or for other indications, that the studies or trials may not be successful or achieve the results desired, that pre-clinical studies and clinical trials may not commence or be completed in the time periods anticipated, that results from one study may not necessarily be reflected or supported by the results of other similar studies and that results from an animal study may not be indicative of results achievable in human studies), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by the company or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that the company and its collaborators hope to develop, evaluation of potential opportunities, issues involving product liability, issues involving patents and whether they or licenses to them will provide the company with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether the company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of the company's technology by potential corporate or other partners or collaborators, our ability to secure new partnerships and collaborations, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2011, our Form 10-Q for the quarter ended September 30, 2012, and other regulatory filings from time to time. There can be no assurance that any product in Inovio's pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate.
CONTACTS:
Investors: Bernie Hertel, Inovio Pharmaceuticals, 858-410-3101, bhertel@inovio.com
Media: Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211, jrichardson@inovio.com
(Logo: http://photos.prnewswire.com/prnh/20120131/LA44118LOGO
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