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$ADMD News>
Advanced Medical Isotope Corporation Announces Three Year Business Strategy Focused on Transitioning From a Development-Stage Company to an Operating Company
Operations to Center on Yttrium-90 Brachytherapy Products Following Anticipated Receipt of FDA Clearance of Y-90 RadioGel(TM) Brachytherapy Device
KENNEWICK, Wash., Dec 02, 2013 (GLOBE NEWSWIRE via COMTEX) -- Advanced Medical Isotope Corporation ("AMIC") (OTCBB:ADMD), a company engaged in the development, production and distribution of medical isotopes, today announced that its Board of Directors has approved a three year business strategy focused on transitioning to full operations in 2014, following the anticipated receipt of FDA clearance for its patented brachytherapy cancer product, Yttrium-90 RadioGel.
The business strategy results from the Company's success in developing a family of three brachytherapy devices and the Company's belief that there is: (1) strong market potential for these products in the United States and internationally, (2) the potential for attractive operating margins from the commercialization of such devices, (3) a considerably smaller capital requirement to complete the regulatory process and deploy these devices, as compared to the capital required for most of the other initiatives the Company is developing and (4) a material potential for the Company to receive advances and minimum guarantees from international licensees of these products.
The business strategy recognizes the advanced stage of development for certain other Company initiatives and prioritizes those initiatives based upon criteria, including: capital requirements and sources; market size and operating margin; competition and strength of AMIC's intellectual property protection; probability of implementation; and support for the Company's immediate goal of deploying its brachytherapy products upon receipt of regulatory approval and sufficient financing.
The Company's financing efforts, allocation of resources, participation in industry events, web site and other activities will be modified to implement the priorities adopted by the Board.
AMIC To Focus on Launch of Yttrium-90 Brachytherapy Products
AMIC announced on November 3, 2013 that it filed a premarket notification with the U.S. Food and Drug Administration (FDA) pursuant to section 510(k) for a patented brachytherapy cancer treatment using the Yttrium-90 (Y-90) RadioGel device. On November 18, 2013, the FDA notified AMIC that an administrative acceptance review was conducted and the Company's premarket notification was found to contain all of the necessary elements and information needed to proceed with the substantive review. Pursuant to Section 510(k), the FDA has until approximately February 2014 in which to clear AMIC's Yttrium-90 RadioGeldevice for commercial distribution or to seek additional information. The FDA previously confirmed that it would review the product as a medical device. Following notification of FDA clearance, the Company would immediately have the right to commence manufacturing, marketing and sales of the product in the United States and its possessions.
The Company intends to file FDA premarket notifications for two related Yttrium-90 brachytherapy devices promptly after receiving either clearance from the FDA for the Y-90 RadioGel device, or any comments from the FDA to its application.
Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area. Annual sales of brachytherapy products exceed $1 billion, about half of which are in the United States. Among the cancers for which brachytherapy is often selected as a treatment are prostate, liver, breast, as well as head and neck tumors. AMIC's products may also offer treatment options for certain pancreatic cancers. Once it receives FDA clearance, AMIC intends to begin marketing efforts in the United States for its Y-90 RadioGel(TM) device. In addition, AMIC intends to seek opportunities to license its products for worldwide sales, subject to the applicable local regulatory approvals.
The composition and uses of AMIC's brachytherapy products are protected by a series of exclusive patent licenses from the Battelle Memorial Institute and the University of Utah.
The three Y-90 brachytherapy devices developed by AMIC are:
- Y-90 RadioGel Device - combines insoluble Y-90 microspheres and a polymer carrier that is injected directly into the tumor;
- Y-90 Fast-Resorbable Polymer Seeds - intended as a safer, more effective and less expensive alternative to existing metal and glass seeds used in other brachytherapy devices;
- Y-90 Polymer Topical Paste - intended as a supplemental treatment to be applied into a surgical incision to kill residual tumor cells.
As noted above, the 510(k) application filed by AMIC pertains only to the Y-90 RadioGel device.
AMIC's analyses support an expectation that its brachytherapy products will achieve a higher therapeutic index than existing brachytherapy products, while reducing collateral damage to healthy tissue due to the shorter penetration distance, shorter half-life and other attributes of the device as compared to brachytherapy devices that use isotopes emitting gamma radiation. These features also reduce the risk of radiation exposure to the patient, family members and medical personnel involved in manufacturing and injecting the device. In addition, the AMIC Y-90 RadioGel device uses a biodegradable carrier with FDA approved components which leaves no metal or glass in the patient.
In the United States, the Company intends to outsource material aspects of manufacturing, distribution, sales and marketing. Outside of the United States, the Company intends generally to enter into licensing arrangements. The Company will evaluate its alternatives before finalizing its plans.
AMIC also to Expand Sales Capability and Consider Acquisition of German Company
The Board approved of two secondary priorities for 2014 and 2015:
-- Expansion of the Company's sales agency activities for isotopes and related equipment manufactured by third parties. This activity requires very little capital, facilitates the Company's interaction with potential partners, customers and vendors and should be immediately cash positive. In the third quarter of 2013, the Company derived approximately $115,000 from such activities. By expanding this activity, the Company expects to be able to raise less capital through the sale of securities, thereby reducing dilution for shareholders. Profits from sales agency activities also could help create greater shareholder value, particularly if the Company is valued based upon its core brachytherapy business.
-- Potential acquisition of a controlling interest in a specific company headquartered in Germany with which AMIC has been cooperating for the last few years. Acquisition of a controlling interest in this company could facilitate the Company's business progress in Germany and other European markets. Germany accounts for the largest market share of the European nuclear medicine market, which is the world's second-largest market for nuclear medicine, after the United States. The target company presently derives less than 1% of its sales in the United States. AMIC believes it could contribute to a significant increase in U.S. sales for this target company.
Although the parties have reached an agreement in principle on a path forward, any transaction would be subject to reaching definitive agreements, AMIC obtaining sufficient financing and any required regulatory approvals. Because the target company is fully-operational and profitable, a business combination likely would be immediately accretive for AMIC shareholders.
The Board's business strategy also contemplates that the Company will continue operation of its linear accelerator located in Kennewick, consider building a larger cyclotron production facility in Southern California in partnership with a major medical facility and continue its research and development activities for other isotopes and technologies, though the pace of all activities will be subject to the needs and performance of the Company's strategic priorities, particularly the successful launch and growth of the brachytherapy products.
AMIC's Financial Requirements and Prospects
Over the next year, the Company anticipates a requirement of about $1.5 million to maintain current operating activities and from approximately $2 million to $5 million to fund: (1) the FDA approval process and initial deployment of the brachytherapy products, and (2) a sales capability for third party isotopes and equipment. The continued deployment of the brachytherapy products would require additional spending. The principal variable in the amount of near-term spending for the brachytherapy products will be the nature of the Company's arrangements with third parties for manufacturing, sales, distribution and licensing of those products.
The acquisition of a controlling interest in the German company likely would require up to approximately $3 million of cash and stock. Following its acquisition, the target company should operate on a cash positive basis. In allocating its capital between the brachytherapy products and the potential acquisition, the Company's first priority is the FDA clearance for, and successful roll-out of, the brachytherapy products. The Company believes that its acquisition of a controlling interest in the German target company would help achieve that goal in Europe and Russia.
The Company anticipates funding the initial six months of its requirements for brachytherapy, sales agency activities and potentially the acquisition of a controlling interest in the German company through the sale of equity or equity-linked securities. In support of these efforts, the Company has reached an agreement in principle with the Company's largest creditors to convert most of their debt into equity concurrent with the Company's receipt of funds on pricing comparable to that obtained in any such financings.
Thereafter, the Company anticipates that funding also would be provided by the Company's business activities, including, potentially, advances from foreign licensees for the brachytherapy products and proceeds from the sales agency activities and the Company's linear accelerator in Kennewick.
There can be no assurance regarding the outcome of the Company's regulatory, financing or commercial efforts. If some of the anticipated results are delayed or do not occur, the Company's anticipated spending and capability to fund that spending would decline. Conversely, if the Company has the financial capacity to do so, the Company could spend additional sums to grow its businesses more rapidly and to maintain or accelerate research and development activities for future products and technologies.
Though there are many uncertainties, if the FDA provides clearance for the RadioGel device during the first half of 2014, the Company believes that its operations could turn cash-positive within four to nine months thereafter and could turn profitable on a GAAP-basis within six to 12 months after clearance is obtained, in each instance despite increased spending to support the deployment.
To bolster its capability to seek funding and to structure and negotiate outsourcing and licensing agreements, in October 2013, the Board elected Kenin M. Spivak to be a Director and Vice-Chairman. Mr. Spivak has extensive experience securing, structuring and negotiating complex transactions, including financings, manufacturing, sales, marketing, distribution, licensing, joint ventures and business combinations and directing roll-outs for a range of technologies, products and services. Though Mr. Spivak will not be a full-time Company officer or direct the Company's roll-out of its brachytherapy products, the Company believes that Mr. Spivak's advice and support will materially benefit the Company's effort.
If the Company obtains the financing it seeks, the Company anticipates that it will be able to employ more of its part-time scientists on a full-time basis and that it will be able to engage marketing professionals with experience directly pertinent to its brachytherapy products.
AMIC's Longer-Term Business Strategy
The business strategy adopted by the Board mandates that the Company's first priority after 2015 would continue to be the deployment of its brachytherapy devices. Second, the Company would continue to nurture and grow the other business activities undertaken in 2014 and 2015. Subject to the success of the Company's business and the availability of sufficient resources, by 2016, the Board has directed that the Company take steps toward the commercialization of other isotopes, businesses and technologies intended to help improve the diagnosis and treatment of cancer and other illnesses.
Among those longer-term projects being considered by the Company are potential solutions for the impending severe shortages of Molybendum-99 and its derivative product Technetium-99m, the most widely used isotopes for diagnostic purposes.
Conclusions
AMIC Founder, Chairman and CEO James C. Katzaroff commented: "The business strategy mandated by the Board is intended to focus AMIC on smoothly and profitably transitioning from a development-stage company into an operating company with a series of products that will help improve lives, can be commercially introduced with limited capital requirements and can reach positive cash flow and profits within a reasonable period after we receive clearance from the FDA."
Mr. Katzaroff added: "Though AMIC will continue to progress our growth as a sales agency and will continue discussions for a possible acquisition in Europe, we will do so in support of our core mission to obtain FDA clearance and funding for our RadioGel(TM) device and other brachytherapy products so that we can commercially roll out these products commencing in 2014. We also will continue discussions for a cyclotron production facility and development of other products and technologies. However, the resources allocated to all AMIC activities will now be assessed against the impact on a successful deployment of our brachytherapy products and using that deployment to deliver therapeutic value to patients and financial value for our shareholders."
About Advanced Medical Isotope Corporation
Advanced Medical Isotope Corporation (OTCBB:ADMD) is a late stage development company engaged primarily in the development of brachytherapy devices and medical isotopes for diagnostic and therapeutic applications. AMIC's focus is on transitioning to full operations upon receipt of expected FDA clearance for its patented brachytherapy cancer product, Yttrium-90 RadioGel. AMIC intends to file FDA premarket notifications for two related Yttrium-90 brachytherapy products. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area. Annual sales of brachytherapy products exceed $1 billion, about half of which are in the United States. The Company intends to outsource material aspects of manufacturing, distribution, sales and marketing for its products in the United States and to enter into licensing arrangements outside of the United States, though the Company will evaluate its alternatives before finalizing its plans. For more information, please visit our website, www.isotopeworld.com.
The Advanced Medical Isotope Corporation logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5139
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, AMIC's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control.
CONTACT: Advanced Medical Isotope Corporation
James C. Katzaroff
(509) 736-4000
6208 W. Okanogan Ave.
Kennewick, WA 99336
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KEYWORD: KENNEWICK, Wash.
INDUSTRY KEYWORD: Medical Supplies
SUBJECT CODE: Company Announcement
MEDICAL
HEALTH
Does anyone remember
Vermillion Inc (VRML.W)
About 4 years ago it went from 3 cents to 38 bucks in less than 5 days.Everything about $ADMD feels the exact same way.If we get FDA approval.(we will fly) Go $ADMD
~ HALO.. huge congrats to captain io_io of pirate ship and his crew members since HALO was your strong strong pick for over the year!!!..you posted your dd(s) after dd(s) there... i couldn't understand well since it looked too difficult for me...
well, i knew the pps would spike after i'm stopped out the other day...
,,,except a few bio-stocks, i placed stops and my HALO was gone...its not all my fault though since at that time, bio market looked very crazy!
is it still ok for me to get back in here...? ...hahaha
~ dumb,,,why did i place the stops on HALO... sometimes, i really hate myself on trading these bio.... btw, i love my CHTP...i know you posted several dd(s) there but was it your pick also? (sorry, i forgot)
where did everyone go? how bout ZLCS?? 2 catalysts late Oct/Nov + ODD designation
NVAX - 9/24 is 1st ever analyst day. if anything surprising positive, this will gap up the stock. otherwise, i think low $3s is fair for now.
DRRX - awaiting for data results.http://biotuesdays.com/2013/09/17/diadexus-awaiting-gsks-darapladib-pivotal-results/
PCHM Recent FDA News 5.85 million shares outstanding
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=91993574
$BONE has a conference call with CEO aftermarket hours today. BONE is schedule to attend Rodman and Renshaw conference tomorrow. If the news was actually bad, the company would of cancelled the conference. The CEO Dan Goldberger started to buy shares into the company when he joined August. The stock offering and NYSE good standing were both done in June. Depending on the news, the stock could fly. Do your own Due Diligence.
POZN exclusive deal with Sanofi
Sanofi US and POZEN Sign Exclusive License Agreement for the Commercialization of PA8140/PA32540 Tablets in the U.S.
BRIDGEWATER, N.J. and CHAPEL HILL, N.J., Sept. 4, 2013 /PRNewswire/ -- Sanofi US (SNY) and POZEN Inc. (POZN) announced the signing of an exclusive license agreement for the commercialization of POZEN's proprietary, investigational, coordinated-delivery tablets combining immediate-release omeprazole, a proton pump inhibitor (PPI), and enteric-coated (EC) aspirin in a single tablet ("PA"), PA8140 and PA32540. Under the terms of the agreement, Sanofi will have exclusive rights to commercialize all PA combinations that contain 325 mg or less of enteric-coated aspirin in the United States. POZEN will receive an upfront payment of $15MM and will be eligible for pre-commercial milestone payments of up to $20MM and other future milestone payments and royalties on product sales.
(Logo: http://photos.prnewswire.com/prnh/20110616/NY20158LOGO)
"Sanofi has a strong heritage and expertise in the cardiovascular space, with Lovenox, Plavix, and most recently Multaq, and the PA products are an important addition to our already strong CV portfolio," said Anne Whitaker, President, North America Pharmaceuticals at Sanofi US. "The PA products have the potential to be an effective solution for the millions of patients at risk for gastric ulcers from chronic aspirin use in the prevention of secondary cardiovascular disease. We look forward to bringing this therapy to patients and healthcare providers."
Sanofi US will have responsibility for all sales, marketing, ongoing manufacturing and future development for the licensed PA products in the U.S. POZEN will retain responsibility for obtaining approval of the New Drug Application (NDA), after which time POZEN will transfer the NDA to Sanofi US. The NDA was submitted in March 2013 and accepted for filing in May 2013 by the U.S. Food and Drug Administration (FDA).
John R. Plachetka, Pharm.D., Chairman, President and Chief Executive Officer of POZEN Inc. said, "We are pleased to have Sanofi US commercialize PA8140 and PA32540 in the US. We have been excited about the results of our Phase 3 clinical trials and look forward to the prospect of making this product available to cardiovascular patients at risk for gastric ulcers. Sanofi's dominant CV heritage and strong commitment to PA, make them the right partner for these products."
About PA
POZEN has created a portfolio of investigational integrated aspirin therapies - the PA product platform. The products in the PA portfolio are being developed with the goal of significantly reducing GI ulcers and other GI complications compared to taking enteric-coated or plain aspirin alone.
The first candidates are PA32540, containing 325 mg of aspirin, and PA8140, containing 81 mg of aspirin. Both products are a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), a proton pump inhibitor, layered around a pH-sensitive coating of an aspirin core. This novel, patented product is intended for oral administration once a day and an indication is being sought for use for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
About Cardiovascular Disease
Patients with established coronary heart disease or cerebrovascular disease have a high risk of a subsequent cardiovascular event including myocardial infarction (MI), stroke and death from cardiovascular disease. For such patients, lifestyle changes and drug therapy are of proven benefit and may improve outcomes. Heart disease is the leading cause of death for both men and women in America today. Coronary artery disease is the most common type of heart disease and is caused by atherosclerosis and often develops into angina pectoris and MI. This condition can lead to angina pectoris and MI and caused more than 405,000 deaths in 2008[ii]. Roughly 16.8 million people have a history of MI and/or angina[iii]. An estimated 24 million have been identified as secondary prevention patients (post-event)[iv]. It is estimated that cardiovascular disease causes one in every three deaths in the United States[v]. Every 25 seconds, someone in the United States will suffer a coronary event[vi]. About every minute, someone will die from one[vii].
About POZEN
POZEN Inc. is a small pharmaceutical company that specializes in developing novel therapeutics for unmet medical needs and licensing those products to other pharmaceutical companies for commercialization. By utilizing a unique in-source model and focusing on integrated therapies, POZEN has successfully developed and obtained FDA approval of two self-invented products in two years. Funded by these milestones/royalty streams, POZEN is creating a portfolio of cost-effective, evidence-based integrated aspirin therapies designed to enable the full power of aspirin by reducing its GI damage.
POZEN continues to seek strategic partners to help maximize the opportunities for its portfolio assets.
The Company's common stock is traded under the symbol "POZN" on The NASDAQ Global Market. For more detailed company information, including copies of this and other press releases, please visit www.pozen.com.
About Sanofi
Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (SAN) and in New York (SNY).
Sanofi is the holding company of a consolidated group of subsidiaries and operates in the United States as Sanofi US, also referred to as Sanofi-aventis U.S. LLC. For more information on Sanofi US, please visit http://www.sanofi.us or call 1-800-981-2491.
CYTK coming back nicely when yesterday AMGN announced it would release the two new data for their partnership drug pipelines. CYTK was suppose to release the data initially but AMGN is taking the lead on PR(maybe positive results, why else would AMGN expose itself more publicly). Wonder if AMGN will announce data on Sept 3 and consider a buyout of CYTK? Anything is possible.
BTW AMGN is on a hot streak, just purchasing ONXX for 10.5 billion and taking a loan to make this purchase due to foreign tax guideline. Plenty of more cash in the bank for more acquisitions.
PBSV -- Pharma-Bio Serv: 62% Upside Based On Last Earnings Results Alone
http://seekingalpha.com/article/1642342-pharma-bio-serv-62-upside-based-on-last-earnings-results-alone?source=yahoo
CPRX $1.47 premarket, gapping higher...
IPCI $2.05, some DD below to browse.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=90520148
BioSpecialist Wednesday, July 31, 2013 11:35:56 AM
Re: None Post # of 1674
Back in this Goldmine
FIRST FDA APPROVAL EXPECTED IN THIS 3Q 2013....
This LOW FLOAT Monster awaiting 8 FDA approvals.IPCI has 15 Drugs in Pipeline many nearing ANDA/NDA filing including two Potential Blockbuster .CEO is the largest Shareholder with over 6 Million Shares .
FOCALIN alone which is Partnered with Par Pharma will drive this Sleeping Giant into Profitability quickly after Market Launch because of the low Burn-rate of around $7 M a year !
4-6 FDA APPROVALS COMING WITHIN NEXT 12 MONTHS = NEXT BILLION DOLLAR COMPANY HERE !
Patience here will payoff big time ! GLTA
Intellipharmaceutics (IPCI)
Market Cap:$ 38 M
Price: $1.90
Shares Out: 21 Mil..(10 Mil Shares held by Insiders/Institutions)
Low Float: 11 M
8 Generic Drug Applications Filed with the FDA
We currently have eight Abbreviated New Drug Applications awaiting FDA approval. These include generics of Focalin XR® Effexor XR®, Protonix ®' Glucophage ® XR,Seroquel XR®, Lamictaf® XR Keppra XR® and Pristiq® .Together, these products represent approximately $4.78 of branded and generic sales.
Our lead product, a generic version of Focal in XR®, is partnered with Par Pharmaceuticals Inc., a top ten U.S.pharmaceutical company.As a result of a settlement with the innovator company, we expect to marketing of our generic versions ofFocalin XR® upon approval. We have a ten year profit-sharing agreement with Par for the sale of a generic version of Focal in XR® in the U.S.,which commences with the commercia/launch of the product by Par .
BioDefense And BioTherapeutics Gain Federal Support
http://www.lifescienceleader.com/component/k2/item/4540-biodefense-and-biotherapeutics-gain-federal-support
iBio Pharmaceutical Technology Embraced by the Government of Brazil
NEWARK, Del., June 24, 2013 /PRNewswire/ -- iBio, Inc. (NYSE MKT: IBIO) today released the following information, which was contained in the Portuguese language report published on June 18, 2013 in the official Journal of the Government of Brazil under the heading, "Brazil Expands Production of Biological Medicines." This information is being released in this translated form by iBio to assure uniform distribution to the public of material information regarding iBio. References to the "factory" refer to the facility described in iBio's press release dated April 9, 2013 and to the "first vaccine in the world from a plant," to the vaccine described in iBio's release dated January 18, 2011.
(Logo: http://photos.prnewswire.com/prnh/20120419/NY91086LOGO )
"The ministry will invest U.S. $ 170 million in the construction of the first national factory of organic products made from plant cell technology unprecedented in the country, in Ceara."
"The first technology platform for the production of biological medicines from plant cells, such as carrot and tobacco, involves partnerships between Fiocruz and the Israeli company Protalix, the American Fraunhofer USA Center for Molecular Biotechnology, and iBio Inc. This was also the first plant-based biotechnological which was registered in the Food and Drug Administration (FDA) and the National Agency for Sanitary Surveillance (ANVISA), worldwide. Operations should start at full steam in 2016. The new Fiocruz center will be installed in the city of Eusebio near Fortaleza (Ceara) and construction starts from 2014. A factory will initially produce drugs for rare diseases as Taliglucerase Alfa Recombinant Human, for Gaucher disease, and the first vaccine in the world from a plant, against yellow fever."
"The production process from the extraction plant is a novelty in the country. The technology ensures higher security than the biological produced from viruses and bacteria. It produces fewer side effects and less resistance facing the human body which receives the treatment. Moreover, it requires less investment."
"Ceara is very happy to help correct regional inequalities. It is the country's time to celebrate because we see investing in Brazil and seeing possibilities," said state governor Cid Gomes.
"Organic products are more effective compared to traditional medicines from chemical synthesis, increasing the chances of successful treatment especially for chronic diseases. They are made from living material and manufactured from processes involving personalized medicine and molecular biology."
"Currently biological resources represent 43% of the medicines used by the Ministry of Health, or about U.S. $ 4 billion per year."
Full text of the original Portuguese language article is available at this link: http://www.jornaldebrasilia.com.br/site/noticia.php?brasil-amplia-producao-de-medicamentos-biologicos&id=476955
CYTK..$2.16. Watch very closely. Strong move last Fri, +22%. Uptrend could continue this week. Looks like heavy buying by institutions are just commencing. Last Tuesday’s 13D filing shows Amgen owns 7.58% of CYTK. Their Phase 2B trial, ATOMIC-AHF, was accepted for presentation as a “Hot Line Late Breaking Trials Session” at the European Society of Cardiology (ESC) Congress, scheduled for September 3. On June 28, CYTK is set to join the Russell Global Index. Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for both passive and active investment strategies.
Needham & Company Sees 150% Upside in Cytokinetics (CYTK) after Expanded Amgen (AMGN) Deal
http://www.streetinsider.com/Analyst+Comments/Needham+%26+Company+Sees+150%25+Upside+in+Cytokinetics+%28CYTK%29+after+Expanded+Amgen+%28AMGN%29+Deal/8413213.html?si_client=st
Jun 12, 2013 Amgen and Cytokinetics Announce Expansion of License for Omecamtiv Mecarbil
Cytokinetics Will Receive $25 Million Plus Potential Milestone Payments and Royalties
http://www.cytokinetics.com/press_releases/release/pr_1371006833
Jun 17, 2013 Cytokinetics Set to Join Russell Global Index
http://www.cytokinetics.com/press_releases/release/pr_1371448381
Jun 18, 2013 Cytokinetics Announces Results From ATOMIC-AHF Will Be Presented At Late Breaking Clinical Trials Session At The European Society Of Cardiology Congress 2013
http://www.cytokinetics.com/press_releases/release/pr_1371514708
PBSV -- Pharma-Bio Serv Announces Results for the Quarter Ended April 30, 2013
DORADO, PUERTO RICO--(Marketwired - Jun 14, 2013) - Pharma-Bio Serv. (OTCQB: PBSV), a global compliance and validation services consulting solutions provider, announced net revenues for the three and six months ended April 30, 2013 of $8.3 and $15.9 million, an increase of approximately $1.2 and $2.5 million, or 17% and 18%, respectively, when compared to the same periods last year.
The Company reported net income for the three and six months ended April 30, 2013 of approximately $1.4 and $2.4 million, an increase of $0.2 and $0.1 million, respectively, when compared with the same periods last year.
Revenue growth for the three and six months ended April 30, 2013, over the same period last year, is mainly attributable to increases in the United States Consulting market and Lab services, respectively, offset by a decrease in revenues in the Integratek division and other minor revenue gains from other Company divisions.
Net income growth, when compared to the same period last year, is attributable mainly to the aggregate increase in overall gross margins, offset by the increase in selling general and administrative expenses to support the favorable revenue trend and business development expenses to diversify our markets, and the effective income tax rates (including Puerto Rico favorable tax grants) over income before tax.
Selling, general and administrative expenses for the three and six months ended April 30, 2013 were approximately $1.4 and $2.7 million, respectively, a net increase in expenses of approximately $0.4 and $0.8 million, respectively, as compared to the same periods last year. Business development and operations support expenses in the Puerto Rico and United States markets were increased to follow the consulting business favorable revenue trend. In addition, the Company made business development investments in Spain to diversify its European division market.
"We are very pleased with our continued performance in expanding our U.S. presence while efficiently managing our costs," said Nélida Plaza, Acting Chief Executive Officer, Acting President, Secretary and President of Puerto Rico Operations. "Our growth is a testament to our ability to continue to expand our US market base and increase our Lab services business," she continued.
About Pharma-Bio Serv Inc.
Pharma-Bio Serv is a global compliance and validation services consulting solutions provider, headquartered in Puerto Rico, with operations in the U.S, Ireland and Spain. Pharma-Bio Serv's core business is FDA and international agencies regulatory compliance related services with integrated portfolio services including microbiological and chemical testing services for clients in the Pharmaceutical, Biotechnology, Chemical, Medical Device, Cosmetic, Food and Allied Products industries, at its laboratory testing facility in Puerto Rico. Services also include "Integratek," an information technology consulting practice and "Pharma Serv Academy" a division that provides technical and regulatory standards seminars/training conducted by industry experts. The Company's global team includes more than 275 leading engineering and life science professionals, quality assurance managers and directors.
Forward-Looking Statements
This news release contains "forward-looking statements" within the meaning of the U.S. federal securities laws, which statements may include information regarding the plans, intentions, expectations, future financial performance, or future operating performance of Pharma-Bio Serv. Forward-looking statements are based on the expectations, estimates, or projections of management as of the date of this news release. Although Pharma-Bio Serv's management believes these expectations, estimates, or projections to be reasonable as of the date of this news release, forward-looking statements are inherently subject to significant business risks, economic and competitive uncertainties, or other contingencies, which could cause its actual results or performance to differ materially from what may be expressed or implied in the forward-looking statements. Important factors that could cause Pharma-Bio Serv's actual results or performance to differ materially from the forward-looking statements include those set forth in the "Risk Factors" section of Pharma-Bio Serv's Annual Report on Form 10-K for the year ended October 31, 2012 and in its other filings with the Securities and Exchange Commission, which filings are available on www.sec.gov. Pharma-Bio Serv disclaims any intention or obligation to update or revise any forward-looking statements to reflect subsequent events and circumstances, except to the extent required by applicable law.
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Contact:.
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Investor Relations
Scott Gordon
President
CorProminence LLC
scottg@corprominence.com
631 703 4900
LBMH -- Liberator Medical Declares Cash Dividend of $0.03 per Share and Board Authorizes a 1,000,000 Share Buyback
Dividend Is to Be Paid to the Shareholders of Record at the Close of Business on July 8, 2013
STUART, FL--(Marketwired - June 14, 2013) - Liberator Medical Holdings, Inc. (LBMH) today announced that on June 13, 2013, its Board of Directors approved a cash dividend of $0.03 per common share to its shareholders and a buyback of up to 1,000,000 shares of its common stock. This is the second cash dividend paid to shareholders in 2013 and in the Company's history.
A cash dividend of $0.03 per common share will be paid on July 22, 2013, to all shareholders of record as of the close of business on July 8, 2013. The Company's policy is to pay a sustainable quarterly dividend to its shareholders. The Company's Board of Directors will evaluate on a quarterly basis the amount and timing of future dividends based on the Company's operating results, financial condition, capital requirements and general business conditions. The amount and timing of any future dividends may vary, and the payment of any dividend does not assure that the Company will be able to pay dividends in the future.
The 1,000,000 share buyback will be implemented at management's discretion and is subject to standard corporate buyback rules and regulations.
Stay up-to-date with current events by visiting Liberator Medical's website at www.liberatormedical.com or by joining the Company's E-Mail Alert List. Join by clicking the following link www.LBMH-IR.com
About Liberator Medical Holdings, Inc.
Liberator Medical Holdings, Inc.'s subsidiary, Liberator Medical Supply, Inc., established the Liberator brand as a leading national direct-to-consumer provider of quality medical supplies to Medicare-eligible seniors. An Exemplary Provider™ accredited by The Compliance Team, its unique combination of marketing, industry expertise and customer service has demonstrated success over a broad spectrum of chronic conditions. Liberator is recognized for offering a simple, reliable way to purchase medical supplies needed on a regular, ongoing, repeat-order basis, with the convenience of direct billing to Medicare and private insurance. Liberator's revenue primarily comes from supplying products to meet the rapidly growing requirements of general medical supplies, diabetes supplies, catheters, ostomy supplies and mastectomy fashions. Liberator communicates with patients and their doctors on a regular basis regarding prescriptions and supplies. Customers may purchase by phone, mail or internet, with repeat orders confirmed with the customer and shipped when needed.
Safe Harbor Statement
In this press release and in related comments by our management, our use of the words "expect," "anticipate," "possible," "potential," "target," "believe," "commit," "intend," "continue," "may," "would," "could," "should," "project," "projected," "positioned" or similar expressions is intended to identify forward-looking statements that represent our current judgment about possible future events. We believe these judgments are reasonable, but these statements are not guarantees of any events or financial results, and our actual results may differ materially due to a variety of important factors. Such risks and uncertainties may include, but are not limited to, regulatory limitations on the medical industry in general, working capital constraints, fluctuations in customer demand and commitments, fluctuation in quarterly results, introduction of new services and products, commercial acceptance and viability of new services and products, pricing and competition, reliance upon subcontractors and vendors, the timing of new technology and product introductions, and the risk of early obsolescence of our products. Liberator's most recent annual report on Form 10-K and quarterly reports on Form 10-Q provide information about these and other factors, which we may revise or supplement in future reports filed with the Securities and Exchange Commission.
Contact:
Individual Investor Relations Contact
WSR Communications
772-219-7525
IR@WSRcommunications.com
http://wsrcommunications.ir.stockpr.com/liberatormedical
Institutional Investor Contact
Lyn Davis
Littlebanc Advisors, LLC
561-948-3005
ld@littlebanc.com
www.littlebanc.com
NWBO: very interesting post from John1045 here on ihub, not about DCVax-L (which my previous post was about), but about DCvax-direct (phase I/II)
"Recent interview with Les Goldman at NWBO
http://www.redchip.com/visibility/investor.asp?symbol=NWBO&from=wu06172013
.....a company with a market cap of $110M way undervalued! At some point the market will wake up as Germany is approved and DCVax Direct goes full steam ahead next 60-90 days now that enrollment has started on terminally ill patients with inoperable pancreatic, liver, ovarian, colon and misc tumors. Being an unbinded trial Linda said they will be providing updates ....imagine if tumor shrinks 20, 30% or more.....or completely eradicates tumor all together?? In my earlier posting #1705 (enclosed below) of Triozzi dendritic cell testing tumor shrinkage began in as little as 4 days after start of treatment with vaccine!
Dr. Bosch cites a trial by Triozzi et. al. wherein a similar trial was conducted with relatively promising results.
Abstract: Intratumoral injection of dendritic cells derived in vitro in patients with metastatic cancer.
BACKGROUND:
Dendritic cells (DCs) are potent initiators of immune responses, and the infiltration of DCs into tumors may confer an improved prognosis. Whether the injection of DCs directly into tumors can mediate biologic activity was examined.
METHODS:
Patients with metastatic dermal or subcutaneous tumors received granulocyte-macrophage-colony stimulating factor to increase the numbers of peripheral blood monocyte precursors. DCs were then generated from monocytes obtained by phlebotomy with granulocyte-macrophage-colony stimulating factor and interleukin-4 in autologous plasma. Tumors were injected at multiple sites with 30 million autologous DCs per tumor.
RESULTS:
Seven patients with melanoma and three patients with breast carcinoma were treated. Injections were well tolerated. Regression of the injected tumors, beginning as early as 4 days after injection, was observed in four patients with melanoma and in two patients with breast carcinoma. Biopsies of regressing lesions showed lymphocyte infiltration associated with DCs and necrosis. Neutrophils and macrophages were not evident. Lymphocytes expanded from the regressing tumors proliferated in response to heat shock proteins, HSP70 and gp96, derived from autologous tumor. The DCs injected produced interferon-alpha and expressed Fas ligand mRNA but did not exhibit cytolytic activity in vitro. Expression of the costimulatory molecule, B7-2 (CD86), decreased on DCs after intratumoral injection.
CONCLUSIONS:
This pilot study demonstrates that DCs derived in vitro can exist viably after intratumoral injection and can mediate biologic activity in situ. Tumor-derived heat shock proteins may be involved in the antitumor activity observed.
Copyright 2000 American Cancer Society. "
NWBO:
Here is a testimonial from one of the survivors, which IMO would already be sufficient for the FDA data monitoring board to grant DCVax-L BLA at the interim analysis, if NWBO is able to reproduce this in phase 3. Which has a big chance (because the very high p-values encountered in phase 1: p< 0.00003
GBM brain cancer patient treated with DCVax-L celebrates 10th anniversary of cancer-free survival
"Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that Brad Silver, an All American swimming and water polo athlete who was diagnosed with Glioblastoma multiforme (GBM) brain cancer in late 2002, and was treated with DCVax-L in March of 2003, just celebrated the 10th anniversary of his continued cancer-free survival.
GBM is the most aggressive and lethal form of brain cancer. With today's standard of care (surgery, 6 weeks of daily radiation to the brain plus daily chemotherapy, followed by monthly chemotherapy), this cancer typically recurs within 7 months and kills within 14.6 months. Without all these treatments, GBM typically kills within months of diagnosis.
When Brad was diagnosed, he was told by his doctors that he had only about 2 months to live.
Brad is now the second patient from the Phase I/II trials with DCVax-L for GBM who has surpassed the 10-year cancer-free survival mark. The first such patient has further passed the 11-year cancer-free mark.
Beyond these two 10-plus year survivors, the long-term follow-up data on the other patients from the Phase I/II trials shows a "long tail" of survival among them. The median survival of GBM patients treated with DCVax-L was 3 years (in contrast to only 14.6 months median survival with standard of care). The "long tail" also stretched significantly further, beyond this median: 33% of the patients reached or exceeded 4 years of survival, and 27% of the patients reached or exceeded 6 years of survival (in contrast, only 3% or so of GBM patients are still alive at the 5-year mark with standard of care treatments). Several of these patients are continuing to move through further years of survival.
"When I was told I had several months left to live in 2002, with my wife several months pregnant, I was determined to find a clinical trial that would allow me to see and raise my son," commented Brad Silver . "When that quest led me to DCVax and Dr. Linda Liau at UCLA, the natural renewal of my own immune system made more sense to me than just a continuation of the system-wide poisoning of chemotherapy. And it worked. Not only did the tumor disappear and stay away for all this time, but the only side effect I had was unbridled happiness and a new freedom. My son Brad II, who was born 10 days after my first DCVax treatment, will be 10 years old next week, and today I am there for my family thanks to DCVax."
Brad is not just in continuing remission, he is also a very hardy physical specimen. While he was a long-time resident of Ohio, Brad coached women's water polo at an NCAA division II College in Ohio. He is currently living abroad with his wife on a project assignment, and teaches swimming, physical education and sailing, and guides kayak tours. For fun he is an avid surfer.
Brad tells his inspiring story in his own words in an interview last year, with a short excerpt on YouTube at http://www.youtube.com/user/NWBioNWBO/featured.
NW Bio is currently conducting a 312-patient Phase III, double blind, randomized, placebo- controlled clinical trial with DCVax-L for GBM brain cancer using the same DCVax-L vaccine that Brad Silver received. This trial currently has 44 active sites across the US, and nearly 30 additional sites in varying states of preparation in Europe.
"We are thrilled to see Brad become our second GBM patient to pass the 10-year cancer-free milestone after treatment with DCVax-L," commented Linda F. Powers , CEO of NW Bio. "With 'state of the art' treatments today, 10-year survival in GBM is unheard of. Indeed, even survival half that long is virtually unheard of. The "long tail" of survival among a large percentage of our patients is a particularly compelling aspect of our DCVax technology."
"Our hat is off to Brad and his family for their courage and trail blazing role in helping demonstrate the potential of DCVax-L for more patients in the future," Ms. Powers continued. "Brad's example reinforces our own determination to bring DCVax to other patients as soon as possible."
http://www.news-medical.net/news/20130419/GBM-brain-cancer-patient-treated-with-DCVax-L-celebrates-10th-anniversary-of-cancer-free-survival.aspx?page=2
BIOYF / RX.V -- BioSyent Pharma Launches New FeraMAX(R) Powder-Water Soluble Polysaccharide-Iron Complex Iron Supplement
TORONTO, ONTARIO--(Marketwired - June 6, 2013) - BioSyent Inc. ("BioSyent")(TSX VENTURE:RX) today announced that its subsidiary BioSyent Pharma Inc. has commenced the Canadian launch of its unique new oral iron supplement - FeraMAX® Powder.
FeraMAX® Powder is the first innovation in the pediatric oral iron market in Canada in almost 50 years. The Canadian market launch will be the global introduction of this new product and provides BioSyent Pharma with a unique offering for international marketing partners.
FeraMAX® Powder joins FeraMAX® 150 in providing healthcare professionals and their patients with a safe, effective, and well tolerated oral iron supplement. It is indicated for the prevention of iron deficiency and iron deficiency anaemia in newborns, infants, children and adults.
FeraMAX® Powder is the only oral iron product available in a dissolvable powder and comes in pleasant tasting grape/raspberry flavoured gluten and alcohol-free crystals which can be conveniently dosed by diluting in water or mixing with soft foods. This innovative new product is based upon the same doctor recommended, proprietary, non-ionic polysaccharide-iron complex technology found in FeraMAX® 150.
Other oral iron products intended for infants and children either have an unpleasant heavy metallic taste which deter patient compliance or they come in formulations containing alcohol which healthcare professionals and caregivers prefer to avoid. In addition to its clear advantages in the pediatric market, FeraMAX® Powder is also well suited for adult patients that have difficulty swallowing pills.
FeraMAX® Powder was exhibited at the recent Primary Care Today medical conference attended by over 3,000 healthcare professionals. Listings have been secured at major wholesalers and shipments of FeraMAX® Powder, to over 30 wholesale distribution centres supplying pharmacies across Canada, will commence over the next week.
"The launch of FeraMAX® Powder further strenghtens BioSyent Pharma's leadership position in providing innovative iron supplement solutions for healthcare professionals and their patients" said René Goehrum, President and CEO of BioSyent. "We now have a full range of solutions and dosing options available for all iron deficient and iron deficient anaemia patients".
For more information regarding FeraMAX® Powder and FeraMAX® 150, visit www.feramax.com
About BioSyent Inc.
Listed on the Toronto Venture Exchange under the trading symbol "RX", BioSyent is a profitable growth oriented specialty pharmaceutical company which searches the globe to in-license or acquire innovative pharmaceutical products that have been successfully developed, are safe and effective, and have a proven track record of improving the lives of patients and supporting the healthcare professionals that treat them.
Once a product of interest has been found, BioSyent then acquires the exclusive rights to the product and manages it through the Canadian governmental regulatory approval process. Once approved, BioSyent markets the product throughout Canada.
At the date of this press release the Company had 13,571,195 shares issued and outstanding.
This press release may contain information or statements that are forward-looking. The contents herein represent our judgment, as at the release date, and are subject to risks and uncertainties that may cause actual results or outcomes to be materially different from the forward-looking information or statements. Potential risks may include, but are not limited to, those associated with clinical trials, product development, future revenue, operations, profitability and obtaining regulatory approvals.
Contact:
BioSyent Inc.
Mr. Rene C. Goehrum
President and CEO
(905) 206-0013
investors@biosyent.com
www.biosyent.com
BIOYF / RX.V -- Pharma Submits Two New Drugs to Health Canada for Marketing
Approval
TORONTO, ONTARIO, May 23, 2013 (Marketwired via COMTEX) -- BioSyent Inc. (TSX
VENTURE:RX) ("BioSyent") is pleased to announce that its subsidiary, BioSyent
Pharma Inc., has submitted two new drug products to Health Canada seeking
marketing approval.
These two urgent care drugs are supplied in a patented delivery system that
offers technical advantages over existing alternatives and will be used in
hospitals and acute care settings. These products will provide hospitals,
clinics, and healthcare professionals with improved patient safety as well as
operational efficiencies and will complement BioSyent's Hospital Division.
"These two products are consistent with our strategy of sourcing unique and
innovative pharmaceutical products for the Canadian market," said Rene Goehrum,
President and CEO of BioSyent. "There are additional products under development
by our European partner and we look forward to exploring additional product
candidates utilizing the same patented technology. Due diligence on the next
product has already commenced."
The products will be launched after Health Canada grants marketing approval.
For a direct market quote (15 minutes delay) for the TSX Venture Exchange and
other Company financial information please visit www.tmxmoney.com.
About BioSyent Inc.
Listed on the Toronto Venture Exchange under the trading symbol "RX", BioSyent
is a profitable growth oriented specialty pharmaceutical company which searches
the globe to in-license or acquire innovative pharmaceutical products that have
been successfully developed, are safe and effective, and have a proven track
record of improving the lives of patients and supporting the healthcare
professionals that treat them.
Once a product of interest has been found, BioSyent then acquires the exclusive
rights to the product and manages it through the Canadian governmental
regulatory approval process. Once approved, BioSyent markets the product
throughout Canada.
At the date of this press release the Company had 13,571,195 shares issued and
outstanding.
This press release may contain information or statements that are
forward-looking. The contents herein represent our judgment, as at the release
date, and are subject to risks and uncertainties that may cause actual results
or outcomes to be materially different from the forward-looking information or
statements. Potential risks may include, but are not limited to, those
associated with clinical trials, product development, future revenue,
operations, profitability and obtaining regulatory approvals.
FOR FURTHER INFORMATION PLEASE CONTACT: BioSyent Inc. Mr. Rene C. Goehrum
President and CEO (905) 206-0013 investors@biosyent.com www.biosyent.com
SOURCE: BioSyent Inc.
© 2013 Marketwire L.P. All rights reserved.
-0-
INDUSTRY KEYWORD: Medical and Healthcare\Alternative
Medical and Healthcare\Dentistry
Medical and Healthcare\Mental Health
Medical and Healthcare\Nursing
Pharmaceuticals and Biotech\Biotech
SUBJECT CODE: HEALTH
NGSX FDA approved can trade 50 cents+things on the works here: http://www.neurogesx.com/img/pipelinemay172012.gif
Apri another bounce off offering play. Got In at 2.59.
APPY - With offering this may be a good time to start postion leading up to phase 3 (or just short term to play the closing bounce) My 1.20 order did not get filled this am, thought it had a chance.
I deleted my FDA picks because I didn't want people investing in my theories.
Call me sensitive but it bothers me if a person looses money on one of my picks.
If even one of my 13 picks disappoints,I feel that i've failed.....raised the bar way too high.
Can you say Icarus?
Enough posturing FDA......
Zogenix decision please.......
It's gathering dust on the desk.
SBFM bio -stock to watch
Sun Biopharma looking to mimic Roche's Billion Dollar Cancer Drug Success.
Adva-27a is Sunshine Biopharma’s lead anticancer compound which has proven very effective at killing multidrug resistant cancer cells in vitro. Current chemotherapy drugs are ineffective against multidrug resistant cancers. To date Adva-27a has been shown to effectively kill three different types of multidrug resistant cancer cell line including MES-SA/Dx5, a Uterine Sarcoma cell line, MCF-7/MDR, a breast cancer cell line and H69AR, a small-cell lung cancer cell line.
.... data indicate that Adva-27a will likely not be toxic or damaging to healthy tissue, a key component for our planned clinical trials, as toxicity is what stops most drugs in early development,” said Dr. Steve N. Slilaty, CEO of Sunshine Biopharma. “This further confirms that Adva-27a will have great utility for cancer therapy in humans, particularly in view of the fact that twenty-four micromolar is over three-times the actual concentration estimated to ultimately be used in patient therapy.”
A stock to watch, and add to your list! Excellent entry point for positioning.
GLTA
EPGL massive awareness campaign begins today
http://epglmed.com
EPGL new bio-med device company
http://epglmed.com
EPGL launched FDA 510k-cleared Muscle Pain Detection Device (MPDD) last month
http://epglmed.com
EPGL the only pink held by major institution PriceWaterhouseCoopers. PWC owns ~45% of the Outstanding Shares, which are all restricted.
http://epglmed.com
EPGL Potential for a classic textbook breakout. Chart technicals are setting up nicely.
http://epglmed.com
To those posting me privately,it is never a bother when a fellow shareholder voices their opinion.
I share my 13 picks with the public at large because it's who I am.
Why hoard and keep to myself?
For those that bought in at a higher price than it is now,don't give up;not now anyway.
At least(the very least) wait until the FDA provides their announcement.
Reported for TOS violation...
Elite Pharmaceuticals, Inc. Secures $10 Million Funding Commitment From Lincoln Park Capital Fund, LLC
Today : Monday 22 April 2013
Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP) announced today that it has entered into a $10 million common stock purchase agreement with Lincoln Park Capital Fund, LLC ("LPC"), a Chicago-based institutional investor. The Company has agreed to file a registration statement with the U.S. Securities & Exchange Commission ("SEC") covering the shares that may be issued to Lincoln Park Capital under the terms of the common stock purchase agreement. After the SEC has declared the registration statement related to the transaction effective, the Company has the right, at its sole discretion over a period of three years to sell up to $10 million of its common stock to LPC under the terms set forth in the agreement. Proceeds from the transaction will be used to develop the Company's pipeline of products, including the abuse resistant opioids, and for general corporate purposes.
Commenting on the new financing, Elite's Chairman and CEO, Jerry Treppel said, "We are pleased to have Lincoln Park as an investor in Elite. Since the fall of 2011, Elite has demonstrated its ability to add new products, having eight new products approved or launched since then. We intend to use some of the proceeds from this financing to help develop and advance our pipeline of products, including the abuse resistant opioids."
Under the terms of the agreement, there are no upper limits to the price that LPC may pay to purchase Elite's common stock. Elite will control the timing and the amount of shares to be sold. LPC has no right to require any sales and is obligated to purchase common stock as directed by Elite. Under the terms of the agreement, LPC has agreed not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of Elite's shares of common stock. In consideration for entering into the agreement, Elite has issued shares of common stock to LPC as a commitment fee and will issue additional commitment fee shares in proportion to the amount of shares purchased by LPC under the agreement.
Additional details regarding the financing are included in a Current Report on Form 8-K filed today by Elite with the Securities and Exchange Commission.
This press release does not and shall not constitute an offer to sell or the solicitation of any offer to buy any of the securities, nor shall there be any sale of the securities, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.
I agree, this may ne the most overvalued stock-make sure you take note of the debt, notice of default, lack of cash etc
ELTP (Elite Pharmaceuticals) .072 NALTREXONE FDA APPROVED--LAUNCH PENDING
http://www.elitepharma.com/product_pipeline.asp
-7 FDA launched drugs in the last 18 months
-Cash Flow Positive by the end of this calendar year
****Abuse Resistant Technology (ART) Patent Press Release: April 23rd (Tuesday) ...FOR ALL OPIOIDS in a 20 Billion Dollar Pain Management Market
-The most undervalued Stock I know of....Check my DD
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=86018448
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=86854395
SBFM BIO STOCK to watch$$
Sunshine Biopharma Looking to Mimic Roche's Billion Dollar Cancer Drug Success
Last year, over 260,000 new cases of breast cancer (invasive and in situ combined) were diagnosed in women in the United States. Over the course of a woman's lifetime, the odds are greater than 12 percent -- or 1 out of every 8 -- that she will develop invasive breast cancer and have only about a 41 percent chance of surviving for five years if not detected until stage IIIB (odds are increased to approximately 90 percent if caught in stage I). Although most people don't consider it, men aren't removed from invasive breast cancer stats either; nearly 2,000 new cases were diagnosed in 2010 as well.
ot: ~ thank you pinky :) i like JCDS better, though...
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=86791123
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee now meeting on May 21. They will recommend classification for Shortwave Diathermy devices that are not used for deep heat.
Agenda: On May 21, 2013, the committee will discuss and make recommendations regarding the classification of one of the remaining preamendments class III devices, shortwave diathermy for all other uses except for the treatment of malignancies. The class III shortwave diathermy is a device that applies electromagnetic energy to the body in a radiofrequency band ranging between 13 megahertz to 27.12 megahertz and is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues.
On July 6, 2012 (77 FR 39953), FDA issued a proposed rule which, if made final, would make shortwave diathermy devices for all other uses class III requiring premarket approval (PMA) applications. In response to the proposed rule calling for PMAs, FDA received petitions under section 515(b)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the FD Act) (21 U.S.C. 360e(b)(2)(B)) requesting a change in classification. The reclassification petitions are available for public review and comment at www.regulations.gov under docket number FDA-2012-N-0378. The prior regulatory history of shortwave diathermy for all other uses has been discussed as part of the proposed rule (77 FR 39953).
The discussion at the panel meeting will involve making recommendations regarding regulatory classification to either reconfirm to class III (subject to PMA), or reclassify to class I or class II (subject to premarket notification (510(k))), as directed by section 515(i) of the FD&C Act.
https://www.federalregister.gov/articles/2013/04/09/2013-08218/orthopaedic-and-rehabilitation-devices-panel-of-the-medical-devices-advisory-committee-notice-of
Elite Pharmaceuticals, Inc. Announces First Shipment of Generic Phentermine Capsules
Date : 04/11/2013 @ 8:00AM
Source : GlobeNewswire Inc.
Stock : Elite Pharma (ELTP)
Quote : 0.0671 0.0 (0.00%) @ 5:32AM
Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP) today announced the initial shipment of phentermine HCl capsules 15 mg and 30 mg under the License, Manufacturing and Supply Agreement with its sales and marketing partner, triggering a milestone payment. Elite's sales and marketing partner will distribute the product as part of a multi-product distribution agreement.
Phentermine is a member of the bariatric class of drugs intended to aid in weight loss. For the twelve months ending December 31, 2012, Adipex-P® 15 mg and 30 mg and its generic equivalents had total U.S. sales of approximately $2.5 million and $5 million respectively according to IMS Health Data. U.S. sales of this product are thought to be greater than the IMS data due to its distribution through channels that are not included in IMS data.
"Elite has successfully launched another product line, this one encompassing two dose strengths. Management remains dedicated to enhancing shareholder value by expanding our generic portfolio of products, continuing the development of our abuse-resistant opioid line of products, enhancing our intellectual property, and strengthening the balance sheet," commented Jerry Treppel, Elite's Chairman and CEO.
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. develops oral sustained and controlled release products. Elite's strategy includes assisting partner companies in the life cycle management of products to improve off-patent drug products and developing generic versions of controlled release drug products with high barriers to entry. Elite has five commercial products currently being sold, an additional product approved and soon to be launched, and one additional product pending approval by the FDA. Elite's lead pipeline products include abuse resistant opioids utilizing the Company's patented proprietary technology, and a once-daily opioid. They are sustained release oral formulations of opioids for the treatment of chronic pain, which address two of the limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential abuse. Elite also provides contract manufacturing for Actavis and Ascend Laboratories (previously a subsidiary of ThePharmaNetwork and now a subsidiary of Alkem Laboratories Ltd.) and has partnered with Mikah Pharma to develop a new product, with Hi-Tech Pharmacal to develop an intermediate for a generic product, and a Hong Kong based company to develop a branded product for the United States market and its territories. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.
off topic : who to follow on twitter #2
if you love traveling the world and nature, i'm sure you'll love this :)
Earth Pics
@Earth_Pics
you will find amazing, awsome, and just beautiful pictures...
IGXT has been moving up slowly for 3 weeks now. Just a matter of time before the real value of this one comes home to roost.
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