|Raptor Pharma recieves Europe orphan status. Neostem's Suzhou Erye subsidiary passes China inspection. After the bell: GenVec seeks strategic alternatives|
|By BioMedReports.com Staff|
|Wednesday, 16 June 2010 00:11|
Below is a list of the companies that made news in the healthcare sector on Tuesday, June 15, 2010.
GenVec, Inc. (Nasdaq:GNVC) rose after the bell today after the company announced that it has engaged Wells Fargo Securities, LLC to conduct a comprehensive review of strategic alternatives aimed at enhancing shareholder value.
Shares of GenVec have been under pressure since March of this year after the company halted a Phase III study of its experimental cancer drug TNFerade. GenVec indicated at that time that the drug would not meet trial goals as a treatment for prostate cancer. The company instead has focused its efforts on its vaccine initiatives including its partnership with Swiss drugmaker Novartis AG with whom it is developing treatments for hearing loss. GenVec has yet to determine any future applications for TNFerade.
Shares of GenVec closed at 51 cents on Tuesday and rose as high as 60 cents in the after hours session, finally settling at 58 cents, more than 13% higher than Tuesdy's closing price.
In news from earlier in the day:
Raptor Pharmaceutical Corp. (Nasdaq:RPTP), moved higher today after the company announced that the European Medicines Agency's ("EMA") Committee for Orphan Medicinal Products has issued a positive opinion recommending orphan medicinal product designation for DR Cysteamine for the potential treatment of cystinosis.
DR Cysteamine is Raptor's proprietary, delayed-release, oral formulation of cysteamine bitartrate. Immediate-release cysteamine bitartrate is the current standard of care for treating cystinosis.
"The granting of orphan medicinal product designation by EMA is a significant milestone in the development and eventual commercialization of DR Cysteamine for the potential treatment of cystinosis as it allows for ten years of market exclusivity in the European Union once the drug is approved," said Ted Daley, President of Raptor. "Our progress with European regulators dovetails well with our work with the U.S. Food and Drug Administration's Office of Orphan Product Development and is an important aspect of our orphan product strategy. Our recent Phase IIb study with DR Cysteamine in cystinosis patients demonstrated improved tolerability and the potential to reduce total daily dosage and administration frequency compared to immediate-release cysteamine bitartrate. Raptor is now poised to initiate its pivotal, Phase III clinical trial in cystinosis patients at multiple sites in the U.S. and Europe in Q2 2010."
Shares of Raptor jumped 31 cents or more than 10% to close the day at $3.32.
NeoStem, Inc. (NYSE Amex: NBS) announced that its Suzhou Erye pharmaceutical subsidiary passed the government inspection by the State Food and Drug Administration in China to manufacture penicillin powder for injection and cephalosporin powder for injection at its new manufacturing facility which provides 50% greater manufacturing capacity than its existing plant. These two production lines produced the materials for over 70% of Erye's product sales in 2009. Coupled with the approval of the lines earlier in 2010 for solvent crystallization sterile penicillin and freeze dried raw sterile penicillin, Erye will be able to relocate over 90% of its 2009 sales to the new facility, placing the process well ahead of the original 2011 goal.
NeoStem's Chairman and CEO, Robin Smith, commented, "Erye's relocation to the new facility is ahead of schedule and we are extremely excited about the increased manufacturing capabilities it will provide. Once fully certified and operational, these production lines will bring Erye another step closer to its goal of becoming one of the largest antibiotic producers in Eastern China."
CombiMatrix Corporation (Nasdaq:CBMX) announced today that its laboratory services subsidiary, CombiMatrix Diagnostics, has received the final licensure documentation and approvals from Medicare in order to begin billing for its suite of array-based diagnostics tests.
Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today announced the dosing of the first patient in a Phase I/II clinical trial of the doxorubicin conjugate of milatuzumab for the treatment of patients with relapsed multiple myeloma.
Inovio Pharmaceuticals, Inc. (NYSE Amex:INO), a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that it has immunized its first subject in a U.S. Phase I clinical trial to evaluate its SynCon™ H5N1 (avian) influenza DNA vaccine, VGX-3400X. This H5N1 vaccine study represents the first step in demonstrating Inovio’s novel universal influenza vaccine approach, which aims to bypass the current requirement for annual strain and subtype-specific influenza vaccines by developing a single vaccine to potentially protect against all strains within multiple targeted subtypes, such as H5N1 and H1N1, posing risk to humans.
Micro Identification Technologies, Inc. (OTC.BB:MMTC) announced today that it has initiated an internal expansion program; made possible in part by the Manufacturing Contract with OSI Optoelectronics to produce its systems and the Equity Placement Agreement from the private equity firm Dutchess Capital through its Dutchess Opportunity Fund, LP. Micro Identification Technologies (MIT) Chairman Michael Brennan stated, "As part of this expansion program, we will be significantly increasing our professional and scientific resources -- great career opportunities."
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) announced today that the Company is nearing completion of a new multi-center U.S. long-term follow-up study of NX-1207, its investigational drug for the treatment of benign prostatic hyperplasia (BPH). Nymox expects to report final results and statistical analysis for the study in the next 1-2 weeks. The new study concerns assessment of the 48-60 month efficacy and benefits of a single treatment of NX-1207. Patients in the new study were followed and have remained blinded subsequent to their participation in Nymox's U.S. Study NX02-0014 in 2005-2006.
Aeterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) a late-stage drug development company specialized in oncology and endocrinology, announced today that it has received commitments from institutional investors to purchase US$12.1 million of securities in a registered direct offering.
Advance Nanotech, Inc. (OTCBB:AVNA) is pleased to announce that Owlstone has released certain results of a pharmaceutical application study using its Ultra-FAIMS technology.
Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced results from DURATION-4, the fourth in a series of studies designed to test the superiority of BYDUREON™ (exenatide extended-release for injectable suspension), an investigational type 2 diabetes therapy, as compared to other type 2 diabetes medications.
Cleveland BioLabs, Inc. (NASDAQ:CBLI) today announced that the Company is scheduled to present at the Sidoti Microcap Conference, June 25, in New York City.
Corgenix Medical Corporation (OTC Bulletin Board:CONX) a worldwide developer and marketer of diagnostic test kits, has announced it will be exhibiting its AspirinWorks® Test June 17-19 at the Pri-Med New York 2010 conference. The meeting will take place at the Jacob K. Javits Convention Center in New York, N.Y.
CVS Caremark (NYSE:CVS) has been named one of the nation's leading corporations for its proactive approach to workplace health and its investment in programs that help employees and their families make better choices about their health and well-being.
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) announced today that it has entered into an Amended and Restated Employment agreement with John V. Talley, Jr., EpiCept's President and Chief Executive Officer.
Global Health Ventures Inc. (OTCBB:GHLV) a specialty pharma company focused on life style products is pleased to announce that it has started working on a new commercial product "Nico-Z".Nico-Z is a sublingual formulation of nicotine that is incorporated through our proprietary technology to deliver the product rapidly to the blood stream.
NexMed, Inc. (Nasdaq: NEXM), a specialty CRO with a pipeline of products based on the NexACT® technology, today announced results from a pre-clinical study showing that calcipotriene 0.005% and betamethasone dipropionate 0.064%, when formulated with NexACT®, results in a topical treatment which shows bioequivalecy in efficacy to Talconex®, one of the leading topical treatments marketed for patients with mild to moderate psoriasis.
OncoVista Innovative Therapies, Inc. (OTCBB: OVIT), a high-growth global biotech company developing proprietary, leading-edge early detection and drug technologies to enable safe, targeted personal cancer treatments, today released a letter to shareholders from Chief Executive Officer, Alexander L. Weis Ph.D. to update shareholders on the Company's progress and potential.
Perrigo Company (Nasdaq: PRGO;TASE) today announced that Perrigo Executive Vice President and CFO Judy Brown will present at the 31st Annual Goldman Sachs Global Healthcare Conference on Tuesday, June 15, at 3:05 p.m. (PT) at the Hyatt Regency Century Plaza Hotel in Los Angeles.
POZEN Inc. (NASDAQ: POZN), today announced the election of Neal F. Fowler to its Board of Directors at the Annual Meeting of Shareholders held on June 10, 2010.
PPD, Inc. (Nasdaq: PPDI) today announced it has appointed Mike Wilkinson, Ph.D., as executive vice president and chief information officer and Paul Colvin as executive vice president of global clinical development effective June 30.
pSivida Corp. (NASDAQ:PSDV)(ASX:PVA), a leader in the development of sustained release back of the eye drug delivery systems for difficult-to-treat conditions, today announced that its president and CEO, Dr. Paul Ashton, will be a speaker at the upcoming Glaucoma & Retinopathies 2010 conference.
Teva Pharmaceutical Industries Limited (NASDAQ: TEVA) announced today that it successfully priced the offering, by its special purpose finance subsidiaries, of a debt offering in three tranches: $500 million of LIBOR+0.40% floating rate senior notes maturing in December 2011; $1.0 billion of 1.50% fixed rate senior notes maturing in June 2012; and $1.0 billion of 3.00% fixed rate senior notes maturing in June 2015.
Vitro Diagnostics, Inc. (OTCBB: VODG), dba Vitro Biopharma, and HemoGenix®, Inc. announced the launch of new high performance stem cell testing products at the International Society for Stem Cell Research annual meeting being held in San Francisco, CA this week.
Walgreens (NYSE: WAG)(NASDAQ: WAG) will release its fiscal 2010 third quarter earnings results at 7:30 a.m. Eastern time Tuesday, June 22, followed by a conference call with Walgreens management beginning at 8:30 a.m. Eastern time.
Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.