BioSante jumps higher on Orphan designation. Momenta tanks on Teva threat. After the bell: Gilead receives FDA set back Print E-mail
By Staff   
Tuesday, 25 January 2011 19:42
Below is a look at some of the headlines for companies that made news in the healthcare sector on January 25, 2011.

After the bell, shares of Gilead Sciences, Inc. (Nasdaq:GILD) were lower after the company announced that it has received a "refuse to file" notification from the FDA regarding the company's NDA for the single-tablet regimen of Truvada and Tibotec Pharmaceuticals’ investigational non-nucleoside reverse transcriptase inhibitor TMC278 for HIV-1 infection in adults. The FDA has asked for additional information pertaining to the Chemistry, Manufacturing and Controls (CMC) section of the Truvada/TMC278 NDA submission. The FDA letter stated that the application requires more information on the analytical methodology to establish acceptable levels of recently identified degradants related to emtricitabine.

"We are working to validate the methodology to resolve this issue and provide the required information to the FDA," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. "We expect to be in a position to resubmit the Truvada/TMC278 NDA with the additional requested information prior to the end of the first quarter of this year."

In extended trading, shares of Gilead slumped $1.06 to $37.10.

On heavy volume, shares of BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) jumped higher today after the company announced the receipt of Orphan Drug designation for its Melanoma Cancer Vaccine in the treatment of stage IIb to IV melanoma, from the FDA.

"We continue to develop our vaccine portfolio in cooperation with the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center," said Stephen M. Simes, president and chief executive officer of BioSante. "Clinical trials of our cancer vaccines are being conducted to treat leukemia, breast cancer, and pancreatic cancer, among other cancer types. In addition, we expect to report on pancreatic cancer study results in the near future."

More than 8 million shares traded hands as the stock gained more than 5%, closing the day at $1.97.

Shares of Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) were rocked today after Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) announced today that it has received correspondence from the FDA regarding the Company’s abbreviated new drug application for generic Lovenox injection. The agency said it has completed its review of the application and is now asking a short list of questions which Teva said it intends to respond in the near future.

Momenta got FDA approval in July 2009 for its generic version of the drug. Should Teva ultimately receive approval, Momenta will lose revenue share that it now receives from its partner Sandoz and will receive royalties instead.

Shares of Momenta lost nearly 21% or $3.30, closing Tuesday trading at $12.50. Teva gained $1.90 or 3.61% to $54.57.

Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), today announced that it has enrolled the first patient in its Phase IIb clinical trial of Serdaxin to treat major depressive disorder (MDD). The randomized, double blind, and placebo-controlled study will recruit up to 300 patients and will be conducted at 40 sites in the United States. Serdaxin will be administered as an oral, extended release tablet. Patient enrollment will occur through the first half of 2011, with preliminary data expected in late 2011.

Rick Soni, President of Rexahn, commented, "This clinical milestone represents another important advance in the development of Serdaxin. Data from our Phase IIa study in MDD suggest that Serdaxin has the potential to improve symptoms of depression without the side effects commonly associated with currently marketed antidepressants, and we look forward to further assessing Serdaxin in patients with MDD."

Bristol-Myers Squibb Company (NYSE:BMY) and sanofi-aventis (EURONEXT:SAN) today announced that the FDA has granted the companies an additional six-month period of exclusivity to market PLAVIX. Exclusivity for PLAVIX in the U.S. is now scheduled to expire on May 17, 2012.

The two companies announced that the FDA granted the extension after the companies conducted extra studies of the drug in infants. The FDA program is designed to reward companies for testing drugs in children, who are typically excluded from medical studies.

Also Tuesday:

Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) today announced it has engaged The Investor Relations Group , a fourteen-year-old, award-winning, investor relations firm based in New York City, to serve as its investor relations agency.

Cephalon, Inc. (Nasdaq:CEPH) today announced positive results from a phase IV clinical trial of NUVIGIL® (armodafinil) Tablets [C-IV] in patients experiencing excessive sleepiness associated with shift work disorder, specifically during the end of their night shifts (i.e., 4:00 a.m. to 8:00 a.m.), including the commute home.

China PharmaHub Corp. (OTC Bulletin Board: CPHB), a biopharmaceutical acquisition and development company, today announced the formation of CPC NuLife, Inc., a subsidiary company.

Codexis, Inc. (Nasdaq:CDXS) today announced the company's first biocatalysis collaboration in Japan, with Dainippon Sumitomo Pharma Co., Ltd. (DSP), one of the ten largest Japanese pharmaceutical manufacturers.

Fresh Start Private (OTCBB: CEYY), a leader in the alcohol treatment and rehabilitation industry, announced today that its first television commercials have begun to air on national networks.

Generex Biotechnology Corporation (OTC Bulletin Board:GNBT) today announced that it entered into a securities purchase agreement with certain institutional investors on January 24, 2011.

Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible robotics and the developer of robotic technology for accurate 3D control of catheter movement, today announced it has named veteran medical device sales executive Michael T. MacKinnon Vice President U.S. Commercial Operations. MacKinnon will report directly to President and Chief Executive Officer Bruce J Barclay.

Healthcare Services Group, Inc. (NASDAQ:HCSG) Our Board of Directors has declared a regular quarterly cash dividend of $ .15625 per common share, payable on March 4, 2011 to shareholders of record at the close of business February 11, 2011.

Imaging3(TM), Inc. (OTCBB: IMGG), developer of a breakthrough medical imaging device that produces 3D medical diagnostic images of virtually any part of the human body in real-time, hosted their annual shareholder meeting on January 20, 2011 at its corporate offices located at 3200 West Valhalla Drive, Burbank, California 91505.

Mediware Information Systems, Inc. (NASDAQ: MEDW) announced today that the Company will release the financial results for the second quarter of its Fiscal Year 2011 on Tuesday, February 1st.

Microholdings US (PINKSHEETS: MCHU) announced today that they have signed a deal with a National Media Direct Response Company to promote and advertise The Racers Edge Pain Chips.

Neuro-Biotech Corp. (MRES-OTSQB) is pleased to announce the signing of a Letter of Intent with a major distributor in Israel.

Oncolytics Biotech Inc. (TSX:ONC; NASDAQ: ONCY) today announced that pursuant to the acceleration of the expiry date of those warrants issued on November 23, 2009, the Corporation has received proceeds of approximately US$6.8 million resulting from the exercise of 1,943,000 warrants.

PDL BioPharma, Inc. (PDL) (Nasdaq:PDLI) today announced the appointment of Caroline Krumel, CPA to the position of vice president of finance and chief accounting officer, effective January 31, 2011. Ms. Krumel will replace Karen Wilson, who is leaving PDL to return to California.

Radient Pharmaceuticals Corporation (RPC) (NYSE Amex: RPC) announced today, its wholly-owned subsidiary NuVax Therapeutics, Inc., has signed an exclusive license agreement with the University of Florida College of Medicine in Gainesville, Florida for the use and commercialization of four innovative and patented immune-gene therapy tools and systems developed by Dr. Lung-Ji Chang, Professor of Molecular Genetics and Microbiology at University of Florida's Research Center.

Savient Pharmaceuticals, Inc. (Nasdaq:SVNT) today announced that its board of directors has named John H. Johnson as Chief Executive Officer, effective January 31, 2011.

SciMeDent Health, Corp. f/k/a Trend Exploration, Inc. (PINKSHEETS: TRDX) is pleased to announce estimated gross revenue (unaudited) for fiscal year end December 2010 will exceed $1 million.

Soligenix, Inc. (OTC Bulletin Board:SNGX), a late-stage biopharmaceutical company, announced today that it has recently received $245,810, net of transaction costs, in non-dilutive financing via the State of New Jersey's Technology Business Tax Certificate Transfer Program (the Program).

Sun Healthcare Group, Inc. (NASDAQ: SUNH) announced the recent promotion of Logan Sexton to president of SunBridge Healthcare, LLC, Sun's inpatient subsidiary.

Vicor Technologies, Inc. (OTCBB: VCRT), today announced that an abstract summarizing the results of a study involving the use of its PD2i® nonlinear algorithm and software to risk stratify congestive heart failure patients has been accepted for the American College of Cardiology 60th Annual Scientific Session and i2 Summit.


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