|BioSante jumps higher on Orphan designation. Momenta tanks on Teva threat. After the bell: Gilead receives FDA set back|
|By BioMedReports.com Staff|
|Tuesday, 25 January 2011 19:42|
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.
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.