Theravance Announces Regulatory Update on Telavancin for the Treatment of Complicated Skin and Skin Structure Infections
Tuesday July 22, 8:00 am ET
SOUTH SAN FRANCISCO, CA--(MARKET WIRE)--Jul 22, 2008 -- Theravance, Inc. (THRX - News) announced today that the U.S. Food and Drug Administration (FDA) has not yet made a decision regarding the New Drug Application (NDA) for telavancin. The Prescription Drug User Fee Act (PDUFA) date for action by FDA was July 21, 2008, and as of that date, the company had not received an action letter from the FDA. Telavancin is a novel, bactericidal, once-daily injectable investigational antibiotic, for the proposed indication to treat complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA).
The company previously announced that the FDA had indicated that it did not expect to take final action on the telavancin NDA prior to completing its further evaluation of study site monitoring and study conduct in the ATLAS Phase 3 program, nor prior to resolution of the manufacturing issues not specifically related to telavancin that were cited in the approvable letter received in October, 2007.
"We continue to work diligently with the FDA to resolve the remaining issues on our cSSSI NDA," said Rick E Winningham, Chief Executive Officer of Theravance. "We remain confident in the data generated in this program and are committed to bringing the potential benefit of telavancin to those patients suffering from cSSSI and more serious infections such as hospital-acquired pneumonia."
About Theravance
Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates. Theravance is focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections and gastrointestinal motility dysfunction. The company's key programs include: telavancin for the treatment of serious Gram-positive bacterial infections with Astellas Pharma Inc., the Horizon program with GlaxoSmithKline plc, and the Gastrointestinal Motility Dysfunction program. By leveraging its proprietary insight of multivalency toward drug discovery focused primarily on validated targets, Theravance is pursuing a next generation strategy designed to discover superior medicines in areas of significant unmet medical need. For more information, please visit the company's web site at www.theravance.com.
surf's up......crikey
AI
