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Theravance Receives Complete Response Letter From FDA On Telavancin NDA - Update

Biopharmaceutical company Theravance, Inc. (THRX) said Friday that the company has received complete response from the U.S. Food and Drug Administration for Telavancin new drug application for the treatment of nosocomial pneumonia.

Telavancin is a bactericidal, once-daily injectable investigational antibiotic for the treatment of NP caused by Gram-positive bacteria such as methicillin-resistant Staphylococcus aureus.

In Telavancin's nosocomial pneumonia clinical trials, Theravance had included clinical response as the primary endpoint, consistent with current draft FDA guidelines for antibacterial clinical trial design in NP, and all-cause mortality as a secondary endpoint.

In the complete response letter, the company is instructed by the FDA to submit additional data and analyses for the NP patient population to support an evaluation of all-cause mortality as the primary efficacy endpoint to demonstrate the safety and efficacy of telavancin, Theravance said.

Japan-based pharmaceutical company Astellas Pharma Inc. (ALPMK, ALPMY) had entered into a collaboration arrangement with Theravance in November 2005 for the development and commercialization of telavancin worldwide except Japan. Later in July 2006, Theravance and Astellas expanded the collaboration to include Japan.

The FDA in its response has also requested the company further rationale for the pooling of the data from the two ATTAIN studies, noted the need for a pediatric drug development plan for the NP indication and a customary safety update.

"We believe that we have already collected the information and completed the analyses required to respond to the FDA. Importantly, the additional data collected to date support our prior conclusions about the telavancin ATTAIN studies. We look forward to submitting our response and continuing to work with the FDA on this NDA," Rick Winningham, Chief Executive Officer said.

The company noted that it had earlier indicated that the FDA's review of the telavancin NDA was likely to extend into 2010. The initial Prescription Drug User Fee Act or PDUFA date for action by FDA was November 26, 2009.

Telavancin is approved in the U.S. and in Canada for the treatment of adult patients with complicated skin and skin structure infections or cSSSI caused by susceptible isolates of Staphylococcus aureus, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group and Enterococcus faecalis Gram-positive microorganisms, the company said.

If the additional data and analyses that Theravance submits to the FDA are deemed insufficient, FDA may not approve the NDA or may require that additional studies be conducted, Theravance noted.

ATTAIN I and ATTAIN II were multi-center, multinational, double-blind, randomized Phase III clinical studies, in which 1,503 patients were enrolled and treated, 464 of whom were infected with methicillin-resistant Staphylococcus aureus or MRSA.

For patients with suspected or proven polymicrobial infections involving Gram-negative and/or anaerobic bacteria in addition to the Gram-positive organisms for which study medication therapy was used, aztreonam, piperacillin-tazobactam, and/or metronidazole were allowed, the company said.

The objective of each study was non-inferiority of telavancin versus vancomycin in clinical cure rate at the test-of-cure visit. Determination of clinical cure was based upon physician-judged resolution of clinical signs and symptoms of NP. In both studies, telavancin achieved the objective of non-inferiority in the all-treated and clinically evaluable patient populations, Theravance said.

Friday, THRX closed at $13.13, unchanged from its previous trading sessions closing price on a volume of 0.23 million shares on Nasdaq. ALPMF closed at $36.78 and ALPMY closed at $36.47, up $0.14.

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