SOUTH SAN FRANCISCO, CA -- (Marketwire) -- 04/24/09 -- Theravance, Inc. (NASDAQ: THRX)
announced today that the U.S. Food and Drug Administration (FDA) accepted
as complete for review Theravance's response to the February 2009 Complete
Response letter, which outlined requirements for approval of telavancin for
the treatment of complicated skin and skin structure infections (cSSSI).
Telavancin is a novel, bactericidal, once-daily injectable investigational
antibiotic studied in the treatment of cSSSI and hospital-acquired
pneumonia (HAP) caused by Gram-positive bacteria, including resistant
pathogens such as methicillin-resistant Staphylococcus aureus (MRSA). The
FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of
September 16, 2009.
"We look forward to further advancing our application through the FDA's
review process," said Rick E Winningham, Chief Executive Officer. "We will
continue to work with the FDA in finalizing the telavancin label, in order
to bring the benefits of telavancin to patients with complicated skin and
skin structure infections."
About Telavancin
Telavancin is a bactericidal, once-daily injectable investigational
antibiotic with a multifunctional mechanism of action. Telavancin was
discovered by Theravance in a research program dedicated to finding new
antibiotics for serious infections due to Staphylococcus aureus, including
MRSA, and other Gram-positive bacteria. Telavancin inhibits the formation
of the bacterial cell wall and disrupts bacterial cell membrane function.
Theravance believes the additive mechanisms of action seen with telavancin
speed bacterial killing while also reducing the risks of inducing
resistance to telavancin or cross-resistance with other antibiotics.
Telavancin has been studied in two Phase 3 programs, one in cSSSI and one
in HAP, both of which demonstrated non-inferiority in the all-treated (AT)
and clinically evaluable (CE) patient populations versus vancomycin.
Theravance believes these clinical programs comprise the largest global
studies ever conducted in patients with confirmed MRSA infections. In
addition to the cSSSI NDA, the FDA is currently reviewing Theravance's NDA
for the treatment of nosocomial pneumonia (also known as hospital-acquired
pneumonia, or HAP).
About the Telavancin Collaboration
In November 2005, Theravance entered into a collaboration arrangement with
Astellas Pharma Inc. for the development and commercialization of
telavancin worldwide except Japan. In July 2006, Theravance and Astellas
expanded the collaboration to include Japan. Under the terms of the
collaboration, Theravance will lead the development of and U.S. regulatory
activities for telavancin for the treatment of cSSSI and HAP, and will
collaborate substantially with Astellas in marketing in the United States
for the first three years.
