TOKYO and SOUTH SAN FRANCISCO, CA, Oct. 28, 2009 (Marketwire) --
TOKYO and SOUTH SAN FRANCISCO, CA -- (Marketwire) -- 10/28/09 -- Astellas Pharma Inc. (Astellas) and Theravance, Inc. (NASDAQ: THRX) announced today that Astellas Pharma Europe B.V. submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for telavancin, a bactericidal, once-daily injectable lipoglycopeptide antibiotic, for the treatment of nosocomial pneumonia (NP), including ventilator-associated pneumonia, and complicated skin and soft tissue infections (cSSTI) in adults.
"We are extremely pleased that this critical step has now been completed," said Mr. Masao Yoshida, President and CEO of Astellas Pharma Europe Ltd. "We look forward to working with the regulatory authorities and our partner, Theravance, to efficiently progress telavancin through the remaining steps to approval."
"The MAA submission represents an important step toward our goal of making telavancin globally available to physicians and patients," said Rick E Winningham, Chief Executive Officer at Theravance. "We will work closely with our partner Astellas in seeking the approval of telavancin in the European Union."
About Telavancin
Telavancin was discovered by Theravance in a research program dedicated to finding new antibiotics for serious infections due to Staphylococcus aureus and other Gram-positive bacteria, including MRSA. Telavancin is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with a dual mechanism of action whereby telavancin both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function. VIBATIV(TM) (telavancin) is approved in the United States and in Canada for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius and S. constellatus) and Enterococcus faecalis (vancomycin-susceptible isolates only). The U.S. Food and Drug Administration is currently reviewing the telavancin New Drug Application for the treatment of nosocomial pneumonia.
About the Clinical Studies
The MAA is based on data from the ATLAS I and II and ATTAIN I and II clinical studies in adult patients.
ATLAS I and ATLAS II were two large, multinational, double-blind, randomized Phase III clinical studies, designed to compare the efficacy and safety of telavancin (10 mg/kg IV once daily) versus vancomycin (1 gm IV q 12hr) in adult patients with complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria. A total of 1,867 patients were enrolled and treated, 719 of whom had infections with MRSA.
