Astellas Pharma Europe Ltd., a subsidiary of Astellas Pharma, Inc. and Theravance, Inc. announced that the European Commission has granted marketing authorization for Vibativ (telavancin hydrochloride), following the Committee for Human Medicinal Products' positive opinion in May 2011.
Vibativ is a bactericidal, once-daily injectable lipoglycopeptide antibacterial agent with a dual mechanism of action against gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus, or MRSA.
Theravance stated the Vibativ marketing authorization from the European Commission is granted for treating adults with nosocomial pneumonia, including ventilator-associated pneumonia, known or suspected to be caused by MRSA when other alternatives are not suitable. The marketing authorization for Vibativ is valid in all Member States of the European Community and Norway and Iceland, the company added.
"We are extremely excited about the European approval of Vibativ for the treatment of nosocomial pneumonia caused by MRSA. This is a significant milestone for the collaboration, marking the first approval for this indication. I believe Vibativ will be a valuable new therapy option for physicians in Europe treating this life-threatening infection," said Rick Winningham, chief executive officer, Theravance.
Vibativ is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with a dual mechanism of action whereby Vibativ both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function. Vibativ 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). Vibativ is approved in Europe for the treatment of adults with nosocomial pneumonia including ventilator-associated pneumonia, known or suspected to be caused by MRSA when other alternatives are not suitable. Vibativ has not been approved for the treatment of patients with nosocomial pneumonia in the United States and Canada or complicated skin and soft tissue infections in Europe.
In November 2005, Theravance entered into a collaboration arrangement with Astellas Pharma Inc. for the development and commercialization of Vibativ worldwide except Japan. In July 2006, Theravance and Astellas expanded the collaboration to include Japan. Under the terms of the collaboration, Theravance is responsible for substantially all the costs to develop and obtain US regulatory approval for telavancin for its initial indications. Theravance collaborates with Astellas in marketing in the United States for the first three years following approval.
Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals.
Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates and strategic collaborations with pharmaceutical companies. 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 central nervous system (CNS)/pain.