Astellas Pharma announces tevlavancin EMEA submission

Astellas Pharma has announced the submission of a marketing authorisation application to the European Medicines Agency (EMEA) for telavancin, a potential treatment for complicated skin and soft tissue infections.

In 2005, Astellas Pharma signed a partnership agreement with Theravance for the development and commercialisation of televancin, with Therevance leading the development of the compound for the treatment of skin infections and hospital-acquired pneumonia.

All other development, regulatory, manufacturing, sales and commercialisation efforts are to be led by Astellas.

The companies report that the compound achieved its primary endpoint of non-inferiority in phase III clinical trials of patients with methicillin-resistant Staphylococcus aureus infection.

Masafumi Nogimori, president and chief executive officer of Astellas Pharma, said: “Astellas has chosen infectious diseases as a targeted therapeutic area and we hope to contribute to patients’ health and well-being, particularly in this growing therapeutic area for our company.”

He added that he firm would collaborate closely with the EMEA and Theravance in order to gain marketing approval for the compound in the European Union.

In January 2007, Astellas Pharma announced the signing of a license and research and development agreement with Kirin Brewery for the human anti-CD40 antagonistic monoclonal antibody.