Theravance Announces Acceptance of Telavancin MAA for the Treatmentof Complicated Skin and Soft Tissue Infections in Europe
May 30, 2007 16:45:22 (ET)
SOUTH SAN FRANCISCO, CA, May 30, 2007 (MARKET WIRE via COMTEX) -- Theravance, Inc. (THRX, Trade ) announced today that the European Medicines Agency (EMEA) has validated the Marketing Authorization Application (MAA) for telavancin, a rapidly bactericidal injectable antibiotic with a unique multifunctional mechanism of action, for the treatment of complicated skin and soft tissue infections (cSSTI) in adults. Astellas Pharma Europe B.V., a European subsidiary of Astellas Pharma Inc. (Astellas), submitted the MAA in April 2007 under the centralized procedure and applied for marketing approval for telavancin in the 27 European Union (EU) Member States, plus Iceland, Liechtenstein and Norway. Completion of the validation period for the MAA signifies that the submission is complete and EMEA's review process has begun.
The MAA submission is based on data from two large, multinational, double-blind, randomized Phase 3 clinical studies. In both of these studies (ATLAS 1 and ATLAS 2), which enrolled and treated 1,867 patients in total, 719 of whom had infections with methicillin-resistant Staphylococcus aureus (MRSA), telavancin achieved its primary endpoint of non-inferiority. Telavancin compared favorably to standard therapy in clinical cure, microbiological eradication, and overall therapeutic response rates. The safety profile of telavancin in these studies was compatible with treatment of patients with serious infections.
"We have taken an important step forward in the development process of this therapeutic candidate," stated Masafumi Nogimori, President and Chief Executive Officer at Astellas Pharma Inc. "The close relationship between Theravance and Astellas has reflected our successful development partnership and mutual commitment to success."
"The start of the formal centralized approval procedure in the EU is another significant step in the global development of telavancin, which has the opportunity to become an important new medicine for the treatment of resistant Gram-positive infections," said Rick E Winningham, Chief Executive Officer at Theravance. "We commend our partner, Astellas, for their continued progress in key global markets."
About Theravance
Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates. 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 gastrointestinal motility dysfunction. Of the five programs in development, two are in late stage -- its telavancin program focusing on treating serious Gram-positive bacterial infections with Astellas Pharma Inc. and the Beyond Advair collaboration with GlaxoSmithKline. By leveraging its proprietary insight of multivalency to drug discovery focused on validated targets, Theravance is pursuing a next generation drug discovery strategy designed to discover superior medicines in large markets. For more information, please visit the company's web site at www.theravance.com .
About Astellas
Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organization is committed to becoming a global pharmaceutical company by combining outstanding R&D and marketing capabilities and continuing to grow in the world pharmaceutical market. For more information about Astellas Pharma Inc., please visit the company's website at www.astellas.com .
About 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 telavancin for the treatment of cSSSI (complicated skin and skin structure infections), also known as cSSTI, and hospital-acquired pneumonia, and will collaborate substantially with Astellas in marketing in the United States for the first three years. Astellas will lead all other development, regulatory, manufacturing, sales and marketing activities.
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