Theravance, Astellas add Japan to collaboration on investigational antibiotic

By E. Janene Geiss

Philadelphia, July 18 - Theravance, Inc. and Astellas Pharma Inc. said Tuesday that they have agreed to add Japan to their collaboration for the development and commercialization of Theravance's investigational antibiotic telavancin, thereby giving Astellas worldwide rights to this potential medicine.

Telavancin is a novel lipoglycopeptide injectable antibiotic discovered by Theravance that targets serious Gram-positive infections including those caused by methicillin-resistant Staphylococcus aureus strains, according to a company news release.

Previously presented data demonstrated that telavancin has a multifunctional mechanism of action that the companies believe results in bacterial killing and may help reduce the risk of inducing resistance.

Telavancin is in phase 3 studies outside of Japan for the treatment of complicated skin and skin structure infections (cSSSI) for which patient enrollment has been completed, and hospital-acquired pneumonia (HAP).

Phase 1 studies for Japanese registration are now in preparation to be started later this year.

For rights to telavancin in Japan, Theravance said it will receive an upfront payment of $10 million from Astellas and is eligible to receive a $5 million milestone payment for regulatory approval in Japan.

These payments are in addition to the $131 million in clinical and regulatory milestone payments that Theravance is eligible to receive related to non-Japanese milestone events.

Theravance said it has received a $65 million license fee and a $25 million milestone payment related to completion of the phase 3 cSSSI program.

Theravance said it is entitled to royalties on global sales of telavancin that will now include sales in Japan.

Under terms of the collaboration, Theravance said it will lead the development of telavancin for skin structure infections and hospital-acquired pneumonia and 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 worldwide, officials said.

Theravance said it will be responsible for substantially all costs to develop telavancin for skin structure infections and hospital-acquired pneumonia.

Astellas said it will be responsible for substantially all costs associated with commercialization and further development of telavancin, including for the Japanese market.

In addition to the license rights to telavancin in Japan, Astellas also receives an option to further develop and commercialize TD-1792 in Japan.

TD-1792 is a unique heterodimer antibiotic compound that combines the antibacterial activities of a glycopeptide and a beta-lactam in one molecule. Theravance said it is conducting phase 1 human clinical studies for TD-1792.

Theravance is a South San Francisco, Calif., biopharmaceutical company.

Astellas, based in Tokyo, is a pharmaceutical company.

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