>>SOUTH SAN FRANCISCO, CA--(MARKET WIRE)--Dec 5, 2005 -- Theravance, Inc. (NasdaqNM:THRX - News) announced today that the previously announced collaboration with Astellas Pharma Inc. for the development and commercialization of Theravance's investigational antibiotic, telavancin, was finalized after receiving US regulatory clearance on November 28th. As a result of the finalization of this transaction, Theravance received an upfront payment of $65 million.
Telavancin is a novel lipoglycopeptide injectable antibiotic discovered by Theravance that targets serious Gram-positive infections including drug-resistant Staphylococcus aureus strains. Previously presented data demonstrated that telavancin has a unique multifunctional mechanism of action that the companies believe results in bacterial killing and may help reduce the risk of inducing resistance. Telavancin is currently in Phase 3 studies for the treatment of complicated skin and skin structure infections (cSSSI) and Hospital-Acquired Pneumonia (HAP).
Collaboration Arrangements
Theravance is eligible to receive up to an additional $156 million in clinical and regulatory milestone payments which include $136 million for completion of enrollment, filing and approval in the ongoing Phase 3 programs in cSSSI and HAP and $20 million if the Phase 3 data demonstrates telavancin's superiority over vancomycin for patients infected with MRSA. Theravance will receive royalties on aggregate, annual global sales of telavancin that, on a percent basis, range from the high teens to the upper twenties.
Under the terms of the collaboration, Theravance will lead the development of telavancin for cSSSI and HAP and collaborate substantially with Astellas in marketing in the US for the first three years. Astellas will lead all other development, regulatory, manufacturing, sales and marketing activities worldwide, except Japan. Theravance will be responsible for substantially all costs to develop telavancin for cSSSI and HAP and Astellas will be responsible for substantially all costs associated with commercialization and further development of telavancin. Japan is excluded from the agreement and Theravance will continue to explore partnering options for this market.
In addition to the license rights to telavancin, Astellas also receives an option to commercialize and further develop TD-1792, a unique heterodimer antibiotic compound which combines the antibacterial activities of a glycopeptide and a beta-lactam in one molecule. TD-1792 is currently in IND-enabling pre-clinical studies.<<
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Cheers, Tuck |
