Theravance Milestone Payment (NASDAQ:THRX)
Theravance, Inc. (NASDAQ:THRX) has announced that they have received a US$20 million milestone payment after their new drug telavancin was approved by the Food and Drug Administration panel. In September 2009, FDA approved the telavancin injection which can be given once daily to patients suffering from complicated skin and skin structure infections that is caused by susceptible Gram positive bacteria. Approval of telavancin was based on data from 2 double-blind randomized Phase 3 trial where telavancin marketed as Vibativ demonstrated its efficacy and safety in clinical trials on patients suffering from various skin structure infections and strains. Although, Vibativ clearly got a green signal from the FDA panel there were some adverse reactions which were registered like taste disturbance, vomiting, nausea and foamy urine.
Theravance will receive this milestone payment from their partners, Astellas Pharma US Inc, which is now taking orders for their approved drug under its trade name of Vibativ. In the year 2005, Theravance and Astellas Pharma entered into a sales and development agreement for telavancin for its marketing and commercialization through the world, excluding Japan, which they later added in the year 2006. Astellas Pharma still handles all the development, regulatory, manufacturing and marketing work on the drug and Theravance will handle the FDA filings for the use of Vibativ drug for the treatment of skin infections.
Tags: Astellas, Theravance, THRX
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