The US Food and Drug Administration has accepted to file Theratechnologies’ New Drug Application (NDA) for its lead compound, tesamorelin. Under the terms of the company’s collaboration and licensing agreement with EMD Serono, the acceptance to file tesamorelin NDA is associated with a milestone payment of $10m.
Theratechnologies submitted an NDA on May 29, 2009, for tesamorelin, an analogue of the growth hormone releasing factor, proposed for the treatment of excess abdominal fat in HIV patients with lipodystrophy.
Theratechnologies, a Canadian biopharmaceutical company with core expertise in peptide-based therapeutics. In late 2008, Theratechnologies completed its phase 3 clinical program which was designed to evaluate tesamorelin in treating excess abdominal fat in HIV patients with lipodystrophy. Consequently, the company signed a collaboration and licensing agreement with EMD Serono for the commercialization of tesamorelin in the US.