Theratechnologies Inc. to Receive a Milestone Payment of US $10 Million Associated With the FDA Acceptance to File Tesamorelin NDA
MONTREAL, CANADA - Theratechnologies (TSX:TH - News) today announced that the US Food and Drug Administration ("FDA") has accepted to file the New Drug Application ("NDA") made by the Company for its lead compound, tesamorelin. Under the terms of the Company's collaboration and licensing agreement with EMD Serono, Inc., the acceptance to file tesamorelin NDA is associated with a milestone payment of US $10 million (approximately CAN $11 million).
Theratechnologies submitted an NDA to the FDA 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. The acceptance to file the NDA means that FDA will now begin its substantive review of the application.
About HIV-Associated Lipodystrophy
Several factors including a patient's antiretroviral drug regimen and the HIV virus itself are thought to contribute to HIV-associated lipodystrophy, which is characterized by body composition changes, dyslipidemia and glucose intolerance. The changes in body composition include excess abdominal fat accumulation. There is currently no approved treatment available for the excess abdominal fat related to HIV-associated lipodystrophy, a condition that can stigmatize patients.
Theratechnologies (TSX:TH - News) is a Canadian biopharmaceutical company with core expertise in peptide-based therapeutics. Its most advanced compound, tesamorelin, is an analogue of the human growth hormone releasing factor.
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. Theratechnologies signed a collaboration and licensing agreement with EMD Serono, Inc., for the commercialization of tesamorelin in the United States.
Theratechnologies' growth strategy is firmly focused on the development of tesamorelin in the United States and in other potential lipodystrophy markets, as well as through additional clinical programs for other medical conditions. Contact:
Contacts: Theratechnologies Inc. Andrea Gilpin Vice President, IR & Communications 514-336-7800, ext. 205 [email protected] Theratechnologies Inc. Aline Vandermeer Coordinator, IR & Communications 514-336-7800, ext. 229 [email protected]