Theratechnologies reports date for FDA Advisory Committee Review of the Tesamorelin New Drug Application
Montreal, Canada - January 18, 2010 - Theratechnologies (TSX:TH) today announced that the U.S. Food and Drug Administration ("FDA") has confirmed that the Endocrinologic and Metabolic Drugs Advisory Committee will meet to review Theratechnologies' New Drug Application ("NDA") for tesamorelin on Wednesday, February 24, 2010. The meeting will take place at the Hilton Washington DC/Silver Spring (8727 Colesville Road, Silver Spring, Maryland). Information related to the meeting is available on The Office of the Federal Register web site at: http://www.federalregister.gov/
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 FDA filed the NDA on August 12, 2009, which initiated a substantive review of the application. The Prescription Drug Fee Act ("PDUFA") date, which is the target date for the FDA to complete its review of tesamorelin NDA, is March 29, 2010.
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) 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.
With a New Drug Application filed with the U.S. authorities in May 2009, Theratechnologies' growth strategy is firmly focused on the development of tesamorelin in the United States and in other potential HIV-associated lipodystrophy markets, as well as through additional clinical programs for other medical conditions.