Theratechnologies inc.
TSX : TH

Theratechnologies inc.

September 11, 2007 07:30 ET

Theratechnologies Learns from the FDA that its Tesamorelin Clinical Program is Moving in the Right Direction

MONTREAL, QUEBEC--(Marketwire - Sept. 11, 2007) - Theratechnologies (TSX:TH) announced today that it has learned from the US Food and Drug Administration (FDA) that, based on the information known today, the tesamorelin (TH9507) clinical development program is moving in the right direction.

The FDA Division of Metabolic and Endocrine Drug Products had recently requested an update on the status of Theratechnologies' clinical trial program and preliminary results for tesamorelin. Upon review of the documentation, the FDA indicated that they were reassured especially given that thus far there are no signals of glucose intolerance or other safety concerns. With the information known today, the FDA indicated that it does not anticipate that additional clinical outcome trials would be required.

HIV-associated Lipodystrophy

HIV-associated lipodystrophy is characterized by a change in the distribution of adipose tissue (fat containing tissue), dyslipidemia and glucose intolerance. The changes in fat distribution include visceral fat accumulation and/or loss of subcutaneous fat, generally in the limbs and in the face. There is no treatment available for the accumulation of visceral fat found in patients with HIV-associated lipodystrophy. It is estimated that approximately 250,000 HIV-infected patients in North America and Europe suffer an excessive accumulation of visceral fat.

About Theratechnologies

Theratechnologies (TSX:TH) is a Canadian biopharmaceutical company that discovers and/or acquires innovative drug candidates in order to develop them and bring them to market. The Company targets unmet medical needs in financially attractive specialty markets. Its most advanced program is tesamorelin, now in a second confirmatory Phase 3 clinical trial for a serious metabolic disorder known as HIV-associated lipodystrophy. The Company also has other projects at earlier stages of development.

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