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Green Light for ThGRF in Phase III.

MONTREAL, March 31 /PRNewswire-FirstCall/ -- Theratechnologies (TSX: TH) reports on a positive meeting with the Food and Drug Administration (FDA) in the United States held on March 30, 2005. The purpose of the meeting was to discuss the Company's plans for late-stage development of ThGRF (TH9507) in HIV-associated lipodystrophy.

In response to a series of questions, the FDA indicated that it agrees with the Company's Phase III study design, the dose to be tested, and the use of visceral adipose tissue (VAT) as the primary endpoint. Secondary endpoints include lipid measures and body self-image. The FDA has also indicated that it accepts the Company's proposed inclusion of glucose-intolerant and diabetic patients in the study, with careful monitoring of glycemic control.

Based on the encouraging response from the FDA, the Company plans to stage two Phase III trials testing ThGRF in HIV-associated lipodystrophy patients. The first trial is expected to begin by mid-year.

"This a great day for Theratechnologies," said Yves Rosconi, President and Chief Executive Officer of the Company. "The FDA response to our submission is positive and strikingly clear. We now understand very well what the regulatory requirements are and our Phase II results give us confidence that we can meet those requirements. From a shareholder value perspective, we can look forward to completing the development of ThGRF in this first indication and begin preparations for a product launch in a market that could reach several hundred million dollars. In short, this is a major achievement and a wonderful tribute to our team of employees," Mr. Rosconi concluded.

About HIV-associated Lipodystrophy

HIV-associated lipodystrophy is a metabolic syndrome that afflicts a large percentage of HIV patients undergoing antiretroviral therapy. It is characterized by changes in distribution of adipose tissue (fat-containing tissue), dyslipidemia and glucose intolerance. The changes in fat distribution include visceral fat accumulation and/or the loss of subcutaneous fat, generally in the limbs and facial area.

There is currently no approved treatment for HIV-associated lipodystrophy, and although some new HIV treatments have shown signs of improving metabolic components of the disease, the accumulation of visceral fat, and the related complications, remains an important unmet medical need. It is estimated that, among the 1.4 million HIV-positive patients in North America and Europe, as many as 200,000 suffer from HIV-associated lipodystrophy with excess visceral fat.

About ThGRF

ThGRF is a stabilized analogue of the growth hormone-releasing factor (GRF) that induces the production and secretion of growth hormone in a specific, physiological, controlled and pulsatile fashion. This property makes it a strong candidate as a potential treatment for many diseases related to aging and obesity, as these conditions are characterized by a significant reduction in growth hormone secretion.

About Theratechnologies

Theratechnologies (TSX: TH) is a Canadian biopharmaceutical company engaged in the discovery and development of therapeutic peptides in the field of endocrinology and metabolism. The Company is steadily expanding its product portfolio through proprietary discovery technologies. The most advanced clinical program (completed Phase II) targets HIV-associated lipodystrophy. Other clinical programs are investigating wasting associated with chronic disease and type 2 diabetes. Theratechnologies' website is located at .

Conference call and webcast

A conference call and webcast will be held today, Thursday, March 31, 2005, at 8:30 a.m. to discuss the outcome of the FDA meeting. You can access the webcast at the following links: sign)1063700 and . The webcast will be posted for 90 days.

For the conference call, interested participants are asked to dial the following numbers: 1-416-640-4127 or 1-800-814-4861 (toll free). A replay of the conference call will be available as of March 31, 2005 at 10:30 a.m. until April 14, 2005 at 11:59 p.m. at the following number: 1-416-640-1917, code 21119698(pound key). Please call 5 minutes prior to the conference in order to ensure your participation.

This press release contains forward-looking statements regarding the clinical development of ThGRF and its future commercialization in the indications described above. Such statements inherently involve numerous risks and uncertainties, including the success and timely completion of clinical trials, the ability of the Company to take advantage of the business opportunities in the biopharmaceutical industry, the granting of the necessary authorizations, and the general economic conditions. The Company, however, is not obligated to update this information and does not intend to do so. Investors are cautioned against placing undue importance on forward-looking information contained herein and should consult the Company's 2004 Annual Report, which contains a more exhaustive analysis of risks and uncertainties connected to the businesses of the Company.

CONTACT: Peter McBride, Vice President, Investor Relations and Public Affairs, (514) 336-4804, ext. 215,
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Date:Mar 31, 2005
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