Theratechnologies inc.

Theratechnologies inc.

November 11, 2009 15:19 ET

Theratechnologies Presents Combined Phase 3 Clinical Results at European AIDS Conference

MONTREAL, CANADA--(Marketwire - Nov. 11, 2009) - Theratechnologies (TSX:TH) announced today that results from a pooled analysis from both its Phase 3 clinical trials evaluating tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy were presented as a poster (Poster number: #BPD2/1) at the 12th European AIDS Conference/EACS in Cologne, Germany. This Poster will also be presented as part of a "Best Poster" discussion on Friday. In addition, as part of its disease awareness program, Theratechnologies will also sponsor a symposium entitled "Lipohypertrophy: Beyond Body Image", which will be held tomorrow morning at the Conference.

The poster outlined pooled data from both Phase 3 clinical trials and demonstrated that treatment with 2 mg tesamorelin daily for 26 weeks resulted in:

- Significant visceral adipose tissue ("VAT") decrease in tesamorelin-treated patients after 26 weeks of treatment (-13.1 more or less 21.1% p less than 0.001 vs. placebo);

- No clinically significant changes in limb fat (0.2 more or less 13.2%, p=0.001 vs. placebo) and in abdominal subcutaneous adipose tissue ("SAT") (0.7 more or less 15.5%, p=0.08 vs. placebo);

- Significant decrease in triglycerides (-0.4 more or less 1.6 mmol/L, p less than 0.001 vs. placebo).

At Week 52, improvements in VAT and triglycerides observed at Week 26 were sustained in the group of patients who received tesamorelin over 52 weeks (-17.5 more or less 23.3% and -0.5 more or less 2.0 mmol/L, respectively, p less than 0.001 vs. baseline). Patients who were switched from tesamorelin to placebo treatment at Week 26, per the study design, regained VAT at Week 52 (0.3 more or less 26.3%, p=0.18 vs. baseline). No clinically important changes in glucose parameters were observed after treatment with tesamorelin at both Weeks 26 and 52.

The poster presented is now available on Theratechnologies' website at

About HIV-Associated Lipodystrophy

Several factors including the antiretroviral drug regimen and the 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 and discourage HIV treatment adherence.

About Theratechnologies

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 2008, Theratechnologies completed its Phase 3 clinical program evaluating tesamorelin in treating excess abdominal fat in HIV-infected patients with lipodystrophy. In addition, the Company signed a collaboration and licensing agreement with EMD Serono, Inc., for the commercialization of tesamorelin in the United States.

With a New Drug Application recently filed with the US authorities, 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.

Forward-Looking Information

This press release contains certain statements that are considered "forward-looking information" within the meaning of applicable securities legislation. This forward-looking information includes, but is not limited to: information regarding the growth of Theratechnologies through the development of tesamorelin and additional clinical programs. Words such as "will", "may", "could", "should", "outlook", "believe", "plan", "envisage", "anticipate", "expect" and "estimate", or the variations of them denote forward-looking information.

Forward-looking information is based upon a number of assumptions and is subject to a number of risks and uncertainties, many of which are beyond the Company's control, that could cause actual results to differ materially from those that are disclosed in or implied by such forward-looking information. These risks and uncertainties include, but are not limited to: the incapacity of Theratechnologies to further develop tesamorelin as a result of serious adverse events related to its administration or non-conclusive results from additional development programs. The Company refers potential investors to the "Risks and Uncertainties" section of its Annual Information Form (the "AIF") dated February 24, 2009. The AIF is available at under the Company's public filings. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements.

Forward-looking information reflects current expectations regarding future events and speaks only as of the date of this press release and represents the Company's expectations as of that date. The Company does not undertake to update or amend such forward-looking information whether as a result of new information, future events or otherwise, except as may be required by applicable law.

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