Theratechnologies inc.
TSX : TH

Theratechnologies inc.

November 13, 2008 14:46 ET

Theratechnologies: Last Patient Treated in the Extension Phase of the Confirmatory Study Testing Tesamorelin in HIV-Associated Lipodystrophy

MONTREAL, QUEBEC, CANADA--(Marketwire - Nov. 13, 2008) - Theratechnologies (TSX:TH) announced that the last patient has completed 52 weeks of treatment in the extension phase of the confirmatory Phase 3 trial testing tesamorelin in HIV-associated lipodystrophy. The Company now expects to be in a position to present top-line 52-week results of this confirmatory Phase 3 trial by year end.

"We are excited to announce the completion of the extension of our confirmatory Phase 3 trial, particularly as it signals the end of our clinical program in lipodystrophy," said Dr. Christian Marsolais, Vice President, Clinical Research and Medical Affairs at Theratechnologies. "This is another important milestone for the tesamorelin program and I would like to take this opportunity to thank patients, investigators, as well as our dedicated clinical team," added Dr. Marsolais.

"With the treatment of the last patient in the Phase 3 program and the 52-week results expected by year end, we believe that we will be in a good position to optimize the product monograph for tesamorelin," noted Mr. Yves Rosconi, President and CEO of Theratechnologies. "After the 52-week results are announced, we will complete our regulatory file in order to submit it to the US Food and Drug Administration. We are targeting to obtain regulatory approval around the end of 2009," concluded Mr. Rosconi.

The confirmatory Phase 3 trial is a 400-patient, multi-center, double-blind, randomized, placebo-controlled study conducted in 48 centers in North America and Europe. It is designed to confirm the results of the first Phase 3 trial by examining the safety and efficacy of a daily administration of 2 mg of tesamorelin for a period of 26 weeks as well as the long-term safety over a period of 52 weeks.

Positive 26- and 52-week results of the first Phase 3 trial were respectively announced in December 2006 and in October 2007. Positive 26-week results from the confirmatory Phase 3 trial were disclosed in June 2008. To date, all results have shown tesamorelin's ability to selectively reduce excess abdominal fat in patients with HIV-associated lipodystrophy while being well tolerated.

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 that discovers 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, which is concluding a confirmatory Phase 3 clinical trial for a serious metabolic disorder involving excess abdominal fat in HIV patients with lipodystrophy. The Company also has other projects at earlier stages of development.

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 timing to present top-line 52-week results from the confirmatory Phase 3 trial, the confirmation of the safety profile of tesamorelin in the confirmatory Phase 3 trial, the completion of its regulatory file and the submission of a New Drug Application ("NDA") for tesamorelin with US regulatory agencies and the market launch of tesamorelin. Words such as "will", "may", "could", "should", "outlook", "believe", "plan", "envisage", "anticipate", "expect" and "estimate", or the negatives of these terms or variations of them and the use of the conditional tense as well as similar expressions 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 delays that may occur in compiling and analyzing the data resulting from the confirmatory Phase 3 trial, the negative results that the confirmatory Phase 3 clinical study may yield, the delay in completing the regulatory file, in submitting the NDA, or the delay in approving or the non-approval of tesamorelin by the applicable regulatory authorities. The Company refers potential investors to the "Risks and Uncertainties" section of its Annual Information Form (the "AIF") dated January 29, 2008. The AIF is available at www.sedar.com under the Company's public filings. The reader is cautioned that the foregoing list of risks and uncertainties is not exhaustive of the risks and uncertainties that may affect any of the Company's forward-looking statements. The reader is also cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements.

Although the forward-looking information contained in this press release is based upon what the Company believes are reasonable assumptions, investors are cautioned against placing undue reliance on this information since actual results may vary from the forward-looking information. Certain assumptions made in preparing the forward-looking information include, but are not limited to, the assumption that past results obtained from the first Phase 3 clinical study will be repeated, that the time required to analyze and report the results of the Company's confirmatory Phase 3 clinical study will be consistent with past timing, and that the applicable regulatory authorities will approve tesamorelin for commercialization within the customary delay after the filing of the NDA.

Consequently, all of the forward-looking information contained in this press release is qualified by the foregoing cautionary statements, and there can be no guarantee that the results or developments anticipated by the Company will be realized or, even if substantially realized, that they will have the expected consequences or effects on the Company, its business, financial condition or results of operation. Furthermore, the forward-looking information reflects current expectations regarding future events and speaks only as of the date of release 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.

Contact Information