Theratechnologies: International Workshop on Adverse Drug Reactions and Co-morbidities in HIV

Montreal, Canada – October 26, 2009 – Theratechnologies (TSX :TH) announced today that additional patient reported outcome results from a combined analysis from both Phase 3 clinical trials evaluating tesamorelin in the treatment of excess abdominal fat in HIV- infected patients with lipodystrophy, were presented today at the 11th International Workshop on Adverse Drug Reactions and Co-morbidities in HIV, in Philadelphia, USA. The data presented today is part of the New Drug Application (“NDA”) submitted by Theratechnologies to the US Food and Drug Administration (“FDA”) at the end of May 2009.

Dr. Ralph Turner, Vice President, Phase V Technologies, Inc., presented combined analysis results from the main phase of Theratechnologies’ two Phase 3 clinical trials and reviewed the impact of tesamorelin on belly and weight image and on health-related quality of life (“HRQOL”) parameters. Self-perceived body image, an important secondary endpoint, was determined by a validated questionnaire developed by Phase V Technologies, Inc. The results indicated that after 26 weeks of treatment the 543 patients treated with 2 mg daily of tesamorelin reported clinically relevant improvements in belly appearance distress, as well as in belly and weight image while maintaining HRQOL, with no increases in symptom incidence and distress. Moreover, the decrease in visceral adipose tissue (“VAT”) observed in tesamorelin treated patients was correlated with various improvements in patient reported outcome parameters.

Patients treated with tesamorelin reported significantly less belly appearance distress than patients on placebo (Week 26 change from baseline: 9.8±28.0 vs. 5.9±25.8, p=0.002) and patient- and physician-reported belly profile improved significantly more in tesamorelin than placebo treated patients (-0.6±1.3 vs. -0.3±1.1, p=0.003 and -0.6±1.1 vs. -0.3±1.1, p<0.001, respectively). Significant improvements were also observed in tesamorelin-treated patients for the evaluation of weight concern and current appearance distress (-7.2±25.0 vs. -2.5±28.7, p=0.014 and 0.8±1.7 vs. 0.4±1.5, p<0.001, respectively). Global HRQOL significantly deteriorated in placebo patients (-0.2±1.5) compared to tesamorelin-treated patients, who maintained their HRQOL (0.0±1.5, p=0.029 vs. placebo). Tesamorelin-treated patients improved significantly versus baseline for symptoms and side effects incidence (17.4±69.0, p<0.001), and no significant differences versus baseline or placebo were observed for symptoms and side effects distress (2.9±38.5 vs. -0.3±40.8, for tesamorelin vs. placebo, p=0.204).

 

The responsiveness unit analysis revealed clinically important effects (effect size≥0.15) in tesamorelin-treated patients for belly appearance, patient- and physician-reported belly profile and each of the weight image endpoints. In contrast, there was a clinically meaningful deterioration in these patient reported outcome parameters in the placebo group. Changes in body image and HRQOL parameters were significantly correlated with changes in VAT (p<0.05) for tesamorelin-treated patients, whereas no correlations were observed in placebo-treated patients.

 

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.

 

Phase V Technologies
Phase V's clinical and outcomes research services include strategic planning, design, conduct, evaluation, and analysis of clinical trials. As part of new drug and device development the Phase V® Outcomes Research System focuses on evaluating the effectiveness and acceptance of new therapies from the patient and health economic perspective.

 

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.

 

With a New Drug Application (“NDA”) 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 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 http://www.sedar.com/ 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.