Theratechnologies inc.
TSX : TH

Theratechnologies inc.

April 27, 2009 08:30 ET

Theratechnologies Presents Additional Data From Studies Evaluating Tesamorelin at the Annual Canadian Conference on HIV/AIDS Research

MONTREAL, QUEBEC--(Marketwire - April 27, 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 patients with lipodystrophy were presented today at the 18th Annual Canadian Conference on HIV/AIDS Research in Vancouver. Results from studies in healthy subjects evaluating the impact of tesamorelin on the pharmacokinetics of two drugs that could potentially be administered together with tesamorelin in HIV patients with lipodystrophy were also presented as a poster at this HIV-focused conference.

Oral Presentation

Dr. Julian Falutz, Director of the HIV Metabolic Clinic at Montreal General Hospital, Assistant Professor at McGill University Medical School, and Lead Investigator for tesamorelin trials in Canada, presented pooled analysis results from the main phase of the Company's two Phase 3 clinical trials. The results indicated that after 26 weeks of treatment (each trial was extended to 52 weeks), the 543 patients treated with 2 mg daily of tesamorelin experienced reduction of visceral adipose tissue ("VAT"), preservation of subcutaneous adipose tissue ("SAT"), and an improvement in triglycerides, without significant changes in glucose parameters.

At Week 26, VAT decreased significantly in tesamorelin-treated patients (-13.1 vs. 2.3%, tesamorelin vs. placebo, p less than 0.001), while no clinically significant changes were observed in limb fat by DEXA (0.2 vs. 3.0%, tesamorelin vs. placebo, p equals 0.001). No significant changes were observed in SAT (0.8 vs. 1.3%, tesamorelin vs. placebo, p equals 0.08). Treatment with tesamorelin was associated with a significant decrease in triglycerides (-0.4 vs. 0.1mmol/L, tesamorelin vs. placebo, p less than 0.001). Mean IGF-I levels increased within physiological range in tesamorelin-treated patients (83.4%, p less than 0.001 vs. placebo). No significant differences were observed between groups in fasting glucose and insulin as well as the 2-hour oral glucose tolerance test.

Poster Presentation

The poster described the results of two randomized, open-label, two-way crossover studies evaluating the impact of tesamorelin on the pharmacokinetics of Simvastatin and Ritonavir in healthy subjects. Simvastatin and Ritonavir are two drugs that could potentially be administered together with tesamorelin. These studies showed that the impact of tesamorelin on CYP3A activity appears to be minimal. Either medication may be co-administered with tesamorelin without changing their dosing regimen.

In these two studies, subjects were administered 2 mg tesamorelin on Days 1 to 7, with 80 mg simvastatin (n equals 58) or 100 mg ritonavir (n equals 32) co-administered on Day 6 (Treatment A), or a single dose of simvastatin or ritonavir alone on Day 6 (Treatment B) in a crossover manner. PK samples collected on Day 6, measured simvastatin, ritonavir and tesamorelin plasma concentrations.

For simvastatin, ratios of least squares geometric means and corresponding 90% CIs for AUC0-t, AUC0-inf and Cmax were contained within the acceptance range. For the metabolite simvastatin acid, only the lower CI for AUC0-inf (78.6%) was slightly outside of the range. For ritonavir, ratios and 90% CIs for AUCs were contained within the acceptance range, but for Cmax, the lower CI was 74.8%, suggesting a slight difference in the maximal concentration of ritonavir in the presence of tesamorelin administration However, since the observed A/B ratios for AUCs and Cmax parameters for rinotavir were approximately 90%, these minor decreases indicated that no dose adjustment of ritonavir is required in the presence of tesamorelin.

The poster presented is now available on Theratechnologies' website at www.theratech.com

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 growth hormone releasing factor. Theratechnologies recently completed two Phase 3 clinical trials evaluating tesamorelin in treating excess abdominal fat in HIV patients with lipodystrophy and signed a collaboration and licensing agreement with EMD Serono, Inc., for the commercialization of tesamorelin in the United States. With a regulatory filing to be submitted to US authorities shortly, Theratechnologies' growth strategy is firmly focused on the development and exploitation of tesamorelin in the United States and in other potential lipodystrophy markets, as well as through additional clinical programs.

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 submission of a regulatory file with US regulatory agencies. 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: a delay in submitting the regulatory file to US regulatory authorities. 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.

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