Theratechnologies inc.
TSX : TH
NASDAQ : THER

Theratechnologies inc.

July 15, 2011 10:00 ET

Theratechnologies: Data Unveiled on the Effect of Tesamorelin on Metabolic Risk Factors at Conference in Italy

MONTREAL, CANADA--(Marketwire - July 15, 2011) - Theratechnologies Inc. (Theratechnologies) (TSX:TH)(NASDAQ:THER) today announced the presentation of a scientific poster on a post hoc analysis which investigated the changes in metabolic risk factors in HIV patients with excess abdominal fat who responded to tesamorelin treatment. The impact of the reduction in visceral adipose tissue (VAT) in this patient population had not been previously investigated.

Available data from two Phase III multicenter, randomized, double-blind trials, consisting of a 26-week, placebo-controlled primary intervention phase followed by a 26-week extension phase, were pooled and analyzed. In the per-protocol population, 402 HIV patients with excess abdominal fat were treated with tesamorelin for the main phase (26 weeks) and 176 patients for both phases (52 weeks).

At Week 26, in the per-protocol patient population, 68.8% of tesamorelin-treated patients were categorized as responders. In addition, 72.4% of patients treated with tesamorelin for 52 weeks were categorized as responders. Responders were defined as patients with a VAT (visceral adipose tissue) decrease of at least 8% at Week 26 or 52. The analysis revealed a significantly greater responder rate in tesamorelin-treated patients compared to placebo. Fasting Blood Glucose and insulin were unchanged in the responders but deteriorated in non-responders. These data show that no clinically significant changes in glucose parameters occurred in the large majority of HIV patients with excess abdominal fat responding to tesamorelin, with significant reductions in VAT. In addition, a difference relating to metabolic risk factors in favor of responders was observed.

"We are pleased with the results of this analysis. This data is encouraging and supports our efforts as we continue to pursue our second generation GRF discovery program," said John-Michel T. Huss, President and Chief Executive Officer of Theratechnologies.

The poster for this study was presented during the 13th International Workshop on Adverse Drug Reactions and Co-Morbidities in HIV held July 14-16, in Rome, Italy.

About HIV-Associated Lipodystrophy

Several factors, including a patient's antiretroviral drug regimen and the HIV virus itself, are thought to contribute to HIV-associated lipodystrophy, which is characterized by body composition changes. The changes in body composition may include accumulation of excess abdominal fat, which is known as abdominal lipohypertrophy.

About Theratechnologies

Theratechnologies (TSX:TH)(NASDAQ:THER) is a specialty pharmaceutical company that discovers and develops innovative therapeutic peptide products, with an emphasis on growth-hormone releasing factor peptides. Its first product, EGRIFTA® (tesamorelin for injection), was approved by the United States Food and Drug Administration in November 2010. To date, EGRIFTA® is the only approved therapy for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. EGRIFTA® has not been approved in Canada.

EGRIFTA® is currently marketed in the United States by EMD Serono pursuant to a collaboration and licensing agreement executed in October 2008. In addition, Theratechnologies has signed distribution and licensing agreements with an affiliate of Sanofi, granting them the exclusive commercialization rights for tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy in Latin America, Africa and the Middle East and with Ferrer Internacional S.A. granting them the exclusive commercialization rights for tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy in Europe, Russia, South Korea, Taiwan, Thailand and certain central Asian countries.

Theratechnologies is also looking to develop tesamorelin for the treatment of patients suffering from muscle wasting associated with Chronic Obstructive Pulmonary Disease (COPD).

Additional Information about Theratechnologies

Further information about Theratechnologies is available on Theratechnologies' website at www.theratech.com. Additional information, including the Annual Information Form and the Annual Report, is also available on SEDAR at www.sedar.com and on the Securities and Exchange Commission's website at www.sec.gov.

Contact Information

  • Roch Landriault
    NATIONAL Public Relations
    514 843-2345