MONTREAL, CANADA--(Marketwire -10/19/11)- Theratechnologies Inc. (TSX: TH.TO - News)(NASDAQ: THER - News) today announced that an affiliate of Sanofi, its commercial partner, has submitted a marketing authorization application for tesamorelin in Mexico with the Federal Commission for the Protection against Sanitary Risk (COFEPRIS).
Tesamorelin is proposed for the reduction of excess visceral fat in HIV-infected adult patients suffering from lipodystrophy with lipohypertrophy of the visceral adipose tissue. Theratechnologies estimates that there are approximately 18,000 HIV-infected patients in treatment suffering from excess abdominal fat in Mexico. Currently, there are no approved treatments available for this condition in Latin America.
"With submissions under review in North and South America, Europe and the Middle East, we are pleased that an application has been filed for tesamorelin by our partner Sanofi in Mexico as well," said Mr. John-Michel T. Huss, President and Chief Executive Officer of Theratechnologies. "The geographic scope of our regulatory filings to date, with the support of our commercial partners, demonstrates our drive to help address a currently unmet medical need and our commitment to maximizing the commercial potential of tesamorelin," concluded Mr. Huss.
Theratechnologies signed a distribution and licensing agreement with an affiliate of Sanofi on December 6, 2010, granting them 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.
Additional applications for tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy are currently under review with regulatory agencies in Europe, Argentina, Brazil, Canada and Israel.
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.
Theratechnologies (TSX: TH.TO - News)(NASDAQ: THER - News) is a specialty pharmaceutical company that discovers and develops innovative therapeutic peptide products, with an emphasis on growth-hormone releasing factor peptides. Further information about Theratechnologies is available on the Company's 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.
This press release contains certain statements that are considered "forward-looking information" within the meaning of applicable securities legislation, which statements may contain such words as "may", "would", "could", "will", "intend", "plan", "anticipate", "believe", "estimate", "expect" and similar expressions. This forward-looking information includes, but is not limited to, information regarding the potential approval of tesamorelin by COFEPRIS and other regulatory agencies for the treatment of excess abdominal fat in adult HIV-infected patients with lipodystrophy and the size of the Mexican market.
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 Theratechnologies' control that could cause actual results to differ materially from those that are disclosed in or implied by such forward-looking information. These assumptions include, but are not limited to, that COFEPRIS and other regulatory agencies will approve tesamorelin for the treatment of excess abdominal fat in adult HIV-infected patients with lipodystrophy, that no additional clinical trials will be required by COFEPRIS and other regulatory agencies in order to approve tesamorelin, and that tesamorelin will be accepted by the marketplace as a treatment for HIV-associated lipodystrophy if approved by COFEPRIS. These risks and uncertainties include, but are not limited to, the risk that COFEPRIS and other regulatory agencies do not approve tesamorelin for the treatment of excess abdominal fat in adult HIV-infected patients with lipodystrophy or that COFEPRIS or other regulatory agencies require additional clinical studies prior to making any decision regarding the approval or non-approval of tesamorelin.
Theratechnologies refers potential investors to the "Risks and Uncertainties" section of its Annual Information Form (AIF) dated February 22, 2011. The AIF is available at www.sedar.com and at www.sec.gov under Theratechnologies' 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 Theratechnologies' expectations as of that date.
Theratechnologies undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.
NATIONAL Public Relations