MONTREAL, CANADA--(Marketwire - Aug. 31, 2011) - Theratechnologies Inc. (TSX:TH) (NASDAQ:THER) today announced that an affiliate of Sanofi, its commercial partner, has filed a marketing authorization application for the registration of tesamorelin in Brazil with the National Health Surveillance Agency (ANVISA), a division of its Ministry of Health.
Tesamorelin is proposed for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. Currently, there are no approved treatments available for this condition in South America.
"This is the first regulatory application for tesamorelin in Latin America and we are excited about the potential of this very important market," said Mr. John-Michel T. Huss, President and Chief Executive Officer of Theratechnologies. "We estimate that there are approximately 60,000 HIV-infected patients suffering from excess abdominal fat in Brazil, representing the largest potential patient base on the continent. If our product is approved, many patients will be able to benefit, and a currently unmet medical need will be addressed," 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, Canada and Israel.
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. For more information about Theratechnologies, please visit 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.
Forward-Looking Information
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 ANVISA and other regulatory agencies for the treatment of excess abdominal fat in adult HIV-infected patients with lipodystrophy and the size of the Brazilian 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 ANVISA 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 ANVISA or other regulatory agencies in order to approve tesamorelin, that and that tesamorelin will be accepted by the marketplace as a treatment of HIV-associated lipodystrophy if approved by ANVISA. These risks and uncertainties include, but are not limited to, the risk that ANVISA and other regulatory agencies do not approve tesamorelin for the treatment of excess abdominal fat in adult HIV-infected patients with lipodystrophy, or that ANVISA 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.
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