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MONTREAL, CANADA-(Oct. 19, 2011) - Theratechnologies Inc. (TSX: TH) (NASDAQ: THER)
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 accumulation, 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. Further information about Theratechnologies is
available on the Company's website at http://www.theratech.com/ . Additional
information, including the Annual Information Form and the Annual Report, is also available on SEDAR at http://www.sedar.com/ and
on the Securities and Exchange Commission's website at http://www.sec.gov/ .
Additional Information about Theratechnologies
Further information about Theratechnologies is available on the Company's website
at http://www.theratech.com/ . Additional information, including the Annual
Information Form and the Annual Report, is also available on SEDAR at http://www.sedar.com/ and on
the Securities and Exchange Commission's website at http://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 EGRIFTA ® for the
treatment of excess abdominal fat in adult HIV-infected patients with lipodystrophy in Canada and in other jurisdictions.
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 Health Canada and
other regulatory agencies in other jurisdictions will approve EGRIFTA ® for the treatment of excess abdominal fat in
adult HIV-infected patients with lipodystrophy and that no additional clinical trials will be required by Health
Canada and other regulatory agencies in other jurisdictions in order to approve EGRIFTA ® . These risks and
uncertainties include, but are not limited to, the risk that Health Canada and other regulatory agencies in
other jurisdictions do not approve EGRIFTA ® for the treatment of excess abdominal fat in adult
HIV-infected patients with lipodystrophy or that Health Canada or other regulatory agencies in
other jurisdictions require additional clinical studies prior to make any decision regarding
the approval or non-approval of EGRIFTA ® .
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 http://www.sedar.com/ and
at http://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.
1 Grunfeld C et al. J Acquir Immune Defic Syndr; 45:286-297 (2007). Lo J et al. JAMA, 300: 509518 (2008).
"Reproduced with permission - Theratechnologies "
Theratechnologies
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