MONTREAL, CANADA--(Marketwire -06/04/12)- Theratechnologies Inc. (TH.TO) (THER) today announced that a marketing authorization application for tesamorelin has been submitted with regulatory agencies in Colombia and Venezuela. Sanofi, Theratechnologies' commercial partner in those countries, filed the application as part of its distribution and licensing agreement for tesamorelin.
Tesamorelin is proposed for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. Theratechnologies estimates that there are approximately 11,000 and 16,000 HIV-infected patients in treatment suffering from excess abdominal fat in Venezuela and Colombia, respectively. At this time, there are no approved treatments available for this condition in Latin America. In this territory, Sanofi also filed applications for tesamorelin in Argentina, Brazil and Mexico in 2011, all of which are currently under review.
"Latin America is a significant territory for tesamorelin, with a potential patient base of over 200,000," said Mr. John-Michel T. Huss, President and Chief Executive Officer of Theratechnologies. "This represents one more step towards developing the full potential of this unique treatment. As the number one healthcare company in Latin America, Sanofi will be in a solid position to successfully commercialize tesamorelin once regulatory approvals are granted," concluded Mr. Huss.
Theratechnologies signed a distribution and licensing agreement with 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 also currently under review with regulatory agencies in Europe, 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 (TH.TO) (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 www.theratech.com, 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 regulatory agencies for the treatment of excess abdominal fat in adult HIV-infected patients with lipodystrophy and the size of the Colombian, Venezuelan and Latin American markets.
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 regulatory agencies in Colombia, Venezuela and in other territories where marketing applications have been filed 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 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 regulatory agencies. These risks and uncertainties include, but are not limited to, the risk that regulatory agencies do not approve tesamorelin for the treatment of excess abdominal fat in adult HIV-infected patients with lipodystrophy, the risk that regulatory agencies require additional clinical trials prior to making any decision regarding the approval or non-approval of tesamorelin or that, even if approved, the commercialization of tesamorelin is not successful because the product is not accepted by the marketplace or reimbursed by third-party payers.
Theratechnologies refers potential investors to the "Risk Factors" section of its Annual Information Form (AIF) dated February 27, 2012. 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.