MONTREAL, CANADA -- (Marketwired) -- 06/28/13 -- Theratechnologies Inc . (TSX: TH) announced today that Sanofi, its commercial partner in Colombia, received a letter from the Specialized Division of Drugs and Biological Products of the Reviewer Commission of INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) stating that it does not recommend the approval of tesamorelin in this country.
In its correspondence with Sanofi, INVIMA justifies its position by stating that additional long-term safety and efficacy studies are needed.
Theratechnologies and its partner will focus on obtaining approvals in Mexico and Brazil, the two most significant markets in the Latin American region, where the regulatory review process is currently underway. Thereafter, Theratechnologies and its partner will determine if the decision in Colombia will be appealed.
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 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.
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.
We refer potential investors to the "Risks Factors" section of our Annual Report on Form 20-F dated February 26, 2013 available at www.sedar.com, www.sec.gov and www.theratech.com. 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 statements reflect current expectations regarding future events and speak only as of the date of this press release and represent our 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 laws.
NATIONAL Public Relations
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