Theratechnologies Provides Regulatory Update for Colombia
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
In its correspondence with Sanofi, INVIMA justifies its position by
stating that additional long-term safety and efficacy studies are
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
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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