EGRIFTA(TM) (Tesamorelin for Injection) Approved in Mexico
(firmenpresse) - MONTREAL, CANADA -- (Marketwired) -- 07/14/15 -- Theratechnologies Inc. (Theratechnologies) (TSX: TH) is pleased to announce that COFEPRIS, Mexico''s health agency, has approved the 2mg/vial presentation of tesamorelin for the treatment of lipodystrophy.
Theratechnologies'' partner, sanofi, will re-submit a file to COFEPRIS to seek approval of the 1mg/vial presentation of EGRIFTA™ which is the one currently marketed in other territories. As was the case with Canada, the commercialization of EGRIFTA™ in Mexico will be initiated upon obtaining approval of the 1mg/vial presentation.
"We are very pleased with COFEPRIS'' decision. We view Mexico as the cornerstone of Latin America for EGRIFTA™ and we are proud that EGRIFTA™ may soon be available to the Latin American population," said Luc Tanguay, President and CEO, Theratechnologies Inc.
EGRIFTA™ was first approved by the United States Food and Drug Administration in November 2010 and was recently approved in March 2015 by Health Canada.
About Theratechnologies
Theratechnologies (TSX: TH) is a specialty pharmaceutical company addressing unmet medical needs in metabolic disorders to promote healthy ageing and an improved quality of life. Further information about Theratechnologies is available on the Company''s website at and on SEDAR at
Forward-Looking Information
This press release contains forward-looking statements and forward-looking information, or, collectively, forward-looking statements, within the meaning of applicable securities laws, that are based on our management''s belief and assumptions and on information currently available to our management. You can identify forward-looking statements by terms such as "may", "will", "should", "could", "would", "outlook", "believe", "plan", "envisage", "anticipate", "expect" and "estimate", or the negatives of these terms, or variations of them. The forward-looking statements contained in this press release include, but are not limited to, statements regarding the approval and availability of EGRIFTA™ in Mexico.
Forward-looking statements are based upon a number of assumptions and are 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, the following: EGRIFTA™ will be approved in the 1mg/vial presentation by the Mexican authorities, if and when available, EGRIFTA™ will be accepted by the Mexican marketplace and will be on the list of reimbursed drugs in that country by third-party payors and the Mexican authorities.
These risks and uncertainties include, but are not limited to, the risk that the 1mg/vial presentation is not approved for commercialization by the Mexican authorities, the risk that EGRIFTA™ is not accepted by the Mexican marketplace as a drug to treat lipodystrophy, the risk that unknown side effects appear resulting in the withdrawal of EGRIFTA™ in this territory, if and when approved, and the risk that our relationships with our commercial partner in this country deteriorates.
We refer potential investors to the "Risk Factors" section of our Annual Information Form dated February 25, 2015 available on SEDAR at . 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.
We undertake 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.
Contacts:
Denis Boucher
EXOCET Public Relations inc.
514-913-1957
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Datum: 14.07.2015 - 05:30 Uhr
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News-ID 1371997
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