MONTREAL, CANADA--(Marketwired - March 8, 2016) - Theratechnologies Inc. (Theratechnologies) (TSX:TH) is pleased to announce that COFEPRIS, Mexico's health agency, has approved the 1mg/vial presentation of tesamorelin for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy, allowing the commercialization of EGRIFTA® in this territory.
The approval of the 1mg/vial presentation comes in the footsteps of the 2mg/vial presentation approval which was received last July from Mexico' s health agency.
"We are very excited by this news especially since it is the result of a long process. We have reached another important milestone towards our goal to offer EGRIFTA® to patients who are looking for a product addressing their condition. Our partner can now focus on the next steps in Mexico consisting in seeking reimbursement for the product and commercializing it," said Luc Tanguay, President and CEO, Theratechnologies Inc.
EGRIFTA® was first approved by the United States Food and Drug Administration in November 2010 and by Health Canada in March 2015.
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 www.theratech.com and on SEDAR at www.sedar.com
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 commercialization 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 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 EGRIFTA® is not accepted by the Mexican marketplace as a drug to treat lipodystrophy and the risk that EGRIFTA® is not reimbursed by third party payors and the Mexican authorities.
We refer potential investors to the "Risk Factors" section of our Annual Information Form dated February 24, 2016 available on SEDAR at www.sedar.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.
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.
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