MONTREAL, CANADA--(Marketwired - March 30, 2015) - Theratechnologies Inc. (Theratechnologies) (TSX:TH) is pleased to announce that Health Canada has approved a Supplement to a New Drug Submission for the 1mg/vial presentation of EGRIFTA™ (tesamorelin for injection) (EGRIFTA™).
This follows the approval of the 2mg/vial presentation which was received in April 2014. For the time being, only the 1mg/vial presentation will be marketed.
"We have eagerly been waiting for this decision. EGRIFTA™ was discovered in Canada and we feel particularly proud that the approval of this presentation will give us the opportunity to make our product available to Canadian patients," said Luc Tanguay, President and CEO, Theratechnologies Inc.
"As we build this new market for EGRIFTA™, on top of commercial activities in the US, we will bring Theratechnologies even closer to our goal to maximize its potential. To that end, our team has been working diligently to prepare for the launch in Canada. We expect that EGRIFTA™ should become available to Canadian patients at the beginning of June" concluded Mr. Tanguay.
EGRIFTA™ was first approved by the United States Food and Drug Administration in November 2010.
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 availability of EGRIFTA™ in Canada and the growth of the Company through the commercialization of EGRIFTA™ in Canada.
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: we will have a continuous supply of EGRIFTA™, our commercialization efforts in Canada will result in sales in this country and third-party payors will reimburse EGRIFTA™.
These risks and uncertainties include, but are not limited to, the risk that our commercial strategy in Canada does not result in satisfactory sales of EGRIFTA™, the risk that we incur delays in the launch of EGRIFTA™, and the risk that our relationships with our third-party service providers deteriorates.
We refer potential investors to the "Risk Factors" section of our Annual Information Form dated February 25, 2015 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.
Contact Information:
514-913-1957