MONTREAL, May 24, 2019 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (Theratechnologies) (TSX: TH) today announced that it requested and obtained from the European Medicines Agency (EMA) an additional month to address new questions received yesterday in regard to the establishment of a post-approval registry to gather long-term data on patients taking Trogarzo^® (ibalizumab) in Europe.

Theratechnologies will submit responses to the EMA by the end of June 2019. The Committee for Medicinal Products for Human Use (CHMP) will then have 30 days to provide a recommendation to the European Union regarding the approval for the commercialization of Trogarzo^® in Europe. 

Assuming a positive CHMP opinion, our plans to launch in Germany before the end of the year remain unchanged.

“Based on our most recent correspondence with the EMA, we came to the conclusion that our marketing authorization application would be better served by seeking this extension period to provide a comprehensive post-approval registry plan and to explain in more details how it would be managed. We believe that this additional information will be sufficient to complete the assessment of the application,” said Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer, Theratechnologies Inc.

About Theratechnologies
Theratechnologies (TSX: TH) is a specialty pharmaceutical company addressing unmet medical needs by bringing to market specialized therapies for people with orphan medical conditions, including those living with HIV. 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 beliefs 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 timing to provide answers to the EMA, the time period required by the CHMP to provide a recommendation, our plan to launch Trogarzo^® in Germany and the completion of the assessment our application.

Forward-looking statements are based upon a number of assumptions and include, but are not limited to, the following: we will meet the deadline of June, 2019, our answers will be accepted as complete by the CHMP, a positive recommendation will be issued and the European Union will approve Trogarzo^® for commercialization.
Forward-looking statements are subject to a variety of risks and uncertainties, many of which are beyond our control that could cause our actual results to differ materially from those that are disclosed in or implied by the forward-looking statements contained in this press release. These risks and uncertainties include, among others, the risk that the we are unable to meet the June, 2019 deadline, the risk that a recommendation from the CHMP is delayed, the risk that such recommendation is not positive and Trogarzo^® is not approved for commercialization and that a launch in Germany is not possible by year-end.

We refer potential investors to the "Risk Factors" section of our annual information form dated February 20, 2019 for additional risks regarding the conduct of our business and Theratechnologies. 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.

For media inquiries:
Denis Boucher
Vice President, Communications and Corporate Affairs
514-336-7800