Subjects: HEALTH, LICENSING AGREEMENTS
Theratechnologies to Seek Regulatory Approval of Trogarzotm (ibalizumab) in Europe
MONTREAL, April 24, 2018 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (Theratechnologies) (TSX:TH) today announced that it will seek regulatory approval from the European Medicines Agency (EMA) for Trogarzotm using efficacy and safety data from the clinical trials submitted to the U.S. Food and Drug Administration (FDA).
The decision follows meetings held last week in Europe with the Rapporteur and Co-Rapporteur countries as well as with representatives from the EMA.
"Based on our discussions, we are satisfied that the filing of Trogarzotm with the EMA can be done with the data currently available on file," said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer, Theratechnologies Inc.
Dr. Marsolais was in Europe last week to hold three separate meetings with representatives from The Netherlands, Italy and the EMA.
Theratechnologies will now prepare the submission for regulatory approval in Europe and expect to file around the end of the third quarter of this year.
"I am very satisfied with the feedback received following the three meetings in Europe. Europe is the second most important market after the United States. It is our hope and our goal to have this novel HIV-1 treatment made available to European patients with multidrug resistant HIV-1 as quickly as possible," said Luc Tanguay, President and Chief Executive Officer, Theratechnologies Inc.
About Trogarzotm (ibalizumab) Injection
Trogarzotm is a humanized monoclonal antibody for the treatment of multidrug resistant HIV-1 infection. Trogarzotm binds primarily to the second extracellular domain of the CD4+ T receptor, away from major histocompatibility complex II molecule binding sites. It prevents HIV from infecting CD4+ immune cells while preserving normal immunological function.
TrogarzoTM was approved by the FDA on March 6, 2018.
About Theratechnologies
Theratechnologies (TSX:TH) is a specialty pharmaceutical company addressing unmet medical needs to promote healthy living and an improved quality of life among HIV patients. 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, the size of the population with multidrug resistant HIV-1 in Europe, the timeline to file a submission with the EMA, Theratechnologies' capacity to obtain approval for Trogarzotm in Europe.
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: no additional clinical studies will need to be conducted to obtain approval of TrogarzoTM from the EMA, no event will delay the timeline to file the regulatory submission with the EMA, and TrogarzoTM will be approved by the EMA with the current data on file.
These risks and uncertainties include, but are not limited to, the risk that the timeline to file with the EMA is delayed, undesirable side effects are observed in the United States, which could result in the FDA withdrawing the product from the market and the risk that the Theratechnologies' team fails to obtain approval of TrogarzoTM in Europe.
We refer potential investors to the "Risk Factors" section of our Annual Information Form dated February 6, 2018 available on SEDAR at www.sedar.com for additional risks and uncertainties about Theratechnologies and its business. 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.
Media inquiries:
Denis Boucher
Vice President, Communications and Corporate Affairs
Email: [email protected]
Tel.: (514) 336-7800
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