Trogarzo® Receives Positive Recommendation from Scientific Advisory Group of CHMP in Europe
MONTREAL, April 11, 2019 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (Theratechnologies) (TSX: TH) is pleased to announce that the Scientific Advisory Group HIV/Viral Diseases (SAG), convened by the Committee for Medicinal Products for Human use (CHMP) in Europe, has given a positive recommendation to Trogarzo® (ibalizumab).
The meeting between the SAG and representatives from Theratechnologies took place this morning in Amsterdam, Netherlands.
“We could not be more pleased with the outcome of today’s meeting. The positive recommendation represents an important step towards the potential approval of Trogarzo® in Europe, which could constitute the second most important market for our product,” said Luc Tanguay, President and Chief Executive Officer, Theratechnologies Inc.
A SAG is convened at the request of the CHMP to provide independent recommendations on scientific or technical matters relating to human immunodeficiency virus (HIV) and viral-disease products under evaluation by the CHMP, or on any other scientific issue relevant to the work of the CHMP that relates to this area.
The recommendation from the CHMP to the European Medicines Agency is expected to be announced around May 29, 2019.
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.
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 the fact that the CHMP will accept the recommendation of the SAG, that the CHMP will submit its recommendation to the EMA around May 29, 2019, that the recommendation made by the CHMP to the EMA is positive, that the EMA will accept the recommendation of the CHMP and that Europe will become the second most important market for Trogarzo®.
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 CHMP recommendation to the EMA will be delayed and/or is negative, that the EMA does not approve Trogarzo® and that Europe does not become the second most important market for Trogarzo®.
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.
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