MONTREAL, March 05, 2019 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (Theratechnologies) (TSX: TH) today announced that Trogarzo® will be reviewed by the Scientific Advisory Group HIV/Viral Diseases (SAG) of the Committee for Medicinal Products for Human use (CHMP) in Europe.
The 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 process is not expected to delay our recently announced timing for the recommendation by the CHMP even though the remainder of the application review will happen under the standard procedure instead of the initial accelerated assessment.
The CHMP aims to convene the SAG in early April. Upon conclusion of the hearings, the SAG will immediately submit its recommendations to the CHMP.
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 the fact that the CHMP recommendation will not be delayed by the SAG review process, that the SAG meeting will occur in April of this year and that the SAG will immediately submit its recommendations to the CHMP.
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 will be delayed by the SAG review process, that the SAG meeting will not happen in April of this year and that the SAG will not immediately submit its recommendations to the CHMP.
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