European Medicines Agengy Issues Certificates for Trogarzo® Manufacturing Sites
MONTREAL, March 20, 2019 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (Theratechnologies) (TSX: TH) is pleased to announce that the Wuxi Biologics facilities set to manufacture Trogarzo® for the European market have received the required Good Manufacturing Practice certificates from the European Medicines Agency (EMA).
Facilities in Wuxi City, China and Shanghai, China, have both been certified by the EMA following thorough inspections in January 2019.
“This is yet another important milestone towards the potential launch of Trogarzo® in Europe. More than ever, we are actively preparing for an approval in this territory to ensure that key markets will be receptive to this unique breakthrough treatment for patients with multidrug resistant HIV”, said Luc Tanguay, President and Chief Executive 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, the approval of Trogarzo® by the EMA and the launch thereof and the acceptance of Trogarzo® by the various stakeholders in European markets.
Forward-looking statements are based upon a number of assumptions and include, but are not limited to, the following: the EMA will approve Trogarzo®, we will be ready to successfully launch Trogarzo® if and when approved and patients, physicians and payors will accept Trogarzo® as a drug to treat HIV patients who are multidrug resistant.
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 additional clinical trials are mandated by the EMA as a result of safety or efficacy issues resulting in delays in obtaining a decision from the EMA for Trogarzo®, that Trogarzo® is not approved by the EMA and that, even if approved and launched, the marketplace does not accept Trogarzo® as a drug to treat HIV patients who are multidrug resistant.
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
