MONTREAL, Aug. 28, 2018 — Theratechnologies Inc. (Theratechnologies) (TSX: TH) is pleased to announce that the application for marketing authorization of Trogarzo™ (ibalizumab) was filed with the European Medicines Agency (“EMA”) through its centralized procedure. Theratechnologies seeks to obtain approval for ibalizumab for the treatment of multidrug resistant Human Immunodeficiency Virus-1 (MDR HIV-1) in the European Union.
The EMA has until mid-September to confirm whether the application is complete, in which case, it will initiate the review of Trogarzo™ under the accelerated assessment procedure.
The accelerated assessment procedure, which was granted in an earlier decision from the EMA, reduces the timeframe for a recommendation by the EMA to 150 review days from 210 review days for the normal procedure.
The application is based on the same clinical trial data that was reviewed by the FDA to grant marketing authorization of Trogarzo™ in the United States.
“Europe is the second most important market in the world for Trogarzo™. Many patients in Europe could benefit from this product if it becomes available in this territory. Knowing what Trogarzo™ represents for patients who have been on various treatment regimens but have a viral load still above detection level, we have spared no effort to ensure that we could file the application within six months after obtaining approval in the United States,” said Luc Tanguay, President and Chief Executive Officer, Theratechnologies Inc.
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.
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 actual timeline for the review of the marketing authorization application and the issuance of a decision by the EMA and Theratechnologies’ capacity to obtain approval for Trogarzo™ 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: the application for marketing authorization will be deemed to be complete by the EMA, no additional clinical studies will need to be conducted to obtain approval of TrogarzoTM from the EMA, and no event will delay the assessment of the marketing authorization application.
These risks and uncertainties include, but are not limited to, the risk that the application is incomplete and, therefore, not validated, the risk that TrogarzoTM is not approved by the EMA and the risk that our commercial infrastructure in Europe is not established in the event the EMA issues a marketing authorization for Trogarzo™.
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.