MONTREAL, Sept. 05, 2018 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies”) (TSX: TH) today announced that the Food and Drug Administration (“FDA”) has set the target date to November 3, 2018 to issue a decision on the supplemental New Drug Application (sNDA) filed on July 3, 2018 regarding the commercialization of a new single-vial formulation of EGRIFTA®.
The sNDA was filed using bioequivalence studies which were completed earlier this year. The new single-vial formulation, known as “F4”, is four times more concentrated than the currently commercialized formulation of EGRIFTA®. The F4 significantly reduces the volume of administration and handling is more user-friendly as it comes in a single vial instead of two. Furthermore, the F4 is stable at room temperature which represents an advantage for patients and Theratechnologies as EGRIFTA® currently requires a cold-chain distribution network from the manufacturer to the patient.
“We believe that continuing to bring improvements to EGRIFTA® will ensure that it remains an important product for Theratechnologies and for patients. The approval of the F4 would represent an important step in that direction,” 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 target date regarding the issuance of a decision by the FDA and the potential approval of the sNDA by the FDA.
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 FDA will issue its decision within the timeline described herein, the FDA will approve the sNDA and, further to the approval of the F4 by the FDA, patients and physicians will welcome such new formulation, leading to increased sales of EGRIFTA®.
These risks and uncertainties include, but are not limited to, the risk that a decision by the FDA is issued after the announced target date, the risk that the FDA does not approve the sNDA and, even if approved, sales of EGRIFTA® using the F4 formulation do not grow.
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.
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