November 25, 2019
Theratechnologies Starts Commercialization of New EGRIFTA SV™ in the United States
Montreal, Canada – November 25, 2019 – Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, is pleased to announce that EGRIFTA SVTM (2mg/vial) is now commercially available in the United States.
Our salesforce has started detailing the product to physicians today while the supply chain is being filled, and people living with HIV and lipodystrophy will have access to a new formulation of tesamorelin for the reduction of hard belly (excess hard abdominal fat) in the next few days. Lipodystrophy is a serious metabolic condition which is associated with the development of insulin resistance, diabetes, fatty liver and high triglyceride levels.
EGRIFTA SVTM is a growth hormone-releasing factor analog. EGRIFTA SVTM is a once-daily small volume subcutaneous injection that is presented in a single vial and stored at room temperature.
“Given its many improvements over the original version of tesamorelin, EGRIFTA SVTM should help sustain growth for tesamorelin over the coming years. We are committed to continue managing the lifecycle of our products in order to help people living with HIV,” said Luc Tanguay, President and Chief Executive Officer, Theratechnologies Inc.
About EGRIFTA SVTM (tesamorelin for injection)
EGRIFTA SVTM is currently approved in the United States only and is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.
Do not use EGRIFTA SVTM if a patient:
- Has a pituitary gland tumor, has had pituitary gland surgery, has other problems related to their pituitary gland, or has had radiation treatment to their head.
- Has active cancer.
- Is allergic to tesamorelin or any of the ingredients in EGRIFTA SVTM.
- Is pregnant or planning to become pregnant.
The most common side effects of EGRIFTA SVTM include: injection site reactions, arthralgia, pain in extremity, myalgia and peripheral edema.
Refer to www.egriftasv.com for the full prescribing information, patient information and instructions for use for further details about this product.
Theratechnologies (TSX: TH) (NASDAQ: THTX) is a commercial-stage biopharmaceutical 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, on SEDAR at www.sedar.com and on EDGAR at www.sec.gov.
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, statements regarding the availability of EGRIFTA SVTM, the sales growth of tesamorelin-based products and the continuous improvements of our products.
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: we will have a continuous supply of EGRIFTA SVTM, the marketplace will accept EGRIFTA SVTM, patient adherence for EGRIFTA SVTM will improve and our vision regarding the improvements of our products will not change.
The risks and uncertainties include, among others, the risk that EGRIFTA SVTM is not accepted by the marketplace (payors, physicians and/or patients), the known long-term safety and efficacy of EGRIFTA SVTM changes over time and the risk that improving our products fail because of scientific limitations, costs and regulatory approval requirements.
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.