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Theratechnologies Announces That National Institutes of Health Will Support Study on EGRIFTA® (Tesamorelin for Injection) in Non-HIV Patients With Non-Alcoholic Fatty Liver Disease

11-05-2018

MONTREAL, May 11, 2018 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (TSX:TH) today announced that the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health (NIH) in the United States has awarded a grant to the Massachusetts General Hospital to conduct a study using EGRIFTA® in non-HIV patients suffering Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatosis Hepatosis (NAFLD-NASH).

Takara Leah Stanley, MD, and Kathleen Elizabeth Corey, MD, will be the principal investigators of the one-year, double-blind, placebo controlled clinical trial. A total of 60 patients will be enrolled with half receiving treatment and the other half receiving a placebo.

Theratechnologies’ role in the study will be limited to providing EGRIFTA® to the Massachusetts General Hospital.

While NAFLD can be benign, it can develop into a serious condition leading to liver failure. NASH is the most severe form of fatty liver disease and can cause significant damage to liver cells including liver cirrhosis. It is not known if tesamorelin is safe or effective for these conditions. EGRIFTA® is not indicated for the treatment of NAFLD-NASH.

Recent epidemiological studies have determined that the prevalence of NAFLD in the United States (U.S.) has risen from 18% in 1988–1991 to 31% in 2011–2012. Estimates of NAFLD prevalence for adults in Western countries is 20–30%, with much higher prevalence in adults with obesity (80–90%), diabetes (30–50%), and hyperlipidemia (90%).1

About Theratechnologies
Theratechnologies (TSX:TH) is a specialty pharmaceutical company addressing unmet medical needs to promote healthy ageing 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.

Forward-Looking Information
This press release contains statements that are considered forward-looking information (“FLI”) within the meaning of 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, statements regarding: the supply of tesamorelin by the Company to the MGH, the enrollment of patients to conduct the study and the execution and conclusion of the study by the MGH.

We refer potential investors to the “Risk Factors” section of our Annual Information Form (AIF) dated February 6, 2018 for additional risks and uncertainties about Theratechnologies. The AIF is available on the Company’s website at www.theratech.com and on SEDAR at www.sedar.com. 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.

Information:
Denis Boucher
Vice President, Communications and Corporate Affairs
514-336-7800 ext. 236

1 Nonalcoholic fatty liver disease: from steatosis to cirrhosis. Farrell GC, Larter CZ Hepatology. 2006 Feb; 43(2 Suppl 1):S99-S112.