Dr. Christian Marsolais reports

THERATECHNOLOGIES RECEIVES COMPLETE RESPONSE LETTER (CRL) FROM THE FDA FOR THE F8 FORMULATION OF TESAMORELIN SBLA

The United States Food and Drug Administration (FDA) has issued a complete response letter (CRL) in response to Theratechnologies Inc.'s supplemental biologics licence application (sBLA) for the F8 formulation of tesamorelin. The company will address the FDA's request and intends to pursue approval of this newer formulation of tesamorelin.

The questions outlined in the CRL are largely related to chemistry, manufacturing and controls (CMC) concerning the microbiology, assays, impurities and stability for both the lyophilized product and the final reconstituted drug product. In addition, the FDA requested further information to understand the potential impact of the proposed formulation on immunogenicity risk.

"While we are disappointed to receive a complete response letter from the FDA for the F8 formulation of tesamorelin containing questions that were not raised during the review process, we plan to address these new comments as swiftly as possible," said Dr. Christian Marsolais, PhD, senior vice-president and chief medical officer at Theratechnologies. "We remain focused on bringing this new formulation of tesamorelin to market as part of our commitment to innovate and simplify treatments for people with HIV."

The company will continue to commercialize Egrifta SV, which is the only approved treatment in the U.S. for the reduction of excess abdominal fat in adults with HIV (human immunodeficiency virus) who have lipodystrophy.

About Egrifta SV (tesamorelin for injection)

Egrifta SV is approved in the U.S. for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. Egrifta SV is a growth-hormone-releasing factor (GHRF) analogue that acts on pituitary cells in the brain to stimulate the production and release of endogenous growth hormone.

Limitations of use:

• Long-term cardiovascular safety of Egrifta SV has not been established. Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue.
• Egrifta SV is not indicated for weight-loss management, as it has a weight-neutral effect.
• There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking Egrifta SV.

Do not use Egrifta SV if a patient:

• Has a pituitary gland tumour, has had pituitary gland surgery, has other problems related to their pituitary gland, or has had radiation treatment to their head or head trauma;
• Has active cancer;
• Is allergic to tesamorelin or any of the ingredients in Egrifta SV;
• Is pregnant or planning to become pregnant.

The most commonly reported adverse reactions to Egrifta SV include: hypersensitivity reactions, hyperglycemia, injection site reactions, arthralgia, pain in extremity, myalgia and peripheral edema.

About Theratechnologies Inc.

Theratechnologies is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs.

We seek Safe Harbor.