Theratechnologies submits tesamorelin F8 formulation sBLA for FDA review

MONTREAL, Sept. 25, 2023 — Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that the Company has filed a supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin to the U.S. Food and Drug Administration (FDA) for review. Tesamorelin is the only medication approved in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy.

Pharmacokinetic studies have shown bioequivalence of the F8 formulation to the original F1 formulation of tesamorelin (previously sold under the trade name EGRIFTA^®). The F8 formulation is eight times more concentrated than EGRIFTA^® and two times more concentrated than the F4 formulation sold in the U.S. under the trade name EGRIFTA SV^®, enabling a smaller volume of administration as well as a new product presentation in a multiple-dose vial (MDV) that is reconstituted only once per week. The new formulation is patent protected in the U.S. until 2033.

“In our interactions with HIV healthcare providers, we have seen their growing concern with the clinical challenges of excess abdominal fat, a condition that can cause a myriad of negative health consequences for their patients,” said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies. “We developed the F8 formulation of tesamorelin to better address this medical need, as we continue to demonstrate our commitment to the HIV community and healthy aging for people with HIV.”

In accordance with the FDA’s filing review period, Theratechnologies expects to receive an acknowledgment letter of the sBLA application within 30 days along with a Prescription Drug User Fee Act (PDUFA) goal date. The proposed proprietary name for the F8 formulation, EGRIFTA MDV^TM, is already under review by the FDA.

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) analog 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 tumor, 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 of EGRIFTA SV^® include: hypersensitivity reactions, hyperglycemia, 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.

About Theratechnologies

Theratechnologies (TSX: TH) (NASDAQ: THTX) is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs. Further information about Theratechnologies is available on the Company’s website at www.theratech.com, on SEDAR at www.sedarplus.ca and on EDGAR at www.sec.gov. Follow Theratechnologies on Linkedin and Twitter.