THERATECHNOLOGIES CONFIRMS ISSUANCE OF U.S. PATENT COVERING THE USE OF TESAMORELIN IN THE TREATMENT OF INDIVIDUALS SUFFERING FROM NAFLD/NASH
Montreal, Canada – October 13, 2020 – Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, is pleased to announce that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,799,562, which is directed to the treatment of Nonalcoholic Steatohepatitis (NASH) and/or Nonalcoholic Fatty Liver Disease (NAFLD) in patients using tesamorelin.
This patent, which is scheduled to expire in 2040, stems from a patent application filed in March 2020 by Massachusetts General Hospital (MGH). Theratechnologies has an exclusive license with MGH to this patent.
“This is another step in further strengthening our position relating to the development and potential commercialization of tesamorelin for the treatment of NASH. With close to 20 years of intellectual property protection in the United States, we can progress with our development plans knowing we can fully reap the benefits of the ambitious plans we have for tesamorelin,” said Paul Lvesque, President and Chief Executive Officer, Theratechnologies Inc. “We also plan on filing patent applications in other jurisdictions to expand our protection of tesamorelin.”
Tesamorelin for the treatment of NASH in the general population
On September 10, 2020, Theratechnologies announced its intention to pursue the development of tesamorelin for the treatment of NASH in the general population by submitting a Phase 3 study protocol to the United States Food and Drug Administration (FDA) and with European regulatory agencies in the fourth quarter of 2020. Subject to feedback from regulatory agencies, Theratechnologies aims at beginning a Phase 3 clinical trial during the first quarter of 2021.
Theratechnologies intends to use a new investigational formulation of tesamorelin, known as “F8”, for the conduct of such Phase 3 clinical trial. The Company is also working on the development of a convenient, multi-dose pen injector using the F8 formulation.
FTV.