Scientists at Theratechnologies discovered EGRIFTA® (tesamorelin for injection) in 1995. For the next fifteen years, Theratechnologies pursued the development of this innovative treatment for lipodystrophy in people with HIV. In 2010, Theratechnologies received a marketing authorization for EGRIFTA® from the Food and Drug Administration in the United States.
EGRIFTA® was first marketed by a third-party commercial partner in the United States. Then, in 2014, Theratechnologies made a strategic decision and reoriented its business model to become a commercial-stage biopharmaceutical company. This is when Theratechnologies regained commercial rights to EGRIFTA® in the United States.
This move gave Theratechnologies the means to look at other acquisitions which came shortly thereafter. In 2016, the Company concluded an agreement to acquire the commercial rights to Trogarzo® in the United States, Europe, Canada, Scandinavian countries, Russia, Israel and Switzerland. Trogarzo® was approved by the FDA in 2018 and was quickly adopted by hundreds of physicians to treat people living with a persistent HIV viral load.
Trogarzo® was approved in Europe in 2019. It is currently commercialized in Germany and other countries should soon follow. Several patients in Europe are already being treated through various early access programs funded by local governments.
An IV push and an intramuscular injection are currently being developed as part of the lifecycle management of Trogarzo®.
The Company is also pursuing the development of a novel and targeted approach for the treatment of solid tumors expressing the sortilin receptor. TH1902 is the leading peptide-drug conjugate derived from Theratechnologies’ sortilin positive SORT1+ Technology™. It is a first-in-class peptide-drug conjugate (PDC) targeting the sortilin receptor. The FDA granted a fast-track designation in early 2021 for TH1902 to be developed as a single agent for the treatment of patients with sortilin positive recurrent advanced solid tumors that are refractory to standard therapy. The phase 1 clinical trial is now underway.
Theratechnologies also intends to pursue Phase 3 clinical development of tesamorelin for the treatment of NASH. The Company completed discussions with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regarding the proposed trial design and protocol for the Phase 3 clinical trial and is evaluating opportunities to most effectively execute this program, including seeking a potential partner for late-stage development.
We develop and commercialize cutting-edge treatments addressing unmet medical needs which give new options for health care practitioners and hope to patients.
To be a biopharmaceutical company which successfully brings to market exceptional innovations.