Expanded Access Policy

 

Theratechnologies Inc. (“Theratechnologies”) is a biopharmaceutical company focused on the development and commercialization of innovative therapies. Our commercialized products and our research pipeline focus on specialized therapies addressing unmet medical needs in HIV, oncology and hepatology. Theratechnologies has begun development of the SORT1+ Technology™, a novel and targeted treatment platform in oncology based on new proprietary peptides targeting sortilin receptor (SORT1). The first peptide-drug conjugate (PDC) generated from this platform, named TH1902, is under investigational evaluation in a Phase 1 clinical trial for the treatment of patients with recurrent advanced solid tumors (i.e. triple negative breast cancer, gynecological cancer, colorectal cancer, and pancreatic cancer) that have relapsed or are refractory to standard chemotherapy, surgery, radiation therapy, and for which no known effective therapies exist (ClinicalTrials.gov Identifier: NCT04706962).

Theratechnologies believes that investigational drugs should be primarily studied within clinical trials designed to obtain data on safety and efficacy about the investigational drug. The data from these trials may then ultimately be used to support approval of the product by regulatory agencies such as the FDA in the United States, the European Medicines Agency in Europe and Health Canada in Canada. The approval by regulatory agencies enables patients to have access to the medicine. Regulators will only authorize a new medicine if the results obtained from these clinical trials, together with other research data, demonstrate that a medicine has a favorable risk/benefit profile when used in a defined and controlled clinical setting. We encourage patients to speak with their physicians and to participate in clinical trials, when appropriate and if eligible.

As a general policy, Theratechnologies will not provide an investigational drug product until there is sufficient clinical data available from its existing clinical trial(s) to identify an appropriate dose and to evaluate preliminary safety and efficacy information to make a risk/benefit analysis consistent with the establishment of an expanded access program. This is typically not expected to occur earlier than after completion of Phase 2 studies and after consultation with regulatory agencies. At such a time, Theratechnologies will disclose the criteria pursuant to which expanded access requests will be assessed. Given the early stage of the clinical development of TH1902, Theratechnologies’ investigational drug product is currently not available for expanded access.

If you are a patient who is interested in receiving TH1902, please consult your physician. You may also learn more about the ongoing clinical trial by visiting www.clinicaltrials.gov and searching for the clinical trial identified NCT04706962.

If you are a physician who is interested in learning more about our investigational drug, please submit a request to communications@theratech.com.

In line with the U.S. 21st Century Cures Act, Theratechnologies Inc. may revise this expanded access policy at any time and the posting of this policy by Theratechnologies Inc. shall not be construed as a guarantee to patients of accessing any specific investigational drug.