Theratechnologies Secures Exclusive Rights to Market Ionis' Olezarsen and Donidalorsen in Canada

Theratechnologies Inc., a pharmaceutical company dedicated to developing and marketing innovative therapies, has announced an agreement with Ionis Pharmaceuticals, Inc. to license two investigational RNA-targeted medicines. Ionis has developed these medicines, and under this new arrangement, Theratechnologies gains exclusive rights in Canada for their use. The two drugs in question are olezarsen, which targets familial chylomicronemia syndrome (FCS) and severe hypertriglyceridemia (sHTG), and donidalorsen, intended for treating hereditary angioedema (HAE).

Theratechnologies will focus on commercializing these drugs within Canada, with plans to submit them to Health Canada for approval in 2025. Paul Lévesque, the President and CEO of Theratechnologies, emphasized the importance of this partnership, noting that it expands the company’s range of treatments beyond its foundational HIV portfolio. This collaboration is seen as a testament to Theratechnologies' ability to drive innovation in North America and commitment to achieving growth and value for shareholders.

Brett Monia, CEO of Ionis, expressed satisfaction with the partnership, highlighting the shared goal of delivering innovative medicines to those suffering from severe conditions. He noted that Ionis is preparing for the possibility of independent commercial launches of these drugs in the U.S., pending regulatory approvals.

Olezarsen is designed to reduce the production of apoC-III, a liver protein that regulates blood triglyceride metabolism. This drug is under evaluation for treating FCS, a condition marked by extremely high triglyceride levels, chronic symptoms, and recurrent acute pancreatitis. In Eastern Québec, the prevalence of FCS is notably higher than the global average, making Canada a significant market for olezarsen. The drug is also being considered for sHTG, which affects a broader patient population and presents serious health risks, including acute pancreatitis. The U.S. FDA has given olezarsen Orphan Drug designation and accepted its New Drug Application (NDA) for Priority Review, with a decision expected by December 19, 2024. Theratechnologies aims to have olezarsen reviewed by Health Canada in 2025, potentially introducing the first approved treatment for FCS in Canada.

Donidalorsen is designed to lower the production of prekallikrein (PKK), a protein involved in inflammatory mediators responsible for acute HAE attacks. HAE is a rare genetic disorder that causes severe swelling in various body parts. The FDA has accepted the NDA for donidalorsen, with a decision anticipated by August 21, 2025. Regulatory submissions for donidalorsen are also progressing in Europe, and the drug has received Orphan Drug Designation from both the FDA and the European Commission. Theratechnologies plans to submit donidalorsen to Health Canada in 2025.

The transaction stipulates that Theratechnologies will pay Ionis $10 million upfront, with additional milestone payments potentially reaching $12.75 million. These payments are contingent on achieving regulatory milestones, public reimbursement, and annual sales targets. Ionis will also receive royalties on the annual net sales of both medicines. Theratechnologies is responsible for securing regulatory approval for these drugs in Canada, while Ionis will manage their manufacturing and supply.

This agreement remains in effect until Theratechnologies ceases commercialization of the licensed products in Canada or terminates the partnership under specific conditions. Theratechnologies continues to build its portfolio of innovative therapies addressing unmet medical needs, reinforcing its position in the biopharmaceutical industry.