Theratechnologies Announces Exclusive Licensing Agreement with Ionis to Commercialize Olezarsen and Donidalorsen in Canada

Core Viewpoint - Theratechnologies has entered into a licensing agreement with Ionis Pharmaceuticals to develop and commercialize two investigational RNA-targeted medicines, olezarsen and donidalorsen, in Canada, expanding its existing HIV portfolio and addressing unmet medical needs [1][2]. Group 1: Agreement Details - The agreement grants Theratechnologies exclusive rights in Canada for olezarsen, aimed at treating familial chylomicronemia syndrome (FCS) and severe hypertriglyceridemia (sHTG), and for donidalorsen, intended for hereditary angioedema (HAE) [1][2]. - Ionis will receive a $10 million upfront payment and milestone payments up to $12.75 million based on regulatory achievements and sales targets, along with tiered double-digit royalties on annual net sales [10][11]. Group 2: Product Information - Olezarsen is designed to lower the production of apoC-III, a protein that regulates triglyceride metabolism, and is being evaluated for FCS and sHTG [3]. - FCS is characterized by extremely elevated triglyceride levels and can lead to life-threatening pancreatitis, with a prevalence in Canada similar to the global average, but significantly higher in regions like Eastern Québec [4]. - sHTG affects a larger patient population, with an estimated 3 million patients in the U.S. and a similar prevalence in Canada [5]. Group 3: Regulatory Status - The FDA has accepted the New Drug Application (NDA) for olezarsen for FCS with a PDUFA action date of December 19, 2024, and Theratechnologies plans to submit to Health Canada in 2025 [6]. - Ionis has completed enrollment for the Phase 3 olezarsen clinical program for sHTG, with results expected in the second half of 2025 [7]. - The NDA for donidalorsen for HAE has also been accepted by the FDA, with a PDUFA action date of August 21, 2025, and submissions are progressing in Europe [9]. Group 4: Company Background - Theratechnologies is a biopharmaceutical company focused on developing innovative therapies for unmet medical needs, with a commitment to sustained growth and shareholder value [2][13]. - Ionis Pharmaceuticals has a strong pipeline in RNA-targeted medicines and aims to deliver innovative treatments for serious diseases [14].