Ionis announces expanded licensing agreement with Otsuka in Asia Pacific for investigational medicine donidalorsen in hereditary angioedema

Core Insights - Ionis Pharmaceuticals has entered into a licensing agreement with Otsuka Pharmaceutical for donidalorsen, granting Otsuka exclusive rights in the Asia-Pacific region while Ionis retains primary responsibility for development [1][2] - Ionis plans to file a New Drug Application with the FDA for donidalorsen this year and will independently launch the drug in the U.S. if approved [2][3] - The agreement includes a $20 million upfront payment to Ionis, with additional milestone payments based on regulatory and sales targets, and tiered royalties similar to the European agreement [3] Company Overview - Ionis Pharmaceuticals specializes in RNA-targeted medicines and has a pipeline focused on neurology, cardiology, and other high-need areas, with five marketed medicines [7] - The company has built a robust commercial infrastructure in preparation for upcoming launches, including donidalorsen for hereditary angioedema (HAE) [3][4] Product Information - Donidalorsen is an investigational medicine designed to target prekallikrein (PKK), which is involved in the inflammatory response associated with HAE attacks [6] - HAE is a rare genetic condition affecting over 20,000 patients in the U.S. and Europe, characterized by recurrent severe swelling [5]