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Ionis announces expanded licensing agreement with Otsuka in Asia Pacific for investigational medicine donidalorsen in hereditary angioedema
Otsuka will be responsible for commercialization efforts for donidalorsen across both Asia Pacific and EuropeIonis plans to independently bring donidalorsen
About this update from Ionis Pharmaceuticals, Inc.
[{"type":"text","content":"Otsuka will be responsible for commercialization efforts for donidalorsen across both Asia Pacific and EuropeIonis plans to independently bring donidalorsen to U.S. patients, if approvedCARLSBAD, Calif., June 18, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that it has entered into a license agreement with Otsuka Pharmaceutical Co., Ltd. (Otsuka) under which Otsuka obtains exclusive rights across the Asia-Pacific region for donidalorsen, an investigational RNA-targeted prophylactic medicine for hereditary angioedema (HAE). Ionis will maintain primary responsibility for the development of donidalorsen, while Otsuka will be responsible for territory-specific development, regulatory filings and commercialization in the Asia-Pacific region and Europe.\n\n \n \n \n \n \n \n\n \nIonis plans to file a New Drug Application with the U.S. Food and Drug Administration (FDA) this year, and will independently launch donidalorsen in the U.S., if approved. Ionis and Otsuka previously announced a licensing agreement for donidalorsen in Europe, and Otsuka is also preparing to submit a Marketing Authorization Application to the European Medicines Agency this year.\n\"Ionis and Otsuka share a steadfast commitment to bring donidalorsen to as many people living with HAE as possible,\" said Brett P. Monia, Ph.D., chief executive officer of Ionis. \"We look forward to working alongside Otsuka to advance regulatory discussions across Europe and the Asia-Pacific region based on our positive Phase 3 results for donidalorsen, which were presented late last month. In the U.S., we've built a robust commercial infrastructure in preparation for our near-term anticipated launches for olezarsen in familial chylomicronemia syndrome and donidalorsen in HAE.\"\nUnder the terms of the Asia-Pacific agreement, Ionis will receive a $20 million upfront payment and milestone payments based on achievement of regulatory and sales targets. Ionis is also eligible to earn tiered royalties, with similar economic terms to the previous agreement for Europe. Originating in Japan, Otsuka brings deep knowledge of regional and local regulations across the Asia-Pacific region, as well as global expertise in delivering rare disease medicines to patients and a robust commercial infrastructure.\nIonis recently reported positive results from the Phase ...