Ionis Pharmaceuticals Expands Licensing Agreement with Otsuka for Hereditary Angioedema Treatment

By Tamara Parker • Tuesday, June 18 15:17 • Permanent Link

Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) has announced an expanded licensing agreement with Otsuka Pharmaceutical Co., Ltd. for their investigational medicine, donidalorsen, in the Asia-Pacific region for hereditary angioedema (HAE). Under the terms of the agreement, Ionis will receive a $20 million upfront payment and milestone payments based on achievement of regulatory and sales targets. Ionis also stands to earn tiered royalties, with similar economic terms to the previous agreement for Europe.

The positive results from the Phase 3 OASIS-HAE and OASISplus studies were presented at the 2024 European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress in Valencia, Spain and published in the New England Journal of Medicine. These results have contributed to the push for regulatory discussions across Europe and the Asia-Pacific region, based on the promising Phase 3 results for donidalorsen.

Donidalorsen, an investigational RNA-targeted prophylactic medicine for HAE, targets prekallikrein (PKK), which plays a crucial role in activating inflammatory mediators associated with acute attacks of HAE. Ionis plans to file a new drug application with the U.S. Food and Drug Administration (FDA) this year, and independently launch donidalorsen in the U.S., if approved.

Ionis Pharmaceuticals has a robust commercial infrastructure in preparation for the near-term anticipated launches for olezarsen in familial chylomicronemia syndrome and donidalorsen in HAE.

This expanded licensing agreement reflects Ionis' commitment to bringing donidalorsen to as many people living with HAE as possible, with Otsuka responsible for commercialization efforts for donidalorsen across both Asia Pacific and Europe. Otsuka will also be responsible for territory-specific development, regulatory filings, and commercialization in the Asia-Pacific region and Europe, drawing on their deep knowledge of regional and local regulations and global expertise in delivering rare disease medicines to patients. As a result of these announcements, the company's shares have moved -0.4% on the market, and are now trading at a price of $40.61. For the full picture, make sure to review Ionis Pharmaceuticals's 8-K report.

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