Ionis Pharmaceuticals has recently entered into a licensing agreement with Otsuka Pharmaceutical, aiming to utilize the latter’s established commercial infrastructure and extensive experience in rare disease drugs to provide the donidalorsen treatment to patients in Europe.
Under this agreement, Ionis has granted exclusive rights to Otsuka for the commercialization of donidalorsen in Europe. Donidalorsen is an investigational preventative treatment designed for individuals suffering from hereditary angioedema, a rare genetic disorder characterized by abnormal fluid accumulation that leads to rapid swelling in various parts of the body including the hands, feet, limbs, face, intestines, or airways.
While Ionis will continue to oversee the development of donidalorsen, Otsuka will spearhead the drug’s regulatory filings and commercialization efforts in European countries. As part of the deal, Ionis will receive an upfront payment of $65 million, along with potential milestone payments based on regulatory and sales targets. Additionally, Ionis will be eligible for royalties ranging from 20% to 30% of aggregate annual net sales.
Dr. Brett Monia, the CEO of Ionis, expressed his satisfaction with the agreement, stating, “This partnership aligns perfectly with our strategy to initially focus on the U.S. market for commercialization efforts. We are highly encouraged by the impressive product profile of donidalorsen thus far, and we eagerly anticipate reporting pivotal Phase 3 results for the treatment of hereditary angioedema in the first half of next year.”
Exciting two-year results from a Phase 2 trial were recently disclosed by Ionis, demonstrating that donidalorsen treatment resulted in an overall sustained mean reduction of 96% in hereditary angioedema attack rates when compared to baseline. Furthermore, the treatment has also obtained Orphan Drug Designation in the U.S., further highlighting its potential significance in addressing the needs of patients with this rare disorder.
For inquiries or further information, please contact Ionis Pharmaceuticals at email.