On January 7, 2022, Regeneron Pharmaceuticals, Inc. and Ultragenyx Pharmaceutical Inc. announced a license and collaboration agreement for Ultragenyx to clinically develop, commercialize, and distribute Evkeeza® (evinacumab) in countries outside of the United States. This includes the European Economic Area, where Evkeeza was approved in June 2021 as a first-in-class therapy for use together with diet and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies to treat adults and adolescents 12 and older with homozygous familial hypercholesterolemia (HoFH). Regeneron discovered and developed Evkeeza and launched the medicine in the U.S. in February 2021 when it was approved by the FDA. Wilson Sonsini Goodrich & Rosati advised Ultragenyx on the transaction.

Under the terms of the agreement, Regeneron will receive a $30 million upfront payment and is eligible to receive up to $63 million in additional potential regulatory and sales milestones. Ultragenyx will receive the rights to develop, commercialize, and distribute the medicine in countries outside of the U.S. and make payments to Regeneron based on net sales. Ultragenyx will share in certain costs for global trials led by Regeneron and also have the right to continue to clinically develop Evkeeza in countries outside of the U.S. for HoFH and other potential indications. Regeneron has also granted Ultragenyx an exclusive option to negotiate a separate agreement to collaborate on the development and commercialization outside of the U.S. of Regeneron's investigational antibody currently in Phase 2/3 development for the treatment of the ultra-rare disease fibrodysplasia ossificans progressiva (FOP) under terms to be agreed upon by both companies.

The Wilson Sonsini team representing Ultragenyx in the transaction included Farah Gerdes, Nechama Potasnick, and Lillian Li.

For more information, please see the companies’ news release.