Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Takeda Pharmaceutical Company Limited (TSE: 4502) announced today that they have entered into a worldwide exclusive license, development and commercialization agreement to co-develop and commercialize pharmaceutical products for the treatment of obesity and related indications.
The agreement includes products to be developed from Amylin's pipeline, including pramlintide/metreleptin and davalintide, which are compounds currently in phase 2 development for treatment of obesity. The agreement also includes additional compounds from both companies' obesity research programs. Amylin will receive a one-time up-front payment of $75 million from Takeda and, over the term of the agreement and in relation to the compounds under the agreement, is eligible to receive additional payments upon achieving certain development, commercialization and sales-based milestones that could exceed $1 billion. The agreement also provides for future tiered, double-digit royalty payments to Amylin based on global product sales.
Under the terms of the agreement, Amylin will be responsible for executing development activities for potential products through phase 2 with the aim of regulatory approval in the U.S. Takeda will lead development activities beyond phase 2 in the U.S., and all development activities outside the U.S. In most instances, Amylin will be responsible for 20% of development costs associated with obtaining approval for products in the U.S. and Takeda will be responsible for 80% of such U.S. development costs. Takeda will be responsible for 100% of development costs associated with obtaining approval for products outside the U.S.
Takeda will lead product commercialization, both in the U.S. and outside the U.S., and will be responsible for 100% of commercialization costs. Amylin will have the option to co-commercialize the first two approved products in the U.S. and any follow-on products containing the identical active ingredients.