Amylin could earn over $1 billion from deal with Takeda to co-develop obesity drugs

The USA's Amylin Pharmaceuticals has signed a deal with Japan's largest drugmaker, Takeda Pharmaceutical, which could earn the US firm in excess of $1 billion. The companies 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 drugmaker needs products to replace sales lost when approval for a combination diabetes treatment that includes Actos (pioglitazone) was delayed by US regulators. The drug also faces patent expiry in January 2011. As much as $2 billion in annual sales await a safe and effective weight-loss drug, according to analyst Michael King, of Merriman Curhan Ford in San Francisco, quoted by Bloomberg.

The deal includes products to be developed from Amylin's pipeline, including pramlintide/metreleptin and davalintide, which are currently in Phase II development for the 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 accord and in relation to the compounds under the agreement, is eligible for 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 deal, Amylin will be responsible for executing development activities for potential products through Phase II with the aim of regulatory approval in the USA. Takeda will lead development activities beyond Phase II there and all development activities outside the USA. In most instances, Amylin will be responsible for 20% of development costs associated with obtaining approval for products in the USA and Takeda for 80% of such US 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 within the and outside the USA, and will be responsible for 100% of commercialization costs. Amylin will have the option to co-commercialize the first two approved products in the USA and any follow-on products containing the identical active ingredients.