Amylin Pharmaceuticals (Amylin) and Takeda Pharmaceutical (Takeda) have entered into a worldwide exclusive license, development and commercialisation agreement to co-develop and commercialise 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. It also includes additional compounds from both companies’ obesity research programs.
Reportedly, Amylin is expected to receive a one-time up-front payment of $75m 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, commercialisation 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 US. Takeda will lead development activities beyond phase 2 in the US, and all development activities outside the US.
Moreover, Amylin will be responsible for 20% of development costs associated with obtaining approval for products in the US and Takeda will be responsible for 80% of such US development costs. Takeda also will be responsible for 100% of development costs associated with obtaining approval for products outside the US.
Takeda will lead product commercialisation, both in the US and outside the US, and will be responsible for 100% of commercialisation costs. Amylin will have the option to co-commercialise the first two approved products in the US and any follow-on products containing the identical active ingredients.
Yasuchika Hasegawa, president and CEO of Takeda, said: “Takeda is excited to realise this partnership with Amylin focused on the treatment of obesity and related indications. By leveraging Takeda’s global development and commercial infrastructure we look forward to maximizing the significant potential of the products under this agreement. Both Amylin and Takeda have extensive experience in the diabetes and metabolic disease area, and this collaboration should allow us to more quickly bring promising new treatments to patients in need.”
Daniel Bradbury, president and CEO of Amylin, said: “This collaboration will leverage Amylin’s experience and expertise with peptide and protein science and Takeda’s worldwide development and commercial expertise. Amylin recognises the enormous potential of this collaboration to advance more options in obesity treatment more quickly than either company could do alone. Amylin and Takeda are excited about working together to address the significant unmet need for the millions of patients who need better solutions to manage obesity.”