Zealand Pharma has signed a global collaboration and license agreement with Roche to develop petrelintide, Zealand Pharma’s amylin analog with best-in-class potential, as a foundational therapy for weight management, while rapidly expanding into related indications.

The two companies will co-develop and co-commercialize petrelintide and combination products with petrelintide, including a fixed-dose combination product of petrelintide and CT-388, Roche’s lead incretin asset and potential best-in-class GLP-1/GIP receptor dual agonist.

Adam Steensberg, President and Chief Executive Officer of Zealand Pharma, said, “We are thrilled to announce this transformational partnership, aiming to maximize the full value of petrelintide to the benefit of people living with overweight and obesity. With relentless focus on innovation, a global manufacturing network and commercial reach, a complementary portfolio of clinical programs in obesity, and importantly a shared vision for petrelintide, we consider Roche the ideal partner for Zealand Pharma. We strongly believe that petrelintide holds potential as a foundational therapy for weight management, addressing unmet medical needs among the majority of people living with overweight and obesity, both as stand-alone therapy and in combination with other agents. This collaboration with Roche is a step change to realize this vision, while solidifying Zealand Pharma as a key player in the future management of obesity”.

Teresa Graham, Chief Executive Officer of Roche Pharmaceuticals, said, “We are excited to collaborate with Zealand Pharma and develop this promising therapy, which we hope will provide people living with obesity and related comorbidities a new treatment option. We share the vision to develop petrelintide as a future foundational therapy. By adding petrelintide to our Pharmaceuticals portfolio and with our Diagnostics expertise in cardiovascular and metabolic diseases, we are aiming to transform the standard of care and positively impact patients' lives".

Zealand Pharma and Roche will co-develop and co-commercialize petrelintide and potential combination products, including a fixed-dose combination product of petrelintide and Roche’s lead incretin asset CT-388. The two companies will co-commercialize petrelintide and other products arising from the collaboration in the US and Europe, whereas Roche obtains exclusive rights to commercialization in the rest of the world.

Under the terms of the agreement, Zealand Pharma can participate in up to 50 percent of commercialization activities in the US and Europe, with opt-out and opt-in rights under certain pre-agreed conditions. Roche will be responsible for commercial manufacturing and supply.

As part of this agreement, Zealand Pharma will receive upfront cash payments of USD 1.65 billion, including USD 1.4 billion due upon closing and USD 250 million over the first two anniversaries of the collaboration.

Zealand Pharma is also eligible for development milestones of USD 1.2 billion, primarily linked to initiation of Phase 3 trials with petrelintide monotherapy, and sales-based milestones of USD 2.4 billion, for a total consideration to Zealand Pharma of up to USD 5.3 billion. Profits and losses for petrelintide and petrelintide/CT-388 will be shared on a 50/50 basis in the U.S. and Europe, and Zealand Pharma is eligible to receive tiered double-digit royalties up to high teens percent on net sales in the rest of the world.

Zealand Pharma will pay Roche USD 350 million, offsetable against the development milestone payments, for the petrelintide/CT-388 fixed-dose combination product or next-generation petrelintide combination products being pursued under the collaboration agreement.