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Roche has revealed that it has secured a licensing agreement and exclusive partnership deal with Zealand Pharma to co-develop and co-commercialize Zealand's amylin analog, petrelintide as both a monotherapy as well as a fixed-dose combination with Roche's lead incretin asset, CT-388.

Petrelintide is a long-acting amylin analog that can be administered subcutaneously once a week. It can be co-formulated and co-administered with other peptides because it is chemically and physically stable and does not fibrillate around neutral pH.

When nutrients are consumed, the beta cells of the pancreas create amylin, which is then co-secreted with insulin. Amylin receptor activation has been demonstrated to decrease body weight by restoring sensitivity to leptin—the satiety hormone—accelerating the sensation of fullness.

Preclinical and current clinical studies point to petrelintide's potential to provide weight reduction similar to that of GLP-1 receptor agonists, but with higher tolerability for a more satisfying patient experience and superior weight loss. Clinical trials in Phase 2b are being conducted to investigate petrelintide.

As per the deal, Zealand Pharma will get USD 1.65 billion in upfront cash payments, of which USD 1.4 billion is due at closure and USD 250 million spread over the first two anniversaries of the partnership.

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In addition, Zealand Pharma will receive up to USD 5.3 billion in consideration for sales-based milestones of USD 2.4 billion and development milestones of USD 1.2 billion, which are mainly related to the start of Phase 3 studies with petrelintide monotherapy.

Petrelintide and petrelintide/CT-388 profits and losses will be split 50/50 in the United States and Europe. In the rest of the world, Zealand Pharma is eligible to collect tiers of double-digit royalties up to high teens percent of net sales.

“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 a 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," said Adam Steensberg, President and Chief Executive Officer of Zealand Pharma.

The agreement will see Zealand Pharma and Roche co-commercialize petrelintide in the U.S. and Europe while Roche will get exclusive rights to commercialize the drug in the rest of the world as it also takes charge of supply and manufacture for the commercial market.

"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,” stated Teresa Graham, CEO, Roche Pharmaceuticals.

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