Roche and Zealand Pharma Enter $5.3B Collaboration to Develop Amylin Analog Petrelintide for Obesity Treatment

March 12, Basel, Roche announced today that it has reached an agreement withZealand Pharma(Nasdaq Copenhagen: ZEAL) entered into an exclusive collaboration and license agreement (CVR-no. 20045078). Under the terms of this agreement, the two companies will collaborate on the development and commercialization of petrelintide, which isZealand PharmaAmylin analog (amylin analog), as a standalone therapy, and in combination with Roche's leading incretin (incretin) Fixed dose of asset CT-388Combination. (Just Now! Roche Acquires Carmot Therapeutics for $3.1 Billion）

In recent years, incretinLeadAdvances in the science of domains and a deeper understanding of disease biology have significantly transformed the possibilities for treating obesity and its many associated health conditions (comorbidities). With these advances, there remains a significant opportunity to provide new treatment options that enhance the efficacy, safety, quality, and durability of weight loss.

Petrelintide is currently in Phase 2 clinical development as a long-acting amylin analog suitable for once-weekly subcutaneous injection. Existing clinical data suggest it has the potential to become the best-in-class amylin monotherapy, with improved tolerability compared to current weight management treatments and expanded applications to adjacent indications.

The combination of Petrelintide with Roche's GLP-1/GIP dual receptor agonist CT-388 will further strengthen and expand Roche's product pipeline in the cardiovascular, renal, and metabolic (CVRM) disease areas. This combination offers the potential for optimal disease efficacy while possibly improving tolerability.

Roche CEO Teresa Graham:"We are delighted toIn collaboration with Zealand Pharma, we are developing this promising therapy, which we hope will provide a new treatment option for patients with obesity and related complications. Our shared vision is toPetrelintide Developed as a Foundation for Future Therapies. By"Petrelintide, combined with our pharmaceutical portfolio and our diagnostic expertise in cardiovascular and metabolic diseases, aims to change the standard of care and positively impact patients' lives."

Zealand Pharma President and CEO Adam Steensberg said:"We are pleased to announce this transformative partnership aimed at maximizing the full potential of petrelintide for the benefit of overweight and obese patients. Through an unwavering focus on innovation, a global manufacturing network and commercial coverage, a complementary portfolio of obesity clinical programs, and importantly, a commitment to...Petrelintide's Shared Vision: We believe that Roche is the ideal partner for Zealand. We are confident that,Petrelintide has the potential to become a foundational therapy for weight management, addressing the unmet medical needs of the majority of overweight and obese individuals, either as a standalone treatment or in combination with other medications. The collaboration with Roche marks a significant shift towards realizing this vision, while solidifying Zealand Pharma's role as a key player in the future of obesity management.

The cooperation agreement coversCo-development and Co-commercialization of Petrelintide to unlock the full value of this asset. As part of this agreement, Zealand Pharma and Roche will co-commercialize in the United States and Europe.Petrelintide, while Roche will obtain exclusive commercialization rights in the rest of the world. Roche will be responsible for commercial production and supply.

According to the terms of the agreement, Zealand will receive$1.65 billion in upfront cashOf which $1.4 billion will be paid upon the completion of the transaction, and $250 million will be used for the first two anniversaries of the collaboration. Zealand is also eligible to receive $1.2 billion in development milestones, primarily related toThe launch of the Phase 3 trial for Petrelintide monotherapy and the $2.4 billion sales milestone.The total consideration for Zealand is up to 5.3 billion US dollars.。Petrelintide andThe profits and losses of Petrelintide/CT-388 will be shared between the United States and Europe on a 50/50 basis.Zealand is eligible to receive double-digit royalties on net sales in the rest of the world, up to a maximum of 15%.

Zealand to Pay Roche $350 Million for Rights to Development Programs Under Collaboration AgreementPetrelintide/CT-388 Fixed-Dose Combination Product or Next-GenerationPetrelintide Combination Product, Which Can Offset Milestone Payments.

The completion of the transaction is subject to regulatory approvals and other customary closing conditions. Both parties expect the transaction to be completed in the second quarter of 2025.

Petrelintide is a long-acting amylin analog suitable for once-weekly subcutaneous administration. It is designed to possess chemical and physical stability, with no fibrillation around neutral pH, allowing co-formulation and co-administration with other peptides. Amylin is produced in pancreatic β-cells and co-secreted with insulin after nutrient intake. Activation of amylin receptors has been shown to reduce body weight by restoring sensitivity to the satiety hormone leptin, thereby inducing satiety more rapidly. Current clinical and preclinical data indicate,Petrelintide has weight-loss potential comparable to GLP-1 receptor agonists but offers a better patient experience and tolerability for high-quality weight loss. Petrelintide is currently undergoing evaluation in a Phase 2b clinical trial. ZUPREME-1 targets obese/overweight individuals without type 2 diabetes (T2D) and was initiated in December 2024 (ClinicalTrials.gov ID: NCT06662539). ZUPREME-2 is designed for obese/overweight patients with T2D and is expected to launch in the first half of 2025.