Roche enters into an exclusive collaboration & licensing agreement with Zealand Pharma to co-develop and co-commercialise petrelintide as a potential foundational therapy for people with overweight and obesity
Roche (RHHBY) has entered into an exclusive collaboration and licensing agreement with Zealand Pharma to co-develop and co-commercialize petrelintide, a long-acting amylin analog for treating obesity. The partnership includes developing petrelintide as both a standalone therapy and in combination with Roche's incretin asset CT-388.
Under the agreement terms, Zealand Pharma will receive $1.65 billion in upfront payments, including $1.4 billion at closing and $250 million over two years. Additional potential payments include $1.2 billion in development milestones and $2.4 billion in sales-based milestones, totaling up to $5.3 billion.
The companies will share profits and losses 50/50 in the US and Europe, with Roche gaining exclusive commercialization rights in other markets. Zealand will receive tiered double-digit royalties up to high teens percentage on net sales in rest of world markets. The transaction is expected to close in Q2 2025, subject to regulatory approvals.
Roche (RHHBY) ha stipulato un accordo di collaborazione e licenza esclusivo con Zealand Pharma per co-sviluppare e co-commercializzare petrelintide, un analogo dell'amylina a lunga durata d'azione per il trattamento dell'obesità. La partnership prevede lo sviluppo di petrelintide sia come terapia autonoma che in combinazione con l'asset incretina di Roche, CT-388.
Secondo i termini dell'accordo, Zealand Pharma riceverà 1,65 miliardi di dollari in pagamenti iniziali, di cui 1,4 miliardi al momento della chiusura e 250 milioni nel corso di due anni. I pagamenti potenziali aggiuntivi includono 1,2 miliardi di dollari in traguardi di sviluppo e 2,4 miliardi di dollari in traguardi basati sulle vendite, per un totale di fino a 5,3 miliardi di dollari.
Le aziende condivideranno profitti e perdite al 50/50 negli Stati Uniti e in Europa, con Roche che otterrà diritti esclusivi di commercializzazione in altri mercati. Zealand riceverà royalties a doppia cifra scalari fino a percentuali elevate nei mercati del resto del mondo. Si prevede che la transazione si chiuda nel secondo trimestre del 2025, soggetta ad approvazioni normative.
Roche (RHHBY) ha entrado en un acuerdo exclusivo de colaboración y licencia con Zealand Pharma para co-desarrollar y co-comercializar petrelintide, un análogo de amiloide de acción prolongada para el tratamiento de la obesidad. La asociación incluye el desarrollo de petrelintide tanto como terapia independiente como en combinación con el activo incretina de Roche, CT-388.
Según los términos del acuerdo, Zealand Pharma recibirá 1.65 mil millones de dólares en pagos iniciales, incluyendo 1.4 mil millones al cierre y 250 millones durante dos años. Los pagos potenciales adicionales incluyen 1.2 mil millones de dólares en hitos de desarrollo y 2.4 mil millones de dólares en hitos basados en ventas, totalizando hasta 5.3 mil millones de dólares.
Las empresas compartirán ganancias y pérdidas 50/50 en EE. UU. y Europa, con Roche obteniendo derechos exclusivos de comercialización en otros mercados. Zealand recibirá regalías escalonadas de dos dígitos hasta un porcentaje alto en las ventas netas en los mercados del resto del mundo. Se espera que la transacción se cierre en el segundo trimestre de 2025, sujeta a aprobaciones regulatorias.
로슈 (RHHBY)는 질랜드 파마와 독점적인 협력 및 라이선스 계약을 체결하여 비만 치료를 위한 장기 작용 아밀린 유사체인 페트렐린타이드를 공동 개발 및 공동 상용화합니다. 이번 파트너십은 페트렐린타이드를 독립적인 치료제로 개발하는 것과 로슈의 인크레틴 자산인 CT-388과의 병용으로 개발하는 것을 포함합니다.
계약 조건에 따라 질랜드 파마는 16억 5천만 달러의 선불 지급을 받게 되며, 이 중 14억 달러는 계약 체결 시 지급되고 2억 5천만 달러는 2년에 걸쳐 지급됩니다. 추가적인 잠재적 지급은 12억 달러의 개발 이정표와 24억 달러의 판매 기반 이정표를 포함하여 총 53억 달러에 이를 수 있습니다.
양사는 미국과 유럽에서 50/50으로 이익과 손실을 공유하며, 로슈는 다른 시장에서 독점적인 상용화 권리를 갖게 됩니다. 질랜드는 나머지 세계 시장의 순매출에 대해 두 자릿수의 단계적 로열티를 받게 됩니다. 이번 거래는 규제 승인을 조건으로 2025년 2분기 내에 완료될 것으로 예상됩니다.
Roche (RHHBY) a conclu un accord de collaboration et de licence exclusif avec Zealand Pharma pour co-développer et co-commercialiser le petrelintide, un analogue de l'amylin à action prolongée pour le traitement de l'obésité. Ce partenariat inclut le développement du petrelintide à la fois comme thérapie autonome et en combinaison avec l'actif incrétine de Roche, CT-388.
Selon les termes de l'accord, Zealand Pharma recevra 1,65 milliard de dollars en paiements initiaux, dont 1,4 milliard au moment de la clôture et 250 millions sur deux ans. Des paiements potentiels supplémentaires incluent 1,2 milliard de dollars en jalons de développement et 2,4 milliards de dollars en jalons basés sur les ventes, pour un total allant jusqu'à 5,3 milliards de dollars.
Les entreprises partageront les bénéfices et les pertes à 50/50 aux États-Unis et en Europe, Roche obtenant des droits de commercialisation exclusifs dans d'autres marchés. Zealand recevra des redevances à deux chiffres échelonnées jusqu'à un pourcentage élevé sur les ventes nettes dans le reste des marchés mondiaux. La transaction devrait être finalisée au deuxième trimestre 2025, sous réserve des approbations réglementaires.
Roche (RHHBY) hat eine exklusive Zusammenarbeit und Lizenzvereinbarung mit Zealand Pharma geschlossen, um petrelintide, ein langwirksames Amylin-Analogon zur Behandlung von Fettleibigkeit, gemeinsam zu entwickeln und zu vermarkten. Die Partnerschaft umfasst die Entwicklung von petrelintide sowohl als eigenständige Therapie als auch in Kombination mit Roches Incretin-Asset CT-388.
Gemäß den Bedingungen des Vertrags wird Zealand Pharma 1,65 Milliarden Dollar an Vorauszahlungen erhalten, darunter 1,4 Milliarden Dollar bei Abschluss und 250 Millionen Dollar über zwei Jahre. Zusätzliche potenzielle Zahlungen umfassen 1,2 Milliarden Dollar an Entwicklungsmeilensteinen und 2,4 Milliarden Dollar an umsatzbasierten Meilensteinen, was insgesamt bis zu 5,3 Milliarden Dollar ergibt.
Die Unternehmen werden Gewinne und Verluste in den USA und Europa im Verhältnis 50/50 teilen, wobei Roche in anderen Märkten exklusive Vermarktungsrechte erhält. Zealand wird gestaffelte zweistellige Lizenzgebühren auf Nettoumsätze in den übrigen Weltmärkten erhalten. Die Transaktion wird voraussichtlich im 2. Quartal 2025 abgeschlossen, vorbehaltlich der behördlichen Genehmigungen.
- Significant market opportunity with obesity expected to affect over 4 billion people by 2035
- Large upfront payment of $1.65 billion demonstrates strong commitment to the partnership
- Potential for best-in-class therapy with improved tolerability compared to current treatments
- Strategic expansion into high-growth obesity treatment market
- Risk-sharing structure through 50/50 profit split in major markets
- High upfront investment of $1.65 billion before proof of commercial success
- Product still in early Phase 2 development with significant clinical trial risks
- Zealand to pay $350 million for combination product development
- Regulatory approval uncertainty could delay expected Q2 2025 closing
- Agreement allows for a range of potentially best-in-class therapy options as monotherapy and fixed dose combination with Roche`s lead incretin asset CT 388
- Collaboration will complement Roche's portfolio in the field of cardiovascular, renal, and metabolic (CVRM) diseases
- Obesity is a heterogeneous disease with over 200 related comorbidities, including cardiovascular and metabolic diseases, and is expected to impact over 4 billion people globally by 2035
Basel, 12 March 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has entered into an exclusive collaboration and licensing agreement with Zealand Pharma (Nasdaq Copenhagen: ZEAL) (CVR-no. 20045078). Under the terms of this agreement, the two companies will collaborate to co-develop and co-commercialise petrelintide, Zealand Pharma’s amylin analog as a standalone therapy as well as a fixed-dose combination with Roche’s lead incretin asset CT-388.
In recent years, scientific advances in the field of incretins and an increased understanding of the disease biology have significantly changed the possibilities to treat obesity and its numerous associated health conditions (comorbidities). With these advances, a large opportunity remains to provide new treatments that offer improved efficacy, safety, quality, and durability of weight loss.
Petrelintide, currently in phase 2 clinical development, is a long-acting amylin analog suitable for once-weekly subcutaneous administration. The available clinical data suggests its potential to become a best-in-class amylin monotherapy, with improved tolerability compared to current weight management treatments and to expand into adjacent indications.
The combination of petrelintide with Roche’s dual GLP-1/GIP receptor agonist CT-388 will further strengthen and expand Roche’s pipeline in the field of cardiovascular, renal, and metabolic (CVRM) diseases. This combination offers the opportunity for best-in-disease efficacy while potentially offering enhanced tolerability.
Teresa Graham, CEO Roche Pharmaceuticals: “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 combining petrelintide with 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.”
Adam Steensberg, President and Chief Executive Officer of Zealand Pharma: “We are thrilled to announce this transformational partnership, aiming to maximise 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 programmes 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 realise this vision, while solidifying Zealand Pharma as a key player in the future management of obesity”.
Terms of the Agreement
This collaboration agreement covers the co-development and co-commercialisation of petrelintide to unlock the full value of the asset. As a part of this agreement, Zealand Pharma and Roche will co-commercialise petrelintide in the U.S. and Europe, whereas Roche will obtain exclusive rights to commercialisation in the rest of the world. Roche will be responsible for commercial manufacturing and supply.
Under the terms of the 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 % royalties on net sales in the rest of the world.
Zealand Pharma will pay Roche USD 350 million, offsettable against milestone payments, for the petrelintide/CT-388 fixed-dose combination product or next-generation petrelintide combination products being pursued under the collaboration agreement.
The closing of the transaction is subject to regulatory approvals and other customary closing conditions. The parties expect that the transaction will close in Q2 2025.
About petrelintide
Petrelintide is a long-acting amylin analog suitable for once-weekly subcutaneous administration that has been designed with chemical and physical stability with no fibrillation around neutral pH, allowing for co-formulation and co-administration with other peptides. Amylin is produced in pancreatic beta cells and co-secreted with insulin in response to ingested nutrients. Amylin receptor activation has been shown to reduce body weight by restoring sensitivity to the satiety hormone leptin, inducing a sense of feeling full faster. Current clinical data and pre-clinical data suggest a potential of petrelintide to deliver weight loss comparable to GLP-1 receptor agonists but with improved tolerability for a better patient experience and high-quality weight loss. Petrelintide is being evaluated in Phase 2b clinical trials. ZUPREME-1 is for people with obesity/overweight without type 2 diabetes (T2D) and was initiated in December 2024 (ClinicalTrials.gov ID: NCT06662539). ZUPREME-2 is for people with obesity/overweight with T2D and is expected to be initiated in the first half of 2025.
About CT-388
CT-388 is a once-weekly subcutaneous injectable, dual GLP-1/GIP receptor agonist being developed for the treatment of obesity and type 2 diabetes (T2D). CT-388 was designed to have potent activity on both the GLP-1 and GIP receptors but with minimal to no ß-arrestin recruitment on either receptor. This biased signalling significantly minimises receptor internalisation and consequent desensitisation, which is expected to lead to prolonged pharmacological activity. CT-388 is currently being studied in Phase 2b clinical trials in people with overweight/obesity with and without type 2 diabetes.
About obesity
Obesity is one of the most extensive health challenges in the world and an area where recent scientific advances can help meet the high unmet medical need. This condition is associated with over 200 comorbidities, including type 2 diabetes, cardiovascular diseases, fatty liver, and chronic kidney disease, which together place an enormous strain on healthcare systems worldwide. Over 4 billion people are estimated to be obese or overweight by 2035, approaching
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.
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