Regulatoriskt pressmeddelande

Cinclus Pharma Partners with Zentiva to Commercialize Linaprazan Glurate in Europe

Cinclus Pharma establishes a strategic alliance and licensing agreement with Zentiva, a leading European pharmaceutical company, for the commercialization and manufacturing of its lead asset, linaprazan glurate, in Europe. The agreement covers all member states in EEA, UK and Switzerland. The total deal value, including upfront and regulatory and commercialization milestone payments is EUR 220 million, which includes an upfront payment of EUR 13 million and a near-term milestone of EUR 5 million in 2026. Cinclus Pharma is also entitled to tiered double-digit royalties on net sales in Europe, starting in the high-teens and exceeding 20% at the highest tier levels.

Cinclus Pharma Holding AB (publ) (STO: CINPHA), a clinical-stage biopharmaceutical company focused on developing novel therapies for the treatment of gastric acid-related diseases, today announced an agreement with Zentiva k.s., a leading European pharmaceutical company, for the commercialization and manufacturing of its lead asset, linaprazan glurate, in Europe.

The product is a next-generation potassium-competitive acid blocker (PCAB) designed for the treatment of severe erosive gastroesophageal reflux disease (eGERD). The addressable market is estimated at 19 million patients globally, including approx. 10 million across Europe and the US. Cinclus Pharma expects to initiate its first Phase III study with linaprazan glurate in Q3 2025.

The total deal value, including an upfront payment and all regulatory and commercial milestones is EUR 220 million (approximately SEK 2,4 billion). As part of the transaction, Zentiva will make an upfront payment of EUR 13 million (approximately SEK 143 million) and Cinclus Pharma is eligible for a near-term milestone payment of EUR 5 million (approximately SEK 55 million) in 2026. Cinclus Pharma is also eligible to receive tiered double-digit royalties on net sales in Europe, starting in the high teens and exceeding 20% at the highest tiers.

“The alliance with Zentiva marks a significant inflection point for Cinclus Pharma,” said Christer Ahlberg, CEO of Cinclus Pharma. “We are particularly excited given Zentiva’s commercial reach and operational strength across Europe. This alliance establishes a fully integrated set of capabilities covering everything necessary to bring linaprazan glurate to the market across Europe. The alliance benefits from world-leading expertise in gastroenterology-focused development, regulatory affairs, manufacturing and commercialization. This collaboration not only de-risks our path to European approval but also positions us to capture significant global value, particularly in the US market where we retain full commercial rights and see a substantial commercial opportunity”

“This partnership marks a key milestone for Zentiva as we continue expanding our portfolio beyond generics into high-value specialty medicines. Linaprazan glurate is a complementary asset that perfectly fits our strategy to leverage our excellence in generics and deliver game-changing treatments to patients across Europe. With our strong pan-European commercial platform, we are proud to be the trusted partner to bring this innovative therapy to those suffering from severe erosive GERD” said Martin Albert, CSO, Zentiva.

About Zentiva
Zentiva provides health and wellbeing for all generations. It is a European company developing, producing, and delivering high-quality, affordable medicines to more than 100 million people in over 30 countries across Europe and beyond. Zentiva has four wholly owned manufacturing sites and a broad network of external manufacturing partners to ensure supply security. The company is private equity-owned, delivering sustainable growth, with an ambitious plan for the years to come.

Invitation to webcast 09.00 CEST
The company will host a webcast today at 09:00 am CEST with a presentation and a Q&A session.

If you wish to participate via webcast please use the link below. Via the webcast you are able to ask written questions.
https://live.events.inderes.com/press-conference-may-22

If you wish to participate via teleconference please register on the link below. After registration you will be provided phone numbers and a conference ID to access the conference. You can ask questions verbally via the teleconference.
https://events.inderes.com/live/press-conference-may-22/dial-in

About Cinclus Pharma

Cinclus Pharma Holding AB (publ) is a late-stage clinical pharmaceutical company developing drugs for the treatment of acid-related diseases and disorders of the upper gastrointestinal tract. The company's leading drug candidate is linaprazan glurate, a prodrug of P-CAB linaprazan, which was originally developed by AstraZeneca. Linaprazan glurate has the potential to heal erosions in the esophageal mucosa and relieve symptoms of gastroesophageal reflux disease (GERD) more effectively than current treatments like proton pump inhibitors (PPI). The safety and efficacy of linaprazan and linaprazan glurate have been documented in over 30 phase I and two phase II studies involving more than 3,000 participants. Planning for phase III studies is currently underway, with an expected start in 2025. GERD affects approximately 133 million adults in the US and EU, and there is a significant need for new drugs to treat the most severe cases: around 10 million patients. Linaprazan glurate is developed to meet these needs. For more information, visit www.cincluspharma.com.