Zentiva to Launch eGERD Drug Across Europe

Zentiva to Commercialize Linaprazan Glurate for eGERD Across Europe in €220M Cinclus Deal

Strategic Commercialization Deal with Cinclus Pharma

Zentiva, the Czech pharmaceutical firm known for its roots in generics, has entered a significant commercialization agreement with Swedish biotech company Cinclus Pharma. The deal, disclosed in a May 22 press release, grants Zentiva the rights to manufacture and commercialize linaprazan glurate in Europe. In exchange, Zentiva will pay Cinclus €13 million upfront and an additional €5 million in near-term milestone payments next year. The total potential value of the agreement stands at €220 million, including all commercial and regulatory milestones.

"This alliance establishes a fully integrated set of capabilities covering everything necessary to bring linaprazan glurate to the market across Europe," said Cinclus CEO Christer Ahlberg. He emphasized that the collaboration not only reduces the risks associated with European regulatory approval but also enhances the company's global positioning, particularly in the U.S. market, where Cinclus retains full commercial rights.

Drug Development Background and Market Expansion

Linaprazan glurate is a potassium-competitive acid blocker currently under development by Cinclus for the treatment of severe erosive gastroesophageal reflux disease (eGERD). The drug, which was originally developed by AstraZeneca, underwent phase 1 and 2 trials between 2001 and 2005. Cinclus was established in 2014 by former AstraZeneca scientists with the goal of reviving and advancing the molecule's development.

A phase 2 dose-selection study presented in November 2022 compared linaprazan to lansoprazole, a commonly used over-the-counter GERD treatment. Although the study was not statistically powered to determine superiority, post hoc analysis suggested that patients treated with linaprazan experienced higher rates of healing based on endoscopic evaluation.

Regulatory and Commercial Milestones

Regulatory momentum for linaprazan glurate continues to build. The drug received approval in China as a GERD treatment in December 2024, with Cinclus aiming to launch it there within 2025. Meanwhile, a phase 3 trial is scheduled to commence in Europe in the third quarter of this year.

Zentiva’s rights to the drug span the U.K., Switzerland, and all countries within the European Economic Area. Cinclus stands to benefit from tiered double-digit royalties on net European sales as part of the agreement.

Zentiva’s Strategic Shift

Historically a producer of generics, Zentiva was once a Sanofi subsidiary from 2008 to 2018, before being acquired by Advent International. The company is now transitioning into the branded pharmaceutical space. "This partnership marks a key milestone for Zentiva as we continue expanding our portfolio beyond generics into high-value specialty medicines," noted Martin Albert, Zentiva’s Chief Scientific Officer. "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."

Highlights

• Zentiva and Cinclus Pharma signed a €220M deal for linaprazan glurate commercialization in Europe.
• The agreement includes a €13M upfront payment and a €5M near-term milestone, with tiered royalties on sales.
• Linaprazan glurate is designed for severe erosive GERD and was originally developed by AstraZeneca.
• A European phase 3 trial is set to begin in Q3 2025, while Chinese regulators approved the drug in December 2024.
• Zentiva, previously focused on generics, is expanding into branded pharmaceuticals with this strategic move.