Cinclus Pharma and Zentiva Team Up to Market Linaprazan Glurate in Europe

Cinclus Pharma Holding AB has announced a strategic alliance with Zentiva, a prominent European pharmaceutical company, to advance the commercialization and manufacturing of its leading drug candidate, linaprazan glurate, across Europe. This collaboration encompasses all countries within the European Economic Area (EEA), along with the United Kingdom and Switzerland. The partnership is valued at a total of EUR 220 million, incorporating upfront and milestone payments related to regulatory approval and commercialization efforts. This includes an initial payment of EUR 13 million and an anticipated milestone reward of EUR 5 million in 2026. Furthermore, Cinclus Pharma stands to gain tiered royalties on European net sales, starting in the high teens and surpassing 20% at the uppermost levels.

Cinclus Pharma is a clinical-stage biopharmaceutical company devoted to developing innovative treatments for diseases associated with gastric acid. The company’s flagship product, linaprazan glurate, is a next-generation potassium-competitive acid blocker (PCAB) aimed at addressing severe erosive gastroesophageal reflux disease (eGERD). The market for this condition encompasses approximately 19 million patients worldwide, with around 10 million located in Europe and the United States. Cinclus Pharma anticipates launching its initial Phase III clinical trial for linaprazan glurate in the third quarter of 2025.

The alliance with Zentiva is seen as a pivotal moment for Cinclus Pharma, as it leverages Zentiva’s extensive commercial reach and operational prowess throughout Europe. Zentiva, known for its expertise in producing high-quality, affordable medicines, is expanding its portfolio beyond generic drugs to include high-value specialty treatments. Linaprazan glurate complements Zentiva’s strategic goals, enabling the company to deliver transformative therapies to European patients suffering from severe erosive GERD.

The collaboration benefits from a comprehensive set of capabilities, encompassing gastroenterology-focused development, regulatory affairs, manufacturing, and commercialization. This union not only mitigates risks associated with gaining European approval but also positions Cinclus Pharma to capitalize on significant global opportunities, particularly in the U.S. market, where it retains full commercial rights.

Martin Albert, Chief Scientific Officer of Zentiva, highlighted the importance of this partnership in expanding Zentiva’s portfolio into specialty medicines. He emphasized the compatibility of linaprazan glurate with Zentiva’s strategy to enhance their offerings and deliver innovative treatments to patients across Europe. With Zentiva’s robust pan-European commercial platform, the company is poised to serve as a trusted partner in introducing this groundbreaking therapy to individuals afflicted with severe erosive GERD.

Cinclus Pharma has invested significantly in the development of linaprazan glurate, a prodrug of P-CAB linaprazan, originally devised by AstraZeneca. This drug has demonstrated potential in healing esophageal mucosa erosions and alleviating gastroesophageal reflux disease (GERD) symptoms more effectively than existing treatments like proton pump inhibitors (PPIs). The safety and efficacy of linaprazan and its glurate form have been validated through over 30 Phase I and two Phase II studies involving more than 3,000 participants. Planning for Phase III trials is underway, with a projected start in 2025.

GERD is a widespread condition affecting approximately 133 million adults in the United States and European Union. There is a pressing need for novel treatments to address the most severe cases, which affect around 10 million patients. Linaprazan glurate is specifically developed to meet these unmet needs, offering new hope for individuals suffering from this chronic condition.