RHEACELL and AOP Health Partner to Commercialize Somatic Cell Therapies in Europe

RHEACELL, a prominent biopharmaceutical company based in Heidelberg, Germany, has announced a strategic partnership with the AOP Health Group. This collaboration grants AOP Health exclusive rights to commercialize RHEACELL’s innovative stem cell products, EBESANAR® and AMESANAR®, throughout Europe, Turkey, Israel, and the MENA region. Meanwhile, RHEACELL retains commercialization rights in North America, Asia-Pacific, and Latin America, where it plans to seek additional distribution partners.

RHEACELL has been at the forefront of developing somatic cell therapeutics, particularly aimed at treating non-healing venous wounds, known as chronic venous ulcers, and Epidermolysis bullosa, a rare pediatric condition often referred to as "butterfly disease." The company remains committed to advancing its clinical trials, with Phase 3 studies for both EBESANAR® and AMESANAR® underway. Preliminary results for the EBESANAR® trial are anticipated by the end of 2025, while the AMESANAR® study is expected to conclude in 2026.

Once marketing approval is granted in Europe, AOP Health will spearhead commercialization, handling sales and regulatory responsibilities across the designated regions. This move aligns with AOP Health’s history of successfully introducing integrated therapies to the European market. RHEACELL will continue to manufacture the therapies at its cutting-edge facility in Heidelberg. The partnership underscores a shared mission between the two companies to swiftly provide advanced therapeutic solutions to patients with significant unmet medical needs. Financial details of the agreement have been kept confidential.

Dr. Christoph Ganss, CEO of RHEACELL, expressed enthusiasm about the partnership, viewing it as a pivotal step in the development of their cell therapy programs. He emphasized the advantage of collaborating with an established entity like AOP Health to efficiently bring their therapies to European markets. Dr. Martin Steinhart, CEO of AOP Health, echoed these sentiments, highlighting the partnership’s potential to deliver much-needed treatment options to patients suffering from Epidermolysis bullosa and chronic venous ulcers, conditions with limited available treatments. Both companies are committed to ensuring these innovative treatments reach patients who need them the most.

RHEACELL specializes in developing stem cell therapies for severe immune and inflammation-related diseases, focusing on patients with high levels of suffering and few treatment options. Their products utilize ABCB5+ mesenchymal stromal cells, offering a unique mechanism of action to control inflammation and promote normal wound healing, either topically or systemically.

AOP Health, an internationally recognized group headquartered in Austria, has been dedicated to creating solutions for unmet medical needs since 1996, particularly in the realm of rare diseases and critical care. With a strong global presence, AOP Health is known for pioneering integrated therapy solutions and maintains strong relationships with healthcare professionals and patient advocacy groups to ensure its offerings meet the needs of stakeholders.

EBESANAR® is designed for systemic treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB) and Junctional Epidermolysis Bullosa (JEB), targeting both skin lesions and overall disease burden. It is currently undergoing a phase 3 trial in the United States and Europe, with data expected in late 2025. Conversely, AMESANAR® is a topical therapy targeting non-healing chronic venous ulcers, focusing on activating macrophages to support wound healing. It is also in a Phase 3 trial in the U.S. and Europe, with results anticipated in 2026.