Pratteln, Switzerland, July 13, 2026. Santhera Pharmaceuticals (SIX: SANN) has announced an extension of its exclusive distribution partnership with Biomedica for AGAMREE® (vamorolone). The expanded agreement adds Georgia, Kazakhstan, Belarus, Azerbaijan, and Uzbekistan to the territories covered by the collaboration.
AGAMREE® is intended for the treatment of Duchenne muscular dystrophy (DMD) in patients aged two years and older.
Biomedica was initially selected as an AGAMREE® distribution partner in October 2025. Under the updated arrangement, the company will oversee distribution activities across the five newly added countries. Santhera will continue receiving an agreed percentage of net sales under the commercial terms established in the original partnership.
An estimated 2,000 people are living with DMD across the additional markets. Treatment availability in these countries has historically been limited, with standard corticosteroids remaining among the primary therapeutic options. The expanded partnership is expected to establish a route through which AGAMREE® may become available to eligible patients in the region.
Marc Clausse, Chief Commercial Officer of Santhera, said Biomedica’s experience and established capabilities in the region made the company a suitable partner for the expansion.
“Biomedica’s proven expertise in the region makes them a natural partner for expansion into these additional markets, where treatment options remain limited,” Clausse said. “This agreement represents another important step in our international partnership strategy and reinforces our continued commitment to making AGAMREE® available to patients wherever they live. We look forward to continuing our collaboration with Biomedica and exploring opportunities to expand into additional markets in the future.”
Oleg Parosin, Founder and Chief Executive Officer of Biomedica, said the company welcomed the opportunity to extend its collaboration with Santhera.
“We are excited to broaden our partnership with Santhera,” Parosin said. “Leveraging our infrastructure and experience bringing innovative rare-disease therapies to patients across the CIS and Caucasus, we are well positioned to deliver AGAMREE® reliably in these five new markets and support families living with DMD.”
About Santhera
Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company engaged in developing and commercializing innovative treatments for rare neuromuscular diseases where significant unmet medical needs remain.
Santhera holds an exclusive worldwide license from ReveraGen covering all indications for AGAMREE® (vamorolone). Vamorolone is a dissociative steroid with a novel mode of action that was evaluated in a pivotal clinical study involving patients with Duchenne muscular dystrophy as a potential alternative to conventional corticosteroid treatments.
AGAMREE® has received regulatory approval for the treatment of DMD in the United States from the Food and Drug Administration, in the European Union from the European Commission, in the United Kingdom from the Medicines and Healthcare products Regulatory Agency, and in Switzerland from Swissmedic.
The treatment has also been approved by the National Medical Products Administration in China, the Department of Health in Hong Kong, and Health Canada.
Santhera has granted regional commercialization rights for AGAMREE® to Catalyst Pharmaceuticals in North America, Sperogenix Therapeutics in China and selected Southeast Asian countries, and Nxera Pharma in Japan, South Korea, Australia, and New Zealand.
Further information is available through Santhera’s official website.
AGAMREE® is a registered trademark of Santhera Pharmaceuticals.
About Biomedica
Biomedica is a pharmaceutical company focused on bringing rare-disease, innovative, and breakthrough treatments to patients in underserved and emerging healthcare markets.
The company operates across Central and Eastern Europe, the Commonwealth of Independent States, Turkey, and Israel. It works with biotechnology and pharmaceutical developers to support the commercialization, market access, and distribution of novel therapies.
Biomedica’s principal therapeutic areas include rare diseases, neurology, haematology, oncology, hepatology, and ophthalmology. Through its regional infrastructure and market-access experience, the company aims to improve the timely availability of innovative treatments for patients with substantial unmet medical needs.
Contact Information
Santhera Pharmaceuticals
Catherine Isted, Chief Financial Officer
[email protected]
ICR Healthcare
[email protected]
Stifel
Telephone: +44 (0)20 7710 7600
Brough Ransom, Charles Hoare and Fred Walsh
Octavian
Telephone: +41 (0)44 520 1588
Serge Monnerat and Marius Zuberbuehler
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The publication may contain forward-looking statements concerning Santhera, its operations, commercial activities, and future performance. Such statements are subject to risks, uncertainties, and additional factors that could cause the company’s actual financial position, results, performance, or achievements to differ materially from those expressed or implied.
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