Pratteln, Switzerland, July 13, 2026 - Santhera Pharmaceuticals (SIX: SANN) today announces an expansion of its exclusive distribution agreement with Biomedica for AGAMREE (vamorolone), extending the partnership to include Georgia, Kazakhstan, Belarus, Azerbaijan and Uzbekistan, for the treatment of Duchenne muscular dystrophy (DMD) in patients two years of age and older.
Biomedica was originally appointed as a distributor for AGAMREE in October 2025. Under the expanded agreement, Biomedica will be responsible for distribution in the additional five markets, while Santhera will continue to receive a percentage of net sales in line with the terms of the original agreement. Approximately 2,000 patients are living with DMD across these additional countries, where treatment options have historically been largely limited to standard corticosteroids. The expanded agreement creates a pathway to making AGAMREE available to these patients.
Marc Clausse, Chief Commercial Officer of Santhera, said: "Biomedica's proven expertise in the region makes them a natural partner for expansion into these additional markets, where treatment options remain limited. 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, added: "We are excited to broaden our partnership with Santhera. 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 focused on the development and commercialization of innovative medicines for rare neuromuscular diseases with high unmet medical need. The Company has an exclusive license from ReveraGen for all indications worldwide to AGAMREE (vamorolone), a dissociative steroid with a novel mode of action, which was investigated in a pivotal study in patients with Duchenne muscular dystrophy (DMD) as an alternative to standard corticosteroids. AGAMREE for the treatment of DMD is approved in the U.S. by the Food and Drug Administration (FDA), in the EU by the European Commission (EC), in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA), in Switzerland by Swissmedic, in China by the National Medical Products Administration (NMPA), in Hong Kong by the Department of Health (DoH) and in Canada by Health Canada. Santhera has out-licensed the rights to AGAMREE as follows: to Catalyst Pharmaceuticals for North America; to Sperogenix Therapeutics for China and certain countries in Southeast Asia; and to Nxera Pharma for Japan, South Korea, Australia, and New Zealand. For further information, please visit www.santhera.com.
AGAMREE is a trademark of Santhera Pharmaceuticals.
About Biomedica
Biomedica is a pharmaceutical company specializing in the commercialization of rare disease, innovative, and breakthrough therapies in underserved and emerging markets. With a strong presence across Central and Eastern Europe (CEE), the Commonwealth of Independent States (CIS), Turkey, and Israel, Biomedica partners with leading biotechnology and pharmaceutical innovators to bring novel treatments to patients. Its key therapeutic areas include rare diseases, neurology, haematology, oncology, hepatology and ophthalmology. Leveraging its regional expertise and established market access capabilities, Biomedica is committed to ensuring the timely access and availability of innovative therapies for patients with high unmet medical needs.
For further information, please contact:
Santhera
Catherine Isted, Chief Financial Officer:
IR@santhera.com
ICR Healthcare:
Santhera@icrhealthcare.com
Stifel
+44 (0)20 7710 7600
Brough Ransom, Charles Hoare, Fred Walsh
Octavian
+41 (0)44 520 1588
Serge Monnerat, Marius Zuberbuehler
Disclaimer / Forward-looking statements
This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Santhera Pharmaceuticals Holding AG. This publication may contain certain forward-looking statements concerning the Company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the Company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. The Company disclaims any obligation to update these forward-looking statements.
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