PRATTELN, Switzerland, July 13, 2026
Santhera Pharmaceuticals announced the expansion of its exclusive distribution agreement with Biomedica, extending commercial rights for AGAMREE® (vamorolone) to Georgia, Kazakhstan, Belarus, Azerbaijan, and Uzbekistan for the treatment of Duchenne muscular dystrophy (DMD) in patients aged two years and older. The agreement builds on the companies’ existing partnership established in October 2025 and represents another significant milestone in Santhera’s international commercialization strategy for its innovative rare disease therapy.
Under the expanded arrangement, Biomedica will oversee product distribution across the five additional countries while Santhera will continue receiving a percentage of net sales under the original commercial agreement. The expansion is expected to improve access to AGAMREE for approximately 2,000 patients living with DMD across these regions, where treatment options have historically been limited primarily to conventional corticosteroids. The move reinforces Santhera’s commitment to increasing global availability of its approved therapy for patients affected by this progressive neuromuscular disorder.
Expanded Regional Partnership Improves Access to Innovative DMD Treatment
The newly expanded collaboration significantly broadens Biomedica’s commercial footprint for AGAMREE, leveraging the company’s established infrastructure and expertise across Central and Eastern Europe (CEE), the Commonwealth of Independent States (CIS), Turkey, and the Caucasus. According to Santhera, the additional territories represent important underserved markets where access to advanced therapies for rare neuromuscular diseases remains limited. Company executives noted that Biomedica’s experience in regulatory access, product commercialization, and rare disease distribution makes it well positioned to introduce AGAMREE efficiently throughout the newly added countries.
Santhera Chief Commercial Officer Marc Clausse stated that the expanded agreement reflects the company’s broader international partnership strategy while reinforcing its commitment to making innovative therapies available regardless of geographic location. Biomedica Chief Executive Officer Oleg Parosin added that the company intends to utilize its regional market expertise to ensure reliable access to AGAMREE while supporting physicians, patients, and families living with Duchenne muscular dystrophy across the newly covered territories.
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AGAMREE Continues Global Commercial Expansion Following Multiple Regulatory Approvals
AGAMREE (vamorolone) is a dissociative steroid developed as an alternative to traditional corticosteroid therapy for Duchenne muscular dystrophy, aiming to provide clinical benefits while potentially reducing steroid-associated adverse effects. The therapy has achieved multiple international regulatory approvals, including authorization from the U.S. Food and Drug Administration (FDA), the European Commission (EC), the UK Medicines and Healthcare products Regulatory Agency (MHRA), Swissmedic, Health Canada, China’s National Medical Products Administration (NMPA), and regulatory authorities in Hong Kong.
Santhera has also established several regional commercialization partnerships worldwide, including agreements with Catalyst Pharmaceuticals for North America, Sperogenix Therapeutics for China and selected Southeast Asian markets, and Nxera Pharma for Japan, South Korea, Australia, and New Zealand. These partnerships form part of the company’s strategy to maximize global patient access while leveraging experienced regional commercial organizations.
Santhera Advances Global Rare Disease Commercialization Strategy
The latest agreement further strengthens Santhera Pharmaceuticals’ position as a company focused on expanding access to therapies for rare neuromuscular diseases with significant unmet medical needs. By partnering with experienced regional distributors, the company continues to accelerate international commercialization while addressing healthcare disparities in emerging markets. The addition of Georgia, Kazakhstan, Belarus, Azerbaijan, and Uzbekistan represents another step toward making AGAMREE available to patients who previously had limited access to modern treatment options.
As commercialization continues to expand globally, Santhera remains focused on building strategic partnerships capable of delivering innovative rare disease medicines efficiently across diverse healthcare systems. The company’s ongoing efforts highlight the growing importance of international collaborations in improving treatment accessibility for patients living with Duchenne muscular dystrophy, supporting broader adoption of AGAMREE while strengthening Santhera’s long-term commercial growth strategy in the global rare disease market.
Source: Santhera Pharmaceuticals,press release
