July 30, 2026
Biomedica Expands %%Partnership with Santhera to Bring AGAMREE® (Vamorolone)%% to Patients in Georgia, Kazakhstan, Belarus, Azerbaijan and Uzbekistan
Biomedica is pleased to announce an expansion of its exclusive distribution agreement with Santhera Pharmaceuticals (SIX: SANN) for AGAMREE® (vamorolone), broadening 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 Santhera's distributor for AGAMREE® in October 2025. Building on that foundation, this expanded agreement extends Biomedica's role to five additional markets, reinforcing the companies' shared commitment to bringing this important therapy to more patients across the region. An estimated 2,000 patients are living with DMD across these five countries, where treatment has historically relied largely on standard corticosteroids. This expanded agreement opens a new pathway for these patients to access AGAMREE®. Oleg Parosin, Founder and Chief Executive Officer of Biomedica, said:
"We are excited to broaden our partnership with Santhera. Our infrastructure and experience bringing innovative rare-disease therapies to patients across the CIS and Caucasus position us well to deliver AGAMREE® reliably in these five new markets and support families living with DMD."
Marc Clausse, Chief Commercial Officer of Santhera, added that Biomedica's established expertise in the region made it a natural partner for this next phase of expansion, and that the agreement marks another meaningful step in Santhera's international strategy to make AGAMREE® available to patients wherever they live, with both companies looking forward to continuing the collaboration and exploring further markets ahead.
About AGAMREE® (vamorolone)
AGAMREE is a novel drug with a mode of action based on binding to the same receptor as glucocorticoids, while modifying its downstream activity. It is not a substrate for the 11-β-hydroxysteroid dehydrogenase (11β-HSD) enzymes thought to be responsible for local drug amplification and corticosteroid-associated toxicity in local tissues. This mechanism has shown the potential to "dissociate" efficacy from steroid-related safety concerns, positioning AGAMREE as a dissociative anti-inflammatory alternative to the corticosteroids that remain the current standard of care for children and adolescents with DMD.
In the pivotal VISION-DMD study, AGAMREE met its primary endpoint — Time to Stand (TTSTAND) velocity versus placebo — at 24 weeks of treatment, with a favorable safety and tolerability profile. The most commonly reported side effects were cushingoid features, vomiting, weight increase and irritability, generally mild to moderate in severity. Available data also show that, unlike corticosteroids, AGAMREE does not restrict growth and has no negative effect on bone metabolism.
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
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 holds an exclusive worldwide license from ReveraGen for AGAMREE® (Vamorolone), a dissociative steroid with a novel mode of action investigated as an alternative to standard corticosteroids for DMD. AGAMREE® is approved for the treatment of DMD in the U.S. by the FDA, in the EU by the European Commission, in the UK by the MHRA, in Switzerland by Swissmedic, in China by the NMPA, in Hong Kong by the DoH, and in Canada by Health Canada. Santhera has out-licensed rights to AGAMREE® to Catalyst Pharmaceuticals for North America, to Sperogenix Therapeutics for China and certain Southeast Asian countries, and to Nxera Pharma for Japan, South Korea, Australia and New Zealand. For more information, visit www.santhera.com.
AGAMREE® is a trademark of Santhera Pharmaceuticals.
For further information, please contact Biomedica via www.biomedica.bio/contacts.