Santhera Pharmaceuticals (SIX: SANN) announces the signing of an exclusive agreement with Biomedica for the distribution of AGAMREE® (vamorolone) in Russia, for the treatment of Duchenne muscular dystrophy (DMD) in patients four years of age and older.
Under the terms of the agreement, Santhera will receive a percentage of net sales, in line with previous distribution agreements, with sales expected to begin in Q1 2026. This collaboration will enable access to AGAMREE for DMD patients across the country, facilitated through regional and national managed access programs. There are approximately 1,400 patients living with DMD in Russia [1].
Dario Eklund, Chief Executive Officer of Santhera, said: “This agreement will enable more children to access this important DMD treatment, and is the latest in a series of global agreements secured in 2025. We look forward to working closely with Biomedica in the months ahead.”
Oleg Parosin, Founder and Chief Executive Officer of Biomedica added: “Our deep expertise in neurology and DMD, particularly with therapies that complement AGAMREE, combined with our track record of successful partnerships with leading EU and US companies, positions us as a strong and trusted partner for Santhera in Russia. We look forward to working together to accelerate access and ensure the availability of AGAMREE from early next year, enabling even more patients to benefit from this essential therapy.”
About AGAMREE® (vamorolone)
AGAMREE is a novel drug with a mode of action based on binding to the same receptor as glucocorticoids but modifying its downstream activity. Moreover, it is not a substrate for the 11-β-hydroxysteroid dehydrogenase (11β-HSD) enzymes that may be responsible for local drug amplification and corticosteroid-associated toxicity in local tissues [2-5]. This mechanism has shown the potential to ‘dissociate’ efficacy from steroid safety concerns and therefore AGAMREE is positioned as a dissociative anti-inflammatory drug and an alternative to existing corticosteroids, the current standard of care in children and adolescent patients with DMD [2-5].
In the pivotal VISION-DMD study, AGAMREE met the primary endpoint Time to Stand (TTSTAND) velocity versus placebo (p=0.002) at 24 weeks of treatment and showed a good safety and tolerability profile [2, 5]. The most commonly reported side effects were cushingoid features, vomiting, weight increase and irritability. Side effects were generally of mild to moderate severity.
Currently available data show that AGAMREE, unlike corticosteroids, has no restriction of growth [6] and no negative effects on bone metabolism as demonstrated by normal bone formation and bone resorption serum markers [7].
▼ 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.