Pratteln, Switzerland, October 9, 2025 - 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-ß-hydroxysteroid dehydrogenase (11ß-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.
References:
[1] Gordey Foundation
[2] Dang UJ et al..
[3] Guglieri M et al.
[4] Liu X et al.
[7] Hasham et al., MDA 2022 Poster presentation. Link.
About Santhera
Santhera Pharmaceuticals.
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
Biomedica
Stan Filippin, Head of Business Development: bd@biomedica.bio
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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Attachment
- 251009 Biomedica distirbution agreement_Final (https://ml-eu.globenewswire.com/Resource/Download/b056949e-7542-4eab-870c-c1357163b795)
