Pratteln, Switzerland, April 16, 2025 - Santhera Pharmaceuticals (SIX: SANN) announces the latest progress on the commercial rollout of AGAMREE® for the treatment of Duchenne Muscular Dystrophy (DMD).
Funding from National Health Serviceand initial sales already achieved in Scotland and Wales.
In addition, Santhera notes that Kye Pharmaceuticals, sub-licensee of its commercialization partner Catalyst Pharmaceuticals, has received acceptance by Health Canada for the New Drug Submission for AGAMREE with Priority Review. This potentially paves the way for the therapy to become the first approved treatment for DMD in Canada by the end of 2025.
Dario Eklund, CEO of Santherasaid: "I'm pleased to share the latest progress on the commercial rollout of AGAMREE, particularly in the UK, where a significant portion of our clinical trials were conducted. These trial sites played a key role in generating the data to support the approval. We are proud to see this milestone translate into access for patients in England living with DMD."
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 [1-4]. 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 [1-4].
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 [1, 4]. 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 [5] and no negative effects on bone metabolism as demonstrated by normal bone formation and bone resorption serum markers [6].
? 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] Dang UJ et al..
[2] Guglieri M et al.
[3] Liu X et al.
[6] Hasham et al., MDA 2022 Poster presentation. Link.
About Santhera
Santhera Pharmaceuticals.
AGAMREE® is a trademark of Santhera Pharmaceuticals.
For further information please contact:
Catherine Isted, Chief Financial Officer:
IR@santhera.com
ICR Healthcare
Santhera@icrhealthcare.com
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
- 250416 AGAMREE commercial update_Final English (https://ml-eu.globenewswire.com/Resource/Download/b2173bb5-ded4-4a68-a029-5933d09a4838)
