Santhera Announces Proposed Inclusion and Reimbursement of AGAMREE® (Vamorolone) within Spain's National Health System for the Treatment of Duchenne Muscular Dystrophy
MWN-AI** Summary
Santhera Pharmaceuticals announced on February 27, 2026, that the Spanish Interministerial Commission on Prices of Medicines has proposed the inclusion of AGAMREE® (vamorolone) in Spain's National Health System, making it available for reimbursement for patients with Duchenne muscular dystrophy (DMD). The specific terms and conditions surrounding this inclusion will be outlined in a forthcoming resolution from the Directorate-General of Pharmacy at the Spanish Ministry of Health. Santhera anticipates receiving the draft resolution soon and expects the product to become available across Spain by early second quarter 2026, assuming typical timelines are followed.
AGAMREE® is a treatment option for DMD in patients aged four and older, which is a genetic disorder characterized by progressive muscle degeneration and weakness. The drug has been accessible in Spain since mid-2024 through a paid named-patient program. Dario Eklund, CEO of Santhera, expressed that this development marks a significant milestone in expanding access to AGAMREE for patients with DMD in Europe and globally, especially following recent launches in Germany, Austria, and the UK.
AGAMREE® functions as a dissociative anti-inflammatory medication that modifies the actions of glucocorticoids without the steroid-associated safety concerns. Clinical trials, including the pivotal VISION-DMD study, indicated that AGAMREE met its primary endpoint in improving motor function over placebo, exhibiting a favorable safety profile with mostly mild to moderate side effects. Notably, AGAMREE does not hinder growth or adversely affect bone metabolism, setting it apart from traditional corticosteroids currently approved for DMD treatment.
Santhera continues to work towards making AGAMREE available in more EU regions throughout 2026, affirming its commitment to providing innovative therapies for rare neuromuscular diseases.
MWN-AI** Analysis
Santhera Pharmaceuticals (SIX: SANN) recently announced that AGAMREE® (vamorolone) has been proposed for inclusion in Spain's National Health System (NHS), which positions it for reimbursement. This is a significant development, as AGAMREE represents a novel approach to treating Duchenne Muscular Dystrophy (DMD), a rare genetic disease affecting muscle function. The anticipated inclusion in the NHS will increase patient access to this innovative treatment, especially following its earlier availability through a named-patient program.
From an investment perspective, this announcement is likely to bolster investor confidence in Santhera, reflecting positively on its growth trajectory. The Spanish approval could catalyze similar reimbursements across other EU markets, following recent commercial launches in Germany, Austria, and the UK. It’s essential for investors to monitor the effective acceptance of the proposed inclusion and the timelines for making AGAMREE widely available in Spain.
Given AGAMREE’s distinct mechanism as a steroid alternative emphasizing safety without growth restrictions, it positions the drug favorably in the competitive landscape of DMD treatments. The drug has already reported favorable clinical outcomes, such as improved muscle function with a manageable safety profile, which may further enhance its marketability.
Potential investors should observe how Santhera navigates the completion of this reimbursement process and any additional partnerships or market expansions. Also, watch for developments regarding clinical trials or further studies which could yield additional insights into AGAMREE’s efficacy and safety profile. Overall, the momentum generated by this positive announcement may present a buying opportunity for those looking at long-term investments in pharmaceutical stocks focused on rare diseases, particularly with their potential for significant market growth in Europe.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
Pratteln, Switzerland, February 27, 2026 – Santhera Pharmaceuticals (SIX: SANN) today announces that the Spanish Interministerial Commission on Prices of Medicines, has proposed to include AGAMREE® (vamorolone), in the pharmaceutical coverage of the Spanish National Health System, making it eligible for reimbursement.
The conditions for such inclusion will be determined in a resolution by the Directorate-General of Pharmacy at the Spanish Ministry of Health. The company expects to receive the draft of such resolution shortly. Once the company accepts the draft, the product will be included in the database of products financed by the National Health System in Spain. Assuming this process proceeds along typical timelines, Santhera plans to start to make the product available across the various regions in Spain from early in the second quarter of 2026.
Agamree® is a product approved by the European Commission for treating Duchenne muscular dystrophy in patients from 4 years of age. Duchenne muscular dystrophy is a genetic disease that gradually causes weakness and loss of muscle function. To date, AGAMREE has been available in Spain through a paid named-patient program since mid-2024.
Dario Eklund, Chief Executive Officer of Santhera, said: “This positive announcement in Spain represents another important milestone in our mission to expand access to AGAMREE for patients with DMD in Europe and globally. This follows our commercial launches in Germany, Austria and the UK with a number of additional EU countries expected to follow during both the first and second halves of the year.”
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-?-hydroxysteroid dehydrogenase (11?-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] Dang UJ et al. (2024) Neurology 2024;102:e208112. doi.org/10.1212/WNL.0000000000208112. Link.
[2] Guglieri M et al (2022). JAMA Neurol. 2022;79(10):1005-1014. doi:10.1001/jamaneurol.2022.2480. Link.
[3] Liu X et al (2020). Proc Natl Acad Sci USA 117:24285-24293
[4] Heier CR et al (2019). Life Science Alliance DOI: 10.26508
[5] Ward et al., WMS 2022, FP.27 - Poster 71. Link.
[6] Hasham et al., MDA 2022 Poster presentation. Link.
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 has an exclusive license from ReveraGen for all indications worldwide to AGAMREE® (vamorolone), a dissociative steroid with novel mode of action, which was investigated in a pivotal study in patients with Duchenne muscular dystrophy (DMD) as an alternative to standard corticosteroids. AGAMREE for the treatment of DMD is approved in the U.S. by the Food and Drug Administration (FDA), in the EU by the European Commission (EC), in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA), in Switzerland by Swissmedic, in China by the National Medical Products Administration (NMPA), in Hong Kong by the Department of Health (DoH) and in Canada by Health Canada. Santhera has out-licensed the rights to AGAMREE as follows: to Catalyst Pharmaceuticals for North America; to Sperogenix Therapeutics for China and certain countries in Southeast Asia; and to Nxera Pharma for Japan, South Korea, Australia, and New Zealand. For further information, please visit www.santhera.com.
AGAMREE® is a trademark of Santhera Pharmaceuticals.
For further information please contact:
Santhera
Catherine Isted, Chief Financial Officer:
IR@santhera.com
ICR Healthcare:
Santhera@icrhealthcare.com
Stifel
Brough Ransom, Charles Hoare, Fred Walsh
+44 (0)20 7710 7600
Octavian
Serge Monnerat, Marius Zuberbuehler
+41 (0)44 520 1588
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.
# # #
Attachment
FAQ**
How will the inclusion of AGAMREE® (vamorolone) in the Spanish National Health System’s pharmaceutical coverage impact the revenue projections for Santhera Pharms Hldgs Ltd SPHDF in the upcoming quarters?
What potential challenges does Santhera Pharms Hldgs Ltd SPHDF foresee in the acceptance and implementation of the draft resolution from the Directorate-General of Pharmacy in Spain?
Considering the positive announcement in Spain, how does Santhera Pharms Hldgs Ltd SPHDF plan to leverage this milestone to enhance its market presence across other EU countries?
With the ongoing monitoring of AGAMREE’s safety profile, what risk management strategies is Santhera Pharms Hldgs Ltd SPHDF putting in place to address potential adverse reactions reported post-launch?
**MWN-AI FAQ is based on asking OpenAI questions about Santhera Pharms Hldgs Ltd (OTC: SPHDF).
NASDAQ: SPHDF
SPHDF Trading
0.0% G/L:
$19.95 Last:
800 Volume:
$19.95 Open:
