Santhera Pharmaceuticals Holding AG

Santhera Signs Distribution Agreement with SteinCares for AGAMREE® (Vamorolone) in 31 countries across Latin America and the Caribbean

Pratteln, Switzerland, November 12, 2026 – Santhera Pharmaceuticals (SIX: SANN) announces it has signed an exclusive agreement with SteinCares for the distribution of AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) across 31 countries in Latin America and the Caribbean.

The agreement expands Santhera’s international distribution network into a region where approximately 15,000 people are living with DMD.¹ The launch will initially focus on Brazil, where SteinCares will pursue regulatory registration in parallel with the expansion to the remaining countries. In Brazil, SteinCares will look to provide access to AGAMREE through exceptional importation pathways, while advancing the ANVISA registration process. The agreement covers selected Latin American countries, including Brazil, Colombia and Argentina in addition to the Caribbean. Santhera will receive a percentage of net sales, consistent with its previous distribution agreements.

Orlando Oliveira, Chief Executive Officer of Santhera, said: “This agreement is an important step towards bringing AGAMREE to patients with DMD in Latin America and the Caribbean. It expands our international distribution network, building on our partnerships across North America, Central and Eastern Europe, Asia and the Middle East. SteinCares’ established expertise in market access and proven capabilities in commercial launches across the region will be key as we work towards initial patient access in Brazil and a phased rollout across further markets.”

Sebastián Katz, Chief Strategy Officer of SteinCares said: We are delighted to partner with Santhera to bring AGAMREE® to patients with DMD in Latin America. This agreement strengthens our rare disease portfolio and reflects our role as a strategic bridge between global pharmaceutical innovation and the healthcare needs of Latin America. By combining Santhera’s expertise in rare neuromuscular diseases with SteinCares’ regional platform and deep understanding of local healthcare systems, we aim to help expand sustainable access to innovative treatment options for patients across the region.”

¹ Based on global DMD prevalence estimates

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 corticosteroid with a 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.

About SteinCares
SteinCares is a leading specialty pharmaceutical company dedicated to expanding patient access to innovative and cost-effective treatments across Latin America. With more than 45 years of experience and an integrated “one-stop-shop” platform across 30+ countries of Latin America and the Caribbean, SteinCares combines deep local expertise, regulatory agility, and end-to-end operational capabilities — from licensing and commercialization to market access and patient support.

For more information, please visit http://www.steincares.com/ or follow the company on LinkedIn.

For further information, please contact:

Santhera
Catherine Isted, Chief Financial Officer:      IR@santhera.com

ICR Healthcare:                Santhera@icrhealthcare.com

Stifel     +44 (0)20 7710 7600
Brough Ransom, Charles Hoare, Fred Walsh

Octavian     +41 (0)44 520 1588
Serge Monnerat, Marius Zuberbuehler

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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• 261112 Santhera Distribution Agreement in LATAM Final ENG (1)