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.”