Swiss drugmaker Santhera Pharmaceuticals has signed an exclusive agreement with SteinCares to distribute AGAMREE (vamorolone), its treatment for Duchenne muscular dystrophy (DMD), across 31 countries in Latin America and the Caribbean.

The deal expands Santhera's international distribution network into a region where about 15,000 people are living with DMD, the company said on Thursday. The launch will initially focus on Brazil, where SteinCares will pursue regulatory registration while seeking access for patients through exceptional importation pathways. The agreement also covers Colombia and Argentina, among other countries, and Santhera will receive a percentage of net sales.

Brazil first, then the region

Santhera chief executive Orlando Oliveira said the agreement was an important step towards bringing AGAMREE to patients with DMD in Latin America and the Caribbean, building on partnerships across North America, Central and Eastern Europe, Asia and the Middle East. SteinCares' expertise in market access and commercial launches across the region would be key as the companies worked towards initial patient access in Brazil and a phased rollout in further markets, he said.

SteinCares chief strategy officer Sebastián Katz said the deal strengthened the company's rare disease portfolio and reflected its role as a bridge between global pharmaceutical innovation and the healthcare needs of Latin America.

What AGAMREE is

AGAMREE is a dissociative corticosteroid investigated as an alternative to standard corticosteroids for DMD, a rare and progressive muscle-wasting condition. It is approved in the United States, the European Union, the United Kingdom, Switzerland, China, Hong Kong and Canada. SteinCares, which has more than 45 years of experience and a platform across more than 30 countries in Latin America and the Caribbean, will handle licensing, commercialisation, market access and patient support in the region. Source: GlobeNewswire