Santhera Signs Deal to Expand Access to DMD Treatment in Latin America and the Caribbean

Rare Daily Staff

Santhera Pharmaceuticals said it signed an exclusive distribution agreement with SteinCares for its Duchenne muscular dystrophy treatment Agamree across 31 countries in Latin America and the Caribbean, with initial efforts focused on Brazil.

The agreement creates a route toward broader access to the medicine in a region where Santhera estimates approximately 15,000 people live with Duchenne. Santhera will receive a percentage of net sales. The companies did not disclose that percentage or other financial terms.

SteinCares, a specialty pharmaceutical company with operations across Latin America and the Caribbean, will handle regional distribution. Sebastián Katz, its chief strategy officer, said the partnership expands the company’s rare disease portfolio and combines Santhera’s expertise in neuromuscular diseases with SteinCares’ knowledge of local healthcare systems.

In Brazil, SteinCares plans to seek access through exceptional importation pathways while pursuing registration with ANVISA, the country’s medicines regulator. The companies did not announce a date for initial patient access, pricing, or reimbursement arrangements.

The agreement also covers Colombia, Argentina, and other selected countries in Latin America and the Caribbean. Santhera said expansion beyond Brazil would take place in phases. The deal itself does not constitute regulatory approval in the covered countries.

Duchenne muscular dystrophy (DMD) is a rare genetic neuromuscular disease that primarily affects boys. It results from a lack of dystrophin, a protein that helps protect muscle cells, and causes progressive muscle weakness that can interfere with walking and other daily activities.

Agamree is an anti-inflammatory corticosteroid developed as an alternative to conventional steroids used to treat DMD. Corticosteroids can help preserve muscle strength and slow deterioration, but long-term treatment can cause side effects, including impaired growth, weight gain, and weakened bones. Agamree was developed to retain treatment benefits while reducing some of those effects, particularly those involving growth and bone health.

Agamree is already approved for Duchenne in the United States, European Union, United Kingdom, Switzerland, China, Hong Kong, and Canada, according to Santhera. The Swiss company has also established licensing partnerships covering North America, parts of Asia, Australia, and New Zealand.

“This agreement is an important step towards bringing Agamree to patients with DMD in Latin America and the Caribbean,” said Orlando Oliveira, Santhera’s CEO.

Oliveira said SteinCares’ experience with regional healthcare systems and commercial launches would support initial access in Brazil and the subsequent rollout in other markets.