Santhera Taps SteinCares to Sell AGAMREE Across 31 Latin American and Caribbean Markets

Santhera Pharmaceuticals signed an exclusive distribution agreement with SteinCares for AGAMREE (vamorolone) in 31 Latin American and Caribbean countries, targeting a region where about 15,000 people live with Duchenne muscular dystrophy. The Swiss company announced the deal on November 12, 2026, according to GlobeNewswire.

How the SteinCares Distribution Deal Works

SteinCares will handle distribution of Santhera Pharmaceuticals's Duchenne muscular dystrophy drug across selected Latin American countries, including Brazil, Colombia and Argentina, as well as the Caribbean. The rollout starts in Brazil, where SteinCares will provide access to AGAMREE through import exception rules while pursuing regulatory approval with ANVISA, the Brazilian health regulator. SteinCares will then expand into the remaining countries.

Santhera will receive a percentage of net sales, consistent with its existing distribution agreements. Orlando Oliveira, chairman of Santhera's board, said: "This agreement is an important step in making AGAMREE available to DMD patients in Latin America and the Caribbean. It expands our international distribution network and builds on our partnerships in North America, Central and Eastern Europe, Asia and the Middle East."

Sebastián Katz, chief strategy officer of SteinCares, said: "This agreement strengthens our portfolio in rare diseases and reflects our role as a strategic bridge between global pharmaceutical innovation and the healthcare needs of Latin America." SteinCares describes itself as a specialty pharmaceutical company with more than 45 years of experience and an integrated platform in over 30 countries in Latin America and the Caribbean.

Santhera's Recorded Deal History

Santhera appointed Orlando Oliveira as chief executive officer in April 2026, completing a planned leadership transition, according to akta.pro company records. In January 2026 the company signed an exclusive licensing agreement with Nxera Pharma for AGAMREE in Japan, South Korea, Australia and New Zealand, valued at up to $205 million plus royalties, including a $40 million upfront payment. Santhera reported full year 2025 total revenue of CHF 77.4 million, 98% year-over-year growth and ahead of its original guidance of CHF 65-70 million, driven by AGAMREE adoption across Europe and the US.

Earlier AGAMREE Expansion Moves

In July 2026, Santhera expanded its exclusive distribution agreement with Biomedica to include five additional markets, Georgia, Kazakhstan, Belarus, Azerbaijan and Uzbekistan, for AGAMREE in patients aged two and older, GlobeNewswire reported. In June 2026, South Korea's MFDS granted AGAMREE Orphan Drug and Global Innovative Products on Fast Track designations for Duchenne muscular dystrophy, BioSpace reported. Santhera reported H1 2026 revenue of CHF 48.3 million, up 101% year-over-year, driven by product sales and the Nxera licensing agreement, FinancialContent Business Page reported.

Brazil Approval Process Underway

SteinCares will pursue regulatory approval for AGAMREE with ANVISA in Brazil while providing access through import exception rules, and will then expand into the other countries covered by the agreement.