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Santhera names SteinCares exclusive Latin American distributor for Duchenne drug Agamree

Santhera Pharmaceuticals Holding AG · Thu 12 Nov 2026

Santhera has granted SteinCares exclusive rights to distribute vamorolone across 31 Latin American and Caribbean countries, with Brazil first in line and ANVISA registration to be pursued.

Santhera Pharmaceuticals announced on 12 November 2026 that it has appointed SteinCares as exclusive distributor of Agamree (vamorolone) for Duchenne muscular dystrophy in 31 countries across Latin America and the Caribbean. Brazil, Colombia and Argentina are among the markets covered.

Brazil will be the first focus. According to the announcement, SteinCares will seek patient access through exceptional importation routes while it works towards registration with ANVISA, the Brazilian health regulator.

Under the financial terms disclosed, Santhera will receive a percentage of net sales. The summary available does not give further details, such as the percentage, the contract length, launch timelines or the full list of countries.

As general context, exceptional or named-patient import mechanisms let a country's authorities allow access to a medicine that has no local marketing authorisation. They are typically a bridge while the full registration process continues.

What it means for your team

  • Market-access teams should note that Brazil's initial supply will depend on exceptional importation, not a full ANVISA registration, which is still to be sought.
  • Regulatory affairs teams tracking Latin American filings should watch for ANVISA submission news and for registration plans in other covered countries.
  • Partnership structures that pair a local distributor with a percentage-of-net-sales model are a way for smaller rare-disease developers to reach multiple regional markets.

Company's press release: Santhera Pharmaceuticals Holding AG ↗

Article written by VigiEye from the official source (Santhera Pharmaceuticals Holding AG). Claims are the company's own. AI-assisted; check the source before acting.

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