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Santhera hands SteinCares regional rights to Duchenne steroid alternative, with Brazil first

The Swiss rare-disease company will earn a share of net sales from vamorolone across 31 Latin American and Caribbean markets, relying on a local partner to open them.

12 Nov 2026 · Santhera Pharmaceuticals Holding AG · Company news

Santhera Pharmaceuticals is outsourcing the commercial rollout of its Duchenne muscular dystrophy therapy across much of Latin America. On 12 November 2026 the company said it had named SteinCares as sole distributor of Agamree (vamorolone) in 31 countries and territories in Latin America and the Caribbean, including Brazil, Colombia and Argentina.

On the money side, Santhera will be paid a percentage of net sales. The announcement as summarised to us does not state that percentage, how long the agreement runs, any upfront or milestone payments, sales expectations or when launches might happen. Nor does it list all 31 markets, so the scale of the revenue opportunity cannot be assessed from the disclosed information.

Brazil is the starting point. SteinCares intends to get the drug to patients there through exceptional importation while it pursues registration with ANVISA, the country's health regulator. That means early supply in Brazil would not rest on a full marketing authorisation, which has yet to be sought.

For context, exceptional or named-patient import schemes allow authorities to permit access to a medicine that has no local marketing authorisation. They usually serve as a stopgap while formal registration proceeds, and the volumes and conditions differ by country. The announcement does not say how the approach will work in the other territories covered.

Why it matters

  • Santhera's route into Latin America is a distributor model paid through a share of net sales, which limits its direct commercial footprint in the region; financial terms beyond that remain undisclosed.
  • Initial Brazilian access depends on exceptional importation, so sales there are tied to that mechanism until ANVISA registration is sought and obtained.
  • Regulatory teams should watch for an ANVISA submission and for registration plans in the other covered countries.
  • The structure shows how smaller rare-disease developers can cover many markets through a single regional partner.

Written by CompePharma's editorial system from the company's filing; claims are the company's. AI-assisted; check the source before acting. Not investment advice.

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