Santhera expects to maximise the reduced financial burden of the Raxone development programme to focus on vamorolone’s European launch. Credit: MIRCO EMMY / Shutterstock.
Chiesi will also inherit the financial responsibility of the €25.3m ($27.9m) reimbursement agreement of Raxone in LHON with French reimbursement authorities, as per the press release.
Since August 2021, and prior to finalising a reimbursement agreement with the French Government in February 2023, Santhera was providing Raxone for free to treat LHON. Drug sales resumed in April 2023, as per unaudited annual results released the same month.
Following the latest news, Santhera would be eligible for US sales milestone payments for Raxone for up to $10m, and other milestone payments if Chiesi expands the use of Raxone in non-ophthalmological indications.
Santhera expects to maximise the reduced financial burden of the Raxone development programme to focus on the vamorolone’s European launch.
Vamorolone has a US FDA’s Prescription Drug User Fee Act (PDUFA) date for approval in DMD on 26 October 2023. Marketing authorisations for vamorolone are also under review with European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
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