Santhera Pharmaceuticals Holding AG announces that it has secured a final reimbursement agreement with the French authorities related to Raxone®(idebenone)for the treatment of Leber's hereditary optic neuropathy (LHON) and sales are expected to resume shortly. In addition, the Company plans to submit a request in Francein the near-term for an early access program for vamorolone for the treatment of Duchenne muscular dystrophy (DMD). The newly agreed price for Raxone in France is lower than the price applied under the temporary pricing scheme, leading to a settlement payment, as announced earlier.

Santhera will make repayments in the total amount of approximately EUR 25 million, with 30% due around mid-2024 and the remainder one year later. The Company has already made accruals for such payments and published these in the interim results for the period to June 30, 2022. The first payment is currently expected to be covered by sales generated until mid-2024, while the majority of the second payment will be covered by sales beyond mid-2025.

Outside of France and North America, Santhera has outlicensed Raxone to Chiesi Group. Santhera plans to submit a request for a vamorolone early access program (AAP, autorisation d'accès précoce) in France. Once approved, this program would enable early availability of vamorolone to patients and could generate product sales in France in the second half of 2023, ahead of an approval by the European Medicines Agency (EMA).