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Santhera Concludes Agreement with French Authorities on Raxone® Reimbursement and Plans to Submit a Request for an Early Access Program for Vamorolone
Pratteln, Switzerland, February 8, 2023 – Santhera Pharmaceuticals (SIX: SANN) 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 France in the near-term for an early access program for vamorolone for the treatment of Duchenne muscular dystrophy (DMD). Since its introduction in 2015, Raxone was available to patients in France for the treatment of LHON and reimbursed under a temporary financing scheme (formerly known as ATU). From August 2021, after the French authorities challenged the temporary pricing and removed Raxone from the list of reimbursed drugs under an ATU, Santhera has supplied LHON patients with Raxone free of charge in order to secure uninterrupted access. Reimbursement discussions have now concluded with an agreement on Raxone pricing. Shortly, Raxone will be on the list of reimbursed products in France, and Santhera can resume generating sales. 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 coveredby sales beyond mid-2025. Outside of France and North America, Santhera has outlicensed Raxone to Chiesi Group. “We are glad to have reached an agreement with the French authorities on the matter of Raxone reimbursement. Most importantly, we are very pleased that we have succeeded in maintaining access to therapeutic care by providing Raxone without any interruption to patients suffering from this devastating disease,” said Dario Eklund, CEO of Santhera. “This settlement now enables us to progress discussions on completing outlicensing of Raxone which are further supported by encouraging clinical data with Raxone from studies completed in the recent past. Meanwhile, we remain fully focused on advancing our lead candidate vamorolone for DMD towards approval and market entry in the U.S. and the EU in late 2023 earliest.” 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). Earlier in January, Santhera announced FDA acceptance of the new drug application (NDA) for vamorolone for DMD for filing. Subject to approval, Santhera plans to launch vamorolone in the U.S. in Q4-2023. European marketing authorization application (MAA) for vamorolone has been validated and is under review by the EMA which could pave the way for a first EU launch in late 2023. About Santhera Raxone® is a trademark of Santhera Pharmaceuticals. For further information please contact: Disclaimer / Forward-looking statements # # #
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