Vienna, 27.10.2020. After two and a half years of arbitration proceedings concerning BESREMi® (Ropeginterferon alfa-2b), the decision by the ICC Arbitral Tribunal has now been made. In 2017 PharmaEssentia had attempted to terminate the contractual agreement with AOP Ophan. The arbitral award states that the termination of the aforementioned contract was unjustified and thus that the license agreement remains in full force and effect. Consequently, AOP Health is entitled to payment of damages for project delays caused by PharmaEssentia, resulting in delays of the approval of the medicinal product for human use BESREMi® in Europe and delays in supply to patients affected by polycythaemia vera. On these grounds, the ICC has awarded AOP Health damages of a total of approximately EUR 143 million.
Based on the above mentioned contract which has a territorial focus on Europe, AOP Orphan started the development of BESREMi® in 2009: Whereas PharmaEssentia supplied the active pharmaceutical ingredient, AOP Orphan completed the development of the drug product, conducted Phase I/II and Phase III clinical trials to verify the use of BESREMi® in patients with polycythaemia vera, and subsequently successfully submitted the dossier for approval by the European Medicines Agency (EMA). Furthermore, AOP Health has started and completed additional clinical trials in polycythaemia vera in a different patient risk group, and in chronic myeloid leukaemia and myelofibrosis under the context of the further overall development program in order to fully exploit the commercial value of BESREMi®.