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ICC ruled in favor of AOP Orphan Pharmaceuticals AG in arbitration proceedings pertaining to BESREMi® (Ropeginterferon alpha-2b)

October 27th 2020
On Tuesday, October 20, 2020 a Tribunal under the auspices of the International Chamber of Commerce (ICC) rendered its final award in an arbitral dispute between PharmaEssentia Corp. (hereinafter “PharmaEssentia”) and AOP Orphan Pharmaceuticals AG (hereinafter “AOP Orphan”). AOP Orphan was awarded approximately EUR 143 million in damages.

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®.

Portrait von Dr. Rudolf Widmann
Portrait von Dr. Rudolf Widmann
Dr. Rudolf Widmann

We are relieved that the ICC ruling compensates AOP Orphan now for the delay in getting BESREMi® approved in the European Union, and the delay in bringing this important medication to the patients suffering from polycythaemia vera, a rare and chronic disease of the blood building cells.

Dr. Rudolf Widmann, Chief Therapeutics Officer, Member of the Board and founder of AOP Orphan explains: “We had initiated the arbitration already in March 2018, to appeal unfounded attempts by PharmaEssentia to terminate the contract, and for a damage compensation for delays caused by PharmaEssentia. Now we are reassured of our situation as the ICC ruled that the contract with PharmaEssentia is in full force and effect, and that AOP Health is entitled to damages of approximately EUR 143 million. Accordingly, we have issued an invoice to PEC on this amount for payment.”

About AOP Health

The brand AOP Health incorporates several companies: The international Healthcare Group is the European pioneer for integrated therapies for rare diseases and in critical care. Over the past 25 years, the company has become an established provider of integrated therapy solutions from its headquarters in Vienna, its subsidiaries and representative offices throughout Europe and the Middle East, as well as through partners worldwide. This development has been made possible by a continually high level of investment in research and development on the one hand and a highly consistent and pragmatic orientation towards the needs of all our stakeholders on the other - especially the patients and their families as well as also the doctors and care professionals treating them. 

Press Contact.

Ms. Nina Roth, MAS.

Head of Corporate Communications


Picture captions:
© AOP Orphan Pharmaceuticals AG / Natascha Unkart & Isabelle Köhler

PC 1: Dr. Rudolf Widmann, founder of AOP Ophan & Board Member, Chief Therapeutic Development Officer.

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