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

https://reurl.cc/2gN424

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, October 27, 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 Orphan. 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 Orphan 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 Orphan 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 Orphan 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®.

“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”,
explains Dr. Rudolf Widmann, Chief Therapeutics Officer, Member of the Board
and founder of AOP Orphan. “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 Orphan is entitled
to damages of approximately EUR 143 million. Accordingly, we have issued an
invoice to PEC on this amount for payment.”

3.心得/評論：
AOP 開始跟公司要賠償金了

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