Articles from AOP Orphan Pharmaceuticals GmbH

Today, the Higher Regional Court of Frankfurt upheld the February 20251 partial final ICC arbitral award in favor of AOP Orphan Pharmaceuticals GmbH (“AOP Health”) in its dispute with PharmaEssentia Corp. (“PharmaEssentia”). The ruling confirms the award which found the Taiwanese company to be liable for certain damages.

AOP Orphan Pharmaceuticals GmbH (AOP Health), based in Vienna, Austria, announced that the U.S. Food and Drug Administration (FDA) has granted regulatory approval for RapiblykTM (landiolol) in the hospital critical care setting for the treatment of the severe heart condition supraventricular tachycardia (atrial fibrillation and atrial flutter). The approval is based on clinical studies which demonstrated that RapiblykTM (landiolol) enables rapid management of the heart rate with minimal reduction of blood pressure. The approval will provide patients in the U.S. with a new treatment option and is an important step for AOP Health in bringing its mission to help patients and make an impact on rare diseases and critical care to the United States for the first time.

AOP Orphan Pharmaceuticals GmbH (AOP Health) in collaboration with Leukos Biotech has achieved a key milestone. The first patient was included in the phase I clinical trial SERONCO-1, in which a substance with a new and unique mechanism of action (first-in-class) is being investigated. The drug candidate is being studied in patients with solid tumors and lymphomas. This development program builds on AOP Health’s proven success in delivering cancer stem cell targeting agents that address patients’ unmet medical needs.

AOP Orphan Pharmaceuticals GmbH (AOP Health) continues a successful clinical research program in hematology/oncology with two abstracts accepted for presentation at the European Hematology Association (EHA) 2024 hybrid congress in Madrid, Spain. One results in an oral presentation of the latest results from the PROUD-PV and CONTINUATION-PV-trials. The outcomes show a correlation between the changes at genetic level (molecular response) and event-free survival (EFS) among patients with a rare blood cancer (polycythemia vera /PV) who received a certain interferon (ropeginterferon alfa-2b/BESREMi®) or best available treatment.1 A second accepted abstract reports on AOP Health’s recently initiated phase III clinical study extending investigation of ropeginterferon alfa-2b to patients with another rare blood cancer, essential thrombocythemia (ET).2 In a further signal of AOP Health’s commitment to innovative research, early development of a first-in-class investigative oncology drug is progressing towards clinical trials.

At the end of November 2023, AOP Orphan Pharmaceuticals GmbH (AOP Health), an Austrian pharmaceutical company based in Vienna, received authorization from the Canadian Health Authority (Health Canada) for its ultra-short-acting, cardioselective β1-blocker Landiolol. The drug is used in intensive care to treat atrial fibrillation and atrial flutter (supraventricular tachycardia) and non-compensatory sinus tachycardia, hence when the heartbeat accelerates acutely without an identifiable cause. The authorization allows a certain group of intensive care patients access to an additional therapy option. In addition, it opens the door to the North American market for AOP Health.

AOP Orphan Pharmaceuticals GmbH (AOP Health), Vienna, Austria, announced the results of an analysis assessing the impact of an individually optimized dosing regimen of ropeginterferon alfa-2b on treatment response in patients with low-risk polycythaemia vera (PV)1 These new data show that some low-risk PV patients require and can tolerate high ropeginterferon alfa-2b doses, and that the optimal dose varies substantially between patients.

AOP Orphan Pharmaceuticals GmbH (AOP Health) announced the publication of final results on the recently developed interferon therapy, ropeginterferon alfa-2b, in patients with polycythemia vera (PV) in the prestigious journal Leukemia1. The full publication expands on results presented at the Annual Meeting of the European Hematology Association. Results of long-term treatment in the CONTINUATION-PV study provide further evidence of the disease modifying capacity of ropeginterferon alfa-2b in PV.

AOP Health announced the final results on Ropeginterferon alfa-2b in patients with Polycythaemia Vera (PV) from its CONTINUATION-PV study in an oral presentation at the prestigious EHA (European Hematology Association) 2022 Annual Meeting by Professor Heinz Gisslinger, Medical University of Vienna, Austria 1.

Since 2017, PharmaEssentia had repeatedly attempted to terminate the agreement with AOP concerning BESREMi® (Ropeginterferon alfa-2b). In October 2020, after two and a half years of arbitral proceedings, the ICC Arbitral Tribunal issued its award in the matter. The award states that PharmaEssentia’s multiple attempts to terminate the agreement were unjustified, and that AOP is entitled to damages of over EUR 143 million for project delays caused by PharmaEssentia. The award also dismissed all of PharmaEssentia's counterclaims against AOP.

In 2009, AOP Orphan in-licensed the exclusive rights for clinical development and commercialization of Ropeginterferon alfa-2b in Polycythaemia Vera (PV), a rare disease, and other myeloproliferative neoplasms (MPNs) for European, Commonwealth of Independent States (CIS), and Middle Eastern markets. Based on a pivotal study development program, which included the studies PEGINVERA, PROUD-PV and CONTINUATION-PV the European Medicines Agency (EMA) authorized BESREMi® for the treatment of PV in February 2019. The whole clinical development program was designed and conducted by AOP Orphan in Europe.