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Merck KGAA, Darmstadt, Germany Expands Oncology Portfolio Through Collaboration Deal With Abbisko for Phase III Candidate, Pimicotinib

Tuesday, December 05, 2023

Merck KGaA, Darmstadt, Germany, a leading science and technology company, has recently unveiled a license agreement with Abbisko Therapeutics Co. Ltd. in Shanghai, China, for pimicotinib (ABSK021). This compound is currently undergoing Phase III trials for the treatment of tenosynovial giant cell tumor (TGCT), a noncancerous tumor affecting the joints and causing symptoms such as swelling, pain, and restricted mobility.

TGCT poses a significant challenge as treatment options are limited, impacting patients' quality of life. Merck KGaA's agreement with Abbisko grants them the license to commercialize pimicotinib in mainland China, Hong Kong, Macau, and Taiwan, with an option for global distribution.

Andrew Paterson, Chief Marketing Officer for Merck KGaA's Healthcare business sector, expressed the company's commitment to addressing the unmet medical needs of the Chinese population and potentially beyond. Pimicotinib, an orally administered small-molecule antagonist of colony-stimulating factor-1 receptor (CSF-1R), is currently undergoing global Phase III trials for TGCT.

In a recent Phase Ib trial, pimicotinib demonstrated significant antitumor activity, with an overall response rate of 87.5% at one-year follow-up among patients receiving the 50mg QD dose. The ongoing Phase III MANEUVER trial is evaluating its efficacy and safety in patients with unresectable TGCT.

Dr. Xu Yao-chang, Chairman of Abbisko Therapeutics, highlighted the collaboration as a crucial step in advancing the global commercialization process of pimicotinib. This partnership is expected to set a new model for Abbisko's pipeline commercialization in the future, aiming to expedite global approvals and bring new treatment options to patients as soon as possible.

The agreement outlines that Merck KGaA will receive an exclusive license for commercialization in certain regions, with an upfront payment of $70 million to Abbisko. Additional payments are specified for achieving regulatory and commercial milestones, along with double-digit tiered royalties on net sales by Merck KGaA.

Pimicotinib (ABSK021), independently developed by Abbisko Therapeutics, has received breakthrough therapy designations from the China National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA), as well as priority medicine (PRIME) designation from the European Medicines Agency (EMA) for the treatment of TGCT not amenable to surgery.

Apart from TGCT, Abbisko Therapeutics is actively exploring the potential of pimicotinib in treating other solid tumors. The company has obtained approval from NMPA to conduct Phase II clinical studies in chronic graft-versus-host disease and advanced pancreatic cancer. The collaboration aims to accelerate the global approval and commercialization pace of pimicotinib, providing new treatment options to patients worldwide.



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