Pharma Focus Asia

Abbisko Therapeutics and Merck Finalize Licensing Agreement for Pimicotinib (ABSK021)

Tuesday, December 05, 2023

Abbisko Therapeutics has recently entered into a licensing agreement with Merck, a prominent science and technology company headquartered in Darmstadt, Germany. The agreement grants Merck an exclusive license to commercialize products comprising or containing pimicotinib (ABSK021) in the Chinese mainland, Hong Kong, Macau, and Taiwan (the "Licensed Territory"). Meanwhile, Abbisko Therapeutics will retain exclusive rights to develop pimicotinib within the Licensed Territory. The deal also includes an exclusive option for Merck to acquire global commercial rights for pimicotinib, with the possibility of co-developing the drug in additional indications under specific conditions.

Under the terms of the License Agreement, Abbisko Therapeutics will receive a one-time, non-refundable down payment of US$70 million. If Merck exercises the Global Commercialization Option, an additional option exercise fee will be paid. The total amount of upfront payment, exercising payment, and development and commercialization milestones totals US$605.5 million, along with a double-digit percentage royalty on actual annual net sales.

Dr. Xu Yao-chang, Chairman of Abbisko Therapeutics, emphasized the significance of the collaboration as a crucial milestone in advancing the global commercialization of pimicotinib. He highlighted the partnership's role in accelerating the global approval and commercialization of pimicotinib, ultimately bringing new treatment options to patients.

Andrew Paterson, Chief Marketing Officer for the Healthcare business sector of Merck, noted the opportunity to deliver a first-in-class treatment for an underserved patient population in China and potentially beyond. Pimicotinib, a highly selective CSF-1R inhibitor, addresses an unmet medical need, and its development aligns with Merck's strategy to expand its commercial presence in oncology in China.

Pimicotinib, independently developed by Abbisko Therapeutics, holds breakthrough therapy designation and Priority Medicine designation from China NMPA, U.S. FDA, and EMA for treating TGCT patients not amenable to surgery. The drug has shown promising results in a Phase III clinical trial, with an impressive objective response rate (ORR) of 87.5%.

Currently lacking approved treatments in China, TGCT patients face unmet medical needs, and pimicotinib presents a potential solution. Abbisko Therapeutics is actively exploring the drug's clinical potential in various solid tumors, with approved Phase II clinical studies in chronic graft-versus-host disease and advanced pancreatic cancer. Notably, as of the announcement date, no highly selective CSF-1R inhibitor has been approved in China.



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