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Abbisko Therapeutics Announced the Entry into a Licensing Agreement for Pimicotinib (ABSK021) with Merck

Dec 05,2023
By Abbisko

On 4 Dec. 2023, Abbisko Therapeutics announced that it has entered into a licensing agreement with Merck, a leading science and technology company headquartered in Darmstadt, Germany. Under the terms of the agreement, Merck will be granted an exclusive license to commercialize products comprising or containing pimicotinib (ABSK021) for all indications in Chinese mainland, Hong Kong, Macau and Taiwan (the “Licensed Territory”), and Abbisko Therapeutics will retain the exclusive rights to develop pimicotinib within the Licensed Territory. Abbisko Therapeutics has also granted Merck an exclusive option for global commercial rights of pimicotinib, subject to the terms and conditions as agreed between the parties (the“Global Commercialization Option”). In addition, Merck has the option to co-develop pimicotinib in additional indications under certain conditions.

Pursuant to the License Agreement, Abbisko Therapeutics will receive a one-time, non-refundable down payment of US$ 70 million. In the event that Merck exercises the Global Commercialization Option, Merck will pay Abbisko Therapeutics an additional option exercise fee. The aggregate amount of upfront payment, exercising payment, and development and commercialization milestone adds up to US$ 605.5 million, plus a double-digit percentage (%) royalty on actual annual net sales.

Dr. Xu Yao-chang, Chairman of Abbisko Therapeutics, said that “The collaboration with Merck is an important milestone in advancing the global commercialization process of pimicotinib, and provides a new model for the commercialization path of the company's pipeline in the future. We are pleased to collaborate with a leading multinational pharmaceutical company, jointly accelerating the global approval and commercialization pace of pimicotinib, and striving to bring new treatment options to patients as soon as possible.”

“We have the opportunity through our partnership with Abbisko to deliver a first-in-class treatment for a critically underserved patient population in China and potentially beyond,” said Andrew Paterson, Chief Marketing Officer for the Healthcare business sector of Merck. “Pimicotinib provides an opportunity to address a significant unmet medical need and for us to expand our commercial footprint in oncology in China, the second largest pharmaceutical market in the world.”

About Pimicotinib (ABSK021)

Pimicotinib is a novel, orally available, highly selective, and potent small molecule CSF-1R inhibitor, independently developed by Abbisko Therapeutics. It has been granted the breakthrough therapy designation (BTD) and Priority Medicine (PRIME) designation by China NMPA, U.S.FDA, and EMA for the treatment of TGCT patients that are not amenable to surgery. The study is the first global Phase III clinical trial of TGCT conducted simultaneously in China, the U.S., Canada and Europe.

Upon 1-year follow-up, striking improvement in efficacy has been observed with pimicotinib treatment and results were presented at CTOS in November of 2023, with an ORR of 87.5% (28/32, including 3 CR) in the 50 mg QD cohort. The Phase I dose-escalation trial for pimicotinib has been completed in the United States previously.

There is currently no approved drug available in China for TGCT patients, and only one drug has been approved in the U.S.. However, it is only available through the Risk Evaluation and Mitigation Strategy (REMS) Program which is a restricted procedure due to the potential liver injuries it may cause. There are unmet medical needs of TGCT patients in China, the U.S., and Europe.

Abbisko Therapeutics is also actively exploring the clinical potential of pimicotinib in many types of solid tumors, and has obtained approval from NMPA to conduct a Phase II clinical study in chronic graft-versus-host disease and a Phase II clinical study in advanced pancreatic cancer.

As of the date of this announcement, no highly selective CSF-1R inhibitor has been approved in China.

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