Merck KGaA has announced a license agreement with Abbisko Therapeutics for pimicotinib (ABSK021), which is currently being evaluated in a late-stage study to treat tenosynovial giant cell tumour (TGCT).
With very limited treatment options available, TGCT is a benign tumour of the joints that can cause swelling, pain, stiffness and limited mobility in the affected areas.
Independently developed by China’s Abbisko, pimicotinib is an orally administered, highly selective and potent small-molecule inhibitor of the colony stimulating factor-1 receptor.
Under the terms of the agreement, Merck will pay an upfront payment totalling £70m to receive an exclusive license to commercialise pimicotinib in China, Hong Kong, Macau and Taiwan and potentially worldwide with an exclusive commercialisation option.
Additionally, Merck will provide Abbisko with an option fee and Abbisko will receive additional payments following the achievement of certain regulatory and commercial milestones, as well as tiered royalties on net sales.
Abbisko will continue to develop the therapy and Merck will have the option to co-develop pimicotinib in additional indications under certain conditions.
The therapy has already received therapy designations from the China National Medical Products Administration and the US Food and Drug Administration, as well as a priority medicine designation from the European Medicines Agency.
The ongoing phase 3 randomised, double-blind placebo-controlled MANEUVER trial is currently evaluating the efficacy and safety of pimicotinib 50mg in patients with unresectable TGCT.
Previously, in a phase 1b study, pimicotinib demonstrated clinically meaningful and sustained anti-tumour activity, with an overall response rate at one-year follow-up of 87.5% among patients receiving the 50mg dose.
Abbisko is also exploring the potential of the therapy for treating other indications, which include multiple types of solid tumours.
Andrew Paterson, chief marketing officer, healthcare business, at Merck, said: “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.”
Dr Xu Yao-chang, chairman at Abbisko, said that the agreement will “[accelerate] the global approval and commercialisation pace of pimicotinib and [strives] to bring new treatment options to patients as soon as possible.”