TGCT is a benign tumor of the joints that can cause swelling, pain, stiffness, and limited mobility of the affected joints.
Treatment options for this disease, which can seriously affect patients’ quality of life, are very limited.
The agreement grants Merck an exclusive license to commercialize pimicotinib in mainland China, Hong Kong, Macau and Taiwan, with an option for rest of world.
“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 at 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.”
Pimicotinib is an orally administered, highly selective and potent small-molecule antagonist of colony stimulating factor-1 receptor (CSF-1R) currently being evaluated in a phase 3 clinical trial as a potential therapy for TGCT.
No drugs are currently approved in China for the disease, and only one medicine has been approved in the U.S.
However, pimicotinib has been granted breakthrough therapy designation by the China National Medical Products Administration (NMPA) and US Food and Drug Administration (FDA) as well as PRIME Designation by the European Medicines Agency (EMA).
In an earlier study, the drug demonstrated ‘clinically meaningful’ and ‘sustained’ antitumor activity, with an overall response rate at one-year follow-up of 87.5%.
“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 Abbisko’s pipeline in the future,” said Dr. Xu Yao-chang, chairman of Abbisko Therapeutics.
“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.”
In addition to TGCT, Abbisko Therapeutics is also exploring the potential of pimicotinib in treating other indications including many types of solid tumors.
The company also has obtained approval from NMPA to conduct phase 2 clinical studies in chronic graft-versus-host disease and advanced pancreatic cancer.