19 April 2018 - - Burlington, Massachusetts-based biopharmaceutical company ArQule, Inc. (NASDAQ: ARQL) has entered into an exclusive license agreement with Basel, Switzerland-based commercial stage biopharmaceutical company Basilea Pharmaceutica International Ltd. (SIX: BSLN) to develop and commercialise derazantinibin globally, excluding the People's Republic of China, Hong Kong, Macau and Taiwan, where Sinovant Sciences Ltd., a Roivant Sciences Ltd. subsidiary, has rights to develop and exclusively commercialise the drug, the company said.
Under the terms of the agreement, ArQule will receive an upfront payment of USD10 m and is eligible for up to USD 326m in regulatory and commercial milestones. ArQule is also entitled to receive staggered single-digit to double-digit royalties on net sales upon commercialization.
Basilea will be responsible for all costs and expenses of development, manufacture and commercialization in its territory.
Under certain circumstances, ArQule may have the opportunity to promote derazantinib in the US directly.
ArQule is currently conducting a registrational trial for derazantinib in the United States, Canada, and Europe as a potential treatment for intrahepatic cholangiocarcinoma (iCCA), a form of biliary tract cancer.
As part of the exclusive license agreement, Basilea intends to continue this trial and the further development of derazantinib in iCCA and other tumor types with FGFR dysregulation.
Derazantinib is a potent, orally administered inhibitor of the fibroblast growth factor receptor family, a key driver of cell proliferation, differentiation, and migration. In a Phase 1/2 study in patients with iCCA harboring FGFR2 gene fusions, treatment with derazantinib resulted in an objective response rate of 21%, nearly 3 times higher than standard-of-care chemotherapy.
ArQule is currently conducting a registrational study with derazantinib in patients with FGFR2 fusion-positive second-line iCCA. The open-label single-arm trial is recruiting in the United States, Canada and Europe with objective response rate as the primary endpoint.
ArQule is engaged in the research and development of targeted therapeutics to treat cancers and rare diseases. The company's mission is to discover, develop and commercialize novel small molecule drugs in areas of high unmet need.
Its clinical-stage pipeline consists of five drug candidates, all of which are in targeted, biomarker-defined patient populations.
Basilea Pharmaceutica is developing products that address the medical challenge of increasing resistance and non-response to current treatment options in the therapeutic areas of bacterial infections, fungal infections and cancer.
With two commercialized drugs, the company is committed to discovering, developing and commercialising innovative pharmaceutical products to meet the medical needs of patients with serious and life-threatening conditions.