Basilea slots ArQule FGF drug into its cancer portfolio

Derazantinib will head up Basilea's emerging cancer pipeline ahead of former lead BAL101553. (Basilea)(Basilea Pharmaceutica)

Deal-hungry Basilea has extended its cancer pipeline by licensing ArQule’s derazantinib, a phase 2-ready drug that slots in ahead of its in-house oncology programs.

The Swiss specialty pharma has negotiated worldwide rights to fibroblast growth factor (FGF) inhibitor derazantinib (ARQ 087)—except for China, Hong Kong, Macau and Taiwan—in exchange for a $10 million upfront payment and another $326 million in milestones plus royalties.

Derazantinib is in development to treat a form of biliary cancer called intrahepatic cholangiocarcinoma (iCCA), with an ongoing late-stage trial that could potentially support registration, as well as earlier studies in other solid tumors. The drug has orphan status in the U.S. and Europe as an iCCA treatment.

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It becomes Basilea’s third and most advanced cancer candidate, along with microtubule-targeting agent BAL101553, in phase 1/2 for glioblastoma, and panRAF/SRC kinase inhibitor BAL3833 in phase 1 for solid tumors including melanoma. And, according to the Swiss company, it complements a pipeline of cancer drugs focused on tumors with limited therapeutic options, with an emphasis on treatment resistance.

Derazantinib is an ideal match for our existing clinical oncology portfolio, said Basilea CEO Ronald Scott. “It is a targeted therapy building on a solid biomarker approach.” FGF receptor mutations have been linked to various cancers, including between 5% and 30% of bladder, breast, gastric and lung tumors.

For ArQule—trying to move on from the failure of its c-MET inhibitor tivantinib program which consumed its attention for several years—the deal brings a partner with a proven ability to bring specialty drugs through to market, and a good track record of licensing them on to pharma partners.

Basilea has signed a series of business development deals for its two anti-infective products Cresemba (isavuconazole) for fungal infections and Zevtera/Mabelio (ceftobiprole) for resistant bacterial infections, including tie-ups with Pfizer and Astellas, that have helped them get off to a strong start commercially.

Its oncology pipeline is being positioned to provide a “second leg of growth,” according to analysts at Goetz Partners, who expect the drugmaker to follow a similar licensing path with its cancer candidates.