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Helsinn Group Licenses Truseltiq to Xediton Pharmaceuticals for Sale in Canada

NEW YORK – Swiss drugmaker Helsinn Group on Monday said it has inked an exclusive licensing and distribution deal with Xediton Pharmaceuticals in Canada to provide infigratinib (Truseltiq) to advanced cholangiocarcinoma patients with FGFR2 fusions or other rearrangements.

Under terms of the deal, Helsinn granted Ontario-based Xediton an exclusive license to distribute, promote, market, and sell infigratinib in Canada. Helsinn will supply the drug for commercialization in the country.

"We believe Truseltiq and its imminent launch will fill a gap in the much-needed therapy for cancer patients," Xediton President George Gafrey said in a statement.

Infigratinib was recently approved under Health Canada's Notice of Compliance with Conditions policy as a treatment for previously treated adults with FGFR2-rearranged unresectable, locally advanced, or metastatic bile duct cancer. The US Food and Drug Administration in May approved infigratinib for the same indication. The drug was reviewed by Canadian regulators within Project Orbis, an FDA-led program that facilitates collaboration between regulators in multiple countries with the goal of expediting access to innovative treatments around the world.

The regulators reviewed data from a Phase II trial involving around 100 previously treated cholangiocarcinoma patients, most of whom had stage IV disease. The objective response rate was 23 percent, and the median duration of response was five months.