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Juniper Biologics to Sell Helsinn's Truseltiq in Certain Asia-Pacific, Africa, Middle East Markets

NEW YORK – Juniper Biologics on Wednesday said it has signed an exclusive licensing agreement with Helsinn Group to develop and commercialize Truseltiq (infigratinib) in Australia, New Zealand, Southeast Asia, and parts of the Middle East and Africa as a treatment for FGFR2-rearranged advanced cholangiocarcinoma.

The US Food and Drug Administration granted accelerated approval to Helsinn and BridgeBio Pharma's application for Truseltiq in 2021 alongside a companion diagnostic from Foundation Medicine to identify treatment-eligible cholangiocarcinoma patients with FGFR2 fusions and other rearrangements. The approval was based on a Phase II trial showing an objective response rate of 23 percent and a median duration of response of five months in about 100 previously treated patients on Truseltiq.

Helsinn, which is headquartered in Switzerland, signed a licensing agreement with QED Therapeutics, a subsidiary of BridgeBio, in March 2021 to codevelop and co-commercialize Truseltiq in the US. BridgeBio then partnered with Shanghai-based LianBio to develop and commercialize the drug in China, Hong Kong, and Macau.

In December, following Canadian approval of Truseltiq, Helsinn signed an exclusive licensing deal with Ontario-based Xediton Pharmaceuticals for distribution and marketing of the drug in that country.

The latest deal with Singapore-headquartered Juniper will make Truseltiq available to patients with bile duct cancer in 40 additional countries. Juniper markets a portfolio of medicines for nausea, vomiting, and wasting in cancer patients and a cell-mediated gene therapy product for osteoarthritis.