Juniper Biologics and Helsinn Group announced the signing of an exclusive license agreement to develop and commercialise infigratinib (INN) in Australia, New Zealand, Southeast Asia and certain markets in the Middle East and Africa, India among others for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma (CCA) with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangements.

In 2021 infigratinib obtained accelerated approval from the U.S. Food and Drug Administration (FDA) under the brand name TRUSELTIQ for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. This indication is based on overall response rate and duration of response. Additionally, infigratinib received conditional approval by Health Canada and provisional approval by the Therapeutics Goods Association in Australia for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or other rearrangement. Continued approval in the U.S., Canada and Australia for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Infigratinib is not FDA-, Health Canada- or Therapeutics Goods Association-approved for any other indication in the United States, Canada and Australia, and is not approved for use by any other health authority.

Raman Singh, CEO of Juniper Biologics, commented: "The acquisition of infigratinib is an important addition to our oncology portfolio and a much-needed treatment for patients whose cancer has spread or cannot be removed by surgery. Our mission is to increase access to proven treatments and we trust that infigratinib will help advance the treatment of patients in markets, where there remains an unmet patient need."

Giorgio Calderari, Helsinn CEO commented: "This agreement with Juniper is another example of our Fully Integrated Targeted Therapy (FITT) Strategy in action as we continue to widen our network of partners for infigratinib. Helsinn's renewed strategic focus is on developing highly innovative oncology assets to address unmet needs, and this license agreement with our trusted partner, Juniper Biologics, will ensure that this important treatment is accessible to patients in Australia, Southeast Asia and certain markets in Middle East and Africa."