Lugano, Switzerland, and Singapore, 04 May 2022 – Juniper Biologics Pte Ltd , a science-led healthcare company focused on researching, developing and commercializing novel therapies,and Helsinn Group, a fully integrated, global biopharma company with a diversified pipeline of innovative oncology assets and strong track-record of commercial execution, announced today 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 (see full list below) 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 rearrangement.
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 2 (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.”
*The full list of countries covered by the license agreement includes: Algeria, Angola, Australia, Bahrain, Brunei, Cambodia, Egypt, India, Indonesia, Ivory Coast, Jordan, Kenya, Kuwait, Laos, Lebanon, Libya, Malaysia, Mauritius, Morocco, Myanmar, Nepal, New Zealand, Nigeria, Oman, Pakistan, Philippines, Qatar, Saudi Arabia, Seychelles, Singapore, South Africa, South Korea, Taiwan, Tanzania, Thailand, Tunisia, Sri Lanka, United Arab Emirates, Vietnam, Zimbabwe.
About Infigratinib
Infigratinib is an orally administered, selective, ATP‐competitive, kinase inhibitor of FGFR 1, 2, and 3. The therapy is currently under investigation as a potential first-line treatment for individuals with unresectable locally advanced or metastatic cholangiocarcinoma (bile duct cancer) with FGFR2 fusion/rearrangement and in the adjuvant setting for individuals with invasive urothelial carcinoma (bladder cancer) with susceptible FGFR3 genetic alterations.
About Cholangiocarcinoma (CCA)
CCA represents an aggressive group of malignancies that form in the bile ducts. Although rare in most countries (with a worldwide estimated incidence of <6 per 100,000 people), the incidence of this malignancy is increasing worldwide. Because the disease is usually asymptomatic at early-stages, diagnosis may be delayed until advanced stages, when CCA typically presents as locally advanced or metastatic disease. Despite continuing advances in treatments, the prognosis for this disease remains poor, with a 5-year survival rate of <20%. FGFR2 genetic alterations are present in approximately 15% to 20% of CCA patients and represent potential targets for treatments.1,2
References
1Banales, J., Cardinale, V., Carpino, G. et al. Cholangiocarcinoma: current knowledge and future perspectives consensus statement from the European Network for the Study of Cholangiocarcinoma (ENS-CCA). Nat Rev Gastroenterol Hepatol 13, 261–280 (2016). https://doi.org/10.1038/nrgastro.2016.51
2Banales, J.M., Marin, J.J.G., Lamarca, A. et al. Cholangiocarcinoma 2020: the next horizon in mechanisms and management. Nat Rev Gastroenterol Hepatol 17, 557–588 (2020). https://doi.org/10.1038/s41575-020-0310-z