Helsinn Group and BridgeBio Amend Infigatinib Strategic Compact
Under the terms of the amended and restated agreement, Helsinn will obtain an exclusive license to commercialize infigratinib in the United States and will be responsible for the development, manufacturing and commercialization of infigratinib in oncology indications worldwide , excluding achondroplasia or any other skeletal dysplasia and excluding mainland China. , Hong Kong and Macau.
BridgeBio will be eligible to receive regulatory and commercial milestone payments as well as tiered royalties on Helsinn’s adjusted net sales. BridgeBio will retain all development, manufacturing and commercialization rights to infigratinib in skeletal dysplasia, including achondroplasia.
In 2021, Helsinn and BridgeBio secured accelerated approval for TRUSELTIQ (infigratinib) from the United States Food and drug administration ( FDA ) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with fibroblast growth factor receiver 2 (FGFR2) fusion or other rearrangement detected by an FDA-cleared test. Additionally, both parties have received conditional approval from Health Canada and tentative approval from the Therapeutics Goods Association in Australia for TRUSELTIQ (infigratinib) for the treatment of adults with previously treated locally advanced or metastatic cholangiocarcinoma, not resectable with an FGFR2 fusion or other rearrangement. Continued approval in the United States, Canada and Australia for this indication may depend on confirmatory trials.
Infigratinib is not approved by the FDA, Health Canada, or Therapeutics Goods Association for any other indication in the United States, Canada, and Australia, nor is it approved for use by any other health authority.
Giorgio Calderari, CEO of Helsinn Group, said: “We are delighted to obtain the exclusive license to commercialize infigratinib in the United States. This perfectly complements our recently announced Fully Integrated Targeted Therapy (FITT) strategy and will utilize our unique capabilities and expertise to advance products through development. and cancer patients around the world. BridgeBio is a great partner, and we look forward to continuing our relationship with them through our non-exclusive collaborative framework to provide co-development and co-commercialization opportunities for precision oncology preclinical programs.
“We are expanding our partnership with Helsinn so that even more patients with FGFR-induced cancers can ultimately access infigratinib. Targeted execution means reducing the scope of our internal activity. We will continue to advance high-quality programs in our pipeline, while enabling Helsinn to develop and commercialize infigratinib in cancer indications for patients in need,” said Neil Kumar, Ph.D. , founder and CEO of BridgeBio.