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news.Helsinn Group has announced an update to its existing collaboration with BridgeBio Pharma to develop, produce and commercialise infigratinib for oncology indications in the US.
Helsinn will develop, produce, and commercialise the therapy across the world in oncology indications. Credit: National Cancer Institute on Unsplash.
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As per the terms of the updated and restated deal, Helsinn will obtain an exclusive license for infigratinib commercialisation in the US.
The company will also develop, produce, and commercialise the therapy across the world in oncology indications except for achondroplasia or any other skeletal dysplasias.
It will exclude Hong Kong, mainland China, and Macau.
Helsinn will make commercial and regulatory milestone payments along with tiered royalties on adjusted net sales to BridgeBio.
Additionally, BridgeBio will retain the rights for the development, production, and commercialisation of infigratinib in skeletal dysplasia, including achondroplasia.
Helsinn and BridgeBio signed a global license and collaboration agreement in March last year for co-commercialising the therapy for oncology in the US.
The deal also included co-development, production and marketing of infigratinib for such indications outside the US, except in Hong Kong, mainland China, and Macau.
Last year, the companies secured accelerated approval from the US Food and Drug Administration (FDA) for Truseltiq (infigratinib) to treat adult patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.
They have also obtained provisional approval from the Therapeutics Goods Association in Australia and conditional approval from Health Canada for Truseltiq for the same indication.
BridgeBio founder and CEO Neil Kumar said: “We are expanding our partnership with Helsinn so that even more patients with FGFR-driven cancers will ultimately be able to access infigratinib. Focused execution means reducing the scope of our internal activity.
“We will continue to advance high-quality programs in our pipeline, while allowing Helsinn to develop and commercialize infigratinib in cancer indications for patients in need.”
Previously, the company partnered with LianBio to develop and commercialise infigratinib for oncology in Macau, Hong Kong, and mainland China.
