Helsinn And BridgeBio Ink Infigratinib Cancer Pact
Duo Will Co-develop And Commercialise FGFR1-3 inhibitor In Oncology
Executive Summary
Helsinn’s strategic collaboration with BridgeBio Pharma to co-develop and commercialise candidate FGFR1-3 inhibitor infigratinib in oncology will give the Swiss family-owned company its first targeted cancer therapeutic for the US market, its CEO tells Scrip.
Switzerland-based Helsinn Group hopes to market its first targeted cancer therapy in the US though a newly agreed global collaboration and licensing pact with BridgeBio Pharma, Inc. to jointly develop and commercialize the latter’s FGFR1-3 inhibitor, infigratinib.
Under the collaboration, announced 31 March, BridgeBio’s affiliate QED Therapeutics and Helsinn plan to co-commercialize infigratinib for oncology and all other indications other than skeletal dysplasias in the US and split the profits equally. QED will retain full rights to infigratinib for use in skeletal dysplasias, including achondroplasia.
Helsinn CEO Riccardo Braglia hopes infigratinib will open a new chapter for the group, which began life in Braglia’s grandfather’s garage in the late 1940s and was formally founded in 1976.
“This deal is very important for Helsinn because it confirms our strategy going forward which is to focus on targeted cancer therapies,” the CEO explained to Scrip.
Infigratinib is currently being considered by the US Food and Drug Administration as a potential treatment for patients with FGFR-altered cholangiocarcinoma, or bile duct cancer. The FDA has granted it a priority assessment under the agency's real-time oncology review pilot program, designed to expedite cancer treatment approvals.
When submitting that New Drug Application last December, QED said it would provide data from a Phase III clinical trial, in which up to 384 patients with FGFR2 fusion-positive cholangiocarcinoma will be randomized to receive either infigratinib or chemotherapy as a first-line option.
An earlier Phase II study assessing infigratinib showed an overall response rate of 27% in bile duct cancer patients who had FGFR2 fusion-positive tumors and had progressed on chemotherapy.
“The FDA PDUFA date for infigratinib is in May and we are very optimistic ahead of that,” said Helsinn CEO Riccardo Braglia. (Also see "BridgeBio’s Hub-And-Spoke Model: An Interview With Cameron Turtle" - Scrip, 1 Mar, 2021.) The orally administered tyrosine kinase inhibitor, designed to inhibit fibroblast growth factors and their receptors (FGFRs), is also being investigated for treatment of individuals with other FGFR-driven conditions, including urinary tract and bladder cancer. “So we hope to develop infigratinib further in the next year or two,” he told Scrip.
Under the agreement, BridgeBio will be eligible to receive more than $2bn in upfront, regulatory and commercial milestones, as well as tiered royalties on adjusted net sales from Helsinn Group. No further details were given
“BridgeBio are interested in rare diseases, so they’ll retain full rights to infigratinib for use in skeletal dysplasias, including for achondroplasia. Our strengths[at Helsinn] lie in cancer drugs and supportive care. So together, we are a perfect fit,” Braglia said.
The family-owned group’s business model is based on four pillars: in-licensing, developing products and obtaining marketing authorization in international markets, and out-licensing products through a network of partners worldwide, as well as direct sales in the US since 2013. The firm’s main business areas have hitherto been cancer supportive care, pain and inflammation, and gastroenterology.
The plan is for QED and Helsinn to co-commercialize infigratinib in oncology indications in the US, sharing profits and losses equally.
Helsinn will have exclusive commercialization rights and lead commercialization for infigratinib in non-skeletal dysplasia indications outside of the US, excluding China, Hong Kong and Macau, which are covered by BridgeBio’s strategic development and commercialization collaboration with LianBio.