BridgeBio Pharma will join with Swiss pharma Helsinn Group to co-develop and commercialize infigratinib (BGJ398) in oncology and other indications except achondroplasia and other skeletal dysplasias, through a partnership that could generate up to approximately $2.45 billion for BridgeBio.

Under the companies’ global collaboration and licensing agreement, Helsinn and BridgeBio will partner on infigratinib, an FGFR1-3 inhibitor that is the sole pipeline candidate of BridgeBio affiliate, QED Therapeutics. Infigratinib is an oral ATP-competitive, tyrosine kinase inhibitor designed to inhibit FGFR.

Infigratinib is under study as a potential treatment of patients with FGFR-driven conditions, including cholangiocarcinoma (bile duct cancer), urothelial carcinoma (urinary tract and bladder cancer), and other FGFR-driven cancers.

BridgeBio and Helsinn Group said they intend to pursue an ambitious co-development plan in oncology indications, including clinical investigation underway in first-line cholangiocarcinoma and adjuvant urothelial cancer.

As infigratinib heads toward potential approval and commercialization in a range of oncology indications, the companies said, Helsinn will distribute the drug globally through its licensing business model, which includes long-standing partners in 190 countries.

QED and Helsinn have agreed to co-commercialize infigratinib in oncology indications in the United States, as well as share profits and losses on a 50:50 basis. Helsinn will have exclusive commercialization rights and lead commercialization for infigratinib in non-skeletal dysplasia indications outside of the United States, except in China, Hong Kong, and Macau, where Shanghai-based LianBio has licensed rights to the drug from BridgeBio through a strategic development and commercialization collaboration.

$100M+ upfront

In return, Helsinn agreed to pay BridgeBio up to $2.45 billion—including more than $100 million in upfront, regulatory, and launch milestone payments. The remaining payments would be tied to achieving specified commercial milestones, as well as tiered royalties in the high teens as a percentage of adjusted net sales by Helsinn of the licensed products sold worldwide, outside of the United States and Greater China.

“Our hope is that partnering with Helsinn will significantly strengthen our anticipated upcoming launch of infigratinib and our ongoing research into infigratinib’s potential across other cancer indications,” BridgeBio CEO and founder Neil Kumar, PhD, said in a statement.

Privately-held Helsinn bases its Helsinn Healthcare pharmaceutical business in Lugano, Switzerland, with operating subsidiaries in the United States and China. Helsinn Healthcare specializes in developing and marketing cancer and rare disease therapies.

“The combination of BridgeBio and its lead oncology product candidate, infigratinib, fall into the strategic sweet spot of a quality company and product with which we look to work,” added Riccardo Breglia, Helsinn Group vice chairman.

The collaboration comes as the FDA is reviewing an NDA for infigratinib in patients with previously treated, FGFR-mutant cholangiocarcinoma (bile duct cancer). The NDA has been granted the FDA’s Priority Review designation, and is being reviewed under the Real-Time Oncology Review (RTOR) pilot program, an initiative of the FDA’s Oncology Center of Excellence designed to expedite the delivery of safe and effective cancer treatments to patients.

Infigratinib is also under review in Australia and Canada under Project Orbis, another initiative of the FDA’s Oncology Center of Excellence that is designed to allow for concurrent submission and review of oncology drugs among participating international regulatory agencies.

Infigratinib represents BridgeBio’s second NDA acceptance; the first was its NDA for fosdenopterin in molybdenum cofactor deficiency (MoCD) Type A in September 2020.