RARE Daily

BridgeBio’s QED Therapeutics Enters Blockbuster Partnership with Helsinn for Infigratinib

March 31, 2021

Rare Daily Staff

BridgeBio Pharma affiliate QED Therapeutics and Helsinn Group entered into a global collaboration and licensing agreement with potential value in excess of $2 billion to develop and commercialize QED Therapeutics’ FGFR1-3 inhibitor, infigratinib.

The agreement covers oncology and all other indications except for skeletal dysplasias (including achondroplasia).

Infigratinib is an orally administered, ATP-competitive, tyrosine kinase inhibitor that is designed to inhibit FGFR, and is being investigated for the treatment of individuals with FGFR-driven conditions, including cholangiocarcinoma (bile duct cancer), urothelial carcinoma (urinary tract and bladder cancer), and other FGFR-driven cancers.

Under the terms of the agreement, BridgeBio will be eligible to receive more than $2 billion in upfront, regulatory and commercial milestones, as well as tiered royalties on adjusted net sales from Helsinn Group. QED and Helsinn will co-commercialize infigratinib in oncology indications in the United States and will 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 U.S., excluding China, Hong Kong, and Macau, which are covered by BridgeBio’s strategic development and commercialization collaboration with LianBio.

“Helsinn has an impressive track record of advancing and commercializing oncology therapies around the globe,” said BridgeBio CEO and founder, Neil Kumar. “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 and Helsinn Group intend to pursue an ambitious co-development plan in oncology indications, including clinical investigation underway in first-line cholangiocarcinoma and adjuvant urothelial cancer. This plan will be underpinned by close collaboration among the parties, with the aim of developing new treatments for patients with FGFR-driven cancers.

The FDA has accepted the New Drug Application for infigratinib for patients with previously-treated advanced cholangiocarcinoma harboring an FGFR2 gene fusion or rearrangement. The NDA has been granted Priority Review designation and the application 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, an initiative of the FDA’s Oncology Center of Excellence that allows for concurrent submission and review of oncology drugs among participating international regulatory agencies.

Photo: Neil Kumar, BridgeBio CEO and founder

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