Kyowa Kirin’s dealmaking continued on Wednesday when BridgeBio Pharma granted the Japanese company an exclusive license to develop and commercialize infigratinib.
Pictured: A sign inside of Kyowa Kirin headquarters/Image courtesy of company
Kyowa Kirin is paying $100 million upfront to secure the exclusive rights to develop and commercialize BridgeBio Pharma’s infigratinib for skeletal dysplasias in Japan, the companies announced Wednesday.
The small oral molecule inhibits FGFR3 and is designed to treat achondroplasia, hypochondroplasia, and other skeletal dysplasias. The drug was given an accelerated approval by the FDA in 2021.
Under the deal, BridgeBio will receive the upfront payment, royalty payments in the high 20% range on sales of infigratinib in Japan, as well as the possibility of netting other milestone-based payments.
“It is important for us to strengthen our portfolio by introducing pipelines in bone and mineral disorders, including achondroplasia. Based on the results from the latest clinical trials, we believe BridgeBio’s infigratinib has a high potential for treating achondroplasia,” Yasuo Fujii, chief strategy officer, managing executive officer, vice president, and head of the strategy division at Kyowa Kirin, said in a statement.
“We will steadily advance the development in Japan and aim to deliver life-changing value to people with skeletal dysplasias, including achondroplasia,” Fujii added.
The drug is currently in Phase III investigating efficacy and safety for achondroplasia patients aged three to less than 18 years, with the first patients being dosed in December 2023. A Phase II trial showed infigratinib in achondroplasia patients having a 3.38cm/yr increase in annualized height velocity, which BridgeBio touts as one of its “strongest clinical results” published to date.
On the regulatory front, Kyowa Kirin is beginning discussions with Japan’s Pharmaceuticals and Medical Devices Agency this year and will seek to start a Japanese registrational trial sometime in 2025.
“By partnering with Kyowa Kirin, we hope to significantly accelerate the development of infigratinib to potentially provide options for children with achondroplasia, hypochondroplasia, and eventually skeletal dysplasias in Japan. We hear the need from the community for a once-daily oral treatment option and are looking forward to initiating our trials in Japan at a later date,” Justin To, CEO of QED Therapeutics, BridgeBio’s affiliate for skeletal dysplasias, said in a statement.
Kyowa Kirin has recently been in a dealmaking mood, with the acquisition of Orchard Therapeutics completed last month. In October 2023, the Japanese pharma purchased Orchard for $478 million as it awaits a March 2024 PDFUA date for its pediatric gene therapy Libmeldy.
Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.
