BridgeBio Pharma and Kyowa Kirin Announce Partnership with an Upfront Payment of $100 Million for an Exclusive License on Infigratinib in Skeletal Dysplasias in Japan
- BridgeBio grants Kyowa Kirin exclusive license to develop and commercialize infigratinib for skeletal dysplasias in Japan
- BridgeBio to receive upfront payment of USD 100 million with royalties up to the high-twenties percent, with additional milestone-based payments
- Infigratinib is a once daily oral treatment option under development for achondroplasia, which was well-tolerated and demonstrated potentially best-in-class efficacy in PROPEL 2, a Phase 2 study in children with achondroplasia
- PROPEL 3, a Phase 3 study of infigratinib in achondroplasia is underway globally outside of Japan with the first child dosed in December 2023
- Infigratinib adds to Kyowa Kirin’s successful portfolio in the therapeutic areas of bone & mineral diseases
PALO ALTO, Calif. and TOKYO, Feb. 07, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio) and Kyowa Kirin Co., Ltd (TSE:4151) (Kyowa Kirin) today announced a partnership wherein BridgeBio’s affiliate, QED Therapeutics, grants Kyowa Kirin an exclusive license to develop and commercialize infigratinib for achondroplasia, hypochondroplasia, and other skeletal dysplasias in Japan. In exchange, BridgeBio will receive an upfront payment of USD 100 million as well as royalties up to the high-twenties percent on sales of infigratinib in Japan, with the potential for additional milestone-based payments. Infigratinib is an oral small molecule designed to inhibit FGFR3 and thus target FGFR3-driven skeletal dysplasias at their source, including achondroplasia and hypochondroplasia.
“We are pleased to partner with Kyowa Kirin given their community-oriented core mission to bring smiles to faces by providing innovative medicines with life-changing value, which has seen success with their commercialization of Crysvita and other rare disease drugs. The BridgeBio vision is to help bring people access to novel treatments and trials, and so we are pleased that this collaboration will ensure the development of infigratinib for children living with achondroplasia, and eventually for other skeletal dysplasias in Japan,” said Neil Kumar, Ph.D., BridgeBio’s CEO and founder.
“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,” said Justin To, CEO of QED Therapeutics, BridgeBio’s affiliate for skeletal dysplasias.
“We are thrilled to announce that we have signed the License Agreement with BridgeBio,” said Yasuo Fujii, MBA., Chief Strategy Officer, Managing Executive Officer, Vice President, Head of Strategy Division at Kyowa Kirin. “It is important for us to strengthen our portfolio by introducing pipelines in the fields of bone & mineral disorders, including achondroplasia. Based on the results from the latest clinical trials, we believe BridgeBio’s infigratinib has high potential for treating achondroplasia. We will steadily advance the development in Japan and aim to deliver life-changing value to people with skeletal dysplasias including achondroplasia.”
In December 2023, BridgeBio dosed the first child in PROPEL 3, a one-year, 2:1 randomized, placebo-controlled Phase 3 pivotal trial, evaluating the efficacy and safety of infigratinib in children with achondroplasia aged 3 to <18 years with open growth plates. The Phase 3 builds on the success of PROPEL 2, a Phase 2 trial of infigratinib in achondroplasia which demonstrated a +3.38cm/yr increase in annualized height velocity, the strongest clinical result published to date. In Japan, Kyowa Kirin will start to discuss with Pharmaceuticals and Medical Devices Agency (PMDA) of Japan in 2024, with the aim of initiating a Japanese registrational trial in 2025.
“As the father of a child with achondroplasia, I am keenly aware of the health and mental health issues of people affected by the physical characteristics of living with achondroplasia. GLORY TO ACHONDROPLASIA is deeply grateful for the time spent by researchers and practitioners who support progress in medicine and society, as well as by people affected by the condition and their families. When considering the future of children with achondroplasia, we as a support organization believe it is ourabsolute responsibility to improve treatment options and social recognition. We are pleased for BridgeBio to partner with Kyowa Kirin and look forward to collaborating on our future responsibilities,” said Eihaku Itooka, founder and president of GLORY TO ACHONDROPLASIA, a Japanese bone dysplasia patient advocacy organization.
Information about PROPEL 3 (NCT06164951) can be found here on clinicaltrials.gov. Additionally, BridgeBio expects to initiate ACCEL, an observational lead-in study for infigratinib in hypochondroplasia, a skeletal dysplasia closely related to achondroplasia and similarly driven by FGFR3 gain-of-function variants, in the first half of 2024. BridgeBio has previously presented promising preclinical data for hypochondroplasia at ENDO 2023 and ASHG 2022.
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