PALO ALTO, Calif. and TOKYO - BridgeBio Pharma, Inc. (NASDAQ:BBIO) and Kyowa Kirin Co., Ltd (TSE:4151) announced a licensing agreement for the development and commercialization of infigratinib, a drug candidate for skeletal dysplasias including achondroplasia, in Japan. Under the terms of the deal, BridgeBio will receive an upfront payment of $100M and is eligible for royalties and additional milestone payments.
Infigratinib is a once-daily oral medication under development that targets FGFR3-driven skeletal dysplasias at their source. The drug has shown promise in the PROPEL 2 Phase 2 study, demonstrating potentially best-in-class efficacy in children with achondroplasia. The continuation of these trials, PROPEL 3, began globally outside Japan in December 2023.
Kyowa Kirin brings a history of success in bone and mineral diseases to the partnership and will start discussions with Japan's Pharmaceuticals and Medical Devices Agency (PMDA) in 2024, aiming to initiate a Japanese registrational trial in 2025.
Achondroplasia is the most common cause of disproportionate short stature and is characterized by an activating mutation in FGFR3. It affects approximately 55,000 people in the U.S. and EU, and 6,000 in Japan, often leading to serious health complications.
BridgeBio, founded in 2015, specializes in creating medicines for genetic diseases and cancers with clear genetic drivers. Kyowa Kirin focuses on novel medicines with life-changing value, particularly in severe or rare diseases.
The collaboration between BridgeBio and Kyowa Kirin is based on a shared mission to advance treatment options for skeletal dysplasias. This partnership is expected to accelerate the development of infigratinib, potentially providing new treatment options for children with these conditions in Japan.
The information in this article is based on a press release statement.
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