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 - Seite 2

“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 our absolute 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.