Janssen, BeiGene enter in-licensing agreement for two clinical-stage oncology compounds

BeiGene, Ltd., today announced that it has entered into exclusive in-licensing and co-development agreements with Janssen Pharmaceutica NV and its affiliates ("Janssen") for two clinical-stage oncology compounds. Under the terms of the agreement, BeiGene will in-license intetumumab (CNTO-95) for clinical development and commercialization within Australia, China, Hong Kong, New Zealand, Korea, Singapore and Taiwan. It will engage in a global co-development program with Janssen for intetumumab in multiple cancer indications and receive a royalty on global sales outside of these regions. BeiGene will in-license MTKi-327 and retain global rights for development and commercialization for human pharmaceutical uses. BeiGene is making an undisclosed upfront payment to Janssen for in-license of MTKi-327. As BeiGene and Janssen are entering into a co-development of intetumumab, no upfront licensing payment from BeiGene is involved, however, both parties will share in the development costs. Furthermore, Janssen is eligible for milestone and royalty payments from BeiGene for MTKi-327. For intetumumab, Janssen and BeiGene are each responsible for royalty obligations to each other based on sales in their respective territories.

Intetumumab is a fully humanized monoclonal antibody against α_v integrins that binds to human integrins, including α_vβ₃, α_vβ₅, α_vβ₁, and α_vβ₆, and blocks their interactions with the extracellular matrix resulting in inhibition of angiogenesis and disrupted tumor cell growth, development and metastases. Previously Janssen completed phase I and phase II clinical trials with intetumumab in melanoma, prostate cancer, and solid tumors. BeiGene will collaborate with Janssen in phase III clinical trials in melanoma and explore additional solid tumor indications in solid tumors prevalent in China and Asia.

MTKi-327 is a novel macrocyclic multi-targeted kinase inhibitor with potent inhibitory activity against several tyrosine kinases such as EGFR, erbB2, erbB4, VEGFR3, Ret, Ack-1, and Yes. Its pharmacological profile from preclinical studies based on in vitro, cell-based and animal xenograft studies suggests that MTKi-327 inhibits directly tumor growth as well as prevents tumor invasion and metastases by interfering with cancer cell motility and tumor-associated lymphangiogenesis. Phase I clinical trials in cancer patients have been conducted by Janssen.

"We are extremely excited to progress these two promising compounds in clinical trials and delighted to be able to initiate a co-development program with intetumumab," said Peter Ho, M.D.-Ph.D., President and co-founder, BeiGene. "Both intetumumab with its encouraging data from phase II clinical trials and MTKi-327, an inhibitor of several critical cancer signaling pathways, represent promising molecules that have great potential to address the unmet medical needs of oncology patients in China and the Asia-Pacific region."

"We look forward to working with Janssen as a strategic collaborator as we strive to build world-class oncology capabilities in China," said John Oyler, Chief Executive Officer and co-founder, BeiGene.