Sanofi, Denali Therapeutics Partner in $1-Billion Pact for Neuroscience Drugs
Sanofi and Denali Therapeutics, a San Francisco, California-headquartered biopharmaceutical company developing drugs for treating neurodegenerative diseases, have partnered in a deal worth up to $1 billion ($125 million upfront) to develop multiple molecules for treating neurological and systemic inflammatory diseases.
The two lead molecules (DNL747 and DNL758) target a signaling protein known as the receptor-interacting serine/threonine-protein kinase 1 (RIPK1) in the TNF receptor pathway, which regulates inflammation and cell death in tissues throughout the body, according to information from Sanofi. The companies plan to study DNL747 in multiple sclerosis (MS), Alzheimer’s disease, and amyotrophic lateral sclerosis (ALS), and DNL758 in systemic inflammatory diseases such as rheumatoid arthritis and psoriasis.
Under the agreement, Sanofi will make an upfront cash payment to Denali of $125 million, with future development and commercial milestone payments that could exceed $1 billion. Sanofi and Denali will share commercial profits and losses from DNL747 in the US and China equally while Denali will receive a royalty from Sanofi for other territories for DNL747 and worldwide for DNL758.
Phase Ib and Phase II clinical development costs for DNL747 will be fully funded by Sanofi for MS, ALS, and other neurological indications, except in Alzheimer’s disease, which will be funded by Denali. Phase III trials for all neurological indications will be jointly funded by Sanofi (70%) and Denali (30%). Sanofi will fully fund the clinical development costs for DNL758 in systemic inflammatory diseases. Clinical trials for DNL758 are expected to begin in 2019.
This collaboration also includes additional preclinical RIPK1 inhibitor molecules.
Sanofi says the transaction is expected to close in the coming months in accordance with customary regulatory approvals.