Sanofi has agreed to develop Principia Biopharma’s Bruton’s tyrosine kinase (BTK) inhibitor (PRN2246) for the treatment of multiple sclerosis (MS) and possibly other central nervous system (CNS) diseases.
The deal gives Sanofi an exclusive, worldwide license to develop and commercialize PRN2246, which is presently in clinical development.
Under the deal, Principia will receive $40m upfront payment, future milestone payments that could total $765m and royalties on product sales.
The experimental oral treatment PRN2246 has been designed to access the brain and spinal cord by getting over the blood-brain barrier and affect immune cell and brain cell signaling.
Sanofi MS/Neuroscience therapeutic research area global head Rita Balice-Gordon said: “Our agreement with Principia is an example of Sanofi’s strategic commitment to build our drug discovery and development pipeline in MS and neurological diseases.
“Complementing our own internal R&D expertise, external relationships like this may accelerate delivery of new treatments to patients living with these serious diseases.”
Principia Biopharma CEO Martin Babler said: “Sanofi is an ideal partner for PRN2246. The agreement allows Principia to maximize the BTK opportunity in neurology with a strong partner for PRN2246 while focusing internal resources on our lead BTK inhibitor in another therapeutic area.
“PRN2246 is a blood brain barrier crossing, highly potent BTK inhibitor, that we believe is especially well suited for the treatment of MS and other neurological disorders.”
As per the deal, Principia has been given an option to co-fund phase 3 development of PRN2246. This would be in exchange of increased royalties on global product sales or a profit and loss sharing arrangement in the US.
According to the partners, the license transaction is anticipated to close in Q4 2017, if it can clear customary regulatory approvals.
Principia has used its Tailored Covalency technology to develop a portfolio of drug candidates that exhibit antibody-like specificity to benefit patients with autoimmune and inflammatory diseases and cancer.
The company is currently assessing PRN1008, a reversible covalent BTK inhibitor, in a phase 2 clinical trial in patients with pemphigus, an orphan autoimmune disease.
PRN1371, a covalent FGFR1-4 inhibitor, is currently being evaluated in a phase 1 clinical trial in cancer patients with various solid tumors.
Image: Sanofi headquarters in Paris, France. Photo: courtesy of Sanofi.