Sanofi and Regeneron Pharmaceuticals have signed a new collaboration to develop and commercialize novel antibody cancer treatments in immuno-oncology. Under this agreement, the newly partnered companies will advance a programmed cell death protein 1 (PD-1) inhibitor, which is currently undergoing Phase I studies, with a projected plan to launch clinical trials in 2016.
“The field of immuno-oncology has shown the potential to dramatically improve outcomes for patients with certain types of cancer. However, the field is still in its very early days,” said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer, Regeneron and President, Regeneron Laboratories. “We believe the approaches most likely to deliver the best results to patients will combine multiple innovative therapies acting on different pathways and targets both in the tumor and the body’s immune response – and will precisely target these medicines to the right patient. The efficiency and power of our suite of technologies, such as VelocImmune® and VelociGene®, combined with our human genetics capabilities, uniquely positions the Sanofi-Regeneron Alliance to accelerate the development of potential new immuno-oncology treatment options for cancer patients.”
According to the terms of the agreement, Regeneron will be entitled to an upfront payment of $640 million, with both companies investing $1 billion in the discovery through proof of concept development of monotherapy and new combinations of immuno-oncology antibody products, to be financed 25% by Regeneron and 75% by Sanofi.
Sanofi will also pay Regeneron a one-time milestone fee worth $375 million if the sales of a PD-1 candidate and any other product of the collaboration exceed $2 billion within a 12-month period. The companies have also agreed to devote $75 million for immuno-oncology antibodies from Sanofi’s $160 million yearly contribution as stipulated in the original collaboration, announced November 2009.
“The Sanofi-Regeneron Alliance has demonstrated its ability to translate cutting-edge science into groundbreaking medicines for patients with serious needs,” said Elias Zerhouni, M.D., President, Global R&D, Sanofi. “With more than eight years of successful collaboration between us, I am confident in our ability to advance these novel programs. In addition to PD-1, the collaboration brings together a range of validated, innovative preclinical programs that have unique potential to help patients either as monotherapy or in combination approaches.”
“Despite many advances over the last decades, cancer remains a leading cause of death and suffering around the world,” said Israel Lowy, M.D., Ph.D., Vice President Clinical Sciences, Head of Translational Science and Oncology, Regeneron. “Although initial advances with immuno-oncology have helped certain patients, there is a tremendous opportunity to further unlock the potential of this new approach to help even greater numbers of people living with cancer.”
Further details of the agreement between the two companies are as follows:
- Regeneron will be responsible for discovery, antibody generation and development through POC, at which time Sanofi will have the ability to opt-in for further development and commercialization. In the existing antibody collaboration, Sanofi has the opportunity to opt-in at the time of an Investigational New Drug application (IND).
- The companies will alternate serving as the lead development and commercialization organization after Sanofi opts-in to an antibody program.
- For programs where Regeneron is the lead, including REGN2810, Regeneron will serve as the U.S. commercial lead, including recording U.S. sales, and the companies will equally fund post-POC development. Sanofi will record sales and serve as the commercial lead for all countries outside the U.S. Sanofi will retain the right to co-promote in the U.S. and Regeneron will retain the right to co-promote outside the U.S.
- For programs where Sanofi is the lead, Sanofi will serve as the U.S. commercial lead and fund 100 percent of post-POC development, with Regeneron reimbursing up to 50 percent of such costs through the IO collaboration development balance, which represents the amount of development funding that Regeneron is obligated to repay out of its share of profits as described below. Sanofi will record sales and serve as the commercial lead for all countries outside the U.S. Regeneron will retain the right to co-promote in the U.S. and outside the U.S.
- Sanofi and Regeneron will share equally in worldwide profits from sale of collaboration immuno-oncology antibodies.
- As in the existing antibody agreement, Regeneron will repay the immuno-oncology collaboration development balance from its share of overall profits of the immuno-oncology antibodies, in an annual amount equal to 10 percent of the Regeneron share of profits.
This partnership will proceed for the next 5 years, with an option to renew the contract for specific research programs for another 3 years.