– Bayer obtains exclusive commercialization rights outside the U.S., where Bayer and Regeneron will share profits
– Regeneron retains full U.S. commercialization rights
TARRYTOWN, NY, USA I January 13, 2014 I Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Bayer HealthCare today announced an agreement to jointly develop an innovative antibody to the Platelet Derived Growth Factor Receptor Beta (PDGFR-beta) as a potential combination therapy with EYLEA® (aflibercept) for the treatment of wet age-related macular degeneration (wet AMD). Preclinical data suggests that combining PDGFR-beta blockade with vascular endothelial growth factor (VEGF) blockade by EYLEA can provide advantages over inhibiting VEGF alone in the treatment of this devastating eye disease. First in human clinical studies are currently planned to begin in early 2014.
“Bayer has been a great collaborator in the development and commercialization of EYLEA outside the U.S.,” said George D. Yancopoulos, M.D., Ph. D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. “We look forward to building on our relationship in ophthalmology with this potential next generation product candidate which will combine Regeneron’s PDGFR-beta antibody and EYLEA in a single intravitreal injection.”
“Given the multi-factorial nature of wet AMD, there is a potential for additional benefits to patients by addressing different pathways responsible for this devastating condition,” said Kemal Malik, M.B., B.S., Member of the Bayer HealthCare Executive Committee and Head of Global Development. “Inhibition of PDGF is one such pathway and we are looking forward to developing a potential combination therapy together with Regeneron. Bayer is strongly committed to expanding its ophthalmology research and development efforts with innovative treatment options and this new development candidate complements our own pipeline perfectly.”
Under the terms of the agreement, Bayer HealthCare will make an upfront payment of $25.5 million to Regeneron and will share global development costs for the program. Bayer HealthCare will have exclusive commercialization rights to the combination product outside the United States where they will share profits from ex-U.S. sales equally with Regeneron. Within the U.S., Regeneron has exclusive commercialization rights and will retain 100 percent of the profits from sales. Under the agreement, Regeneron is eligible to receive up to $40 million in option and milestone payments through regulatory approval from Bayer HealthCare, and Bayer HealthCare is responsible for certain payments due a third party, including royalties on ex-U.S. sales and a share of development milestones.
About Regeneron Pharmaceuticals
Regeneron is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, asthma, and atopic dermatitis. For additional information about the company, please visit www.regeneron.com.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 18.6 billion (2012), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 54,900 employees (Dec 31, 2012) and is represented in more than 100 countries. More information at www.healthcare.bayer.com.
SOURCE: Bayer HealthCare
