Arrangement marks Watson’s first in-licensing of a follow-on biologic.

Watson Pharmaceuticals entered an exclusive, worldwide licensing agreement with Itero Biopharmaceuticals to develop and commercialize Itero’s biosimilar for the treatment of female infertility. Recombinant follicle stimulating hormone (rFSH) is currently in preclinical development.

Watson will pay Itero an up-front licensing fee and make additional payments based on the achievement of certain development and regulatory performance milestones. Upon successful commercialization, Itero will also earn a percentage of net sales or net profits in various regions of the world. Watson will assume responsibility for all future development, manufacturing, and commercial expenses.

Watson is currently engaged in the development and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on urology and women’s health.

“Acquiring the rights to Itero’s rFSH product represents our first in-licensing of a biosimilar development project and demonstrates the execution of our plan to build a pipeline of biosimilar products through both internal development and external partnering with high-quality biopharmaceutical companies such as Itero,” says Paul Bisaro, Watson’s president and CEO. “This project will capitalize on the biologics capabilities of our Eden Biodesign group and represents a substantial step in Watson’s goal to build a significant position in the global biopharmaceutical marketplace.”

Founded in 2000, Eden Biodesign is an integrated biopharmaceutical development and manufacturing organization that provides strategic consultancy, process development, cGMP manufacturing, and analytical development services. Eden’s facility, located in Liverpool, U.K., is reportedly custom designed for multiproduct operation and supports the development of biopharmaceuticals from proof-of-concept through to cGMP manufacture for clinical trials, market launch, and commercial supply.

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