Watson Pharmaceuticals, Inc. announced an exclusive, worldwide licensing agreement with Itero Biopharmaceuticals, Inc., a venture-backed specialty biopharmaceutical company, to develop and commercialize Itero's Recombinant Follicle Stimulating Hormone (rFSH). The product is currently in preclinical development as a biosimilar molecule for the treatment of female infertility.
Under the terms of the agreement, Watson will pay Itero an undisclosed licensing fee and make additional payments based on the achievement of certain development and regulatory performance milestones. Upon successful commercialization, Watson will also pay Itero 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 related to Itero's rFSH product.
"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," said Paul Bisaro, Watson's president and CEO. "This project will capitalize on the world-class 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."
"Our agreement with Itero also represents continued delivery on our commitment to expand our brand product pipeline with distinctive product opportunities in the growing women's health market," said Watson's Fred Wilkinson, Watson's executive vice president, global brands. "The Eden and Brand research and development teams will manage the development activities, and if we are successful, the Brand commercial organization will add another major product to our portfolio."
"We are excited to partner with an industry leader in women's health to complete the development and commercialization of our first biologic asset. Watson has a strategic focus on growing its women's health business and this product targets the expanding $1.2 billion infertility segment of this market," said V. Bryan Lawlis, Ph.D., president and CEO of Itero Biopharmaceuticals. "Itero has created significant value in our rFSH program in just two years, and this collaboration validates our business strategy and capabilities for the cost efficient development of protein therapeutics. Moreover, it gives Itero the resources to further pursue the development of additional biopharmaceutical products and partnering activities."
Development of the product will be managed by Watson's Eden Biodesign biologics unit in collaboration with the Brand research and development team. Founded in 2000, Eden Biodesign is an integrated biopharmaceutical development and manufacturing organization that provides strategic consultancy, world-class process development, cGMP manufacturing and analytical development services for every significant biopharmaceutical product technology. Eden's state-of-the-art facility, located in Liverpool, UK, is custom designed for multi-product operation and supports the development of biopharmaceuticals from proof-of-concept through to cGMP manufacture for clinical trials, market launch and commercial supply.
Itero Biopharmaceuticals, Inc. is a San Mateo, California-based specialty biopharmaceutical developer focused on clinically and commercially differentiated protein therapeutics. Itero leverages strategic collaborations to provide capital efficient process and manufacturing development as well as global clinical development and commercialization.
Watson Pharmaceuticals, Inc. is a leading global specialty pharmaceutical company. The company is engaged in the development and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on urology and women's health.