WATSON AND ITERO ENTER WORLDWIDE LICENSE AGREEMENT ON BIOLOGIC DEVELOPMENT CANDIDATE
Recombinant Follicle Stimulating Hormone (rFSH) Would Expand Watson's Global Presence in Women's Health
MORRISTOWN, New Jersey and SAN MATEO, California – July 15, 2010 – FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE:WPI - News) today 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.
About Itero Biopharmaceuticals, Inc.
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. The company's management team consists of accomplished executives with extensive development, manufacturing and commercialization experience relating to therapeutic proteins, including monoclonal antibodies. For additional information on Itero Biopharmaceuticals, please visit the company's Web site at http://www.iterobiopharm.com.
About Watson Pharmaceuticals, Inc.
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. Watson has operations in many of the world's established and growing international markets.
In the U.S., the Watson brand portfolio includes RAPAFLO®, GELNIQUE®, Oxytrol®, TRELSTAR® and INFeD®. In addition, Watson markets the following brands under co-promotion agreements: AndroGel®, with Solvay Pharmaceuticals, Inc., and Femring®, with Warner Chilcott Limited. The Watson brand pipeline portfolio includes a number of products, including URACYST®, under development for cystitis; and four novel new contraceptives. All other trademarks are property of their respective owners.
For press release and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.
Statements contained in this press release that refer to non-historical facts are forward-looking statements that reflect Watson’s current perspective of existing information as of the date of this release. It is important to note that Watson’s goals and expectations are not predictions of actual performance. Actual results may differ materially from Watson’s current expectations depending upon a number of factors affecting Watson’s business. These factors include, among others, the difficulty of predicting the timing or outcome of product development efforts, including FDA and other regulatory agency approvals and actions, if any; the impact of competitive products and pricing; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to Watson, its subsidiaries, and its third party manufacturers' facilities, products and/or businesses; changes in the laws and regulations, including Medicare and Medicaid and similar foreign laws, affecting among other things, pricing and reimbursement of pharmaceutical products; and such other risks and uncertainties detailed in Watson’s periodic public filings with the Securities and Exchange Commission, including but not limited to Watson’s annual report on Form 10-K for the year ended December 31,2009 and Watson’s quarterly report on Form 10-Q for the period ended March 31, 2010. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.