Shionogi & Co., Ltd. and QuatRx Pharmaceuticals Company, a privately-held pharmaceutical company, today announced that they have entered into a worldwide license agreement to develop and market ospemifene, a selective estrogen receptor modulator ("SERM").
Under the terms of this agreement, Shionogi will have worldwide marketing rights to ospemifene. QuatRx will receive an up-front payment of $25 million and is eligible to receive in excess of $100 million in development and regulatory milestone payments. QuatRx will also be eligible to receive additional payments for approval of ospemifene outside the US as well as sales milestones and royalties on product sales. A New Drug Application ("NDA") with the FDA is planned to be filed in 2010 for ospemifene for the treatment of post-menopausal vulvovaginal atrophy ("VVA"), utilizing the Phase 3 clinical trials that were conducted by QuatRx.
Patrick Fourteau, President and CEO of Shionogi Pharma, Inc., a US-based group company of Shionogi, said, "All of us at Shionogi are excited about the potential of ospemifene and, upon FDA approval, we look forward to bringing the first non-estrogen treatment option to millions of women in the US who are living with post-menopausal vulvovaginal atrophy. Our efforts to market ospemifene represent an important step in our strategy to further diversify Shionogi Pharma's Women's Health portfolio and broaden the Company's R&D pipeline."