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 U.S. 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 U.S.-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 U.S. 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.”
Ospemifene is a SERM designed to mimic the positive effects of estrogen on the vaginal epithelium while avoiding estrogen stimulation of breast and other tissues. In September 2009, QuatRx announced the results of a second pivotal Phase 3 study for ospemifene. The results showed highly statistically significant positive results in four co-primary endpoints (p?0.0001), including a decrease in percentage of parabasal cells and an increase in percentage of superficial cells from the vaginal smear, decrease in vaginal pH and improvement in the patient’s most bothersome moderate to severe symptom of dyspareunia. The first Phase 3 trial for ospemifenemet all the co-primary endpoints at a 60 mg dosage, with statistically significant improvements in vaginal dryness and dyspareunia, as well as statistically significant improvement in the proportion of parabasal and superficial cells in the epithelium of vaginal walls and a decline in vaginal pH levels. Data from the long term safety studies demonstrated that daily doses of 60 mg of ospemifeneare well-tolerated.
Robert L. Zerbe M.D., CEO and Co-Founder of QuatRx, said, “QuatRx is very pleased to have completed the comprehensive development program for ospemifene. Pending regulatory approval, the results of our clinical research for ospemifene indicate that this promising non-estrogen therapy could play a significant role in the treatment of vulvovaginal atrophy in the years ahead. Shionogi is the ideal company to successfully support the effort to commercialize ospemifene in the U.S. and around the world.”