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Shionogi Enters Into Exclusive License Agreement With QuatRx Pharmaceuticals To Market Ospemifene
Date:3/2/2010

one 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."  

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 < or = 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
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SOURCE QuatRx Pharmaceuticals Company
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