Shionogi, QuatRx Pharma Enter Into License Agreement To Market Ospemifene

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.

As per the terms of the agreement, Shionogi is expected to have worldwide marketing rights to Ospemifene. QuatRx will receive an up-front payment of $25m and will be eligible to receive in excess of $100m in development and regulatory milestone payments.

Additionally, QuatRx is also expected to 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), utilising the Phase 3 clinical trials that were conducted by QuatRx.

Patrick Fourteau, president and CEO of Shionogi Pharma, 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.”

Robert Zerbe, 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 commercialise ospemifene in the US and around the world.”