Shionogi gains global marketing rights to QuatRx' ospemifene in up to $125 million deal; Astellas sues OSI over acquisition plan

Japanese drug major Shionogi has entered into a worldwide license agreement to develop and market ospemifene, a selective estrogen receptor modulator (SERM), with QuatRx Pharmaceuticals of the USA.

Under the terms of the deal, Shionogi gains worldwide marketing rights to ospemifene. In return, QuatRx will get an up-front payment of $25 million and is eligible to receive in excess of $100 million in development and regulatory milestones. The US firm will also be eligible for additional payments for approval of ospemifene outside the USA, as well as sales milestones and royalties on product sales. A New Drug Application with the Food and Drug Administration is planned to be filed in 2010 for ospemifene for the treatment of post-menopausal vulvovaginal atrophy (VVA), utilizing the Phase III clinical trials that were conducted by QuatRx.

Expressing excitement about the prospects for ospemifene, Patrick Fourteau, president and chief executive of Shionogi Pharma in the USA, said that, "upon FDA approval, we look forward to bringing the first non-estrogen treatment option to millions of women in the USA 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."