QuatRx Pharmaceuticals Company, a privatelyheld biopharmaceutical company, announced positive topline efficacy results from the first of two patient cohorts in its second pivotal Phase 3 trial of the investigational compound, Ophena(TM) (ospemifene tablets), for the treatment of postmenopausal vulvovaginal atrophy (VVA). The Company has also successfully completed two long term safety extension studies from its first pivotal Phase 3 studies. QuatRx intends to use these results in support of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in early 2010 seeking approval for Ophena(TM), a new SERM (selective estrogen receptor modulator) for the treatment of the symptoms of vulvovaginal atrophy. Ophena(TM) is the only nonestrogen therapy currently in latestage development for the treatment of vaginal symptoms associated with menopause.

“We are delighted with the progress in our Phase 3 program of Ophena(TM), which provides further evidence of the potential of Ophena(TM) as a firstinclass nonestrogen drug for the treatment of vaginal atrophy, a highly prevalent and symptomatic condition” said Robert L. Zerbe, M.D., Chief Executive Officer of QuatRx. “These new efficacy data confirm results seen in our first phase 3 pivotal study and are an important milestone towards our planned NDA submission.”

This second Phase 3 study of Ophena(TM) is a randomized, doubleblind, placebocontrolled trial of 919 patients with vulvovaginal atrophy conducted at 116 sites in the United States. Patients were stratified into two cohorts based on their most bothersome moderate to severe vaginal atrophy symptom either vaginal dryness or dyspareunia (sexual pain). The results announced focus on the cohort of 314 patients from this study identifying vaginal dryness as their most bothersome symptom. The positive efficacy results in this cohort, achieved in all four coprimary endpoints, confirm the results seen in the first pivotal Phase 3 trial of Ophena(TM). The results also demonstrate that Ophena(TM) was welltolerated. A second cohort of the study, consisting of 605 patients with the most bothersome moderate to severe vaginal atrophy symptom of dyspareunia, is fully enrolled and will report out in late summer of this year.

The latest results showed statistically significant changes from baseline to week 12 compared to placebo in four coprimary endpoints the percentages of both parabasal cells and superficial cells in the vaginal maturation index, changes in vaginal pH (all p