Teva Says New Data from Phase III Trial of Milprosa Showed Comparable Multiple Pregnancy Rates

Teva Pharmaceutical Industries Ltd.

today presented data from a sub-analysis of a Phase III clinical trial of Milprosa™ (progesterone) vaginal ring, an investigational, once-weekly therapy for luteal phase support in women undergoing in vitro fertilization (IVF). The results were presented at the 61^st Annual Meeting of the Pacific Coast Reproductive Society (PCRS). These data are from a sub-analysis of a Phase III, single-blinded, randomized study of 1,297 women that compared the efficacy and safety of once-weekly Milprosa™ to daily 8 percent progesterone vaginal gel for luteal phase support in IVF. The data reported the mean number of embryos transferred and demonstrated comparable multiple pregnancy rates (twins or triplets) and multiple live births for each treatment. “This data analysis provides further evidence that Milprosa™ is comparable to progesterone vaginal gel in efficacy, regardless of how many embryos are transferred,” said Vicki Schnell, M.D., FACOG, founder and medical director of the Center of Reproductive Medicine in Webster, Texas. “Additionally, these data are consistent with the recent trend towards the transfer of fewer embryos during IVF. Transferring fewer embryos is beneficial for women as it reduces the risk of higher order gestations, which may lead to safer pregnancies.” The analysis also found: * At eight weeks gestation, the overall multiple pregnancy rates were 41.3 percent among women treated with Milprosa™ and 39.7 percent among women treated with the vaginal gel. * At 12 weeks gestation, the overall multiple pregnancy rates were 39.3 percent and 37.8 percent for Milprosa™ and the vaginal gel, respectively. * The overall multiple live birth rates were 38.7 percent and 36.2 percent for Milprosa™ and the vaginal gel, respectively. * The mean number of embryos transferred was 2.13 for both treatment groups. * The majority of women in both treatment groups had one or two embryos transferred (81.8% in the Milprosa™ group; 80.8% in the vaginal gel group). * No higher order multiple gestations beyond triplets were recorded.