Phase III clinical trial data of Milprosa vaginal ring presented at PCRS annual meeting

Apr 18 2013

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) 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).

“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.”

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.

"We believe this data supplements the scientific evidence supporting the efficacy and safety of Milprosa™ for luteal phase support," said Henk Jan Out, M.D., Ph.D., vice president, Global Clinical Development for Teva Women's Health. "Further, we are proud to contribute to the growing literature about the mean number of embryo transfers and multiple births at reproductive centers across the United States. This is an important trend that reproductive medicine experts carefully monitor in developing and guiding best practices."