Phase 3 Data Released for In Vitro Fertilization Drug Milprosa

Teva presented data from a sub-analysis of a Phase 3 clinical trial of Milprosa (progesterone) vaginal ring, an investigational, once-weekly therapy for luteal phase support in women undergoing in vitro fertilization (IVF).

The data is from a sub-analysis of a single-blinded, randomized study of 1,297 women that compared the efficacy and safety of once-weekly Milprosa to daily 8% progesterone vaginal gel for luteal phase support in IVF. The overall multiple pregnancy rates were 41.3% and 39.3% among women treated with Milprosa and 39.7% and 37.8% among women treated with the vaginal gel at 8 and 12 weeks gestation, respectively. The overall multiple live birth rates were 38.7% for Milprosa and 36.2% for vaginal gel. 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 and 80.8% in the vaginal gel group).

Milprosa is flexible and designed to continuously release a steady dose of micronized progesterone. It is in development to support embryo transplantation and early pregnancy (up to 10 weeks post-embryo transfer) by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women.

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