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Data on Teva's Milprosa - Analyst Blog
4/18/2013 7:13:00 PM
Teva Pharmaceuticals ( TEVA ) recently announced new data from a phase III study on Milprosa (progesterone) vaginal ring which is being developed for luteal phase support in women undergoing in vitro fertilization (IVF).
The data was from a sub-analysis of a phase III, single-blind, randomized study, which was conducted on 1,297 women. The study was conducted to compare the efficacy and safety of once-weekly Milprosa to daily 8% progesterone vaginal gel for luteal phase support in IVF. The data included the mean number of embryos transferred and showed comparable multiple pregnancy rates and multiple live births for each treatment.
A New Drug Application (NDA) was submittedwith the US Food and Drug Administration (FDA) for Milprosa in 2010. Teva, however, received a complete response letter (CRL) in 2011 and was asked to conduct a safety/efficacy study in women aged over 34 years prior to approval or as a post-marketing commitment. Teva expects to file a response to the FDA's letter in 2013.
Oxybutynin is another vaginal ring phase III candidate in Teva's pipeline which is being developed to treat overactive bladder (OAB).
Teva's Women's Health segment sales came in at $448 million in 2012. This segment focuses on several therapeutic areas including oral contraceptives, hormone therapy treatments for menopause/perimenopause women, and therapies for infertility and urinary incontinence.
Key products in Teva's Women's Health portfolio include Plan B One-Step OTC/Rx (an emergency oral contraceptive), ParaGard T380 A (a non-hormonal intrauterine copper contraceptive), Zoely (a 28-day regimen combination contraceptive oral pill) and Enjuvia (an oral treatment for moderate to severe vasomotor symptoms associated with menopause).
Teva currently carries a Zacks Rank #3 (Hold). The company is going through a transition period. Headwinds include EU pricing pressure, new competition for branded products (especially multiple sclerosis drug, Copaxone) and fewer generic product launches compared to 2012. Competition in the multiple sclerosis market will increase given the recent FDA approval of Biogen 's ( BIIB ) oral multiple sclerosis product, Tecfidera.
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