) 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
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
(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
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
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
) oral multiple sclerosis product, Tecfidera.
Currently, companies like
) look more attractive with Zacks Rank #2 (Buy).
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