Teva Pharmaceutical Industries Ltd. (TEVA) recently announced that its 91-day oral contraceptive, Quartette, gained FDA approval for the prevention of pregnancy.
Quartette, a next-generation extended regimen oral contraceptive, has been shown to reduce breakthrough bleeding (:BTB) between scheduled periods. BTB, which is usually experienced during the first few months of using a birth control pill, is a major reason for the discontinuation of extended regimens by several women.
Results on Quartette showed a decline in BTB and unscheduled spotting over successive 91 day cycles. Meanwhile, Teva said that Quartette has been shown to be 97% effective in preventing pregnancy.
Quartette’s launch should help boost sales of Teva’s Women’s Health segment which came in at $448 million in 2012. Teva’s Women’s Health segment focuses on several therapeutic areas including oral contraceptives, hormone therapy treatments for menopause/perimenopause, and therapies for use in 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).
Other candidates in Teva’s Women’s Health pipeline include Milprosa (luteal support for in vitro fertilization - a response to the FDA’s previously issued complete response letter is expected in 2013), DR-3001 (overactive bladder), XM17 (treatment of female infertility – application submitted in Europe) and LeCette (28-day oral contraceptive – currently in phase III with a new drug application filing expected in 2013).
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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