Teva Pharmaceutical Industries Ltd.
) subsidiary, Teva Women's Health, Inc., recently announced the
acceptance of its new drug application (NDA) for its oral
contraceptive candidate, Quartette (levonorgestrel/ethinyl
estradiol tablets and ethinyl estradiol tablets).
Teva had filed for US Food and Drug Administration (FDA)
approval on May 31, 2012. The company is looking to get Quartette
approved for the prevention of pregnancy. On approval, Quartette
could be the first ascending-dose, extended regimen oral
Teva's Women's Health segment focuses on several therapeutic
areas including oral contraceptives, intrauterine contraception,
hormone therapy treatments for menopause/perimenopause, and
therapies for use in infertility and urinary incontinence.
Key products in the Women's Health portfolio include Plan B
One-Step OTC/Rx (an emergency oral contraceptive), and ParaGard
T380 A (non-hormonal intrauterine copper contraceptive). Teva
expanded its Women's Health portfolio with the January 2011
acquisition of Theramex, a Europe-based women's health business
with a presence in several countries.
Quartette's approval would help boost sales of the Women's
Health segment which came in at $438 million in 2011. Teva expects
sales from this segment to increase to $500 million in 2012. We are
pleased to see Teva progressing with its pipeline.
Earlier this month, the company and Active Biotech had announced
their intention to commence a phase III study with their oral
multiple sclerosis candidate, laquinimod. The study will be
conducted under the FDA's Special Protocol Assessment (SPA)
The phase III study, CONCERTO, will be conducted in patients
with relapsing-remitting multiple sclerosis (RRMS). Two doses of
laquinimod (0.6 mg and 1.2 mg) will be evaluated in the study for
up to 24 months with the primary endpoint being confirmed
disability progression as measured by the Expanded Disability
Status Scale (EDSS).
Laquinimod has been evaluated in two other phase III trials
(ALLEGRO and BRAVO) earlier. The candidate is also being studied
for Crohn's disease and lupus.
The successful development and launch of laquinimod would help
strengthen Teva's multiple sclerosis drug portfolio. Being an oral
formulation, laquinimod could provide an advantage over therapies
that require injection or infusion. Key players in the multiple
sclerosis market include
) among others.
We currently have a Neutral recommendation on Teva, which
carries a Zacks #3 Rank (short-term 'Hold' rating). We expect
investor focus to remain on the full strategic update that will be
provided in December 2012.
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