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Teva's Quartette Filing Accepted

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Teva Pharmaceutical Industries Ltd.’s (TEVA - Free Report) 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 contraceptive.

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) program.

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 Biogen (BIIB - Free Report) and Novartis (NVS - Free Report) 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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