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Teva's Contraceptive Gets Positive CHMP Opinion

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Teva Pharmaceutical Industries Ltd.’s (TEVA) extended-regimen oral contraceptive, Seasonique got a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for the prevention of pregnancy. The CHMP was of the opinion that the benefits associated with the use of Seasonique outweigh the risks.

If approved, Teva plans to launch Seasonique in several European countries by the end of 2014 starting with Austria, Slovakia and Poland with additional country launches next year.

Seasonique is already available in the U.S. and is approved in several other countries including Brazil and Chile.

Meanwhile, Teva also announced that it has submitted a citizen petition (CP) to the FDA related to the approvability of purported generic versions of its relapsing-remitting multiple sclerosis (RRMS) product, Copaxone. The CP contains new data on gene expression and evidence to support arguments regarding active ingredient sameness, immunogenicity and bioequivalence testing with regard to Copaxone.

Several generic companies including Momenta Pharmaceuticals, Inc. (MNTA)/Sandoz Inc., a subsidiary of Novartis (NVS) are looking to get their generic versions of Copaxone in the market.

Teva is working hard to delay the release of generic versions of Copaxone. The product generated approximately $1.1 billion in worldwide sales in the first quarter of 2014, accounting for more than 21% of the company’s total revenues.

Teva has undertaken several initiatives to mitigate the impact of genericization. It launched a new formulation of Copaxone (40mg/mL) in the U.S. According to the company, Copaxone 40 mg/mL enjoyed a market share of 10.5% in the U.S. as of Apr 18, 2014. Meanwhile, we remind investors that competition in the multiple sclerosis market is intense. Apart from injectables, several oral therapies including Gilenya and Tecfidera are also available.

Teva carries a Zacks Rank #2 (Buy). Other well-ranked stocks in the health care sector include Akorn Inc. (AKRX), carrying a Zacks Rank #1 (Strong Buy).

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