Teva Pharmaceutical Industries Ltd.
) 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.
)/Sandoz Inc., a subsidiary of
) are looking to get their generic versions of Copaxone in the
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
), carrying a Zacks Rank #1 (Strong Buy).
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