Teva Pharmaceutical Industries Ltd.
) recently announced disappointing top-line results from a study
evaluating Nuvigil (armodafinil) as an adjunct therapy in adults
with major depression associated with bipolar I disorder.
Top-line results showed that although Nuvigil showed a
numerical improvement, it failed to achieve statistical
significance in Study 3072.
Earlier, Teva had reported positive results from another phase
III study - Study 3071. Two more studies (3073 and 3074) are
currently ongoing. Teva expects to report results from Study 3073
later in 2013.
Nuvigil is currently approved for the improvement of
wakefulness in adults who experience excessive sleepiness due to
obstructive sleep apnea, shift work disorder, or narcolepsy.
Nuvigil is expected to generate sales of $280 - $320 million in
Teva is working on driving Nuvigil sales by expanding its
label. Nuvigil, which became a part of Teva's portfolio following
its acquisition of Cephalon, could start facing generic
competition from 2016. With Study 3072 failing to deliver
positive data, we expect a delay in Teva's plans for seeking
approval for Nuvigil's label expansion for the bipolar I disorder
indication. Positive data from Study 3072 would have allowed Teva
to file for FDA approval and potentially launch the product for
this indication in the first quarter of 2014.
Teva currently carries a Zacks Rank #3 (Hold). Teva, which is
going through a transition period, provided disappointing
guidance for 2013. However, with the company not including the
impact of the cost-savings plan in its guidance, we believe Teva
is leaving some room for delivering above expectations. Share
buybacks also leave some room for upside. We expect investor
focus to remain on the execution of the company's new strategy.
Earlier this year, Teva sold off its animal health business in
the US to
). This will allow Teva to focus on developing, manufacturing and
marketing branded and generic drugs globally -- Teva's primary
areas of strength.
Among generic companies,
) currently looks better-positioned with a Zacks Rank #2 (Buy).
Pernix Therapeutics Holdings, Inc.
), a specialty pharmaceutical company that also sells generic
products, also carries a Zacks Rank #2.
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