Teva Pharmaceutical Industries Ltd.
) recently announced disappointing top-line data from the final
phase III study evaluating Nuvigil (armodafinil) as adjunct
therapy in adults with major depression associated with bipolar I
Although results showed that Nuvigil achieved statistical
significance in several important secondary endpoints (like
responder rate and remission), it failed to achieve the primary
endpoint. The primary endpoint was to see whether Nuvigil (150mg
per day) was more effective compared to placebo as adjunct
therapy to mood stabilizers and/or atypical antipsychotics.
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 sales were $157 million in the first half of 2013. Teva
was looking to drive sales by expanding the label into additional
indications. However, based on the final phase III study results,
Teva has decided that it will not go ahead with regulatory
filings for expanding Nuvigil's label for the treatment of major
depression associated with bipolar I disorder.
Teva currently carries a Zacks Rank #3 (Hold). The company is
going through a tough transition period given fewer large generic
opportunities, potential new competition for branded products
(especially Copaxone) and a higher cost base.
However, we are encouraged by Teva's plans to improve its
position. Teva said that it intends to accelerate growth
platforms, protect and expand core franchises, expand its global
presence, pursue strategic deals and reduce the cost base. We
expect investor focus to remain on the execution of the company's
At present, companies like
) look well-positioned with all three being Zacks Rank #2 (Buy)
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