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Teva suffers setback as Nuvigil fails late-stage trial

Disappointing results in treating bipolar disorder but drug development continues

Teva Nuvigil armodafinil

Teva's Nuvigil has failed to show efficacy in a phase III trial in bipolar disorder, although the pharma company insists it will press on with the drug's development.

Nuvigil (armodafinil) did not show a significant improvement over placebo when added on to therapy with mood stabilisers or atypical antipsychotics in the study, which involved patients with major depression associated with bipolar 1 disorder, although Teva said there was a trend towards improvement.

Results of an earlier phase III study reported in May 2012 were positive, while a third pivotal trial is currently ongoing and is expected to generate results later this year.

Teva had planned to file for approval of Nuvigil in bipolar disorder on completion of the second study, with a view to launch it for this indication in early 2014, according to comments made by the firm's head of global medicines John Congleton at an investors' presentation last month.

However, the trial failure looks set to hold the project back by at least a year.

At the time Congleton made his comments, he noted that Nuvigil had the potential to become a "very unique first-in-class molecule to help treat bipolar disease", adding this was "an extremely exciting opportunity".

The drug is a once-daily follow-up to Teva's narcolepsy drug Provigil (modafinil) - both of which came from the Israeli company's acquisition of Cephalon in 2011.

It is approved for sleepiness associated with narcolepsy, shift work disorder and obstructive sleep apnoea, although efforts by Cephalon to extend Nuvigil's indications to include sleepiness associated with jet lag were unsuccessful.

Nuvigil made $269m in sales in the first nine months of 2012 while Provigil mustered $392m, well down from its former highs of around $1.4bn a year thanks to the onset of generic competition in 2012.

Some analysts believe the availability of Provigil generics will also dampen down sales growth of Nuvigil - which loses patent protection itself in 2016.

RBC Capital Markets suggested late last year that the drug will be unable to boost sales above the current $300m-$350m range with its current indications.

"While we are disappointed that the second study did not reach statistical significance, we are firmly committed to continuing with the third, phase III trial based on the promising results of the first study, the trend seen in the second, and comparable safety results between the two studies," commented Teva's R&D chief Michael Hayden.

24th January 2013

From: Research

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