Cephalon, Inc. (CEPH) recently presented positive data on Nuvigil from a six-week, multi-center, double-blind phase IV study that was conducted in patients suffering from excessive sleepiness associated with shift work disorder, especially during the end of their night shifts.
Results from the study showed that patients in the Nuvigil arm experienced a statistically significant difference in improvement in overall clinical condition related to late-shift sleepiness compared to placebo.
No serious adverse events were associated with Nuvigil. Cephalon intends to present the data initially at an annual meeting of the Society of General Internal Medicine in May 2011.
Nuvigil (armodafinil) is a follow-on version of Provigil (modafinil) which contributed about 48% to revenues in 2009. Cephalon has been looking to maximize market penetration ahead of the entry of generic versions of Provigil in 2012. Several generic players including Mylan Labs (MYL) and Teva (TEVA) are seeking to launch generic versions of Provigil. Moreover, generic companies like Teva, Watson Pharma (WPI), Mylan, Sandoz, Lupin Pharma and Actavis are also looking to market a generic version of Nuvigil.
Cephalon received FDA approval for Nuvigil in June 2007 for the treatment of excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy and shift work sleep disorder (SWSD).
The company launched Nuvigil in June 2009 and is promoting the product aggressively. Cephalon has taken several initiatives to ensure the smooth transition of users to Nuvigil, which has been priced at a significant discount to Provigil. 2009 sales came in at $79.4 million.
Cephalon has been looking to drive Nuvigil sales by gaining approval for additional indications like bipolar depression, schizophrenia, and excessive sleepiness associated with jet lag disorder. Unfortunately, Cephalon’s efforts to expand Nuvigil’s label have not met with much success.
Besides deciding to discontinue the development of Nuvigil for the jet lag disorder indication, Cephalon discontinued the development of Nuvigil for excessive sleepiness associated with traumatic brain injury due to poor enrolment.
Our Take
We currently have a Neutral recommendation on Cephalon. The positive shift work disorder data should help Cephalon in its efforts to promote Nuvigil for this indication. Cephalon has been focusing on this market segment that offers significant opportunity for growth. According to the company, there are 15 million shift workers in the US of which about 1/3 suffer from excessive sleepiness associated with shift-work disorder.
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