West Coast Editor
The FDA's expected approval of Cephalon Inc.'s Nuvigil (armodafinil) for sleepiness related to sleep apnea, shift work and narcolepsy arrived on schedule - changed label and all - and Wall Street took the news rather drowsily, sending the company's shares (NASDAQ:CEPH) down $1.22 cents, to close Monday at $82.64.
Nuvigil is the longer-acting isomer of Frazer, Pa.-based Cephalon's marketed Provigil (modafinil), approved in 1998, and will bear a similar label, with a boldface warning about hypersensitivity reactions and skin rash such as Stevens-Johnson Syndrome. A single suspected case of the rash last summer made the company drop a different formulation of modafinil, intended for attention-deficit/hyperactivity disorder. The rash earned a not-approvable letter from the FDA. Provigil's label also will bear the warning. (See BioWorld Today, April 3, 2007, and Aug. 11, 2006.) Cephalon likely will launch Nuvigil around 2009 or 2010, before generic competition to Provigil hits the market (the patent expires in the spring of 2012), noted CIBC World Markets in a research report.
More gold in the modafinil franchise could lie in broader indications such as cancer, schizophrenia, Parkinson's disease and bipolar depression, where clinical programs are under way. Not until 2023 does the patent expire for Nuvigil, which also is to be used as an adjunct to standard treatment for obstructive sleep apnea/hypopnea syndrome.
Since doctors already have experience with Provigil, and since neither Provigil nor Nuvigil will be used in children, who are more likely to have reactions, the label changes probably won't affect sales much, predicted CIBC, which maintained its "sector outperformer" rating for Cephalon and recommended buying the stock.