Sleepwalking: Cephalon Takes A Hit On Nuvigil
11 CommentsBy Ed Silverman // June 3rd, 2010 // 7:12 am
For the past couple of years, Cephalon has been scrambling to bolster its Nuvigil sleep-disorder pill as a successor to its older Provigil medication, which is marketed to treat the same problem, but faces generic competition in 2012. To cope, the drugmaker has been steadily raising the price on Provigil and trying to win new indications for Nuvigil.
Yesterday, though, Cephalon took a big hit because a Phase IIb study found Nuvigil failed to meet its primary endpoint for treating schizophrenia symptoms. This follows a complete response letter issued in March by the FDA for using the drug to treat jet lag disorder (see this). Meanwhile, Nuvigil is being tested to treat excessive daytime sleepiness related to traumatic brain injury and as an add-on therapy for bipolar disorder, but these aren’t likely to hit the market for some time, notes William Tanner of Lazard Capital Markets.
As a result, the Provigil “long-term franchise value remains uncertain,” he writes in an invstor note. “Because there will likely be a market for generic (Provigil), if new lifecycle indications for Nuvigil don’t expand overall utilization, we believe it is impossible to contemplate Cephalon not facing significant revenue erosion.”
Meanwhile, Cephalon is relying on an old trick to get by. The drugmaker recently raised the price of Provigil by an oh-so modest 29 percent, according to RW Baird analyst Tom Russo. The idea, of course, is to convert patients from Provigil to Nuvigil; the price on this pill rose only 8 percent. You can compare prices here. However, as Russo points out, “with generic Provigil available starting in 2012, payers could begin to pressure Nuvigil with steps designed to encourage use of the generic.”
Condor
Hello sven –
Ed’s content is, was and remains top-notch. Here, content is king.
I don’t care whose tab appears at the top, I trust Ed.
He is the franchise I buy, when I visit these pages. Ed is the brand — in my mind. He plainly is NOT doing anyones’ bidding — his stories are truly “free-range, home grown”. So, why should we care about some blue-logo (or any older pink one) in the corner?
Even mystics need to pay the bills, right? I think it fabulous that Ed makes a living this way.
Namaste
Josh
I think Sven got deleted…..
Josh
Or Condor is going crazy.
sven
Wrong:
Ed often used this blog as a subtle advertising vehicle for his employer’s content at the PinkShiz. He left there (or got fired) and I wonder if he wasn’t spending too much time on this and not enough on the other details?
Don’t get me wrong.. I enjoy Ed’s ED (erectile dysfunction) coverage as much as anybody… I didn;t think he would last long at Pinkie though.
Condor
Note to self — Don’t feed trolls (i.e., sven)
Namaste
Anonymous
Cephalon. What a gem of a company.
In Spring 2006 the FDA had an advisory committee hearing on the approval of Provigil for ADHD. The drug worked so-so. However the FDA presented information that it was causing Stevens Johnson’s Syndrome in kids as well as other immunologically mediated reactions. FDA also presented information indicating that this was likely due to a sulfone metabolite that was present in kids at 16 times the levels that adults were exposed to. Cephalon’s behavior at the advisory committee hearing was sad. They weren’t prepared and kept changing their story based on what the FDA said and what they were asked. It was clear that use could not be approved in kids due to the risk of lethal reactions.
In late September 2006 Cephalon got stories into both the Seattle Post-Intelligencer and the New York Times complaining how unfair FDA was because it was just a little rash.
It still took nearly a year before FDA finally required a bolded warning against use in children. The following is from the action letter to Cephalon from Drugs@fda.gov.
“Specifically, in the August 16, 2007 telephone conversation, it was agreed that the following statement would be included as a bolded statement in the Warnings section of the Provigil labeling:
“Modafinil is not approved for use in pediatric patients for any indication.” ”
I wish I could tell you why it took nearly a year for FDA to ask for this labeling and what scared FDA management into finally requesting it.
Anonymous
P.S. Two months previously in June 2007 the FDA approved Nuvigil (Armodafinil)without this contraindication even though it’s essentially the same drug as Provigil (modafinil).
This of course would make it much easier for Cephalon to engage in off-label promotion which they have been accused of
http://hcrenewal.blogspot.com/2006/11/cephalons-promotion-of-actiq.html
and for which they subsequently paid a $425 million fine, for not only off-label promotion of Actiq but also Provigil.
http://blogs.wsj.com/law/2008/09/30/alleged-off-label-marketing-at-cephalon-leads-to-big-settlement/
JaT
Just a little rash? Egads!
Don’t click this if you have a weak stomach:
http://www.google.com/images?q=stevens+johnsons+syndrome&rls=com.microsoft:*:IE-SearchBox&oe=UTF-8&rlz=1I7ACAW_en&um=1&ie=UTF-8&source=univ&ei=e_QHTIHgBKCeM-H4ibYE&sa=X&oi=image_result_group&ct=title&resnum=4&ved=0CD4QsAQwAw
Salmon
10% of SJS sufferers die.
no kiddin
Sal-
Interestingly enough, 100 percent of everyone living dies of something or other, right?
Provigil
Who is getting Provigil at $390 per month with no insurance? What’s your dosage??
I’m at 200 MG twice a day, and it’s almost $900 a month now. I have insurance (I’m lucky to have it), but my copay is still $200.