Cephalon Q2: Not Taking Nuvigil to Stay Awake Yet? You Will Be, Company Believes

Cephalon is in the middle of a titanic struggle to move patients off its Provigil wakefulness drug onto its new brand, Nuvigil, which it just launched. Provigil goes off-patent sometime between now and April 2012, sooner if the FTC prevails in its anti pay-for-delay suit against the company.

In the meantime, Provigil and Nuvigil accounted for half of Cephalon’s Q2 2009 revenues. With Nuvigil in the fresher patent position, it’s crucial for the company to switch as many users as it can to the new drug before a generic version kills the franchise.

Bob Roche, Cephalon’s head of worldwide pharmaceutical operations, told Wall Street:

We believe clearly that NUVIGIL can be the dominant brand here. It’s in our interest and in patients’ interests to move business from PROVIGIL to NUVIGIL. I think we’re off to a terrific start doing that.

Part of the problem is that Provigil became one of those pop-culture drugs that draws as much controversy as praise: In addition to people with actual narcolepsy, it’s used by students for late-night cram sessions and finance whiz-kids who work around the clock (and cocaine-addicted monkeys). So Cephalon wants to extend its reach to people who have never shown any previous interest in wakey-wakey pills. Roche:

Right now, we are running at about 6,000 prescriptions a week for NUVIGIL and growing very nicely. Of that number of 6,000 or so prescriptions a week, over half is actually for patients who are naive to category therapy, right?

… It’s really, as we mentioned during the call, going to be the advent of new uses, new indications, new focus on even approved indications, such as shift work sleep disorder that we believe hold a good opportunity for the product over the next really 18 to 36 months.

“Shift work sleep disorder”? Until now, disrupted sleep from working at night was regarded as a normal, healthy response to an unnatural condition. Not any more. There’s a drug for that. And look how slight the criteria are under the indication for SWSD. In Nuvigil’s PI, it says that Nuvigil treatment for SWSD was demonstrated in:

• a 12-week trial with just 254 patients.
• who had a primary complaint of excessive sleepiness or insomnia which is temporally associated with a work period (usually night work)
• patients were also required to work a minimum of 5 night shifts per month, have excessive sleepiness at the time of their night shifts … and have daytime insomnia …
• and not all patients with a complaint of sleepiness who are also engaged in shift work meet the criteria for the diagnosis of SWSD.

In other words, normal sleep disruption from shift work now counts as SWSD.

As for that Nuvigil patent, analyst Louise Chen of Collins Stewart clearly had some doubts:

Chen - Then the other question is just on your patent for NUVIGIL; can you talk about your patent landscape and then why you’re confident in the strength of your intellectual property for NUVIGIL?

General counsel Jerry Pappert - Well, I think we’ll use a couple of things; number one, companies like ours don’t develop products and base future plans on products with weak intellectual property estates and that’s certainly not what we have done in this case.

Here’s hoping.

• See previous BNET coverage of Cephalon and Provigil:
• Cephalon’s Nuvigil Test Included “Vacation” in France
• The FTC’s Pay-for-Delay Threat: It’s All Cephalon CEO Baldino’s Fault
• Is Cephalon’s Provigil Addictive? Ask the Cocaine-Using Monkeys It Was Tested On.
• List of 56 Drugs That Should Not Be Mixed With Viagra Contains Some Surprises
  
• Cephalon: Damn the Torpedoes! We’re Raising Prices!
  
• “Pain Is Pain”: Cephalon’s Marketing Comes Under DOJ Control
  
• Behind Cephalon’s Numbers: a Big Cancer Bet and Signs of Skepticism
  
• Insomnia Pill Makers Go After Elderly With New ‘Fear of Falling’
  
• FTC accuses Cephalon over Provigil in patent case