Cephalon plans to meet with FDA to discuss clinical requirements for a Provigil attention deficit hyperactivity disorder indication following positive results from a Phase II pediatric study, CEO Frank Baldino, PhD, said.

"We'll present these data to the FDA, and discuss the steps necessary to pursue a Provigil label in ADHD," Baldino announced during Cephalon's third quarter conference call Oct. 6.

The 12-week Phase II study enrolled 248 children ages six to 13 years. Two regimens - a 300 mg morning dose, and a morning dose of modafinil 200 mg followed by 100 mg in the evening - "significantly improved performance as measured by standard ADHD rating scales."

Cephalon cautioned that it was unlikely it could file an sNDA for Provigil in ADHD based on the existing data. "I'm sure we will need to do another study. I think the FDA will enjoy seeing the data we've got from the Phase II work," Senior VP-Clinical Research & Regulatory Affairs Paul Blake said.

After meeting with FDA, Cephalon plans to initiate Provigil Phase III ADHD trials at the beginning of the 2003/2004 school year. Provigil was approved for excessive daytime sleepiness associated with narcolepsy in December 1998.

Development of the indication will likely be limited to children. An earlier six-week study of Provigil in 113 adults with ADHD failed to show superior efficacy over placebo (¹ Also see "Cephalon Provigil ADHD Trial Failure Cuts Anesta Merger Value By One-Third" - Pink Sheet, 7 August, 2000., p. 22).

Cephalon also announced positive results from a study of Provigil in shift work sleep disorder. In a 12-week, 209-patient trial, subjects on 200 mg modafinil "significantly improved wakefulness" versus placebo, as measured by the Multiple Sleep Latency Test, the company said.

The shift work trial is the final portion of an excessive sleepiness sNDA Cephalon will file by year-end. The package also include studies in obstructive sleep apnea and the original narcolepsy data. Cephalon expects a 10-month review from FDA.

Ahead of the expanded label for Provigil, Cephalon plans to increase the size of its central nervous system sales force to 240 reps from 185. The company will also assume a "large jump in Provigil-related marketing and medical education activities until the end of 2002 and into next year," Baldino said.

Investors reacted strongly to Cephalon's plans for Provigil, with shares up 10.3% on the news. The increase came on the heels of a strong October on the NASDAQ, with shares up 23.2%, outperforming the "F-D-C" OTC Pharmaceutical Index, which was up 11.4% (see chart: " ² Monthly 'F-D-C' Index of OTC Drug-Wholesaler Stocks ").

Provigil sales were down 6.5% to $50.2 mil. in the third quarter, reflecting unusual buying patterns from a year ago. In the third quarter of 2001, Provigil sales more than doubled to $53.7 mil. as a result of speculative buying and a large initial stocking order from a chain pharmacy (³ [A#00630460027], p. 34).

Cephalon pointed to Provigil's underlying prescription demand to characterize the drug's growth during the third quarter. Provigil scripts totaled 287,000, a 60% increase over the prior-year period and a 9% increase over the second quarter of 2002, according to IMS Health data.

Cephalon has taken steps to prevent forward buying through agreements with three major wholesalers. "We agree that if we put in a price increase, that we'll provide them credit for future purchases based upon their buying history and based upon the size of the price increase," CFO Kevin Buchi said.

"We then attempt to monitor their compliance...by requiring them to provide us with their data on their inventory holdings by distribution center."

Cephalon has increased its guidance for year-end 2002; total product sales are now expected to be $460 mil., versus previous estimates of $430 mil.-$435 mil. The total includes Provigil sales of $200 mil.-$202 mil.; Actiq sales of $120 mil.-$125 mil.; and Gabitril sales of $47 mil. to $50 mil.

Cephalon Provigil Focus: Studying ADHD In Children, Filing Shift Work sNDA

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