said Wednesday that it will experience another delay in marketing Sparlon, a treatment for attention deficit hyperactivity disorder, or ADHD.
The Frazer, Pa., company was scheduled to hear from the Food and Drug Administration earlier this week. Now, Cephalon says the earliest launch will be the second quarter.
The FDA granted conditional approval for Sparlon in October, but Cepahlon didn't discuss the conditions or a timetable for meeting the agency's requirements for fully clearing the drug, which is aimed at children between ages 6 and 17.
Although Cephalon made its announcement after markets had closed, the stock plunged during the final 30 minutes of regular trading, losing $5.94, or 8.2%, to $66.83. Volume of 6.9 million shares was more than triple the daily average of 2.1 million shares for the past three months. After hours, the stock fell another $2.07, or 3.1%.
Cephalon said its experimental drug was caught up in the FDA's planned review of existing ADHD drugs to determine if there's any link to sudden death, hypertension, stroke or heart attack for both adults and children. Cephalon says FDA advisory panels will examine these issues on Feb. 9 and March 22.
The agency said recently that some cases of death and dangerous side effects have been reported "in association with therapeutic doses" of ADHD drugs. The agency didn't identify specific drugs. "The few controlled clinical studies of longer term drug treatment of ADHD provided little information on cardiovascular risks," the FDA said.
Because Sparlon is still experimental, it won't be analyzed during the advisory panel sessions. Instead, Sparlon will be reviewed at a special March 23 meeting of a separate advisory committee, Cephalon says.
Sparlon, known as Attenace during its development, contains the same main ingredient as the company's sleep-disorders drug Provigil. Cephalon is awaiting an FDA decision of Nuvigil, a follow-up version of Provigil. The FDA is expected to act by the end of the month.
Cephalon also said it would issued revised 2006 earnings guidance on Feb. 14. The current prediction became "outdated" because of the settlement of three Provigil patent infringement suits with generic drug companies, the closing of a recent acquisition, the delay in the Sparlon launch and "the impact of the recent rise in the company's stock price on the number of shares included in the income per share calculation."
Cephalon previously predicted 2006 sales would be in the range of $1.35 billion to $1.40 billion while earnings, excluding special items, would be $2.90 to $3 a share.