Cephalon to seek OK for new use of Provigil

0 Comments | Deseret News (Salt Lake City), Aug 20, 2004 | by John Lauerman Bloomberg News

Cephalon Inc. will seek U.S. approval this year for a new use of the anti-drowsiness drug Provigil, its best-selling product, after studies showed the medicine also eases attention-deficit symptoms in children.

The company, which is based in West Chester, Pa., and has manufacturing operations in Salt Lake City, said it will apply for the new use in the fourth quarter, instead of waiting until 2005 as originally planned. Provigil was cleared in 1998 to prevent drowsiness in adults with night jobs or sleep disorders such as narcolepsy.

Attention-deficit hyperactivity disorder affects as many as 5 percent of U.S. children, causing symptoms such as inattention and impulsiveness, according to the National Institutes of Health. Provigil will compete against medicines such as Eli Lilly & Co.'s Strattera and Novartis AG's Ritalin. The market for ADHD treatments totals $2 billion annually, Cephalon said.

"The landscape for treating ADHD is crowded," said Michael King, a Banc of America Securities analyst in New York who rates Cephalon shares "neutral" and doesn't own them. "The one drug that's growing is Lilly's Strattera, and I think the issue is going to be how Cephalon can compete with that." He spoke in a telephone interview.

Sales of Strattera, which Eli Lilly & Co. introduced in January 2003, more than doubled in the second quarter to $178.6 million. Provigil sales totaled $102.8 million in the same period.

Cephalon shares rose 12 cents to close at $45.57 Thursday on Nasdaq. They have dropped 5.9 percent this year. Indianapolis-based Lilly's shares fell 21 cents to $64.35 in New York Stock Exchange composite trading.

Cephalon tested Provigil, also known by its chemical name modafinil, in 600 children aged six to 17. Children treated with the drug exhibited fewer of the symptoms associated with attention- deficit disorder than those who received a placebo, the company said.

Provigil allows people to stay awake without causing the shakiness and jitters associated with amphetamines or stimulants such as Ritalin, Cephalon says. People also are less likely to become addicted to Provigil than to amphetamines, which are more carefully regulated than other drugs because of the potential for abuse.

"Four years ago, when Provigil came on the narcolepsy market, that was dominated by amphetamines," Chip Merritt, a Cephalon spokesman, said in a telephone interview. "We feel very comfortable competing with amphetamines."

World-champion sprinter Kelli White was banned from competition for two years in May after tests showed she used Provigil. White said the drug, which is banned, was part of her treatment for a sleep disorder.

Cephalon plans to release full results of its three clinical trials at a meeting of the American Psychiatric Association in May, Merritt said.