By RICHARD SINE / The News Journal
Cephalon Inc. has asked federal regulators to approve a version of its narcolepsy drug Provigil to be used to treat children with attention deficit hyperactivity disorder, the West Chester, Pa.-based drug maker announced Tuesday.
Cephalon said it has conducted trials of its drug Attenace on more than 600 patients and found significant reduction in ADHD symptoms, with only mild and transient side effects. The company aims to launch Attenace in early 2006.
Attenace contains the same active ingredient, modafinil, as Provigil, Cephalon’s top-selling drug.
Cephalon estimates it will sell more than $400 million of Provigil this year, or more than 40 percent of total revenues. Provigil has garnered controversy because some people are said to use it to forestall sleep rather than to treat any sleep disorder.
Cephalon’s patents on Provigil last until 2014, but the company is facing five legal patent challenges from generic drug makers, said company spokeswoman Jenifer Antonacci.
If the Food and Drug Administration approves Attenace, Cephalon will receive a patent on the drug that lasts until 2020, she said.
The Attenace application is one way Cephalon is trying to protect its Provigil revenues, said Ilya Kravets, an analyst with investment research firm Mehta Partners of New York. Because Attenace is a different dose of modafinil than Provigil, the FDA treats it as a different drug and it can receive its own patent protections.
To further protect sales, the company also plans to seek approval of Armodafinil (Nuvigil), a longer-lasting version of Provigil.
Kravets believes the company will successfully withstand patent challenges and that revenues from its modafinil drugs will exceed $1 billion by 2010. His firm manages a hedge fund that invests in Cephalon stock.
Kravets estimates that 20,000 ADHD patients already receive Provigil from doctors who prescribe it “off-label.”
Doctors often prescribe drugs for uses not approved by the FDA, and they can do so legally. But companies are forbidden from promoting their drugs for off-label uses. By receiving FDA approval, Cephalon will be allowed to market the drug for ADHD, Kravets said.
ADHD affects 3 percent to 5 percent of children, according to the National Institute of Mental Health. Antonacci estimated the total market for ADHD drugs at about $3 billion, though she said it could grow because ADHD is underdiagnosed.
The ADHD market is already dominated by two other drugs, according to investment firm Friedman Billings Ramsey: Adderall/XR, made by Wayne, Pa.-based Shire Pharmaceuticals, and Concerta, a longer-lasting version of Ritalin made by Fort Washington, Pa.-based McNeil-PPC. A new ADHD treatment, Eli Lilly & Co.’s Strattera, has proven disappointing because it appears to be less effective than the older treatments, said Dr. Andrew Andesman, chief of behavioral pediatrics at Schneider Children’s Hospital in New York.
Attenace may have an advantage over the older drugs because it isn’t classified as a controlled substance, Antonacci said. That means physicians can call refills into a pharmacy, and patients do not have to visit a doctor as often.
Andesman noted that the clinical trials for Attenace compared it to a placebo, not to its potential competitors.
“Whether it’s better than standard medications has yet to be seen,” he said.