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Sparlon

Generic name: modafinil
Treatment for: ADHD in Children and Adolescents

Cephalon Files Application for Marketing Approval of New Modafinil Formulation for the Treatment of Children and Adolescents with Attention-Deficit/Hyperactivity Disorder


Accelerated Submission Date Based on Highly Significant Results From Three Studies of New Once-Daily Doses

WEST CHESTER, Pa., December 21, 2004 -- Cephalon, Inc. (NASDAQ:CEPH) today announced that it has filed a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) requesting marketing approval of Attenace (modafinil) Tablets [C-IV], a new proprietary dosage form of modafinil for the treatment of attention- deficit/hyperactivity disorder (ADHD) in children and adolescents between the ages of six and 17.

In August 2004, Cephalon announced results from three multi-center clinical trials that showed that ATTENACE 340 mg and 425 mg tablets significantly improve symptoms of ADHD in children and adolescents. Based upon the strength of the study results, the company accelerated the filing of its application with the FDA from the first quarter of 2005 to the fourth quarter of 2004. The company is targeting a launch of Attenace by early 2006.

"Physicians and parents continue to seek treatment for children and adolescents with ADHD that provides a balanced efficacy and tolerability profile. In our phase 3 trials, we were encouraged that ATTENACE improved the symptoms of many children and adolescents with ADHD to levels within the range considered normal for those without ADHD, as measured by the ADHD rating scales used in our studies. There was a low discontinuation rate due to adverse events in these studies as well," said Paul Blake, MB, FRCP, Senior Vice President of Clinical Research and Regulatory Affairs.

"The consistency of the effectiveness of Attenace to treat the full range of ADHD symptoms uniformly across the three studies allows us to present what we believe is a strong submission package to FDA," Dr. Blake added.

Frank Baldino Jr., Ph.D., Chairman and CEO, said, "We are enthusiastic about the data from our clinical trials and the potential for Attenace, once approved, to capture a substantial portion of the ADHD market. We expect that Attenace will provide another exceptional growth opportunity for Cephalon."

About the Clinical Trials
In three nine-week, double-blind, placebo-controlled studies, more than 600 children and adolescents between the ages of six and 17 with ADHD were randomized to either placebo or Attenace. The primary endpoint in all studies was the teacher-completed school version of the ADHD Rating Scale IV. All of the Attenace-treated groups showed a highly statistically significant improvement on the ADHD rating scale compared to placebo (p<0.0001). Attenace was generally well tolerated, with a safety profile consistent with that observed in other studies of modafinil. The most common adverse events observed in the phase 3 trials with children and adolescents with ADHD included mild transient insomnia, headache and loss of appetite. The complete Phase 3 study data are expected to be presented at major medical meetings in 2005.

Attenace
Data from earlier clinical trials in children and adolescents with ADHD led to the development of Attenace as small, film-coated tablets in unique dosage strengths. The new tablets will be available in 85 mg, 170 mg, 255 mg, 340 mg, and 425 mg strengths and will allow for tailored dosing with a single tablet for children and adolescents with ADHD. The active ingredient in Attenace, modafinil, is currently available as Provigil (modafinil) Tablets [C-IV] in 100 mg and 200 mg strengths. Provigil is indicated for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS) and shift work sleep disorder. The most frequently reported adverse events in clinical trials with Provigil were headache, nausea, nervousness, stuffy nose, diarrhea, back pain, anxiety, trouble sleeping, dizziness and upset stomach.

Attention-Deficit/Hyperactivity Disorder
According to the National Institutes of Mental Health, ADHD is one of the most common psychiatric disorders among children, affecting three to five percent of American children. The most common ADHD behaviors fall into three categories: inattention, hyperactivity, and impulsivity. A diagnosis of ADHD is generally made when these behaviors become excessive, long-term, and pervasive. Studies have shown that children with ADHD have higher medical costs than children without ADHD due to the risk of accidents and injury resulting from inattention, impulsivity and hyperactivity.

Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and marketing of innovative products to treat sleep and neurological disorders, cancer and pain.

Cephalon currently employs approximately 2,100 people in the United States and Europe. U.S. sites include the company's headquarters in West Chester, Pennsylvania, and offices and manufacturing facilities in Salt Lake City, Utah, and suburban Minneapolis, Minnesota. Cephalon's European offices are located in Guildford, England, Martinsried, Germany, and Maisons-Alfort, France.

The company currently markets three proprietary products in the United States: Provigil, Gabitril(R) (tiagabine hydrochloride) and Actiq(R) (oral transmucosal fentanyl citrate) [C-II] and more than 20 products internationally.

Posted: December 2004

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