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McNeil Consumer & Specialty Pharmaceuticals Announces Agreement With Cephalon to Co-Promote Modafinil for Attention-Deficit/Hyperactivity Disorder

Posted on: Thursday, 1 September 2005, 09:01 CDT

FORT WASHINGTON, Pa., Sept. 1 /PRNewswire/ -- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc., announced today that it has entered into an agreement with Cephalon, Inc. to co-promote modafinil.

This proprietary dosage form of modafinil is awaiting U.S. Food and Drug Administration (FDA) approval for the treatment of attention- deficit/hyperactivity disorder (ADHD) in children and adolescents. Cephalon submitted a Supplemental New Drug Application (sNDA) for modafinil to the FDA in December 2004 and anticipates a response on the PDUFA date of October 20, 2005.

More than 300 McNeil sales representatives who currently sell the ADHD product CONCERTA(R) (methylphenidate HCl) C-II Extended-release Tablets will promote modafinil upon approval in the United States primarily to pediatric specialists. Cephalon will use its existing CNS specialty sales force of approximately 400 representatives to promote modafinil to psychiatrists, neurologists, primary care physicians, and other appropriate health care professionals.

"Our company has extensive experience with ADHD and the pediatric medical community," said Colin F. Watts, president, McNeil Consumer & Specialty Pharmaceuticals, a subsidiary of Johnson & Johnson. "We are excited about the prospect of collaborating with Cephalon on this new ADHD therapy."

The co-promotion agreement will run for up to three years following the date of commercial launch of modafinil. Cephalon will pay McNeil commission fees calculated as a percentage of annual net sales of modafinil during the term of the agreement. Cephalon will retain all responsibility for the development, manufacture, distribution, and sale of the product. Cephalon and McNeil will form a joint commercial committee to manage the promotion of modafinil.

MODAFINIL

Data from earlier clinical trials in children and adolescents with ADHD led to the development of modafinil 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 modafinil is currently available as PROVIGIL(R) (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 four million 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.

McNeil Consumer & Specialty Pharmaceuticals

McNeil Consumer & Specialty Pharmaceuticals markets prescription pharmaceuticals and over-the-counter (OTC) products. Prescription products include CONCERTA(R) (methylphenidate HCl) [CII] for attention deficit hyperactivity disorder and FLEXERIL(R) (cyclobenzaprine HCl) 5 mg for the relief of muscle spasm associated with acute, painful musculoskeletal conditions. The company's OTC products include complete lines of TYLENOL(R) acetaminophen and MOTRIN(R) IB ibuprofen products for adults and children. Other McNeil brands include IMODIUM(R) A-D anti-diarrheal, ST. JOSEPH(R) Adult Regimen Aspirin and NIZORAL(R) A-D Shampoo.

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's (Johnson & Johnson) expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99(b) of the Company's Annual Report on Form 10-K for the fiscal year ended January 2, 2005. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov/ or on request from the Company. The Company assumes no obligation to update any forward-looking statements as a result of new information or future events or developments.

McNeil Consumer & Specialty Pharmaceuticals

CONTACT: Media, Julie Keenan, +1-908-704-4564, McNeil Consumer &Specialty Pharmaceuticals, jkeenan2@ompus.jnj.com; or Investors, Helen Short,+1-732-524-6491, or Stan Panasewicz, +1-732-524-2454, both of Johnson &Johnson

Source: PRNewswire

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