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.

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