TITUSVILLE, N.J., July 24, 2008 /PRNewswire via COMTEX News Network/ -- Ortho-McNeil Neurologics, a
division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., announced today that
the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity
for TOPAMAX(R) (topiramate), based on studies submitted in response to a
Written Request by the FDA to investigate the use of TOPAMAX in pediatric
patients aged 1 to 24 months with partial onset seizures.

In addition to granting pediatric exclusivity, the FDA is continuing its
review of the application to determine the safety and efficacy of TOPAMAX in
this patient population. Based on the data submitted, no indication is sought
for this age group.

A recent court decision confirmed the validity of the TOPAMAX patent,
which is set to expire in September 2008. However, this grant will extend the
period of exclusivity through March 2009. TOPAMAX is not approved for use in
pediatric patients aged 1 to 24 months.

TOPAMAX(R) is indicated as initial monotherapy in patients 10 years of age
and older with partial onset seizures or generalized tonic-clonic seizures.
It also is indicated as adjunctive therapy for adults and children (aged two
and above) with partial onset seizures or generalized tonic-clonic seizures,
and in adults and children as adjunctive therapy for the treatment of seizures
associated with Lennox-Gastaut syndrome. TOPAMAX(R) is indicated in adults
for the prophylaxis of migraine headache.

Important Safety Information: Serious risks associated with TOPAMAX
include lowered bicarbonate levels in the blood resulting in an increase in
the acidity of the blood (metabolic acidosis). Symptoms could include
hyperventilation (rapid, deep breathing), tiredness, loss of appetite,
irregular heartbeat or changes in the level of alertness. Call your doctor
immediately if you get these symptoms. Your doctor may want to do simple
blood tests. Chronic, untreated metabolic acidosis may increase the risk for
kidney stones or bone disease.

Other serious risks include decreased sweating, increased body
temperature, kidney stones, sleepiness, dizziness, confusion, difficulty
concentrating, and increased eye pressure (glaucoma). Call your doctor
immediately if you have any decrease in vision or eye pain. These problems
can lead to blindness if not treated right away.

More common side effects are tingling in arms and legs, loss of appetite,
tiredness, nausea, diarrhea, taste change and weight loss.

Headquartered in Titusville, NJ, Ortho-McNeil Neurologics, Division of
Ortho-McNeil-Janssen Pharmaceuticals, Inc., focuses exclusively on providing
solutions that improve neurological health. The company currently markets
products for Alzheimer's disease, epilepsy and acute and preventive migraine
treatment. In conjunction with internal and external research partners,
Ortho-McNeil Neurologics continues to explore new opportunities to develop
solutions for unmet health care needs in neurology.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD)
is a wholly-owned subsidiary of Johnson & Johnson, the world's most
broadly-based producer of health care products. J&JPRD is headquartered in
Raritan, N.J., and has facilities throughout Europe, the United States and
Asia. J&JPRD is leveraging drug discovery and drug development in a variety
of therapeutic areas, including CNS, Internal Medicine and Oncology, to
address unmet medical needs worldwide. More information can be found at
http://www.jnjpharmarnd.com.

(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 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 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal
year ended December 30, 2007. Copies of this Form 10-K, as well as subsequent
filings, are available online at www.sec.gov, www.jnj.com or on request from
Johnson & Johnson. The Company does not undertake to update any
forward-looking statements as a result of new information or future events or
developments.)

SOURCE Ortho-McNeil-Janssen Pharmaceuticals, Inc.

http://www.jnjpharmarnd.com

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