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ORTHO-McNEIL NEUROLOGICS® NEWS RELEASE
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FDA Issues Complete Response Letter for Carisbamate
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TITUSVILLE, N.J., Aug. 21 /PRNewswire/ -- The U.S. Food and Drug
Administration (FDA) issued a complete response letter regarding the
New Drug Application (NDA) for carisbamate, an anti-epileptic drug
in development, announced Ortho-McNeil-Janssen Pharmaceuticals, Inc.
The NDA, filed in October 2008 by Johnson & Johnson Pharmaceutical
Research and Development, L.L.C. (J&JPRD) on behalf of
Ortho-McNeil-Janssen Pharmaceuticals, Inc. seeks approval to market
carisbamate (COMFYDE
TM
) for the adjunctive treatment of partial onset seizures in patients
16 years of age and older.
The company is currently evaluating the FDA's complete response
letter, and will respond to the agency's questions as quickly as
possible.
About Partial Onset Seizures and Epilepsy
According to the Epilepsy Foundation, epilepsy is one of the most
common disorders of the nervous system. It is defined by recurrent
unprovoked seizures. It is categorized as "generalized" or "partial"
depending on the location of the abnormal electrical activity in the
brain that characterizes the disorder. Partial-onset seizures are
common and are often difficult to treat. Partial-onset seizures are
most often characterized by simple or complex repetitive movements,
but virtually any sensory or emotional symptom can also occur as
part of a partial seizure, including complex visual or auditory
hallucinations. There are two categories of partial onset seizures:
simple partial seizures (in which consciousness is retained), and
complex partial seizures (in which consciousness is impaired or
lost). Partial seizures can generalize and lead to tonic clonic
seizures, during which the patient loses consciousness and is at
risk for falling or injury.
About Carisbamate (COMFYDE
TM
)
Carisbamate has demonstrated anti-epileptic drug activity when given
in addition to other AEDs in clinical trials. Although the precise
mechanism of action remains to be elucidated, carisbamate modulates
brain neuron activity and thereby reduces epileptic activity and
seizures. Carisbamate has been studied in three placebo-controlled,
double-blind clinical studies with most common adverse events of
dizziness, headache, somnolence, nausea and fatigue.
Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI), a subsidiary of
Johnson & Johnson, provides medicines for an array of health
concerns, including central nervous system disorders, such as
schizophrenia and epilepsy; metabolic diseases, such as diabetes;
cardiovascular diseases; women's health; urology; gastrointestinal;
and infectious diseases. The company strives to provide innovative,
high quality, safe and effective treatments and continually seeks
new opportunities to offer solutions for unmet health care needs.
Ortho-McNeil-Janssen Pharmaceuticals, Inc. is headquartered in
Raritan, New Jersey.
Johnson & Johnson Pharmaceutical Research &
Development
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
(J&JPRD) is a 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
Ortho-McNeil-Janssen Pharmaceuticals, Inc. and/or Johnson &
Johnson'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 28, 2008. Copies of this
Form 10-K, as well as subsequent filings, are available online at
http://www.sec.gov,
http://www.jnj.com or on request
from Johnson & Johnson. Neither OMJPI nor Johnson & Johnson
undertake to update any forward-looking statements as a result of
new information or future events or developments.)
CONTACT: Media, Tricia Geoghegan, +1-609-730-3746 begin_of_the_skype_highlighting +1-609-730-3746 end_of_the_skype_highlighting or Srikant
Ramaswami, +1-609-647-8195; or Investors, Louise Mehrotra,
+1-732-524-6491 or Tina Pinto, +1-732-524-2034
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