Janssen, L.P. Selects INVEGA(TM) (paliperidone) Extended Release Tablets As Brand Name For Its Investigational Atypical Antipsychotic

Janssen, L.P., a wholly owned
subsidiary of Johnson & Johnson, announced that it has selected INVEGA(TM)
as the brand name for paliperidone extended release tablets, the company's
investigational oral atypical antipsychotic. The company is seeking
approval from the U.S. Food and Drug Administration (FDA) to market
INVEGA(TM) for the treatment of schizophrenia.



The FDA recently informed the company that it has assigned a class 1
(i.e., two month) review for INVEGA(TM). The new user fee goal date for an
FDA action on the new drug application (NDA) is now December 20, 2006.



Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (JJPRD)
submitted an NDA to the FDA in November 2005 seeking approval to market the
drug, and in September the company received an approvable letter from the
FDA. The December 20th action date applies to the response provided by
JJPRD to the approvable letter that was issued by the FDA this September.
Once approved by the FDA, INVEGA(TM) will be marketed in the U.S. by
Janssen, L.P.



INVEGA(TM) combines paliperidone with the patented OROS
extended-release technology developed by ALZA Corporation. ALZA, Janssen
and JJPRD are wholly owned subsidiaries of Johnson & Johnson.



Based in Titusville, N.J., Janssen is the only large pharmaceutical
company in the U.S. dedicated solely to mental health. The company
currently markets prescription medications for the treatment of
schizophrenia, bipolar mania and for the treatment of irritability
associated with autistic disorder, including symptoms of aggression,
deliberate self-injury, temper tantrums and quickly changing moods, in
children and adolescents aged 5 to 16 years. The INVEGA(TM) submissions are
based on an extensive global clinical development program that involved
more than 1,600 patients in 23 countries.



A global leader in pharmaceutical research and development, Johnson &
Johnson Pharmaceutical Research & Development, L.L.C. is committed to
bringing to market high-value, cost-effective products that treat disease
and significantly improve the health and lifestyles of people worldwide.



Worldwide, it is estimated that one person in every 100 develops
schizophrenia, one of the most serious types of mental illness. In the
United States, there are currently two million people with schizophrenia,
with men and women affected in equal proportions. The disease is
characterized by hallucinations, delusions, depression, blunted emotions
and social withdrawal, as well as disorganized thinking.


Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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