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Janssen-Cilag AG Submits Marketing Authorisation Application in Europe for Paliperidone Palmitate for the Treatment of Schizophrenia



12/4/2009 10:14:44 AM

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Beerse, Belgium (December 4, 2009) -- Janssen-Cilag International NV, has submitted a Marketing Authorisation Application to the European Medicines Agency for paliperidone palmitate, an investigational once-monthly atypical antipsychotic intramuscular injection for the treatment of schizophrenia.

Paliperidone palmitate utilises the NanoCrystal® Technology, which is a proprietary technology developed by Elan Drug Technologies through Elan Pharma International Limited and other Elan affiliates.

The paliperidone palmitate filing is based on an extensive global clinical development programme. Paliperidone palmitate was approved in the United States in July 2009. Marketing applications in other regions of the world are ongoing.

Upon approval, paliperidone palmitate will be marketed in Europe by the Janssen-Cilag companies, subsidiaries of Johnson & Johnson, the world's most comprehensive manufacturer of health-care products and related services. More information about the company can be found at www.janssen-cilag.com.

About Schizophrenia An estimated one percent of the world's population suffers from schizophrenia - a serious and usually chronic brain disorder that impairs a person's ability to think clearly, relate to others and distinguish between reality and imagination. It typically develops in adolescence or the early 20s, although symptoms may not become immediately obvious and requires long-term or life-long treatment with antipsychotic drugs. More information can be found about schizophrenia at http://www.psychiatry24x7.com

About Janssen-Cilag The Janssen-Cilag companies are part of the Johnson & Johnson family of companies. They have a long track record in developing and marketing treatments for central nervous system disorders, pain management, oncology, infectious diseases, reproductive health and gastrointestinal disorders. More information about Janssen-Cilag can be found at http://www.janssen-cilag.com.

About NanoCrystal® Technology and Elan Drug Technologies NanoCrystal® Technology is a registered trademark of Elan Pharma International Limited, Ireland, a subsidiary of Elan Corporation plc (NYSE:ELN). The NanoCrystal® Technology is a proven, robust, drug optimization technology, enabling solubility for many poorly water-soluble compounds. More information is available at www.elandrugtechnologies.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 Janssen-Cilag 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 www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Janssen-Cilag nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)

Contacts: Media (Europe)

Sue Silk: +44 (0)1494 553955 Email: ssilk@its.jnj.com

Brigitte Byl: +32 1040 0747 Email: bbyl@its.jnj.com Investors

Louise Mehrotra: +1 (732) 524-6491 Johnson & Johnson

Lesley Fishman: +1 (732) 524-3922 Johnson & Johnson


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