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Phase III Study Demonstrates INVEGA(R) SUSTENNA(TM) (paliperidone palmitate) Statistically Similar to RISPERDAL(R) CONSTA(R) (risperidone) Long-Acting Injection
Date:12/10/2009

rformance (PSP) Scale.

Results showed similar improvement in the mean change from baseline to endpoint in PANSS total score for IS (-18.6) and RC groups (-17.9). Because the lower limit of the 95% CI exceeded the pre-specified margin of -5, IS was concluded to be non-inferior to RC. Patients' severity of illness (CGI-S) and personal and social performance (PSP) improved similarly in both groups.

The overall incidence of treatment-emergent adverse events (TEAEs) were comparable in the IS group (57.9%) and in the RC group (52.8%). TEAEs that occurred in more than 5% in both treatment groups were: insomnia, headache, somnolence, and injection-site pain. The incidence of extrapyramidal symptom-related TEAEs was similar for both treatment groups. The mean increases in body weight at endpoint also were similar between treatment groups (IS: 1.1 [3.36] kg; RC: 1.0 [3.14] kg).

The study was sponsored by Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD). In the U.S., Janssen®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. markets INVEGA SUSTENNA and RISPERDAL CONSTA. Visit www.invegasustenna.com and www.risperdalconsta.com for full prescribing information.

INVEGA SUSTENNA was approved in July 2009 in the U.S. for the acute and maintenance treatment of schizophrenia in adults and utilizes the NanoCrystal® Technology, which is a proprietary technology developed by Elan Drug Technologies through Elan Pharma International Limited and other Elan affiliates.

RISPERDAL CONSTA was approved in 2003 for the treatment of schizophrenia and was approved in May 2009 for monotherapy and adjunctive therapy in the maintenance treatment of Bipolar I Disorder in adults.

IMPORTANT SAFETY INFORMATION FOR INVEGA® SUSTENNA(TM)

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SOURCE Janssen(R), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
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