StelaraTreatment for Psoriasis, Psoriatic Arthritis, Crohn's Disease, Maintenance, Ulcerative Colitis
Update: Stelara (ustekinumab) Now FDA Approved - September 25, 2009
Centocor and Janssen-Cilag Submit Applications Requesting Approval of Ustekinumab in the U.S. and Europe for Treatment of Moderate to Severe Plaque Psoriasis
Two International Phase 3 Trials Evaluated Infrequent Dosing of Ustekinumab in Nearly 2,000 Patients
HORSHAM, Pa. and BEERSE, Belgium, December 04, 2007 /PRNewswire/ -- Centocor, Inc. and Janssen-Cilag International NV announced today that regulatory applications have been submitted requesting the approval of ustekinumab (CNTO 1275) in the United States and Europe for the treatment of adult patients with chronic moderate to severe plaque psoriasis. Centocor has submitted a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) and Janssen-Cilag International NV has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA). Ustekinumab is a new, human monoclonal antibody with a novel mechanism of action that targets the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), naturally occurring proteins that are important in regulating immune responses and that are thought to be associated with some immune-mediated inflammatory disorders, including psoriasis.
It is estimated that 125 million people worldwide have psoriasis, including two percent of both the U.S. and European populations, or some 7.5 million Americans and 10 million Europeans. Nearly one-quarter of people with psoriasis have cases that are considered moderate to severe.(1)
The submissions are based on a comprehensive development program including data from two large Phase 3 multicenter, randomized, double-blind, placebo- controlled trials involving nearly 2,000 patients that evaluated the safety and efficacy of ustekinumab in the treatment of moderate to severe plaque-type psoriasis. The primary endpoint of each pivotal study was the proportion of patients who achieved at least a 75 percent reduction in psoriasis as measured by the Psoriasis Area and Severity Index (PASI 75).
"We are very encouraged by the promising results that we have seen through the ustekinumab clinical development program evaluating the efficacy and safety of this novel biologic in the treatment of moderate to severe plaque psoriasis," said Jerome A. Boscia, M.D., senior vice president, Clinical R&D, Centocor, Inc. "We remain committed to developing safe and effective new therapies for patients with inflammatory diseases like psoriasis through continued research and development in disease areas where unmet needs in treatment remain."
Psoriasis is a chronic, immune-mediated disease, which results from the overproduction of skin cells resulting in their accumulation on the surface of the skin, which causes red, scaly plaques that may itch and bleed. It is estimated that approximately 7.5 million people in the United States and 10 million Europeans are living with psoriasis and nearly one-quarter of those people have cases that are considered moderate to severe.(1)
Ustekinumab is a new, human monoclonal antibody in Phase 3 development by Centocor, Inc. for the treatment of moderate to severe plaque psoriasis, and is being investigated as an infrequently administered subcutaneous injection. Ustekinumab is a novel biologic therapy that targets interleukin 12 (IL-12) and interleukin 23 (IL-23), naturally occurring proteins that are important in regulating the immune system and that are also believed to play a role in immune-mediated inflammatory disorders.
Centocor discovered ustekinumab and has exclusive marketing rights to the product in the United States. Janssen-Cilag companies have exclusive marketing rights in all countries outside of the United States. Centocor, Inc. and the Janssen-Cilag companies are members of the Johnson & Johnson family of companies.
About Centocor, Inc.
Centocor is harnessing the power of world-leading research and biomanufacturing to deliver innovative biomedicines that transform patients' lives. Centocor has already brought innovation to the treatment of Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, pediatric Crohn's disease and psoriasis.
The world leader in monoclonal antibody production and technology, Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders.
About Janssen-Cilag International NV and Janssen-Cilag
Janssen-Cilag International NV and Janssen-Cilag companies have a long track record in developing and marketing treatments for central nervous system disorders, pain management, infectious diseases, gastrointestinal disorders and oncology.
1. National Psoriasis Foundation. About Psoriasis: Statistics. Available at: http://www.psoriasis.org/about/stats
CONTACT: Media, Brian Kenney of Centocor, Inc., +1-215-325-2107, Mobile,+1-215-620-0111; or Satu Schmidt of Janssen-Cilag, 0049-179-67-64-649; orInvestor, Louise Mehrotra, +1-732-524-6491, or Tina Pinto, +1-732-524-2034,both of Johnson & Johnson
Web site: http://www.psoriasis.org/about/stats/
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Posted: December 2007
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- FDA Issues Complete Response Letter to Centocor for Ustekinumab Biologic License Application - December 19, 2008
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- FDA Advisory Committee Unanimously Recommends Approval of Ustekinumab for Treatment of Moderate to Severe Plaque Psoriasis - June 18, 2008
- Centocor Announces Ustekinumab Biologic License Application Accepted for Filing by FDA - February 4, 2008
- Medarex to Receive Milestone Payment for Submission of Regulatory Applications Requesting Approval of Ustekinumab (CNTO 1275) for Treatment of Psoriasis - December 7, 2007
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