StelaraTreatment for Psoriasis, Psoriatic Arthritis, Crohn's Disease -- Maintenance, Ulcerative Colitis
Update: Stelara (ustekinumab) Now FDA Approved - September 25, 2009
FDA DODAC Recommends Approval of Ustekinumab for Psoriasis
FDA Advisory Committee Unanimously Recommends Approval of Ustekinumab for Treatment of Moderate to Severe Plaque Psoriasis
HORSHAM, Pa., June 17, 2008 /PRNewswire/ -- Centocor, Inc. announced today that the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) of the U.S. Food and Drug Administration (FDA) has unanimously recommended the approval of ustekinumab, a new subcutaneous, investigational biologic therapy for the treatment of adult patients with moderate to severe plaque psoriasis. 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 the body's regulation of immune responses and that are also believed to play an important role in psoriasis.
"We are very pleased with the advisory committee's support for the approval of ustekinumab," stated Jerome A. Boscia, M.D., Senior Vice President, Clinical, Centocor R&D. "For many patients, psoriasis is a serious disease, and they are in need of additional treatment options. It is our hope that the FDA will consider this recommendation and, upon completion of its review process, make ustekinumab available to patients with moderate to severe psoriasis."
The committee reviewed data from one of the largest biologic clinical programs in psoriasis, which included two large Phase 3 multicenter, randomized, double-blind, placebo-controlled trials evaluating the safety and efficacy of ustekinumab involving more than 2,000 patients. Results of these Phase 3 trials were recently published in The Lancet, which showed that a majority of patients treated with ustekinumab experienced significant skin clearance by week 12 and sustained efficacy through at least week 76 with ustekinumab maintenance therapy every 12 weeks. In December 2007, Centocor announced that a Biologics License Application had been submitted to the FDA.
DODAC is convened on request of the FDA to review and evaluate safety and efficacy data of human drug products for use in the treatment of dermatologic and ophthalmologic conditions. The committee provides non-binding recommendations based on its evaluation; however, final decisions on approval of the drug are made by the FDA.
Psoriasis is a chronic, immune-mediated disease, caused by 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 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.
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 psoriasis.
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.
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. Centocor is a wholly-owned subsidiary of Johnson & Johnson.
CENTOCOR DISCLOSURE NOTICE: 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 Centocor'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 30, 2007. 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. Centocor does not undertake to update any forward-looking statements as a result of new information or future events or developments.
CONTACT: Media, Michael Parks of Centocor, Inc., +1-215-325-4010, Mobile,+1-215-983-8000; or Investors, Louise Mehrotra, +1-732-524-6491, or TinaPinto, +1-732-524-2034, both of Johnson & Johnson
Web site: http://www.jnj.com/
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Posted: June 2008
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