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The Complete Response letter requests additional information, including aproposal by Centocor for a Risk Evaluation and Mitigation Strategy (REMS).FDA requires REMS to ensure that benefits of an investigational or marketedtreatment outweigh the risks. The ustekinumab REMS must contain a MedicationGuide and communication plan. It does not require restricted distribution.The FDA has not requested any new non-clinical or clinical studies evaluatingthe efficacy or safety of ustekinumab prior to approval.
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"We are confident that we can expeditiously address the questions setforth in the Complete Response letter," said Jerome A. Boscia, M.D., seniorvice president, Clinical R&D, Centocor, Inc. "We anticipate responding to theFDA in January 2009 and remain focused on bringing ustekinumab to market andultimately to appropriate patients living with psoriasis and in need oftreatment."
On June 17, 2008, the FDA's Dermatologic and Ophthalmic Drugs AdvisoryCommittee (DODAC) unanimously recommended ustekinumab for approval. DODAC isconvened on request of the FDA to review and evaluate safety and efficacy dataof human drug products for use in the treatment of dermatologic andophthalmologic conditions. The committee provides non-binding recommendationsbased on its evaluation; however, the FDA makes the final decision on approvalof the drug.
About Psoriasis
Psoriasis is a chronic, immune-mediated disease, which results from theoverproduction of skin cells, resulting in their accumulation on the surfaceof the skin, which causes red, scaly plaques that may itch and bleed. It isestimated that approximately 7.5 million people in the United States and 10million Europeans are living with psoriasis and nearly one-quarter of thosepeople have cases that are considered moderate to severe.
About Ustekinumab
Ustekinumab is a new, human monoclonal antibody in Phase 3 development byCentocor, Inc. for the treatment of moderate to severe plaque psoriasis, andis being investigated as an infrequently administered subcutaneous injection.Ustekinumab is a new, human monoclonal antibody with a novel mechanism ofaction that targets the cytokines interleukin-12 (IL-12) and interleukin-23(IL-23), naturally occurring proteins that are important in the body'sregulation of immune responses and that are also believed to play a role ininflammatory disorders, including psoriasis.
On November 21, 2008, the European Medicines Agency's (EMEA) Committee forMedicinal Products for Human Use (CHMP) adopted a positive opinion forustekinumab for the treatment of moderate to severe plaque psoriasis in adultpatients who failed to respond to other systemic therapies.
On December 12, 2008, the Canadian Health Authority approved the use ofustekinumab for the treatment of chronic moderate to severe plaque psoriasisin adult patients who are candidates for phototherapy or systemic therapy.
Centocor discovered ustekinumab and has exclusive marketing rights to theproduct in the United States. Janssen-Cilag companies have exclusivemarketing rights in all countries outside of the United States.
About Centocor, Inc.
Centocor is harnessing the power of world-leading research andbiomanufacturing to deliver innovative biomedicines that transform patients'lives. Centocor has already brought innovation to the treatment of Crohn'sdisease, 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 fromdebilitating immune disorders. Centocor and Janssen-Cilag are subsidiaries ofJohnson & Johnson.
CENTOCOR DISCLOSURE NOTICE: This press release contains "forward-lookingstatements" as defined in the Private Securities Litigation Reform Act of1995. These statements are based on current expectations of future events.If underlying assumptions prove inaccurate or unknown risks or uncertaintiesmaterialize, actual results could vary materially from Centocor's expectationsand projections. Risks and uncertainties include general industry conditionsand competition; economic conditions, such as interest rate and currencyexchange rate fluctuations; technological advances and patents attained bycompetitors; challenges inherent in new product development, includingobtaining regulatory approvals; domestic and foreign health care reforms andgovernmental laws and regulations; and trends toward health care costcontainment. A further list and description of these risks, uncertainties andother factors can be found in Exhibit 99 of Johnson & Johnson's Annual Reporton Form 10-K for the fiscal year ended December 30, 2007. Copies of this Form10-K, as well as subsequent filings, are available online at www.sec.gov,www.jnj.com or on request from Johnson & Johnson. Centocor does not undertaketo update any forward-looking statements as a result of new information orfuture events or developments.
SOURCE Centocor, Inc.
