Navigation Links
Centocor and Janssen-Cilag Submit Applications Requesting Approval of Ustekinumab in the U.S. and Europe for Treatment of Moderate to Severe Plaque Psoriasis
Date:12/4/2007

Two International Phase 3 Trials Evaluated Infrequent Dosing of Ustekinumab

in Nearly 2,000 Patients

HORSHAM, Pa. and BEERSE, Belgium, Dec. 4 /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."

About Psoriasis

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)

About Ustekinumab

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


'/>"/>
SOURCE Centocor, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. CLIA Waiver Submitted for Rapid HIV Test Employs StatSures Barrel Technology
2. BioMarin Partner AnGes MG, Inc. Submits BLA to Japanese Ministry of Health
3. Peregrine Pharmaceuticals Submits Clinical Protocol to Initiate Bavituximab Phase II Trial in Patients With Metastatic Breast Cancer
4. Vanda Pharmaceuticals Submits Iloperidone New Drug Application
5. Peregrine Pharmaceuticals Submits Clinical Protocol for New Phase II Trial of Bavituximab in Patients With Metastatic Breast Cancer
6. Roche Submits Application for FDA Approval of ACTEMRA(R) for the Treatment of Rheumatoid Arthritis
7. Medarex Announces Allowance of Investigational New Drug Applications for Wholly Owned Fully Human Anti-CD19 Antibody, MDX-1342
8. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
9. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
10. CryoCor Receives FDA Approval for Right Atrial Flutter
11. Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/19/2017)... , April 19, 2017 ... stimulate an immune response in pets such as ... products are of various types such as Attenuated ... Toxoid Vaccines, DNA Vaccines and Recombinant Vaccines. Attenuated ... as virus or bacteria, which have been weakend ...
(Date:4/19/2017)... N.J. , April 19, 2017  Novartis ... by the National Heart, Lung, and Blood Institute ... demonstrating that 58% of patients with treatment-naïve severe ... months when treated with eltrombopag at the initiation ... . The study evaluated three sequential treatment groups, ...
(Date:4/18/2017)... April 18, 2017  Cardinal Health (NYSE: ... fiscal 2017 earnings per share (EPS) guidance and providing ... is in conjunction with this morning,s announcement of the ... and Nutritional Insufficiency businesses. Cardinal Health now ... will be at the bottom of its previous guidance ...
Breaking Medicine Technology:
(Date:4/26/2017)... ... April 26, 2017 , ... The National ... upon National Registry of Emergency Medical Technicians and welcomes this organization ... Dr. Jan G. West, Ph.D. , CEO & Organizational Psychologist at NBRI. ...
(Date:4/26/2017)... ... April 26, 2017 , ... ... improve the profitability of ready-to-drink, high-protein beverages by helping beverage manufacturers more effectively ... dairy proteins, providing direct cost savings as well as more stable pricing over ...
(Date:4/25/2017)... ... April 25, 2017 , ... ... signed an agreement to be the preferred physical therapy provider for Derby City ... them to Derby City CrossFit as quickly and effectively as possible, ProRehab’s sports ...
(Date:4/25/2017)... ... ... The doctors at Wall Centre Dental are now expanding their practice by ... to receive dental care. The doctors offer three treatment options to put victims of ... surgery, at their dental office in Vancouver. Wall Centre Dental is currently welcoming even ...
(Date:4/25/2017)... ... 25, 2017 , ... Back Pain Centers of America (BPC), which ... physician in their area, announces the launch of a new and proprietary customer relationship ... looking for reputable physicians to help them with back or neck pain and helps ...
Breaking Medicine News(10 mins):