Navigation Links
Centocor Announces Ustekinumab Biologic License Application Accepted for Filing by FDA
Date:2/4/2008

HORSHAM, Pa., Feb. 4 /PRNewswire/ -- Centocor, Inc. announced today that the Biologics License Application (BLA) for ustekinumab (CNTO 1275) has been accepted for review by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with chronic 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 regulating immune responses and that are thought to be associated with some immune-mediated inflammatory disorders, including psoriasis.

"We are pleased by the FDA's acceptance of our Biologics License Application for review of ustekinumab," stated Jerome A. Boscia, M.D., senior vice president, Clinical R&D, Centocor, Inc. "Ustekinumab has yielded promising efficacy and safety results in Phase 3 clinical trials, and we look forward to working closely with the FDA during their ongoing review of this potential new treatment for psoriasis."

Centocor, Inc. announced that it had submitted the BLA for ustekinumab in December 2007 based on its 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 both studies 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). Acceptance of the BLA filing does not mean that a license has been issued for this product nor does it represent any evaluation of the adequacy of the data submitted in the BLA. In December 2007 the Marketing Authorization Application (MAA) for ustekinumab was submitted in Europe and is currently under review by the European Medicines Agency (EMEA).

One-year findings from one of two ustekinumab Phase 3 trials were presented for the first time at the annual meeting of the American Academy of Dermatology this past Saturday, February 2.

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 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)

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.

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.

1. National Psoriasis Foundation. About Psoriasis: Statistics. Available at: http://www.psoriasis.org/about/stats


'/>"/>
SOURCE Centocor, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Medarex Announces Extension of Broad Antibody Development Relationship with Centocor
2. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
3. YM BIOSCIENCES ANNOUNCES COMPLIANCE WITH AIM RULE 26
4. Emisphere Technologies, Inc. Announces Pricing of Registered Direct Offering
5. BioLife Solutions Announces Exclusive CryoStor(TM) Supply Agreement With the New England Cryogenic Center, Inc.
6. Carrington Announces Nasdaq Communication; Prepares for Shares to Be Quoted on the OTC Bulletin Board and Pink Sheets
7. China Kangtai Cactus Biotech Files 2nd Quarter 2007 10QSB and Announces Unaudited Quarterly Results
8. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
9. Advanced Life Sciences Announces Receipt of Nasdaq Staff Letter
10. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
11. Angiotech announces additional diameters of sutures to further expand its Quill(TM) SRS PDO product line
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... ... February 11, 2016 , ... Global ... new agreement with Bankok,Thailand-based Global Stem Cells Network (GSCN) to distribute exosome injection ... American countries, including Mexico, Costa Rica, Dominican Republic, Colombia, Argentina, Nicaragua, Panama, El ...
(Date:2/10/2016)... 2016 /PRNewswire/ - BioAmber Inc. (NYSE: BIOA ), ... that Mitsui & Co. Ltd., its partner in the ... is investing an additional CDN$25 million in the joint ... from 30% to 40%.  Mitsui will also play a ... in Sarnia , providing dedicated resources ...
(Date:2/10/2016)... 2016  The Maryland House of Delegates and House ... University of Maryland School of Medicine Dean E. ... Maryland Medical System President and CEO Robert Chrencik ... highest honor given to the public by the leader ... Reece and Mr. Chrencik for their contributions to ...
(Date:2/10/2016)... ASAE is introducing a hybrid membership model which will ... of joining or renewing through an organizational purchasing model. ... every employee in any size association or AMC office ... member benefits.   John H. Graham, IV ... allow organizations of any size and their employees to ...
Breaking Biology Technology:
(Date:2/10/2016)... , February 10, 2016 ... According to 2016 iris recognition market report, ... recognition is more widely accepted for border ... both fingerprint and iris recognition technology in ... to avoid purchasing two individual biometrics devices. ...
(Date:2/5/2016)... , Feb. 5, 2016 ... of the "Global Facial Recognition Market ... --> http://www.researchandmarkets.com/research/5kvw8m/global_facial ) has announced the ... Market 2016-2020" report to their offering. ... http://www.researchandmarkets.com/research/5kvw8m/global_facial ) has announced the addition of ...
(Date:2/3/2016)... LIVERMORE, Calif. , Feb. 3, 2016 ... Police Department in Missouri ... of license plate reader (LPR) data from Vigilant Solutions. ... a hit-and-run case in which the victim was walking out ... a parking space next to his vehicle, striking his ...
Breaking Biology News(10 mins):