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:8/21/2017)... (PRWEB) , ... August 21, 2017 , ... Today Aether ... a project, funded by a Bill and Melinda Gates Foundation grant, to ... Bill & Melinda Gates Foundation, also known as the Gates Foundation, is said to ...
(Date:8/17/2017)... ... August 17, 2017 , ... ... news outlet had provided a research update on Aytu Bioscience and cited promising ... , According to Soulstring, prescription rates for Natesto® have more than doubled since ...
(Date:8/16/2017)... Arizona (PRWEB) , ... August ... ... proud to introduce the Fluidnatek® Electrospinning and Electrospraying ... electrospraying equipment scales from table-top equipment for the lab to fully automated ...
(Date:8/16/2017)... ... August 16, 2017 , ... Today, 3Bar ... has secured $2M in funding from an impressive group of investors, including Rev1 ... Thrive Fund. With this investment, 3Bar is broadening availability of its groundbreaking offering ...
Breaking Biology Technology:
(Date:5/23/2017)... robotic gym for the rehabilitation and functional motor sense evaluation of lower ... . The first 30 robots will be available from June in ... The technology was developed and patented at the IIT laboratories and has ... to a 10 million euro investment from entrepreneur Sergio Dompè. ... ...
(Date:4/24/2017)... 2017 Janice Kephart , former ... Strategy Partners, LLP (IdSP) , today issues the ... Trump,s March 6, 2017 Executive Order: Protecting ... can be instilled with greater confidence, enabling the ... refugee applications are suspended by until at least ...
(Date:4/13/2017)... April 13, 2017 UBM,s Advanced Design and ... will feature emerging and evolving technology through its 3D ... will run alongside the expo portion of the event ... and demonstrations focused on trending topics within 3D printing ... and manufacturing event will take place June 13-15, 2017 at ...
Breaking Biology News(10 mins):