SimponiTreatment for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Ulcerative Colitis
Update: Simponi Now FDA Approved - April 24, 2009
BLA Submitted for Golimumab
Centocor, Inc. Submits BLA to FDA for Golimumab in the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
Extensive Clinical Development Program Investigating Golimumab in the Treatment of These Diseases Serves as Basis for the Application
HORSHAM, Pa., June 27, 2008 /PRNewswire/ -- Centocor, Inc. announced today that a Biologics License Application (BLA) has been submitted to the U.S. Food and Drug Administration (FDA) requesting the approval of golimumab (CNTO 148) as a monthly subcutaneous treatment for adults with active forms of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Golimumab, Centocor's next-generation human anti-TNF-alpha monoclonal antibody, is being studied as an every four week subcutaneous injection and is also being studied as an intravenous (IV) infusion therapy. In February 2008, Centocor submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) requesting the approval of golimumab as a monthly subcutaneous treatment for the same indications.
"This submission marks a major milestone in the clinical development program of golimumab, and we look forward to working with the FDA to bring golimumab to market," said Jerome A. Boscia, M.D., senior vice president, Clinical R&D, Centocor, Inc. "We remain focused on our commitment to innovation in the field of biomedicines, to addressing the ongoing needs of patients living with these debilitating diseases and to physicians in need of additional therapeutic options to effectively treat their patients."
Five pivotal Phase 3 trials support the BLA, which include the GOlimumab Before Employing methotrexate as the First-line Option in the treatment of Rheumatoid arthritis of Early onset (GO-BEFORE) study; the GOlimumab FOR subjects With Active RA Despite MTX (GO-FORWARD) study; and A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Human Anti-TNF-alpha Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNF-alpha Agent(s) (GO-AFTER) study were recently presented at the European League Against Rheumatism Annual Congress. In November 2007, primary endpoint study findings from the Golimumab - A Randomized Evaluation of Safety and Efficacy in Subjects with Psoriatic Arthritis Using a Human Anti-TNF Monoclonal Antibody (GO-REVEAL) trial and the Golimumab - A Randomized Study in Ankylosing Spondylitis Subjects of a Novel Anti-TNF mAB Injection (SC) Given Every Four Weeks (GO-RAISE) trial were reported at the American College of Rheumatology Annual Scientific Meeting.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic and debilitating disease that affects approximately 1.3 million people in the United States and more than three million people in Europe. Signs and symptoms of RA include pain, stiffness and motion restriction in multiple joints. Because RA is a progressive disease, it can cause permanent joint deformity and severe disability if not diagnosed early or if initial treatment is delayed. RA can occur at any age, but is most common in adults 30-50 years old and is two-to-three times more prevalent in women than in men. The cause of RA is unknown, although genetic factors may contribute to the disease.
About Psoriatic Arthritis
Psoriatic arthritis is a chronic inflammatory arthropathy manifesting with joint pain and swelling that can lead to joint destruction and debilitation. It is frequently associated with inflamed, scaly, red patches of skin psoriasis and psoriasis nail involvement. Symptoms may include stiffness and tenderness of the joints and surrounding tissue and reduced range of motion. Joints of the hands, wrists, knees, ankles, feet, lower back and neck are commonly affected. Psoriasis affects an estimated two to three percent of the world's population, and approximately one out of three patients affected by psoriasis may develop psoriatic arthritis. Both men and women are equally affected by psoriatic arthritis, most commonly between the ages 30 and 50, in the peak of their productive years.
About Ankylosing Spondylitis
Ankylosing spondylitis (AS) is a painful and progressive form of spinal arthritis and symptoms of inflammatory back pain often first present in people before age 35. It typically begins in the late teens and early twenties and in severe cases may result in fusing spinal vertebrae and may cause structural damage to hips and other joints. Often misdiagnosed as "just back pain" or undifferentiated arthritis, AS is a systemic inflammatory disease that, in addition to its effect on the spine, can affect internal organs, peripheral joints and vision. The Arthritis Research Campaign estimates that on the European continent, AS prevalence ranges from 0.2 to 1 percent of the entire population. The Spondylitis Association of America estimates that between 350,000 and one million people in the U.S. suffer from ankylosing spondylitis.
Golimumab, Centocor, Inc.'s next-generation human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody, is currently in the most comprehensive Phase 3 development program to date for an anti-TNF-alpha biologic therapy. With ongoing studies for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, golimumab is being studied as an every four week subcutaneous injection and an intravenous (IV) infusion therapy. Golimumab targets and neutralizes both the soluble and membrane-bound forms of TNF-alpha.
Centocor discovered golimumab and has exclusive marketing rights to the product in the United States. Pending regulatory approval, Schering-Plough will assume exclusive marketing rights outside the United States except in Japan, Indonesia and Taiwan where golimumab will be co-marketed by Mitsubishi Tanabe Pharma Corporation and Janssen Pharmaceutical Kabushiki Kaisha; Hong Kong, where golimumab will be exclusively marketed by Janssen-Cilag; and China where golimumab will be exclusively marketed by Xian-Janssen.
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 adult and pediatric Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis 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 www.sec.gov, 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: Brian Kenney of Centocor, Inc., +1-215-325-2107, Mobile:+1-215-620-0111, 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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