Biotech Values

[DewDiligence]

FDA Approves Simponi

[The approval includes three indications: RA, psoriatic arthritis, and ankylosing spondylitis. Please see #msg-37300642 for musings on how Simponi will be positioned relative to Remicade.]

http://finance.yahoo.com/news/SIMPONITM-golimumab-Receives-prnews-15028864.html

›SIMPONI (golimumab) Receives FDA Approval as First Once-Monthly Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

Friday April 24, 2009, 3:50 pm EDT

First Subcutaneous Anti-TNF to Launch with Three Rheumatic Indications Simultaneously and with Novel SmartJect™ Autoinjector

HORSHAM, Pa., April 24 /PRNewswire/ -- Centocor Ortho Biotech Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved SIMPONI (golimumab) for the treatment of moderately to severely active rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis. SIMPONI is the first patient-administered anti-tumor necrosis factor (TNF)-alpha therapy that offers an effective once-monthly treatment option. Rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis are chronic inflammatory diseases that result in pain and inflammation, and in some cases, joint destruction and disability. These diseases affect more than three million Americans combined.

"SIMPONI has been studied in a broad range of patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis who had previously received a wide variety of treatments, including adults with rheumatoid arthritis previously treated with anti-TNF therapies, and has been shown to be significantly effective in reducing the signs and symptoms of each of these diseases," said Jonathan Kay, MD, Associate Clinical Professor of Medicine, Harvard Medical School and lead study investigator. "The approval of SIMPONI offers rheumatologists an effective new anti-TNF therapy for patients living with rheumatic diseases."

In the U.S., SIMPONI is approved as a 50 mg subcutaneous injection once a month and is indicated:

• In combination with methotrexate for the treatment of adult patients with moderately to severely active rheumatoid arthritis

• Alone or in combination with methotrexate for the treatment of adult patients with active psoriatic arthritis

• For the treatment of adult patients with active ankylosing spondylitis

SIMPONI is available in two dosage forms. The SIMPONI SmartJect(TM) is a novel autoinjector designed to meet the needs of arthritis patients that has received the Ease-of-Use Commendation by the Arthritis Foundation. SIMPONI is also available as an easy to use prefilled syringe.

The efficacy and safety of SIMPONI have been evaluated in one of the most comprehensive clinical development programs for an anti-TNF-alpha therapy, which included simultaneous studies in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. The program, which includes more than 2,000 patients across five pivotal Phase 3 trials, served as the primary basis for FDA approval. In rheumatoid arthritis, SIMPONI has been studied in a broad range of patients, including adults naive to methotrexate, adults responding inadequately to methotrexate and adults previously treated with at least one anti-TNF-alpha agent. In each of the three trials, significantly more patients receiving SIMPONI 50 mg plus methotrexate achieved at least a 20 percent improvement in arthritis symptoms (ACR20), compared with patients receiving placebo plus methotrexate and/or other disease modifying anti-rheumatic drugs. Improvements were seen as early as four weeks after the first SIMPONI injection and continued to improve over time. A proportion of patients also achieved substantial improvements in arthritis symptoms, 50 percent improvement (ACR50) and 70 percent improvement (ACR70), with continued SIMPONI treatment.

A Phase 3 trial, the largest of its kind, evaluating SIMPONI in the treatment of psoriatic arthritis showed that SIMPONI 50 mg significantly improved signs and symptoms of active psoriatic arthritis. Similarly, a Phase 3 study evaluating SIMPONI in the treatment of ankylosing spondylitis showed that SIMPONI 50 mg significantly improved signs and symptoms of active ankylosing spondylitis. Patients with psoriatic arthritis and ankylosing spondylitis experienced rapid and sustained improvements with continuous SIMPONI treatment.

"With the approval of SIMPONI, we enhance our commitment to delivering effective and innovative treatments to the millions of patients living with chronic inflammatory diseases while expanding our immunology portfolio," said Kim Taylor, President, Centocor Ortho Biotech Inc. "Importantly, as patient safety remains our top priority, we have collaborated with the FDA to develop a Risk Evaluation and Mitigation Strategy to help ensure the risks of ant-TNF therapy are appropriately managed by doctors prescribing and patients receiving SIMPONI."

"The approval of new and effective treatment options is always good news for the arthritis community, as not all patients respond the same to currently available treatment options," said Dr. John Hardin, Chief Scientific Officer for the Arthritis Foundation. "Anti-TNF agents have become an important advancement in the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, and each approval offers physicians and patients yet another option within this important class of therapy."

About Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

Rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis affect more than three million Americans collectively. RA is characterized by persistent and progressive joint inflammation, causing pain, stiffness and functional disability. The Arthritis Foundation estimates that approximately 1.3 million people in the United States are affected by RA. For more information visit the Arthritis Foundation.

Psoriatic arthritis is a chronic inflammatory disease that causes joint pain and swelling and can lead to joint destruction. Psoriatic arthritis is frequently associated with inflamed, scaly, red patches of skin psoriasis and nail psoriasis. According to the National Psoriasis Foundation, up to 30 percent of people with psoriasis also develop psoriatic arthritis. For additional information visit the National Psoriasis Foundation.

Ankylosing spondylitis is a painful and progressive form of spinal arthritis. In severe cases, the disease can result in fusing of the spinal vertebrae and cause structural damage to hips and other joints. An estimated 500,000 people in the U.S. are living with ankylosing spondylitis. For more information visit the Spondylitis Society of America.

About SIMPONI (golimumab)

SIMPONI is a human monoclonal antibody that targets and neutralizes excess TNF-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. The first once-monthly subcutaneous anti-TNF-alpha therapy, SIMPONI is approved for the treatment of moderately to severely active rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis, and is available either through the SIMPONI SmartJect autoinjector or a prefilled syringe. SIMPONI is also being studied as an intravenous infusion therapy for the treatment of rheumatoid arthritis. For more information about SIMPONI, visit www.SIMPONI.com.

In March 2008, Centocor Ortho Biotech Inc. and Schering-Plough Corporation announced that a Marketing Authorization Application (MAA) had been submitted to the European Medicines Agency (EMEA) requesting the approval of golimumab as a monthly subcutaneous treatment for adults with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.

Centocor Ortho Biotech Inc. developed and discovered SIMPONI and has exclusive marketing rights to the product in the United States. Following regulatory approval, Schering-Plough will assume exclusive marketing rights outside the United States except in Japan, Indonesia and Taiwan, where SIMPONI will be co-marketed by Mitsubishi Tanabe Pharma Corporation and Janssen Pharmaceutical Kabushiki Kaisha; Hong Kong, where SIMPONI will be exclusively marketed by Janssen-Cilag; and China, where SIMPONI will be exclusively marketed by Xian-Janssen.‹