Centocor Ortho Biotech, Inc and Schering-Plough Corporation announced that Health Canada has granted approval of Simponi (golimumab) as a once-monthly, subcutaneous therapy for the treatment of moderately to severely active rheumatoid arthritis (RA), active psoriatic arthritis (PsA) and active ankylosing spondylitis (AS).

With this approval in Canada, Simponi, in combination with methotrexate (MTX), is indicated for reducing the signs and symptoms in adult patients with moderately to severely active RA; reducing signs and symptoms in adult patients with moderately to severely active PsA, alone or in combination with MTX; and reducing signs and symptoms in adult patients with active AS who have had an inadequate response to conventional therapies. Simponi is the first biologic therapy to be approved concurrently in three distinct rheumatologic diseases. Schering-Plough anticipates that the medication will become available in Canada in the second half of 2009.

"This first approval marks a major milestone in the clinical development programme for Simponi," said Jerome A Boscia, senior vice president, clinical R&D, Centocor Research & Development, Inc. "More importantly, the approval of Simponi expands the therapeutic options for physicians and offers patients an effective new medication that can be self-administered once monthly."

"This is the first approval for Simponi, one of the five stars in our late-stage pipeline," said Thomas P Koestler, executive vice president, Schering-Plough Corporation and president, Schering-Plough Research Institute. "Offering once-monthly subcutaneous dosing, Simponi will provide an important and convenient new treatment option to rheumatologists and their patients. Simponi expands our leading immunology franchise in meeting the needs of the rheumatology community."

Centocor Ortho Biotech developed and discovered SIMPONI and has exclusive marketing rights to the product in the United States. Following regulatory approvals, 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.

The approval of Simponi in Canada is based on data from five pivotal clinical trials: Go-Before, Go-Forward, Go-After, Go-Reveal and Go-Raise. Each trial found Simponi to be effective in reducing the signs and symptoms of RA, PsA and AS.

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.