Merck's SIMPONI anti-TNF therapy now reimbursed in New Brunswick, Nova Scotia and Alberta

First once-monthly patient-administered anti-TNF therapy now reimbursed for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis

Merck is pleased to announce that New Brunswick, Nova Scotia and Alberta are the first provinces in Canada to reimburse SIMPONI(TM)(golimumab) for the treatment of three different rheumatic conditions. SIMPONI(TM), a subcutaneous anti-tumor necrosis factor (TNF) therapy, is now reimbursed by the drug formularies of these three provinces for people living with moderately to severely active rheumatoid arthritis, moderately to severely active psoriatic arthritis and active ankylosing spondylitis. All three rheumatic conditions are inflammatory and can cause debilitating pain and stiffness.

Now patients in Nova Scotia, Alberta and New Brunswick living with these severe arthritic conditions have access to a new treatment option, SIMPONI(TM), a once-monthly, patient-administered subcutaneous injection. SIMPONI(TM) is indicated for reducing signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis, in combination with methotrexate (MTX); for reducing signs and symptoms in adult patients with moderately to severely active psoriatic arthritis, alone or in combination with MTX and for reducing signs and symptoms in adult patients with active ankylosing spondylitis who have had an inadequate response to conventional therapies.

"SIMPONI(TM) represents an advance as the first once-monthly patient-administered anti-TNF alpha therapy. Clinical evidence from the SIMPONI(TM) clinical trials GO-FORWARD, GO-AFTER, GO-BEFORE, GO-REVEAL and GO-RAISE demonstrated a sustained decrease in symptoms and marked improvement in physical function in these patients over time," explained Dr. Walter P. Maksymowych, Professor, University of Alberta, Department of Medicine, Division of Rheumatology. "Having access to this new option will allow us to make optimal treatment choices to help bring relief to patients living with these severe rheumatic diseases."

Alberta, Nova Scotia and New Brunswick's decisions follow a positive recommendation for SIMPONI(TM) in March 2010 by the Common Drug Review (CDR), which conducts objective, rigorous reviews of the clinical and cost effectiveness of drugs, and provides formulary listing recommendations to the publicly-funded drug benefit plans in Canada (except Québec).

NIHB decision reaches almost one million Canadians

The Non-Insured Health Benefits (NIHB) Program, Health Canada's national health benefit program that provides coverage for eligible First Nations people and Inuit, also confirmed its approval to reimburse SIMPONI(TM) for the treatment of moderately to severely active rheumatoid arthritis, moderately to severely active psoriatic arthritis and active ankylosing spondylitis in June 2010, thereby giving access to more than 815,000 people across Canada who are covered by this plan and could potentially benefit from this decision.

"These decisions regarding SIMPONI(TM) are great news for patients. An optimal medication regimen is key to controlling symptoms of rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and it is important that patients without private insurance plans have the same access to new, innovative treatments that become available in Canada," added Dr. Maksymowych. "We hope that all provinces will follow this example."

Merck will continue to work with the other provinces currently considering providing access to SIMPONI(TM) for appropriate patients diagnosed with these rheumatic conditions.