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Alberta, New Brunswick, Nova Scotia and NIHB (Non-Insured Health Benefits
Program) lead the way with the listing of SIMPONI™ for three rheumatic
conditions


News provided by

Merck

Aug 17, 2010, 06:59 ET

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

MONTREAL, Aug. 17 /CNW Telbec/ - Merck is pleased to announce that New Brunswick, Nova Scotia and Alberta are the first provinces in Canada to reimburse SIMPONITM(golimumab) for the treatment of three different rheumatic conditions. SIMPONITM, 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, SIMPONITM, a once-monthly, patient-administered subcutaneous injection. SIMPONITM 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.

"SIMPONITM represents an advance as the first once-monthly patient-administered anti-TNF alpha therapy. Clinical evidence from the SIMPONITM 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 SIMPONITM 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 SIMPONITM 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 SIMPONITM 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 SIMPONITM for appropriate patients diagnosed with these rheumatic conditions.

About SIMPONITM
SIMPONITM 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, SIMPONITM is approved in Canada for the treatment of moderate to severe rheumatoid arthritis, moderate to severe psoriatic arthritis and ankylosing spondylitis, and is available for administration either with the SIMPONITM SmartJectTM autoinjector or with a pre-filled syringe.

About Merck
Today's Merck is a global healthcare leader. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.ca.

Forward Looking Statement
This information includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the proposed merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's and Schering-Plough's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.

The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period, due to, among other things, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to litigation and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2008 Annual Report on Form 10-K, Schering-Plough's Quarterly Report on Form 10-Q for the quarterly period ended Sept. 30, 2009, the proxy statement filed by Merck on June 25, 2009 and each company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).

TM SIMPONI and SmartJect are trademarks of Centocor Ortho Biotech Inc., used under license by Schering-Plough Canada Inc.

For further information:

Media Contacts: Mona Aubin       Tamara Macgregor


Merck
514-428-376
[email protected]
      Hill and Knowlton Canada
      416-413-4625
      [email protected]

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