SIMPONI™ (golimumab) Receives Positive Opinion From CHMP in Europe for Reduction in the Rate of Joint Damage Progression in Treatment of Active Rheumatoid Arthritis

MSD (known as Merck in the U.S. and Canada) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for use of SIMPONI™ (golimumab), in combination with methotrexate (MTX) in adults with severe, active and progressive rheumatoid arthritis (RA) not previously treated with MTX and for the reduction in the rate of progression of joint damage as measured by X-ray in RA patients. The EMA granted approval of SIMPONI in October 2009 as the first once-monthly subcutaneous injection anti-tumor necrosis factor (TNF)-alpha for the treatment of moderate-to-severe RA, active and progressive psoriatic arthritis (PsA) and severe, active ankylosing spondylitis (AS).

"MSD is proud to be a leading provider of rheumatic disease therapies within the European rheumatology community,” said Dr. Alan Ezekowitz, senior vice president and franchise head, Merck Research Laboratories. "The CHMP's recommendation is an acknowledgement of the potential benefits that rheumatoid arthritis patients may realize through therapy with SIMPONI. This is an important step toward a final decision by the European Commission (EC) on the pending label variation for SIMPONI.”

The CHMP adopted their opinion based on a review of data from the Phase III GO-BEFORE (GOlimumab Before Employing methotrexate as the First-line Option in the treatment of Rheumatoid arthritis of Early onset) trial, in which two-year study data showed the efficacy of SIMPONI in a MTX-naïve patient population and in reducing the rate of joint damage as evaluated by X-ray.

The request for a Type II label variation for SIMPONI is following the Centralized Procedure. MSD anticipates receiving a final decision from the EC by early 2011. The EC decision will apply to all 27 European Union (EU) Member States.

Centocor Ortho Biotech Inc. ("Centocor") discovered and developed SIMPONI and has exclusive marketing rights to the product in the United States.

A subsidiary of MSD has exclusive marketing rights outside the United States except in China, Japan, Indonesia, Taiwan and Hong Kong. The subsidiary's rights to market SIMPONI are the subject of an arbitration with Centocor, which has been previously disclosed.

About SIMPONI

SIMPONI is a human monoclonal antibody that targets and neutralizes excess tumor necrosis factor (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 RA in combination with methotrexate, active PsA and active AS and is available either through the SIMPONI™ autoinjector or a prefilled syringe.

About Rheumatoid Arthritis

RA is a chronic and debilitating disease that affects 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 the GO-BEFORE Trial

GO-BEFORE, a Phase III, multi-center, double-blind, placebo-controlled study included 637 MTX-naïve adults with RA. Patients with active RA who had more than four tender and swollen joints were included in the multicenter study. The primary endpoint was ACR50 at week 24. Patients were randomized into four groups to receive placebo plus methotrexate (Group 1), SIMPONI 100 mg plus placebo (Group 2), SIMPONI 50 mg plus methotrexate (Group 3) or SIMPONI 100 mg plus methotrexate (Group 4).

Important Safety Information

In the EU, SIMPONI is contraindicated in patients with active tuberculosis, severe infections such as sepsis, opportunistic infections, in patients with moderate or severe heart failure (NYHA Class III/IV), as well as in patients who are hypersensitive to SIMPONI or any of its excipients. Serious infections, including sepsis, pneumonia, tuberculosis, invasive fungal and other opportunistic infections have been observed with the use of TNF antagonists including SIMPONI. Some of these infections have been fatal. SIMPONI should not be given to patients with a clinically important, active infection. Caution should be exercised when considering the use of SIMPONI in patients with a chronic infection or a history of recurrent infection. Patients should be monitored for signs and symptoms of infection before, during and for several months after treatment with SIMPONI. If a patient develops a serious infection or sepsis, SIMPONI therapy should be discontinued and appropriate antimicrobial therapy should be initiated. Patients should be advised of and avoid exposure to potential risk factors for infection as appropriate. For patients who have resided in or traveled to regions where invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of SIMPONI treatment should be carefully considered before initiation of SIMPONI therapy. Patients must be evaluated for the risk of tuberculosis (TB), including latent TB, prior to initiation of SIMPONI. If active TB is diagnosed, SIMPONI must not be initiated. If latent TB is suspected then the benefit/risk balance should be considered for the following: treatment of latent TB infection should be initiated prior to therapy with SIMPONI. Antituberculosis therapy prior to initiating SIMPONI should also be considered in patients who have several or highly significant risk factors for TB infection and have a negative test for latent TB. Patients receiving SIMPONI should be monitored closely for signs and symptoms of active TB during and after treatment, including patients who tested negative for latent TB infections.

The use of TNF-blocking agents including SIMPONI has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of the virus. Some of these cases have been fatal. Chronic carriers of HBV should be appropriately evaluated and monitored prior to the initiation of, during treatment with, and for several months following discontinuation of SIMPONI. In patients who develop HBV reactivation, SIMPONI should be discontinued.

Lymphomas have been observed in patients treated with TNF-blocking agents, including SIMPONI. The incidence of non-lymphoma malignancies was similar to controls, and lymphoma is seen more often than in the general population. The potential role of TNF-blocking therapy in the development of malignancies is not known. Based on an exploratory clinical trial in patients with COPD, caution should be exercised when using any TNF-blocking therapy in COPD patients, as well as in patients with an increased risk for malignancy due to heavy smoking.

Worsening and new onset congestive heart failure (CHF) and increased mortality due to CHF have been reported with another TNF blocker. SIMPONI has not been studied in patients with CHF. SIMPONI should be used with caution in patients with mild heart failure and must be discontinued if new or worsening symptoms of heart failure appear. TNF-blocking agents, including SIMPONI, have been associated in rare cases with new onset or exacerbation of demyelinating disorders, including multiple sclerosis. The benefits and risks of anti-TNF treatment should be carefully considered before initiation of SIMPONI therapy in patients with pre-existing or recent onset of demyelinating disorders. There is limited safety experience of SIMPONI treatment in patients who have undergone surgical procedures, including arthroplasty. A patient who requires surgery while on SIMPONI should be closely monitored for infections, and appropriate actions should be taken.

The possibility exists for TNF-blocking agents, including SIMPONI, to affect host defenses against infections and malignancies. Treatment with SIMPONI may result in the formation of auto-antibodies and, rarely, in the development of a lupus-like syndrome. There have been postmarketing reports of pancytopenia, leukopenia, neutropenia, aplastic anemia, and thrombocytopenia in patients receiving TNF blockers. Cytopenias including pancytopenia, have been infrequently reported with SIMPONI in clinical trials. Discontinuation of SIMPONI should be considered in patients with significant hematologic abnormalities.

The concurrent administration of TNF-antagonists with anakinra or abatacept is not recommended. Concurrent administration has been associated with increased infections, including serious infections without increased clinical benefit.

Patients treated with SIMPONI may receive concurrent vaccinations, except for live vaccines. Non-serious allergic reactions associated with SIMPONI occurred in clinical trials, and included urticaria, bronchospasm, and hypersensitivity. If an anaphylactic reaction or other serious allergic reactions occur, administration of SIMPONI should be discontinued immediately and appropriate therapy initiated.

The needle cover on the syringe in the pre-filled pen is manufactured from dry natural rubber containing latex, and may cause allergic reactions in individuals sensitive to latex. SIMPONI also contains sorbitol; patients with rare hereditary problems of fructose intolerance should not take SIMPONI. All patients should be monitored for anaphylactic or other serious allergic reactions.

Patients should be given detailed instructions on how to administer SIMPONI. After proper training, patients may self inject if their physician determines that this is appropriate. The full amount of SIMPONI should be administered at all times. Mild injection site reactions commonly occur. In case of severe reaction(s) SIMPONI should be discontinued.

Women of childbearing potential must use adequate contraception to prevent pregnancy and continue its use for at least six months after the last SIMPONI treatment. Women must not breast feed during and for at least six months after SIMPONI treatment.

The most common adverse drug reaction reported from clinical trials through week 16 was upper respiratory tract infection (7.2 percent of SIMPONI-treated patients compared with 5.8 percent in control-treated patients). In controlled Phase III trials through Week 16 in RA, PsA and AS, 5.8 percent of SIMPONI-treated patients had injection site reactions compared with 2.2 percent in control-treated patients. The majority of the injection site reactions were mild and moderate, and the most frequent manifestation was injection site erythema.

For complete EU prescribing information, please visit www.emea.europa.eu. For the full U.S. Prescribing Information and Medication Guide, please visit www.SIMPONI.com.

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