SIMPONI® (Golimumab) Receives European Commission Approval for Reduction in the Rate of Peripheral Joint Damage Progression in Treatment of Active Psoriatic Arthritis

Revised Labeling Includes Reducing Structural Damage in Treatment of Psoriatic Arthritis

06/06/2011 — WHITEHOUSE STATION, N.J. — (BUSINESS WIRE)

MSD (known as Merck in the United States and Canada) today announced that the European Commission (EC) has approved a new indication for SIMPONI® (golimumab) in the treatment of active and progressive psoriatic arthritis to reduce the rate of progression of peripheral joint damage as measured by X-ray in psoriatic arthritis patients with polyarticular symmetrical subtypes of the disease. SIMPONI, alone or in combination with methotrexate (MTX), is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. The EC approval of reducing radiographic progression in psoriatic arthritis follows a positive opinion adopted on 14 April 2011 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.

“This recent European Commission approval recognizes the value of SIMPONI in reducing peripheral joint damage progression and reflects the range of important therapeutic effects of this once-monthly anti-TNF-alpha therapy in the treatment of psoriatic arthritis,” said Rupert Vessey, MRCP–DPhil, Senior Vice President, Franchise Head, Respiratory and Immunology at Merck Research Labs. “The announcement marks another major milestone for SIMPONI and for the patients living with psoriatic arthritis who might benefit from this treatment.”

The EC granted the approval based on a review of data from the multi-centre, randomized, double-blind, placebo-controlled GO-REVEAL (GOlimumab – A Randomized EValuation of Safety and Efficacy in Subjects with Psoriatic Arthritis Using a Human Anti-TNF MonocLonal Antibody) trial that showed the efficacy of SIMPONI in reducing the rate of progression of peripheral joint damage in patients. Structural damage in both hands and feet was assessed radiographically by the change from baseline in the van der Heijde-Sharp (vdH-S) score, which was modified for psoriatic arthritis with the addition of hand distal interphalangeal (DIP) joints. Out of 146 patients who were randomized to SIMPONI 50 mg, 52-week X-ray data were available for 126 patients, of whom 77 percent showed no progression compared to baseline. At week 104, X-ray data were available for 114 patients, and 77 percent continued to show no progression from baseline.

The EC granted the 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 active rheumatoid arthritis (RA), active and progressive psoriatic arthritis (PsA) and severe, active ankylosing spondylitis (AS). In January 2011, the EC approved a new indication for the use of SIMPONI in combination with MTX allowing for the treatment of adults with severe, active and progressive RA not previously treated with MTX, and for the reduction in the rate of progression of joint damage as measured by X-ray in patients with RA.

About the GO-REVEAL Trial

The GO-REVEAL trial involved 405 adults with active psoriatic arthritis. Patients were randomly assigned to receive subcutaneous injections of placebo or SIMPONI (50 or 100 mg) every four weeks for 24 weeks. The primary endpoint was ACR 20 response at week 14 for combined SIMPONI groups and individual SIMPONI dose groups versus placebo. At week 16, patients with inadequate response entered early escape. Patients randomized to placebo were transitioned to SIMPONI 50 mg at week 24. In the open-label trial extension, patients could be dose-escalated from SIMPONI 50 mg to SIMPONI 100 mg. Analyses at 104 weeks were based on observed data and randomized groups, and no statistical comparisons were done. Patients are followed for approximately five years.

About Psoriatic Arthritis

Psoriatic arthritis is a chronic inflammatory arthropathy manifesting with joint pain and swelling that can lead to joint destruction and debilitation over time. Symptoms may include stiffness and tenderness of the joints and surrounding tissue and reduced range of motion. Joints of the hands, wrists, knees, ankles, feet, lower back and neck are commonly affected. Psoriasis affects an estimated two to three percent of the world’s population, and approximately one out of three patients affected by psoriasis may develop psoriatic arthritis. Both men and women are equally affected by psoriatic arthritis, most commonly between the ages of 30 and 50, in the peak of their productive years.

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 rheumatoid arthritis in combination with methotrexate, active psoriatic arthritis and active ankylosing spondylitis and is available either through the SIMPONI® SmartJect® autoinjector or a prefilled syringe.

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

Under the terms of an amended distribution agreement announced on April 15, 2011, Merck’s subsidiary, Schering-Plough (Ireland), will relinquish exclusive marketing rights for SIMPONI [and REMICADE® (infliximab)] to Johnson & Johnson’s Janssen pharmaceutical companies in territories including Canada, Central and South America, the Middle East, Africa and Asia Pacific* effective July 1, 2011. Merck (MSD) will retain exclusive marketing rights throughout Europe, Russia and Turkey. (*In Japan, Indonesia, and Taiwan, Centocor Ortho Biotech, Inc. continues to license distribution rights to SIMPONI [and REMICADE] to Mitsubishi Tanabe Pharma Corporation).

Important Safety Information

In the European Union, 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 tuberculosis, 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 tuberculosis infection should be initiated prior to therapy with SIMPONI. Antituberculosis therapy prior to initiating SIMPONI should also be considered in patients who have several risk factors for tuberculosis infection and have a negative test for latent tuberculosis. Patients receiving SIMPONI should be monitored closely for signs and symptoms of active tuberculosis during and after treatment, including patients who tested negative for latent tuberculosis infections.

The use of TNF blocking agents including SIMPONI has been associated with reactivation of hepatitis B virus in patients who are chronic carriers of the virus. Some of these cases have been fatal. Chronic carriers of hepatitis B 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 the incidence of 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 with another anti-TNF agent, 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 6 months after the last SIMPONI treatment. Women must not breast feed during and for at least 6 months after SIMPONI treatment.

The most common adverse drug reaction reported from controlled Phase 3 clinical trials in RA, PsA and AS 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 3 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.

About MSD

Today’s MSD is a global healthcare leader working to help the world be well. MSD is a tradename of Merck & Co., Inc., with headquarters in Whitehouse Station, N.J., U.S.A. 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.msd.com.

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