Merck Annual Report 2000

    In less than two years on the market, Vioxx has become the world’s fastest-growing branded prescription drug for osteoarthritis and acute pain and Merck's second largest-selling medicine. Global sales are running at an annual rate of more than $2 billion, bringing it level with the other entry in the COX-2 field, despite a later start in the United States, the world’s largest market. Our drug already accounts for about half of all new COX-2 prescriptions written in the United States.
    Vioxx is the only COX-2 indicated in the United States both for osteoarthritis and acute pain. In a new study presented late in 2000, Vioxx reduced moderate to severe acute pain caused by dental surgery to a significantly greater degree than a single dose of a narcotic combined with acetaminophen.
    No wonder that more and more physicians are prescribing Vioxx for their patients. It has gained significant use in the COX-2 inhibitor class, and has seized about 20 percent of the $9 billion worldwide market for arthritis and pain medications. We believe our medicine’s rate of growth will be aided by a combination of patient outreach programs that include a U.S. consumer advertising campaign designed to encourage patients to see their doctors. Yet, Merck believes this is just the beginning.
    The global market is growing rapidly because the populations of countries in the developed world are aging rapidly. For such patients, physicians prefer medications that are strong but well-tolerated; once-daily Vioxx qualifies on all counts.
    Nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen are associated with serious gastrointestinal (GI) side effects in some patients. In November 2000, The New England Journal of Medicine published the results of VIGOR, our 8,000-patient study, which showed that Vioxx reduced the risk of serious GI complications by half when compared with the NSAID naproxen. The Food and Drug Administration Arthritis Advisory Committee recommended in February 2001 that the study’s results, as well as data on certain cardiovascular events, should be included in the labeling. The FDA is not obligated to follow the advice of the Advisory Committee.
    Although the VIGOR study was a GI outcomes study and was not designed to show differences in cardiovascular effects, significantly fewer heart attacks were observed in patients taking naproxen (0.1 percent) compared to the group taking Vioxx 50mg (0.5 percent) in this study. There was no difference in cardiovascular mortality between the group treated with Vioxx or naproxen.
    Further growth prospects exist in potential new uses for Vioxx. These include:
    Rheumatoid Arthritis: We are exploring the use of Vioxx as a treatment for this disease. Millions of people around the world – 2.1 million of them Americans – suffer from the inflammation, swelling, and joint pain that characterize rheumatoid arthritis. In severe cases, the disease cripples by destroying joints, cartilage, bones and ligaments. Musculoskeletal conditions, which include rheumatoid arthritis, cost the U.S. economy nearly $65 billion per year in medical care, lost wages and production, according to the Arthritis Foundation.
    Colon Polyps and Cancer: We are running clinical studies to see if Vioxx reduces the rate and progression of “spontaneously-occurring” colorectal polyps when taken regularly. These small polyps growing in the large intestine may be benign at first but pose a potential danger. They can grow in size and may lead to bleeding and colon cancer. Indeed, The American Cancer Society estimates that 90 percent of this third-most prevalent of all cancers affecting Americans develops from previously benign polyps. Our study is designed to see if Vioxx can play a role in reducing the number of these growths and thereby help reduce incidence of this cancer.
    Alzheimer’s Disease: Alzheimer’s disease causes tens of millions of people over the age of 65 – 4 million of them Americans – to lose all or most of their memory and their ability to function. The Alzheimer’s Disease Foundation warns these numbers will increase exponentially, tripling in the next 20 years alone, as more and more people live into their 80s and 90s. Epidemiological studies suggest that people who regularly take NSAIDs like aspirin and ibuprofen have a lower risk of developing Alzheimer’s. That has prompted us to study whether Vioxx has a role to play.

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