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To: Anthony Wong who wrote (1023)	11/10/1998 10:18:00 PM
From: Anthony Wong	Respond to of 1722

11/10 19:38 Merck says new drug Vioxx effective in arthritis By Mark Egan LOS ANGELES, Nov. 10 (Reuters) - A new drug designed to compete with popular anti-inflammatory pills like Motrin and aspirin, is effective in treating the most common and severe forms of arthritis, researchers said on Tuesday. Researchers said phase III trials of Vioxx, known generically as rofecoxib, showed it was equally effective in relieving pain and inflammation in patients with osteoarthritis as the most commonly prescribed drugs currently available. Phase III trials are typically the last stage before seeking regulatory approval for a drug. Osteoarthritis is the most common form of arthritis affecting about 20 million Americans. It is caused by the wearing down of cartilage in the joints and often results in patients needing hip or knee replacement surgery. The two trials compared Vioxx with high doses of diclofenac, which is marketed as Voltaren, and ibuprofen, which is marketed as Advil and Motrin, and found the new drug to be as effective in treating pain and improving joint functions. Vioxx, made by Merck & Co. <MRK.N> is part of a new class of drugs knows as Cox-2 inhibitors. The drug fights pain and inflammation by blocking the so-called Cox-2 enzyme. Commonly available drugs such as Motrin, aspirin and Voltaren also work by inhibiting the Cox-2 enzyme, but often cause ulcers and other gastrointestinal side effects by also blocking the Cox-1 enzyme which protects the stomach lining. "When we looked at Vioxx's effectiveness compared to the most commonly used drugs available it was equally effective," Dr. Michael Franklin, chief of rheumatology at the Abington Memorial Hospital, Philadelphia, and a lead investigator in the trials -- paid for my Merck -- told Reuters. "The bottom line that we hope to show is that we can have equal effectiveness with significantly decreased side effects like ulcers, bleeding and other stomach problems," he said. Franklin said about 76,000 people are admitted to hospitals annually as a result of side effects from anti-inflammatory drugs with about 7,600 deaths each year attributed to the drugs. He said those problems could be largely eradicated with the use of Cox-2 inhibitors. A separate phase II trail of Vioxx found it to be effective in treating rheumatoid arthritis, the most severe form of the disease. Rheumatoid arthritis affects 2.5 million Americans and can cripple patients as the joints are destroyed. The rheumatoid arthritis trial showed that twice as many patients taking the drug compared to those taking a placebo reported an easing of symptoms and pain. Results of the trials were presented at the American College of Rheumatology's annual meeting in San Diego. Merck plans to file for regulatory approval of Vioxx as a treatment for osteoarthritis later this year. Another company, Monsanto Co.'s <MTC.N> G.D. Searle drug unit, will present data on a competing Cox-2 inhibitor called Celebra at the meeting later this week.

To: Anthony Wong who wrote (1023)	11/10/1998 10:39:00 PM
From: Anthony Wong	Read Replies (2) \| Respond to of 1722

New Arthritis Drugs Praised Tuesday November 10 5:58 PM ET By PHIL GALEWITZ AP Business Writer NEW YORK (AP) - The pharmaceutical industry is announcing big gains in the fight against arthritis this week, with several companies reporting they can now reduce pain and slow progression of the often debilitating illness. The federal government has approved two new drugs to treat rheumatoid arthritis since September, drugs that aim to help those with moderate-to-severe forms of the disease. But industry observers say the biggest advances will occur next year with the expected approval of arthritis drugs made by Searle Inc. and Merck & Co. These drugs will treat the pain and inflammation associated with arthritis without the stomach problems associated with today's over-the-counter and prescription drugs, the companies say. These drugs, called Cox-2 inhibitors, are likely to be marketed to people with rheumatoid arthritis and osteoarthritis - or nearly 40 million Americans. The arthritis drugs, those in testing and those on the market, are being showcased this week at the American College of Rheumatology meeting in San Diego, where each company is trying to show arthritis doctors why its treatment works best. ''This is a tremendous time,'' said Dr. Brian Butcher, an official with the Arthritis Foundation. ''We have gone from where we could not offer much hope to people to where we can diagnose, provide early treatment and stop the progression of the disease.'' Rheumatoid arthritis afflicts 2.1 million Americans. It occurs when patients' immune systems go awry and attack their joints, causing inflammation and stiffness as rogue immune cells eat away cartilage. Osteoarthritis affects more than 37 million Americans, and is usually associated with the aging process. In the past year, doctors wrote 76.7 million prescriptions for anti-arthritis drugs, according to IMS Health, a research group. With a number of new drugs coming on the market, analysts expect sales to increase from $1.9 billion to $3 billion by 2001. Among its many players, the pain wars pit Merck, the largest drug company worldwide in terms of sale, against the fastest growing company, Pfizer. Pfizer will market Celebra, the Cox-2 inhibitor made by Searle, a division of Monsanto. The federal Food and Drug Administration's advisory committee has scheduled a hearing on Celebra for Dec. 1. Merck hopes to file for FDA approval for its Vioxx drug later this year. Company officials say they are not concerned about lagging behind Celebra for federal approval. One reason is because Vioxx is designed as a once-a-day pill, while Celebra will have to be taken several times daily. Dr. Bennett Shapiro, an executive vice president with Merck, attributed the surge of interest in arthritis to scientific discoveries in 1991 that showed that two different enzymes cause the body to make hormones that bring pain and inflammation and also protect the stomach lining. As a result, drugs could be developed that stopped the pain, but left the stomach alone. Immunex Corp., which won federal approval last week for its Enbrel arthritis drug, is working with American Home Products Corp. to market it. Enbrel is given via injection twice a week and studies show it reduces pain and duration of morning stiffness and improves swollen and tender joints. Enbrel used the meeting in San Diego to show that the drug is also effective in children. Centocor Inc. used the meeting to show its experimental drug Remicade also provides relief from rheumatoid arthritis. Remicade is already approved to treat Crohn's disease, an intestinal disorder. The company hopes to win approval to treat arthritis with the drug next year. Enbrel and Remicade will compete with Arava, the arthritis drug approved by the FDA in September. Arava, made by Hoechst Marion Roussell, bills itself as the only approved drug that helps stop the progression of rheumatoid arthritis. dailynews.yahoo.com