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CYTOTEC (MISOPROSTOL) RECEIVES REGULATORY APPROVAL AND PRICING IN JAPAN

 CHICAGO, March 24 /PRNewswire/ -- Searle announced today that Cytotec (R) (misoprostol) has received a reimbursement price in Japan and has been added to the Pharmaceutical Tariff, the Ministry of Health and Welfare's listing of drugs permitted for Japan's national insurance system. This addition was published March 19 by the Ministry of Health and Welfare with immediate effect.
 Approval for marketing of Cytotec in Japan -- the world's second largest pharmaceutical market -- was obtained on Jan. 19 of this year. The product will be launched March 25.
 Misoprostol is manufactured and marketed by Searle under the trade name Cytotec in more than 70 countries around the world, including the U.S., Canada, Italy, Germany, France and the U.K., for the prevention and/or treatment of NSAID-induced ulcers. Japan represents the final major market in which Cytotec will be launched.
 In Japan, Cytotec is the only drug approved and proven effective for the treatment of NSAID-induced gastric ulcers and duodenal ulcers.
 Cytotec, a synthetic prostaglandin analogue, has a distinct mode of action that differentiates it from anti-ulcer drugs previously on the market. Cytotec inhibits gastric acid secretion, stimulates gastric mucus production, increases bicarbonate secretion and enhances mucosal blood flow, thus strengthening the integrity of the gastric mucosal barrier against the damage caused by NSAIDs. This distinct mechanism of action makes Cytotec uniquely indicated for gastric ulcers and duodenal ulcers associated with long-term treatment with nonsteroidal anti- inflammatory drugs (NSAIDs).
 NSAIDs include non-prescription drugs such as aspirin (acetylsalicylic acid), as well as dozens of prescription medications. Regular use of NSAIDs is necessary to transform many patients afflicted with arthritis pain into active, relatively pain-free individuals, but NSAIDs may also lead to unwanted side effects such as stomach ulcers. Thousands of deaths worldwide each year are believed to result from complications of NSAID-induced ulcers.
 A recent epidemiological study of Japanese arthritis patients shows that ulcers are a common occurrence among patients receiving NSAIDs for treatment of chronic pain and inflammation. The extensive study of 1,008 rheumatic patients was reported in 1992 by Professor Masashi Nobunaga, M.D., at the Seventh Asia-Pacific League Against Rheumatism (APLAR) Congress of Rheumatology in Bali, Indonesia. Nobunaga, a professor at the Medical Institute of Bioregulation at Kyushu University in Japan, coordinated the study for the Japan Rheumatism Foundation. The study shows that 17.4 percent of patients on NSAID therapy for rheumatic disease had gastroduodenal ulcers.
 "Perhaps the most important finding was that there is no significant correlation between gastroduodenal damage and the presence of gastrointestinal symptoms in these patients," said Nobunaga. "Over 40 percent of the patients with ulcers had not reported symptoms that would indicate the presence of those ulcers. The high proportion of asymptomatic disease is important because of the potential for gastrointestinal bleeding and perforation associated with undiagnosed ulcers."
 Serious complications can be associated with NSAID-ulcers, especially in patients who lack symptoms of developing ulcers. According to recent research, most Japanese physicians currently coprescribe some kind of anti-ulcerants with NSAIDs. These drugs, such as H2-antagonists, are not indicated for NSAID-ulcers. Cytotec, when prescribed as cotherapy with NSAIDs, allows physicians to provide relief from pain and inflammation while substantially reducing the incidence of NSAID-induced ulcers.
 Previously, physicians have attempted to treat NSAID ulcers with H2-antagonists, but the ulcers often resist this treatment. It has been demonstrated that Cytotec is effective for the treatment of H2- antagonist resistant NSAID-induced gastric and duodenal ulcers while NSAID use is continued.
 NSAID-induced ulcers are not to be confused with recurrent duodenal ulcers that may be caused by the bacteria H. pylori. A recent study published in The New England Journal of Medicine suggests a causal role of H. pylori in recurrent duodenal ulcers and brings to light the inefficacy of exclusive treatment with H2-antagonists in eliminating these types of ulcers. Antibiotics, including metronidazole, are effective in the treatment of recurrent duodenal ulcers associated with H. pylori, according to the study. The study recommended that Cytotec should be used for NSAID-induced ulcers.
 In clinical trials with misoprostol the most frequently reported side effects were diarrhea, abdominal pain and flatulence. These events were usually transient and mild to moderate in severity. Misoprostol is contraindicated in pregnancy.
 Searle is a research-based pharmaceutical company that develops, manufactures and markets prescription pharmaceuticals worldwide. It is a wholly owned subsidiary of Monsanto Company (MTC/NYSE).
 -0- 03/24/93
 /CONTACT: Jack Domeischel, 708-470-6720, or Jeff Newton, 708-470-6280, both of G.D. Searle & Co./
 (MTC)


CO: G.D. Searle & Co.; Monsanto Company ST: Illinois IN: MTC SU:

AH -- NY035 -- 9085 03/24/93 11:55 EST
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Date:Mar 24, 1993
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