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Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly) -- Ignore unavailable to you. Want to Upgrade?

To: Anthony Wong who wrote (1198)	12/7/1998 12:10:00 AM
From: Anthony Wong	Respond to of 1722

Sankyo Says It Can't Confirm Report About 33 Deaths From Its Diabetes Drug Bloomberg News December 6, 1998, 10:57 p.m. ET Tokyo, Dec. 7 (Bloomberg) -- Sankyo Co., Japan's second- biggest pharmaceutical company, said it can't confirm a U.S. newspaper's report that a diabetes drug it makes is linked to the deaths of 33 people since its 1997 introduction. The drug Rezulin (troglitazone), sold as Noscal in Japan, is marketed in the U.S. by Warner-Lambert Co. of Morris Plains, New Jersey, under a licensing agreement. ''We're trying to find out what's going on,'' said Shigemichi Kondo, a spokesman at Sankyo. ''We know about the report, and are waiting for Warner-Lambert's statement.'' Thirty-three deaths have been blamed on liver injuries in Rezulin patients, up from 21 fatal cases cited earlier this year, the Los Angeles Times reported yesterday. Since Rezulin's introduction in March 1997, the language on its warning label has been strengthened three times. A black box on the label -- considered the Food and Drug Administration's strongest warning measure -- highlights a description of Rezulin's risks. ''Obviously it's not positive news, but as the FDA has noted, the drug's benefits continue to outweigh the risks,'' said Mayo Mita, a pharmaceutical analyst at Morgan Stanley Japan Ltd. who has an ''outperform'' rating on the drug. ''I continue to believe the drug will be used, but carefully.'' ''We still feel that the drug is safe and effective when used as indicated,'' said FDA spokesman Brad Stone. As with any drug, the FDA will monitor reports of problems and update the drug's label when necessary, Stone said. Sankyo rose as much as 55 yen to 2,750 yen in morning session, on volume of 603,000 shares, almost half of three-month daily average. Rezulin Sankyo, the world's 21st-largest drugmaker, said it's expecting Rezulin sales to rise 6.1 percent to 185.1 billion yen for the year ending in March 1999. That's because the number of patients taking the drug has increased to a million -- 800,000 in the U.S. and 200,000 in Japan -- after the company modified the prescription stipulations to require monthly blood tests, according to HSBC Securities Co. Rezulin, used to treat type II diabetes, accounted for 6.4 percent, or 29.4 billion yen of Sankyo's sales for the year ended in March. Of Rezulin's 29.4 billion yen sales, 73 percent is exported, mainly to the U.S., where it is marketed through Warner- Lambert. Sankyo said in November that a 65.6 percent rise in sales of Rezulin helped lift parent first-half profit 3 percent. Rezulin sales account for about 3 percent of Japan's 5-trillion- yen prescription drug market. Prior to the launch of Rezulin, there was no drug that had the same efficiency as Rezulin, analysts said. Sankyo's drug is different from competitors' diabetes drug because it improves the the body's ability to use insulin, while others don't they said. The company has acknowledged the six deaths in the U.S. and Japan and 13 cases of liver problems in Japan linked to the drug. No further deaths have been reported to Sankyo, Kondo said, because doctors have begun monitoring liver function in patients using the drug, Sankyo's Kondo said. Rezulin sales in the U.S. recovered 6.1 percent to 25.9 percent of revenue for the six months ended Sept. 30, compared to the same period a year earlier. The company expects sales of the drug in the U.S. will rise 12.3 percent for the year ending in March 1999. Glaxo Wellcome Plc suspended sales of Rezulin in the U.K. in December 1997 after reports linking it to patients' deaths, but the U.K. drugmaker plans to reintroduce the drug and is in talks with the British government. --Kae Inoue with reporting from Hidekiyo Sakihama and Jim Bonner