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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 (429)	6/29/1998 5:01:00 PM
From: Anthony Wong	Respond to of 1722

WSJ: FDA Received Adverse Data About Viagra June 29, 1998 By Rochelle Sharpe Staff Reporter of The Wall Street Journal WASHINGTON -- Nearly three months after approving Viagra, the Food and Drug Administration had received about 100 reports of men suffering serious adverse reactions or dying after taking the impotence drug, but regulators remain convinced Viagra is safe. Altogether, as of mid-June, the FDA had received about 30 reports of men dying after taking Pfizer Inc.'s blockbuster impotence drug. Most were elderly, with other health problems. In addition to the deaths, the reports show seven men had heart attacks, eight suffered strokes, four blacked out and six had vision problems, according to government reports obtained through the Freedom of Information Act. The reports, however, probably cover only a fraction of the cases of serious side effects suffered by the two million men who have used Viagra since it hit the market in April. The government doesn't require reports on serious adverse reactions, and public-health experts figure that the FDA typically receives reports on only 1% to 10% of these reactions. Rather than track all reactions, the government searches for signals that a drug may cause unusual effects on patients, which it says it can detect from just one or two cases. The FDA has convened a team of about seven specialists to study the reports on Viagra, but has found no signals that anything unusual had occurred, said Dr. Murray Lumpkin, deputy director of the FDA's Center for Drug Evaluation and Research. It is clear that Viagra shouldn't be mixed with nitrates, a warning Pfizer puts on the drug's label. Still, several men have died after mixing Viagra and nitrates. But the latest reports raise questions about whether other drugs should be taken with Viagra, said Dr. Raymond Woosley, chairman of Georgetown University's pharmacology department. "All highblood-pressure medications are suspect," he said, since Viagra can lower blood pressure, causing a potentially dangerous drop in pressure, he said. According to the reports, at least 14 people were taking some kind of blood-pressure medication when they took Viagra, including at least four who died, three who blacked out and two who developed vision problems. Although Pfizer's package insert states that blood-pressure medications were tested and could safely be taken with Viagra, Dr. Woosley said the numbers in the study may have been so small that the company couldn't detect any reactions. He also raised concerns about taking Viagra with Glucatrol, a diabetes drug. At least five patients taking Viagra and Glucatrol or a similar drug have had bad reactions. Two died. To be sure, many of the patients who had adverse effects had a variety of diseases and were on multiple medications; without further study, it would be impossible to explain why they had bad reactions. One stroke victim was taking Viagra and 11 other medications. Some of the reports sound serious but provide so little information that it is impossible to tell whether the reactions cited actually occurred. Also, some of the reports may be duplicates. Pfizer received reports that four men in West Virginia went blind after taking the drug, but Pfizer spokesman Andy McCormick said the reports came from one salesman who heard it from an osteopath, who heard about the men. The company, which is required to forward all reports of serious reactions to the FDA, couldn't find more information about the situation. Several ophthalmologists said that the vision reactions reported to the FDA aren't cause for alarm. --- Otesa Middleton in Washington and Robert Langreth in New York contributed to

To: Anthony Wong who wrote (429)	6/29/1998 5:11:00 PM
From: Anthony Wong	Read Replies (2) \| Respond to of 1722

17:01 ET Warner Lambert/DLJ -2: Recommends Switching Out Of Pfizer By Melanie Trottman NEW YORK (Dow Jones)--Shares of pharmaceutical giant Warner-Lambert Co. (WLA) shot up to a new 52-week high Monday after Donaldson Lufkin analyst Kent Blair issued a bullish report on the company. Shares of the Morris Plains, N.J., company reached a new 52-week high of 70 1/2, displacing the previous record of 68 1/8 set on May 26. Several analysts cited the DLJ report as a reason for the stock increase. Also cited was the release of the weekly prescription numbers by healthcare auditor IMS America, which showed Warner Lambert's Lipitor and Rezulin drugs continue to gain ground in their markets. In his research note, Blair recommended that investors switch out of prescription drug manufacturer giant Pfizer Inc. (PFE) - cited as "the highest multiple pharmaceutical stock" - and into Warner Lambert. "We have a high degree of conviction that WLA will meet the numbers, whereas longer term sales of Viagra are expected to fall far short of the bull's expectations," the report said. Shares of Warner-Lambert are trading at 69 15/16, up 3, or 4.5%, on volume of 3.2 million shares. Average daily volume is 2.8 million shares. Pfizer's stock is trading down 3 1/16 Monday, or 2.7%, at 108 7/8. Volume has reached 4.7 million shares, compared with a daily average of 5.3 million. (MORE) DOW JONES NEWS 06-29-98 03:32 PM ABN Amro analyst Mario Corso said Rezulin's increased market share data released Monday for the week ended June 19 probably lifts investor concern about the drug that developed in early June. At that time, the company said a federal study trying to determine if diabetes drug Rezulin could be used to prevent the onset of diabetes was discontinued after a patient taking the drug died. The company said the death was caused by complications unrelated to the study of the medication. The incident was thought to have renewed concerns about Rezulin's impact on the liver. One analyst said that the removal of Rezulin from the National Institute of Health study could cause a short-term drop in prescriptions of the drug. According to a company spokesman, Rezulin's share of new prescriptions in the oral diabetes market increased to 10.9% for the week ended June 19, from 10.6% the previous week. The number was about 9.5% two months ago, Corso said. That was a dropoff from a high of 12% in November where it stood before the drug was relabeled to emphasize the need for more diligent liver function tests, Blair said in his report. Now, Rezulin's market share "continues to claw its way back up toward the November '97 high," the report said. Warner Lambert's cholesterol-lowering drug Lipitor also gained new prescription market share for the week ended June 19. Lipitor's share in the statin market was 38.3%, up from 38.1% a week earlier, a company spokesman said. About two months ago, the number was about 36%, Corso said. Blair expects second-quarter sales at Warner Lambert to be up about 25%, paced by what he called an "almost doubling" in the U.S. pharmaceutical business, where Lipitor and Rezulin "remain tremendously strong." Foreign pharmaceutical revenues are forecast to have expanded 25% to 30%, according to the report. Blair noted that Warner Lambert's stock has performed well in the second quarter, rising 18%, compared with the 3% increase in the S&P 500 index. Year-to-date, the company is up 62%, the report said, "significantly more" than the market's 17% gain. "Although WLA is selling at 48 times estimated '98 EPS and 37 times projected '99 EPS, we continue to recommend that investors switch out of PFE" and into Warner Lambert, the report said. Blair estimates Warner Lambert will earn $1.40 a share in 1998 and $1.82 a share in 1999. Blair, who rates the company a buy, has a 12-month price target of 80. Corso's 6-to-12-month price target is 78. Shares of Warner Lambert settled a bit from the day's high, closing at 69 3/16, up 2 1/4, or 3.4%. Pfizer finished at 109 3/4, down 2 3/16 or 2.0%. -Melanie Trottman; 201-938-5099 (END) DOW JONES NEWS 06-29-98 05:01 PM