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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 (726)9/1/1998 6:19:00 PM
From: Anthony Wong  Read Replies (2) | Respond to of 1722
 
FDA panel rejects Warner prostate cancer drug
Tuesday September 1, 1:03 pm Eastern Time

BETHESDA, Sept 1 (Reuters) - A U.S. Food and Drug Administration advisory panel voted unanimously on Tuesday against approving Warner-Lambert Inc.'s (WLA - news) Metaret drug for prostate cancer.

The panel said that the drug did not work against the cancer, but said that it did relieve pain. The FDA generally follows its panels' advice.

In voting against approval, panel members said they were not sure which patients would benefit from Metaret, noting that only those with the mildest pain had some improvement in the main Warner-Lambert study.

''The patients who seem to be in most need of help miss out,'' said panelist Derek Raghavan of the University of Southern California.

In the study, 42 percent of the 228 patients taking Metaret had less pain, compared with only 28 percent of a similar number of patients taking placebo. The improvement lasted an average 240 days, said Michael Slichenmyer, senior director of oncology research at Warner-Lambert's Parke-Davis division.

The drug also halved narcotic use, and delayed disease progression, said Slichenmyer.

But the FDA said Metaret only modestly decreased pain and narcotic use, and only in patients who had mild pain at the start.

Prostate cancer, the second leading cause of cancer death in U.S. men, kills 40,000 men a year. About 5 percent of the 244,000 men diagnosed each year in the United States have advanced disease.

Those men have severe pain and require increasing doses of narcotics. Survival is only about two to three years.

Warner-Lambert could not say whether its drug, known generically as suramin, increased survival, partly because almost 70 percent of patients switched from placebo to suramin before the study ended.

Metaret has been around since the 1920s, when it was first used as an anti-parasite drug.

It has never been sold in the United States, but in the 1980s, the National Cancer Institute discovered that the drug might have anti-tumor effects. Warner-Lambert jointly developed Metaret with the NCI.

More study has shown that Metaret inhibits the function of certain growth factors that are thought to be involved in pain, and that it also may block growth of capillaries that feed tumor growth.

The most common side effects were rash, swelling, and weakness. Warner-Lambert said the effects were mostly mild, noting that only twenty-four Metaret patients dropped out of the study.




To: Anthony Wong who wrote (726)9/1/1998 6:29:00 PM
From: Anthony Wong  Respond to of 1722
 
Drug group, minus AHP , partially rebounds
Tuesday September 1, 5:51 pm Eastern Time

NEW YORK, Sept 1 (Reuters) - The largest U.S. drugmakers Tuesday collectively recovered over half the losses they suffered in Monday's sharp decline, with only American Home Products Corp. (AHP - news) bucking the bounce-back trend.

Analysts said AHP was left behind after quietly lowering its earnings guidance slightly for the third quarter and for 1998 on Monday.

The American Stock Exchange Pharmaceutical Index, comprised of 11 of the largest U.S. drug companies and several European players, rose 4.96 percent -- recouping the majority of its 8.4 percent loss from Monday.

The Dow Jones Industrials Average finished up 288 points, or 3.82 percent. It had plunged 512 points, or 6.37 percent on Monday.

''The drug stocks have recaptured a big part of yesterday's losses in line with the recovery we've seen today in the (broad) U.S. stock market,'' said Southeast Research Partners drug analyst Neil Sweig.

''There's nothing wrong with the fundamentals or the operating earnings of these pharmaceutical companies, so they're recovering,'' Sweig said, adding most of them were swept along willy-nilly in Monday's market selloff.

American Home Products, however, skipped Tuesday's festivities, instead edging down 7/8 to 49-1/4. Its shares had fallen 6-3/16 on Monday.

Salomon Smith Barney drug analyst Christina Heuer issued a research call note Tuesday saying American Home had ''talked down'' its earnings guidance to $0.46 for the third quarter of 1998 and to $1.80 for the full year of 1998.

She said AHP's new third quarter guidance was one cent below the consensus forecast of analysts polled by First Call and that its 1998 guidance was three cents below the First Call projection.

Heuer was not immediately available for comment, but a member of her staff told Reuters that AHP had lowered its guidance in a telephone conversation with Salomon Smith Barney on Monday.

AHP spokesman Lowell Weiner said he could not comment on the reported change in AHP's earnings guidance, adding the company had made no news announcements of any kind Tuesday.

Shares of Bristol-Myers Squibb Co. (BMY - news) jumped 7-1/4 to 105-1/8 on Tuesday. They had plunged 10-15/16 on Monday.

Warner-Lambert Co (WLA - news), which markets the blockbuster anti-cholesterol drug Lipitor, rose 6-3/8 to 71-5/8. It had fallen 9-1/4 on Monday.

Drug giant Merck & Co (MRK - news) reclaimed 6-1/8 of its 11-7/16 loss from Monday, closing Tuesday at 122-1/16.

Schering-Plough Corp (SGP - news), which fell 9 points on Monday, snatched back 5-3/8 to close at 91-3/8.

Eli Lilly and Co (LLY - news), which markets the antidepressant Prozac and schizophrenia drug Zyprexa, rose 3-15/16 to 69-7/16. It had fallen 6-3/4 on Monday.

Pfizer Inc (PFE - news), which fell 8-5/8 on Monday, recouped 3-9/16 to 96-9/16.

Johnson & Johnson, which slipped 5-3/16 on Monday, rose 3-1/2 to 72-1/2. And Pharmacia & Upjohn, which dropped 3-1/4 on Monday, edged 11/16 higher to 42-1/4.

Although most major U.S. drug companies are well off their highs for 1998, the American Stock Exchange Pharmaceutical Index remains ahead 19.7 percent for the year to date.