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Biotech / Medical : wla(warner lambert) -- Ignore unavailable to you. Want to Upgrade?

To: AARON DIDICH who wrote (424)	1/19/1999 1:29:00 PM
From: Anthony Wong	Respond to of 942

Aaron, you may wish to refer to the Bloomberg article at Post# 407: Message 7320337 Excerpts: The FDA is calling the panel hearing to ask experts how it might insure the drug is marketed safely in the future, and is not considering recalling the product, said Murray Lumpkin, the deputy director of the FDA's Center for Drug Evaluation and Research. ''That's not the issue for the advisory committee,'' he said. ''It is an open ended question. ... Are there are other things we can do to market the drug more safely?'' While Warner-Lambert is scaling back some studies on wider use of the drug, it's continuing others and will ask the FDA panel to recommend it be allowed to promote the drug's use in combination with other diabetes drugs. Pressure The drug will be the only item considered by the endocrinology panel at the one-day March meeting, said Kathleen Reedy, the panel's executive secretary. ''This is a highly sensitive, highly public issue,'' she said. The hearing could end up taking some pressure off Warner- Lambert, said Ira Loss, an analyst with HSBC Washington Analysis who covers the FDA. The agency held a similar meeting to review Eli Lilly & Co.'s depression drug Prozac after it was linked to a series of violent incidents, he said. The public vetting of the drug's safety reduced pressure on Lilly and the FDA, Loss said. ''The same might also be FDA's intent here,'' Loss said. Rezulin was invented by Japan's Sankyo Co. and licensed to Warner-Lambert in the U.S. and Glaxo Wellcome Plc in Europe. Glaxo halted sales of its version of the drug last year in the U.K after at least five people died. Glaxo declined comment today except to say it is ''in the process'' of seeking U.K. approval to begin selling the drug again. Warning Strengthened Since Rezulin's introduction in March 1997, 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 the section on Rezulin's risks. No deaths or liver transplants have been reported in patients who started the drug after the third label change in July, the company said last month. That label extended the time doctors need to do monthly monitoring of Rezulin patients for possible liver damage to eight months from six months. Even with the ''black-box'' warning, doctors have still been prescribing the drug. Rezulin's third-quarter sales rose 32 percent to $181 million. Competition Concerns The real concern for Warner-Lambert may be competition. Rezulin belongs to a new class of drugs called glitazones that also includes drugs being developed by SmithKline Beecham and Eli Lilly & Co., which appear to have fewer side effects.

To: AARON DIDICH who wrote (424)	1/19/1999 4:37:00 PM
From: Anthony Wong	Read Replies (1) \| Respond to of 942

NEW YORK (Dow Jones)--Shares of Warner-Lambert Co. (WLA) fell nearly 5% Tuesday after Salomon Smith Barney downgraded the stock to outperform from buy on concerns about the diabetes drug Rezulin. But several others on Wall Street, including SG Cowen & Co. and PaineWebber Inc., said they are maintaining their buy ratings on the Morris Plains, N.J., pharmaceutical company. Warner-Lambert recently traded at 66 9/16, down 3 1/4, or 4.7%, on volume of 4.7 million shares, compared with a daily average of 2.9 million. The company announced last week that the Food and Drug Administration's Endocrinologic & Metabolic Drugs Advisory Committee will review Rezulin's post-marketing safety and efficacy data on March 26 along with a supplemental new drug application for combination therapy. The safety review follows increasing concern about the drug's potential to cause deadly liver damage. Since the March 1997 launch, 32 deaths have been linked to liver damage in patients taking the drug. Rezulin's patient population totals about 1.4 million, according To Salomon. After adverse events, the drug's label was downgraded to include "a gauntlet" of 11 liver function tests during the first year of therapy to identify patients at risk, Salomon analyst Christina Heuer wrote in a research note issued Tuesday morning. Her concerns stem from questions about whether the FDA will add more liver tests to Rezulin's label or will relegate the drug to a last-resort therapy for diabetes. Concerns about potential competitors to Rezulin were also cited. In late November, Smithkline Beecham PLC (SBH) filed a New Drug Application with the FDA for the drug Avandia. And on Monday, the U.S. unit of Takeda Chemical Industries filed to market Actos, a drug that will be promoted in the U.S. with Eli Lilly & Co. (LLY). Both companies requested six-month expedited reviews. If the potential competitors receive safety labels superior to Rezulin's, that could pose a serious threat to Warner-Lambert, said Hambrecht & Quist Inc. analyst Alex Zisson, who estimates 1998 U.S. sales of the drug at about $750 million. But he noted that "by far, Lipitor is still the most important profit contributor" to the company. Zisson, who is maintaining his neutral rating on the company, estimates 1998 sales of the blockbuster cholesterol drug at about $2.1 billion worldwide. (MORE) DOW JONES NEWS 01-19-99 11:40 AM SG Cowen analyst Jonathan Moran said that despite the FDA's review of Rezulin, his company is maintaining its strong buy rating on Warner-Lambert. "I think that we view this as a neutral to slight positive for Warner," he said, adding that the FDA review will provide an open and objective scientific forum for discussion about the drug. PaineWebber analyst Jeffrey Chaffkin, who said his company is also maintaining its buy rating on Warner-Lambert, said the stock price already reflects investors' Rezulin concerns and added that benefits of the drug outweigh its risks. The shares, he said, will be "pretty volatile" between now and the March meeting. Even Salomon noted the upside potential at Warner-Lambert in its research note and said an expected strong fourth-quarter earnings report next week could "enhance" the stock price. The absence of an expedited review for Avandia and Actos could also benefit the stock. And Warner-Lambert could stand to gain if Rezulin escapes new restrictions on its use and is recommended for new indications for combination therapy, Salomon's note said. But for now, Rezulin is "mired in controversy" amid upcoming patent expirations on other key drugs at Warner-Lambert, and Salomon cut its 1999 earnings estimate to $1.90 a share from $1.95. Analysts surveyed by First Call see 1998 earnings at $1.48, up from $1.04, adjusted for a stock split, for 1997. Until the FDA meeting, Salomon wrote, the stock "could continue to trade within a narrow range." - Melanie Trottman; 201-938-5287 (END) DOW JONES NEWS 01-19-99 12:31 PM