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Biotech / Medical : PFE (Pfizer) How high will it go? -- Ignore unavailable to you. Want to Upgrade?

To: Anthony Wong who wrote (6666)	1/11/1999 8:08:00 AM
From: BigKNY3	Read Replies (1) \| Respond to of 9523

Merck and Monsanto to Contest Arthritis Market ---- By Michael Waldholz and Thomas M. Burton Staff Reporters of The Wall Street Journal In what could be the most bruising drug-marketing battle in years, Merck & Co. expects to claim its arthritis medicine -- likely to be approved by late spring -- is more effective in treating a wide range of pain problems than Monsanto Co.'s Celebrex, which recently won government approval. Merck believes clinical trial data it filed with the Food and Drug Administration two months ago will show that its drug, Vioxx, is effective against treating several types of severe pain such as those associated with dental procedures, surgery and menstrual cramps. Most existing arthritis medicines are approved for treatment of nonarthritis pain, and St. Louis-based Monsanto had hoped to market Celebrex in the same way. But the FDA dealt Monsanto's Searle unit a blow by saying Celebrex can be marketed only as a treatment for arthritis-related pain. The FDA also said Searle can't claim Celebrex won't cause general gastrointestinal problems. Wall Street analysts have focused on the gastrointestinal issue. But Merck believes it can eke out an advantage on two fronts: pain and ulcers. It hopes the FDA will allow it to market Vioxx to treat a broad assortment of pain relief and make the claim that Vioxx doesn't cause gastrointestinal problems. "Our pain data are unambiguous," said Edward Scolnick, director of Merck's research and development operations. Dr. Scolnick said trials using Vioxx for postsurgical pain showed the drug produced 24 hours of pain relief and also didn't promote bleeding, a common concern in using pain-relief medicines. Searle hopes to be able to make the broader claims on pain relief when it completes further studies. But the restricted label for Celebrex, while far from damaging to its potential for huge sales, may indeed give Merck the crucial marketing edge it needs. Celebrex and Vioxx are a new class of drugs called Cox-2 inhibitors that appear to work as well as current medicines against inflammation without producing bleeding ulcers and other stomach irritations. Wall Street analysts believe the Cox-2 drugs will become one of the industry's largest-ever blockbusters, perhaps generating combined world-wide sales of almost $5 billion by 2003. Neither Merck nor Monsanto want the other company to get the lion's share of that revenue. Merck needs a green light from the FDA on the broad pain-relief claim because it's in for a tough fight. That is because Searle will have at least a five-month marketing lead, and also because Searle is co-promoting its drug with Pfizer Inc., one of the industry's premier marketers. Late last week Joseph Papa, Searle's president of U.S. operations, said Searle and Pfizer intend to make more "detailing," or sales, visits to doctors than have ever been made for any drug. Mr. Papa also said the company plans to use direct-to-consumer advertising to market the new drug in addition to ads in medical journals targeting rheumatologists and other doctors treating arthritis patients. In its sales calls, Searle officials said, they will point out to doctors that Celebrex is associated with far fewer ulcers that can be seen through an optical tube called an endoscope than other arthritis drugs. But Merck, of Whitehouse Station, N.J., is hopeful its studies will convince the FDA that Vioxx is safer. Meanwhile, Searle is busy convincing managed-care firms to pay for the Cox-2 drugs instead of inexpensive generic versions of existing arthritis medicines. Celebrex likely will sell at about $3 to $4 at retail, while the generic drugs it replaces can sell for pennies a day. Lee Newcomer, medical director of United HealthCare Corp., Minneapolis, said the HMO initially will insist that patients pay $25 of the cost of any prescription. But United HealthCare's caution regarding Celebrex may prove temporary because any managed-care company will find it difficult to try to limit Celebrex to patients who are "at risk" for bleeding ulcers. That is because it is nearly impossible to predict who is likely to get a bleeding ulcer. Dr. Newcomer said he is impressed by Monsanto's data that show significantly fewer visible ulcers with Celebrex compared with patients on other drugs like naproxen. Dr. Newcomer said he expects to meet this week with Searle officials to learn more about their clinical-trial evidence on Celebrex, adding that United HealthCare's current position on the drug is very preliminary.

To: Anthony Wong who wrote (6666)	1/13/1999 8:12:00 AM
From: Anthony Wong	Respond to of 9523

UK: Doctors Give Dobson Ultimatum Over Viagra Tuesday January 12, 3:50 PM Doctors are threatening to start prescribing the impotence drug Viagra on the NHS - in defiance of Government advice - within the next 10 days. The GPs' committee of the British Medical Association has issued an ultimatum to Health Secretary Frank Dobson demanding he should lift the ban on the drug and allow doctors to prescribe it for clinical reasons. The committee says it wants "clear advice" from the Government before it meets next on January 21 - and warns that it will defy the ban and advise GPs to prescribe Viagra on the NHS. The drug is currently available privately but NHS prescriptions could cost the cash-strapped NHS millions of pounds. A BMA spokesman said: "The whole thing is a mess at the moment. "The Government sent advice to GPs last September saying they should not prescribe Viagra and said they would be issuing more advice soon but we have had no more. "It put doctors in a very difficult position, because on the one hand the Government was telling them not to prescribe Viagra on the NHS but on the other hand GPs realised they would be in breach of terms of service if they did not prescribe Viagra for someone who clinically needed it." A spokesman for the Department of Health said: "Substantive advice will be issued soon. "There is no actual ban on prescribing the drug. There has simply been advice issued." The spokesman refused to say when the advice would be issued. yahoo.co.uk