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

To: BigKNY3 who wrote (5233)	8/26/1998 11:47:00 PM
From: Anthony Wong	Respond to of 9523

Pfizer Gets Australian Approval to Sell Impotence Drug Viagra [not as detailed as the Dow Jones article, but the more exposure the better] Bloomberg News August 26, 1998, 9:17 p.m. ET Pfizer Gets Australian Approval to Sell Impotence Drug Viagra Canberra, Aug. 27 (Bloomberg) -- Pfizer Inc. has been given approval to sell its Viagra impotency drug in Australia, the local drug authority said. ''I think it will be used more widely than even something like the introduction of penicillin,'' said Federal Health Minister Michael Wooldridge. More than 1 million Viagra prescriptions were written in the U.S. within a weeks of its launch in May. The drug is also sold in Switzerland and Thailand and is set to get marketing approval in the 15-nation European Union, subject to an agreement about warning labels. Viagra will be available in Australian drugstores in a matter of weeks, Wooldrige said, provided Pfizer change the packaging to include a health warning. Clinical studies have showed patients using Viagra reported impaired vision and headaches in greater frequency than could be expected by people not using the drug. The U.S. Food and Drug Administration also estimates that the drug was taken by 69 patients in the U.S. who later died. Many of those men were also taking drugs for heart disease. Pfizer shares rose 1 1/2 to 108 1/2 in the U.S. yesterday. The shares have doubled in the past year on optimism about Viagra sales. The announcement by Australian government was made before the U.S. market opened. --Vivienne Stanton in Canberra (612) 6273-1415, with reporting quote.bloomberg.com

To: BigKNY3 who wrote (5233)	8/26/1998 11:55:00 PM
From: Anthony Wong	Respond to of 9523

Reuters - Viagra for sale in Australia, with health warning Wednesday August 26, 10:49 pm Eastern Time biz.yahoo.com

To: BigKNY3 who wrote (5233)	8/27/1998 9:10:00 AM
From: BigKNY3	Respond to of 9523

More Details on the EU Approval EU Approval of Viagra Due In September August 27, 1998 Marketletter via NewsEdge Corporation : Approval in the European Union for Pfizer's Viagra (sildenafil citrate) has been supported by a scientific committee representing the health ministries of all 15 EU member states. Final EU approval is now expected on September 15, according to media reports. The approval recommendation followed a positive opinion from the European Medicines Evaluation Agency's Committee on Proprietary Medicinal Products on the marketing application from Pfizer UK and Roerig Farmaceutici at the end of May (Marketletter June 8). Change To Label Wording The recommendation for approval was not, however, unanimous, with Germany reportedly having asked for more information included in the instructions about the contraindications of the drug. The word " painful" is now included on the label which now includes the statement that "rarely, prolonged and painful erections have been reported after taking Viagra. If you have such an erection which lasts continuously for more than four hours, you should contact a doctor immediately," according to the Wall Street Journal. The Marketletter's European correspondent notes that in order to avoid tortuous and lengthy negotiations, Pfizer has not applied for Viagra to be reimbursed in France or southern Europe. The level of reimbursement is to be discussed with the UK, where it is estimated it will cost the taxpayer L1 billion ($1.64 billion). German regional funds and the Swiss Health Ministry have rejected reimbursement (Marketletter August 10). In the USA Viagra is reimbursed up to a mean 40% of its price. Recent reports from the US Food and Drug Administration on Viagra's "death toll" do not seem to have upset Pfizer's campaign for EU approval. According to the Wall Street Journal, the FDA has received voluntary notification of 123 deaths in patients prescribed Viagra between late March and July out of a total of 3.6 million prescriptions. Actual use of the drug could not be verified in 12 patients. Of the 69 American patients evaluable, the cause of death was unknown in 21, stroke in two patients and cardiovascular events in 46 patients. The mean age of the 55 patients whose age was known was 64. Concomitant use of nitroglycerin or other nitrate medications, either self- medicated or administered, was present in 12 cases and 51 (74%) patients had one or more risk factors for cardiovascular or cerebrovascular disease such as hypertension, hypercholesterolemia, cigarette smoking, diabetes mellitus, obesity or previous cardiac history. 36% of the patients died or developed symptoms leading to death four to five hours after taking the drug. The dose was known in 31 patients, of whom 26 had taken the 50mg dose, three the 100mg dose and two 50mg-100mg. Some patients died three to four days after initial drug use. Only five (7.2%) patients who died had no history of heart disease or other risk factors.