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Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly) -- Ignore unavailable to you. Want to Upgrade?

To: Ibexx who wrote (366)	6/19/1998 4:50:00 PM
From: Anthony Wong	Respond to of 1722

Ibexx, I agree that it's not a financial disaster. Expect Pfizer to get approval eventually, maybe the date would be pushed forward 6 months to one year. The market, however, is not to be sneezed at. LLY's Zyprexa (approved in late 1996) had $730 million in 1997 sales, and JNJ's Risperdal's 1997 sales (approved 4 years ago) have estimated 1997 sales of more than $840 million. Schizophrenic patients used to be delinquent in taking the drugs prescribed to them because of the drugs side effects. Pfizer may be able to take some of the market share away from LLY and JNJ. This weakness would be short-lived. Viagra would be approved in Europe in September and that should improve the sales figures for the last quarter, and their new antibiotic drug is also doing well.

To: Ibexx who wrote (366)	6/19/1998 5:13:00 PM
From: Anthony Wong	Respond to of 1722

Pfizer's Schizophrenia Drug Doesn't Get FDA Approval (Update2) Bloomberg News June 19, 1998, 1:41 p.m. PT Pfizer's Schizophrenia Drug Doesn't Get FDA Approval (Update2) (Adds analyst, company comment, closes shares.) New York, June 19 (Bloomberg) -- Pfizer Inc., maker of the impotence pill Viagra, said its schizophrenia drug Zeldox failed to get marketing approval from the U.S. Food and Drug Administration. Pfizer, one of the world's largest drugmakers with $9.2 billion in 1997 drug sales, said it plans to meet with FDA officials to discuss the agency's decision that Zeldox isn't approvable at this time. ''We are obviously disappointed at this development, but remain confident of the safety and efficacy of Zeldox,'' John Niblack, executive vice president and head of research and development at Pfizer, said in a statement. Pfizer officials believe they can get the FDA any additional information required ''in a relatively short period,'' he said. The FDA's initial decision on the drug comes as a blow to Pfizer, as Zeldox was expected to be a powerful entry in the multibillion dollar market for psychotherapies. It's good news for Indianapolis-based Eli Lilly & Co. and New Brunswick, New Jersey-based Johnson & Johnson, which currently dominate the schizophrenia market. Shares of New York-based Pfizer fell 3 1/8 to 111 1/4 after the news, while Lilly shares climbed 1 7/16 to 66 9/16. J&J shares rose 3/4 to 75 5/8. A Pfizer spokesman declined to comment further. It's unclear what the FDA's concerns are, said Alex Zisson, an analyst with Hambrecht & Quist who has a ''buy'' rating on Pfizer. ''There's some thought that the FDA is really starting to walk on eggshells now,'' following very public problems with drugs such as Roche Holding AG's Posicor, pulled off the market earlier this month because of its potential to have dangerous interactions with other drugs, he said. ''The open question now is how much is Zeldox going to be delayed?'' or whether it will hit the market at all, Zisson said. Best case scenario would be that the FDA only wants further analyses or information from ongoing studies, he said. Still, because Pfizer has many profitable drugs, Zeldox becomes less important, he said. ''In the scheme of things, even if Zeldox completely goes away, it's not a tragedy,'' he said. While schizophrenia only affects about 1 percent of the population, drugs to treat the condition have spurred a growing market. The growth comes as drugmakers develop better products. J&J's four-year-old Risperdal was the first drug to treat schizophrenia without the serious side effects of earlier drugs. It's now losing share to Lilly's Zyprexa. Zyprexa, approved by the FDA in late 1996, had $730 million in 1997 sales. Risperdal's 1997 sales have been estimated at more than $840 million. Zeneca Group Plc's Seroquel, meanwhile, had sales of just over $50 million after winning FDA approval late last year. Schizophrenia affects between 2 million and 3 million Americans, normally striking younger people, between the ages of 15 and 30. It's characterized by delusions, paranoia, hallucinations and extreme withdrawal and apathy. While the new drugs are more expensive, doctors are willing to turn to them because of serious side effects associated with cheaper existing treatments. These include twitching and involuntary movement of facial muscles, a condition known as dyskinesia. Analysts had expected Zeldox to complete a triumvirate of powerful new drugs from Pfizer, after the approval of the antibiotic Trovan and its Viagra impotence treatment in recent months. --Kerry Dooley in Princeton (609) 279-4016 and Kristin Jensen in

To: Ibexx who wrote (366)	6/19/1998 6:08:00 PM
From: Anthony Wong	Read Replies (1) \| Respond to of 1722

Dow Jones: FDA Declares Pfizer Schizophrenia Drug Zeldox Non-Approvable' June 19, 1998 3:59 PM NEW YORK -(Dow Jones)- In a surprise blow for Pfizer Inc., the Food and Drug Administration declared the pharmaceutical giant's schizophrenia drug Zeldox "non-approvable." Pfizer (PFE), which has been on a roll since April with the launch of its blockbuster impotence drug Viagra, said Friday it plans to meet with FDA officials to discuss the issues raised by the agency, and will submit additional data if necessary. Along with the now-ubiquitous Viagra, Zeldox was one of several new drugs Pfizer expected to launch this year. It was to join the antidepressant Zoloft in Pfizer's portfolio of mental-health drugs. Zeldox (known generically as ziprasidone) was expected to compete aggressively against Eli Lilly & Co.'s Zyprexa and Risperdal from Johnson & Johnson. Zyprexa is expected to become the first the world's first $1 billion-a-year schizophrenia drug. Another schizophrenia drug, Seroquel, sold by Zeneca Group PLC, won FDA approval late last year. Zyprexa and Risperdal have been a boon to schizophrenia patients because they don't carry some of the disabling side effects of older drugs. Schizophrenia, a chronic disorder that involves hallucinations and a profound withdrawal from society, has long been one of the world's most devastating diseases, leading millions to be institutionalized or to lead desperate lives on the streets. Schizophrenia and psychosis are probably best known for causing hallucinations and voices that "speak" to patients. These are called the "positive" symptoms of schizophrenia. The disease also has so-called negative symptoms like lethargy, inability to socialize and lack of spontaneity. Many patients can't tolerate the side effects of older drugs like haloperidol (Haldol) and chlorpromazine (Thorazine). These drugs cause "extrapyramidal symptoms," which are jerky, uncontrollable movements of the arms and legs similar to Parkinson's disease symptoms. "We are obviously disappointed at this development, but remain confident of the safety and efficacy of Zeldox," John F. Niblack, Ph.D., executive vice president and head of research and development at Pfizer, said in a statement. "We remain committed to making every effort to bring this medicine to patients in the U.S. and around the world," he said. Copyright (c) 1998 Dow Jones & Company, Inc. All Rights Reserved.