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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 (364)	6/19/1998 3:49:00 PM
From: Anthony Wong	Read Replies (1) \| Respond to of 1722

[PFE/LLY/JNJ] Pfizer's Schizophrenia Drug Doesn't Get FDA Approval Bloomberg News June 19, 1998, 12:37 p.m. PT Pfizer's Schizophrenia Drug Doesn't Get FDA Approval (Update1) (Adds background, updates shares, adds competitors, more about schizophrenia market.) New York, June 19 (Bloomberg) -- Pfizer Inc. said its schizophrenia drug Zeldox failed to get marketing approval from the U.S. Food and Drug Administration. Pfizer, maker of the impotence pill Viagra, 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,'' said John Niblack, executive vice president and head of research and development at Pfizer, in a statement. The company still plans to try to win approval for the drug and company officials believe additional studies suggested by the FDA can be conducted, 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 Eli Lilly & Co. and Johnson & Johnson, which currently dominate the schizophrenia market. Shares of New York-based Pfizer fell 2 11/16 to 111 11/16 in recent trading after the news, while Lilly shares climbed 1 7/8 to 67. J&J shares rose 1/8 to 75. Pfizer officials weren't immediately available for further comment on the release. While schizophrenia only affects about 1 percent of the population, drugs to treat the condition have proven to be 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