To: Anthony Wong who wrote (1518 ) 4/23/1998 1:56:00 PM From: Anthony Wong Respond to of 9523
Pfizer Sees FDA Filing For Eletriptan In September (see last 2 para.) April 23, 1998 1:05 PM NEW YORK (Dow Jones)--Pfizer Inc. (PFE) expects to file a new drug application with the Food and Drug Administration in September for its migraine drug, Eletriptan, according to Executive Vice President John Niblack. The company will at the same time submit an application for market clearance with European health regulators. During Pfizer's annual shareholders meeting, Niblack reviewed the clinical status of Eletriptan and other new drugs in the company's product pipeline. Alond, a new drug Pfizer is developing to treat complications caused by diabetes, has shown some improvement in nerve function in diabetics, according to preliminary clinical data collected so far, Niblack said. The company also is developing an inhaled insulin product for diabetics to replace insulin injections, with full-scale clinical development planned for November. Niblack said the effectiveness of the inhaled insulin appears to be equal to that of injected insulin. He added, however, that severe diabetics will still need a long-acting insulin injection at night. Chairman and Chief Executive William Steere Jr. said the company is evaluating potential sources of insulin for the product. Besides developing new chemical entities, Pfizer is working to find new applications for its existing products, Niblack said. As an example, he cited the company's efforts to examine the use of its antibiotic Zithromax to prevent coronary artery disease. He said a microorganism, chlamydia, recently was implicated in promoting the buildup of plaque in coronary arteries. Zithromax is being studied to prevent plaque buildup, he said, because it is one of the most potent antichlamydia drugs available. The company has enrolled 3,300 patients in the so-called Wizard clinical trial to study the potential benefits of Zithromax in preventing heart disease. Steere said he was pleased with the positive response to the company's new impotence drug, Viagra. Industry estimates indicate a very strong sales launch for the product, but Steere didn't provide any preliminary sales figures. During a sometimes light-hearted question and answer session with shareholders at the end of the meeting, Steere confirmed news reports that Pfizer had consulted with the Vatican about its marketing of Viagra. The Vatican was "supportive" of Viagra, he said, because it "restores healthful families" and can "restore a relationship that has serious difficulties." -Louis Hau; 201-938-5240