Updated from 7:40 a.m. EDTWyeth ( WYE) reported second-quarter earnings that beat Wall Street estimates, and the company predicted a very strong performance for the back half of the year. Last week, Wyeth said
By June 30, Wyeth had recorded total net pretax charges of $265.2 million since the cost-cutting program began. The productivity push will continue for several years, and Wyeth said additional cuts could be worth $750 million to $1 billion on a pretax basis. The company repeated remarks, issued last week, that it's moving quickly to resolve manufacturing problems cited by the Food and Drug Administration at a Puerto Rico plant. Bernard Poussot, vice chairman and president, said Wyeth has filed a comprehensive response to an FDA warning letter. He said he hopes the matter can be resolved by year-end. Companies that fail to act quickly on manufacturing issues cited by the FDA can be subject to fines and even product seizures. The FDA can also refuse to review new-drug applications until the problems are corrected. Poussot said he didn't believe there would be any impact on its product applications assuming Wyeth settles the matter by the end of 2006. The company said it expects to file three applications with the FDA in the next nine months for treating schizophrenia, kidney cancer and side effects from opioid painkillers. Wyeth expects final approval from the FDA in early 2007 for Lybrel, an oral contraceptive that eliminates menstrual periods. It also expects FDA clearance approval sometime next year for the antidepressant DVS-233. An FDA advisory committee is expected to review DVS-233 in September.