Wyeth provides mid-year update

This estimate is pro forma as it excludes any potential restructuring charges resulting from the company’s ongoing review of business processes and systems.

“Our expectations for 2006 reflect solid ongoing operating performance driven both by revenue growth and cost control. We expect to deliver on our stated goal of growing earnings at a meaningfully faster rate than revenue,” said Robert Essner, chairman and CEO of Wyeth.

The company also said that it has submitted a timely response to a May 8, 2006 warning letter from the FDA that raised several specific concerns about manufacturing at Wyeth’s Guayama, Puerto Rico facility.

Since receiving the warning letter, the company has put a comprehensive corrective action plan in place and is working with the regional FDA office to determine the next steps.

“While it is too early to predict with any assurance how long it will take to resolve these issues, Wyeth believes it is moving in the right direction and it is the company’s goal that resolution of these issues be reached by the end of this year,” the company said in a statement.

Wyeth also said that it expects to launch Lybrel, its new oral contraceptive, in 2007, subject to the satisfactory resolution of items outlined in the FDA’s June 27, 2006 approvable letter and a satisfactory pre-approval inspection at the Guayama manufacturing site.

Finally, the company said that it will conduct additional studies to further define the profile of its DVS-233 depression drug and test it at lower doses. Wyeth plans to launch the product in 2007 with those lower dose data available, subject to the FDA’s approval of the new drug application (NDA).