Wyeth works to resolve Guayama manufacturing facility issues

By Elaine Rigoli

Tampa, Fla., July 12 - Wyeth Pharmaceuticals said Wednesday that it has set a goal to resolve the issues raised in the Food and Drug Administration's warning letter that raised specific concerns about manufacturing at Wyeth's Guayama, Puerto Rico, facility by the end of the year.

Wyeth said it submitted a timely response, has put a comprehensive corrective action plan in place and is working with the regional FDA office to determine next steps.

In other financial and product news:

• Wyeth reaffirmed its 2006 full-year pro forma diluted earnings per share guidance of $2.97 to $3.07 and announced that, if current business trends continue, full-year earnings would reach at least the upper end of the range. This estimate is pro forma as it excludes any potential restructuring charges resulting from the company's ongoing review of business processes and systems;

• Wyeth reported that in order to further define the profile of DVS-233, a serotonin norepinephrine re-uptake inhibitor, additional clinical trials in depression are being conducted, including studies at lower dosage levels. The company plans to evaluate the results of these studies in early 2007 with a product launch in 2007, subject to FDA approval;

• Wyeth said it expects to launch Lybrel, an oral contraceptive, in 2007 subject to satisfactory resolution of items outlined in the FDA's June 27 approvable letter and a satisfactory preapproval inspection at the company's Guayama manufacturing site.

Wyeth is a pharmaceutical and health care products company based in Madison, N.J.

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