Executive Summary

Merck raises 2007 earnings guidance on the assumption that Arcoxia (etoricoxib), its follow-on product to the withdrawn arthritis medication Vioxx, will be approved by FDA, the company announces Dec. 6. The Arcoxia NDA has a user fee action date in April 2007 following Merck's submission of a response to FDA's November 2004 "approvable" letter (1"The Pink Sheet" Nov. 13, 2006, In Brief). The submission limits the proposed indication for the COX-2 inhibitor, which has been approvable since October 2004, to osteoarthritis. Merck anticipates that 2007 earnings per share will be in the range of $2.36 to $2.49. "Other sales," which includes products Arcoxia, Januvia and Proscar among many others, is expected to be between $5.2 billion and $5.6 bil...