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Forest Laboratories, Inc. Reports Fiscal Year 2009 Fourth Quarter Reported EPS of $0.31 Including $0.45 Per Share Charge Related to the Ongoing United States Attorney's Office Investigation
Date:4/21/2009

of congestive heart failure, which if approved, will further enhance the sales potential of this already successful recent product launch. By mid-year we expect to report Phase III clinical data for ceftaroline, a broad-spectrum cephalosporin antibiotic with activity against gram-positive bacteria, including MRSA and gram-negative bacteria, for the treatment of community acquired pneumonia (CAP). If the CAP data is positive, we will submit an NDA, together with the positive results that we have already reported for the treatment of complicated skin and skin structure infections, around the end of this calendar year. We are in the process of initiating additional Phase III studies for dutogliptin, for the treatment of Type 2 diabetes mellitus. Also around mid-year we expect to begin Phase III studies for levomilnacipran, for the treatment of depression. We have commenced Phase III studies for linaclotide, for the treatment of chronic constipation and shortly, we expect to begin Phase III trials for the additional indication of constipation predominant irritable bowel syndrome. Linaclotide is a promising novel compound that may offer a much needed therapy for this very large and underserved patient population. Later this year we anticipate receiving Phase II-b data for cariprazine, for the treatment of schizophrenia, and if positive, we expect to initiate Phase III studies for the treatment of patients with acute mania associated with bipolar I disorder. We also expect to receive Phase II clinical data for oglemilast, for the treatment of COPD, later this year.

As is evident from our pipeline of both late and earlier stage products, Forest continues to have access, often preferential access, to the many new compounds initially developed by other companies, some also based in the U.S. and others outside the U.S. Importantly, Forest is viewed as a highly desirable development and marketing partner, often precisely because of our size and past
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