MDS Reports Third Quarter 2007 Results(red of them by the FDA. Todate we have b...),Health

Date:9/6/2007

red of them by the FDA. To date, we have been in contact with sponsors responsible for approximately 85% of the 217 ANDA submissions under review. Based on our communication with customers and on the work done at our facility since January, 150 ANDA submissions have been subjected to third party audits. The FDA imposed a six-month time limit on completing this work in their January 10, 2007 letter to ANDA sponsors and we therefore believe that substantially all of site audit work for these ANDA studies has now been done. Most of our efforts at this time are focused on follow-up questions and supporting the finalization of our customers' remaining audit reports.

In addition to generic studies, the FDA has requested information regarding submitted NDA applications for innovative drugs that contain data from bioanalytical studies conducted from January 2000 to December 2004 in our St. Laurent and Blainville, Quebec facilities. As of today it is difficult to estimate the full extent of the FDA's intent relative to innovator studies. To August 29, 2007, we had assisted on 38 study audits for a smaller number of NDA submissions for which the FDA has requested additional review.

Also during the quarter, we continued to respond to questions from customers and from European regulators about the nature of the work being done for the FDA. At this time, we are not able to assess the impact of possible European regulatory actions. We are working closely with these regulators to address their questions utilizing work prepared in the FDA review.

During the second quarter, we approved and recorded a $61 million provision for a reimbursement policy for clients who have incurred or will incur third party audit costs to complete the work required by the FDA and other regulators. During the third quarter, we utilized $5 million of this reserve for such costs. Based on information currently available, we believe that the existing provision will be sufficient to cover a
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SOURCE MDS Inc. Copyright©2007 PR Newswire. All rights reserved

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