MDS lose C$10m to FDA review in Q4
procedural review of its bioanalytical operations, but still
managed to report quarterly earnings of C$53m (€35m).
Fourth-quarter revenues for the Canadian firm's bio-analytical services fell by 20 per cent after customer reaction to a letter from the FDA stating that submissions containing data from their Montreal facility would not be processed until the completion of a review of operations. The Pharma Services division focussed significant resources on completing the FDA review, incurring C$10m. While recent discussions were described as promising, there was no guarantee that the resolution would be swift or painless.
Stephen DeFalco, MDS CEO, said the company had: "voluntarily suspended all commercial bioanalytical chromatography mass spectrometry operations in the facility to allow the facility to focus solely on the retrospective review."
MDS reported an operating profit C$114m profit for the full-year compared with C$47m in 2005, with much of the profit coming from divestment, including the C$1.3bn sale of the MDS Diagnostics Services unit to Borealis Infrastructure Management to shift the company's business focus to the life sciences market.
Commenting on the discussions with the FDA, DeFalco, said: "we did meet with the FDA in October and shared details of the progress that had been made since their March inspection."
"We believe that the recent dialogue with the agency has been productive, and from our perspective, the tone has been positive. We remain committed to finishing this review as fast as possible, but the timing is dependant on the FDA's satisfaction with our work."
"There can be no assurance that the FDA will be satisfied with the MDS response - or that the agency will not take further action."
MDS are looking to restructure the lab services operator into a smaller global life sciences company focused on faster-growing businesses, expanding its drug research, medical isotopes and analytical instruments businesses.
