MDS Pharma continues efforts to move on from FDA review

By staff reporter

- Last updated on GMT

Related tags Pharmacology Pharmacokinetics

MDS Pharma is continuing its efforts to move on from the trouble
caused in its Pharma Services segment by a US Food and Drug
Administration (FDA) review of its Montreal-area bioanalytical

In its fourth quarter results, the company saw a 10 per cent gain in its late-stage business to bring in $57m in revenue, although this was largely offset by a 6 per cent decline in its early-stage segment, with sales of $66m.

Meanwhile, backlog during the quarter was down 10 per cent from the prior year, "resulting from an increased conversion of backlog to revenue and a number of contract cancellations in our Phase II-IV business", although the firm did point out that it is "encouraged that its bioanalytical and Phase I customers continued to return this quarter" and that new orders services in this early-phase unit increased 85 per cent over the comparable period last year.

The saga with its early-phase unit started when an inspection of the company's two Canadian plants in 2003 found a range of problems with its pharmacokinetics testing procedures, including failure to identify and fix sources of contamination in bioanalytical tests, which measured drug levels in the blood of patients.

As a result, the FDA began a review in February 2005 of all the bioequivalence tests performed by the pharma services unit of MDS between 2000 and 2004, and in September last year, MDS voluntarily suspended its LC/MS services in order to undertake its own internal review.

In January this year, the FDA gave MDS' clients until June to take one of the three following actions: repeat their bioequivalence studies, re-analyse their original study samples at a different bioanalytical facility, or independently audit original study results.

The FDA stressed that the retesting was only a precautionary measure and it also made clear that it did not have any evidence that there were problems with the quality, purity, or potency of the affected drug products.

Financial difficulties ensued for the company, which said it is now 80 per cent through a restructuring plan designed to return profit growth to the services segment.

During the quarter, MDS consolidated its central laboratory operations in Europe, finalising the closure of UK facility in Sittingbourne; while in North America, its Montreal team transferred DMPK operations to Bothell, Washington and LC-MS operations to Lincoln, Nebraska; and also completed most of the staff reductions at its St. Laurent facility.

These staff reductions include "most of the staff supporting the FDA site audits, which appear to be winding down as we enter 2008", the firm said.

Meanwhile, MDS said it recently expanded its central lab operations in Beijing, China "to meet the growing demands" from biopharma companies now operating in the country.

The firm also indicated that the 300-bed expansion of its Phase I business in Phoenix, Arizona will open in January.

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