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MDS Pharma expands services in EU market

MDS Pharma Services is expanding its development and regulatory services (DRS) business in Europe, but adds that its bioanalytical operations performing less well.

MDS Pharma Services is expanding its development and regulatory services (DRS) business in Europe, but adds that its bioanalytical operations performing less well.

The US-based contract research organisation (CRO) offers DRS consulting services to support pharma firms in the discovery and development of their new drugs and biologics in EU markets.

MDS added that its European DRS organisation will also be fully integrated with consultants in the US and Canada to provide product development consulting, programme management, and regulatory affairs services. To support the expansion, the company has made two new appointments in its management team.

MDS is currently refocusing on this business area to offset the difficulties it has been facing in its bioanalytical business, the performance of which is negatively affecting the company's financial results.

The firm was hit by a restructuring charge of USD 26m (EUR 19m) in Q2 FY07 and suffered a 12 per cent decline in its early-stage segment, which is being affected by the impact of FDA-related issues at its Montreal site.

The company's two bioanalytical facilities in Canada have been under scrutiny by the FDA after inspections by the regulator in 2003 found problems with its pharmacokinetics testing procedures, including failure to identify and fix sources of contamination in bioanalytical tests.

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 2006, MDS voluntarily suspended its LC/MS services in order to undertake its own internal review.

MDS said it has now completed approximately 70 per cent of the audits for its bioanalytical clients which cost the company an extra USD 61m in Q2 to fund the completion of these activities. The company said it expects to have the FDA audits substantially complete by the end of 2007.

3rd August 2007

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