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Drug Firm Insolvency

5th July 2006

The German drug firm behind an experimental drug at the heart of a disastrous clinical trial which left six men with multiple organ failure has declared itself insolvent.

TeGenero, a small German pharmaceutical company based in Würzburg said it could not continue in business and blamed the side-effects of the UK trial of its TGN 1412, saying the publicity made it impossible for them to attract investors to continue.

The drug developer, which will be taken over by court-appointed receivers with the task of selling off assets to help pay its debts, said the results of the trial carried out in March "were personally devastating for everyone at the company".

The trial was carried out by US-based company Parexel, a clinical research organisation on behalf of TeGenero. Six previously healthy men who took part in the trial of the drug, TGN1412, became seriously ill.

All six men who were injected with the drug suffered severe reactions within hours and were treated in intensive care at Northwick Park hospital in north-west London. One now faces the prospect of amputation of fingers and toes, and he and others are seeking damages. They claim the side-effects could have been predicted.

The company says these men had been informed of the insolvency and any claims for compensation arising from the trial will continue to be handled by TeGenero's insurers.

The Medicines and Healthcare products Regulatory Authority (MHRA), the UK medicines regulator concluded problems lay with the underlying experimental scientific mechanisms rather than the trial itself or manufacturing problems.

TeGenero was founded in 2000 as a spin-off from the University of Würzburg and employed 15 staff.

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