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German Company Behind Disastrous Clinical Trial Goes Bankrupt

DW staff (dc)July 5, 2006

German drug manufacturer TeGenero has filed for bankruptcy, four months after patients developed severe adverse reactions to a drug it was testing in an English hospital.

TeGenero can't find any funding for its futureImage: picture-alliance/ dpa

The company said the disastrous clinical trial in London's Northwick Park Hospital was the reason behind the move. The trial was run in Britain by US drug research company Parexel International Corp., on behalf of TeGenero.

Six men taking TeGenero's trial drug TGN1412, which it was developing to treat certain types of cancer and other immunological diseases, fell seriously ill in March. One suffered multiple organ failure.

Zwei Briten nach Pharma-Test in Lebensgefahr - Northwick Park Hospital
Six men became ill after participating in a drugs trial at Northwick Park Hospital in LondonImage: picture-alliance/ dpa/dpaweb

"As a result of the unforeseen adverse reaction candidates experienced in the clinical phase of the TGN1412 study, it has become impossible to find funding which is vital for the continued existence of the company," TeGenero said in a statement.

The company, which was established in 2000 and employed 15 people, was not at fault for the botched trial, according to the official investigation report into the incident. After studying the evidence, British regulators concluded that the drug caused an unforeseen biological reaction in humans that had not been seen in animals. Previous tests had been conducted on rabbits and monkeys.

The TGN1412 trial was halted by Britain's medicines watchdog, which also alerted its counterparts across the European Union and the US Food and Drug Administration.

Compensation claims

TeGenero confirmed that the drug had been shelved. It said that compensation claims would continue to be handled by its insurers, but the lawyers representing the trial volunteers were concerned.

Martyn Day, who represents four of the men, told Reuters that his clients were "deeply shocked" by news of the bankruptcy.

"This has massively added to their fears for the future," Day told the news agency. "It is going to greatly add to their fears of being able to get proper compensation."