Company behind Northwick Park trial files for insolvency

pharmafile | July 7, 2006 | News story | Sales and Marketing  

The pharmaceutical company behind TGN 1412, the drug which caused near-fatal reactions in six clinical trials volunteers at Northwick Park, has filed for insolvency.

Germany company TeGenero says the fall-out from the trials, including extensive investigations into the drug and how the trial was conducted, have scared off potential investors.

"The unforeseeable adverse reactions caused by TGN1412 in the phase I trial have made it impossible to attract the investment necessary for the company to continue operations," the company said in a statement.

Subsequent investigations have failed to pinpoint why the drug produced such dangerous reactions in the volunteers, and the company says this continuing uncertainty proved too great for investors.

Preliminary findings from the UK regulator have cleared TeGenero of any wrongdoing, and the six men who suffered extensive injuries in the trial have agreed not to sue the company after accepting initial payments of 10,000 pounds each.

Despite this settlement, the law firm representing the volunteers, Irwin Mitchell, says it believes the men still have good grounds for claiming more compensation from TeGenero and also from Paraxel, the contract research company which carried out the trial on behalf of the pharmaceutical company.

Receivers have now been called in to wind up TeGenero and sell off its assets, which include its drug candidates.

TeGenero says further trials of TGN 1412 in humans will be impossible until the exact reason for the reactions is identified, which could mean the drug will be abandoned for good.

TeGenero was founded in 2000 as a spin-off from the University of Wurzburg and employed 15 full-time staff.  The company generated  13.8m euros in initial seed money and two rounds of private financing including from Bear Stearns Health Innoventures, as well as funding from the Bavarian regional government.

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