TeGenero, the German biotechnology firm whose experimental drug TGN1412 caused multiple organ failure in six men during a clinical trial in England, has filed for bankruptcy.
“The unforeseeable adverse reactions caused by TGN1412 in the TGN1412-HV phase I trial have made it impossible to attract the investment necessary for the company to continue operations,” the company said in a statement. “In view of the fact that there appears [to be] no reasonable prospect that the company can continue its business, TeGenero’s management had no alternative but to commence insolvency proceedings.”
The Bavarian company, founded in 2000 by scientists from Würzburg University, will be administered by an official receiver as its assets are wound up. One of those assets is the experimental monoclonal antibody TGN1412, the flagship product in TeGenero’s development portfolio but also the company’s nemesis.
“TeGenero’s development portfolio, including TGN1412, will be treated as an asset,” the company announced. “It is one of the aims of the insolvency proceedings to realise the value of all assets for the benefit of all creditors of the company.”
No further testing of the drug in humans will be possible, however, until investigators have determined the cause of the severe adverse reactions in the six men who were given the drug at London’s Northwick Park Hospital in March (BMJ 2006;332:683). TeGenero “will continue to make its expertise available for the purposes of such investigations,” the company promised.
It is unclear whether the bankruptcy will affect potential claims for damages from the six men. The most severely affected, Ryan Wilson, was discharged from hospital at the end of June. He has been told that parts of his fingers will probably have to be amputated, because of gangrene. The men’s long term prognosis remains uncertain.
TeGenero announced that “claims for compensation will continue to be handled by our insurers.” But the solicitor Ann Alexander, who represents two of the six trial participants, said the company’s coverage was insufficient. “The total liability limit on TeGenero’s insurance is £2m (€2.9m; $3.7m). This is wholly inadequate, and we call for greater scrutiny of the precautions these companies should be made to take.”
“However,” she added, “it is my opinion that this announcement should not affect in any way the claims our clients have. We believe that there are good grounds against both TeGenero, who manufactured the drug, and Parexel, who were responsible for managing the trial.”
The UK Medicines and Healthcare Products Regulatory Agency, which investigated the phase I trial, found that no errors in formulation or administration of the drug contributed to the adverse reactions. It attributed the reactions to an “unpredicted biological action in humans” (BMJ 2006;332:1290, 3 Jun).
But the agency’s report did list several departures from good practice in the management of the trial by the US research firm Parexel.
The solicitor Martyn Day, who represents four of the six men, said of the bankruptcy: “This devastating news could not come at a worse time for our clients, who are in the midst of having their immediate and long term health problems investigated by a number of medical experts. Our clients are anxious to know how a small and potentially inadequately insured company was able to test a drug which had a devastating effect on their lives.”