Trial misconduct halts Evotec/Hyperion drug
pharmafile | September 10, 2014 | News story | Research and Development, Sales and Marketing | DiaPep277, Evotec, amdromeda, diabetes, hyperion
Development of Evotec and Hyperion Therapeutic’s diabetes drug DiaPep277 has been terminated following ‘serious misconduct’ in one of its trials.
The two companies entered into a licensing deal for the treatment in 2007, which saw Hyperion developing the diabetes offering with Evotec entitled to receive royalties from the venture.
Hyperion says that it has since uncovered evidence that employees of Andromeda Biotech, which was recently acquired by the US firm, colluded with a third-party biostatistics company to receive un-blinded data for the DIA-AID 1 and DIA-AID 2 trials and manipulate these result to appear positive.
Donald Santel, president and chief executive officer of Hyperion, says that the company now has ‘no viable regulatory path forward’ and has decided to terminate further development of DiaPep277. He adds however, that the DIA-AID 2 Phase III trial will continue until completion to see if it yields ‘useful insights’ into type 1 diabetes. The last patient visit in the trial is expected to occur in the fourth quarter of 2014.
The company expects to record record a non-cash impairment charge of in the range of €19 million to €43 million, and adds that no Hyperion employees were involved in the misconduct.
DiaPep277 was one of Evotec’s advanced pipeline projects and the only drug in its portfolio in Phase III trials, but in a statement the German firm says that it no longer expects the drug to hit the market and that it is therefore likely to suffer a charge of €8.7 million. Shares in Evotec fell by 23% following the announcement.
A potential treatment for newly-diagnosed type 1 diabetes, DiaPep277 uses a combination of amino acids to prevent the immune system from destroying pancreatic cells that secret insulin.
Evotec is due a payment of €3.4 million from Hyperion and Andromeda, however, which it now needs to receive in order to be able to meet its profit targets for the year.
George Underwood
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