Severe misconduct: Hyperion and Evotec halt diabetes drug trial
- German firm Evotec and Hyperion Therapeutics entered into a licensing deal in 2007 in order to develop Evotec’s diabetes drug, DiaPep277.
- Hyperion recently uncovered evidence that employees at its recently acquired company, Andromeda, had conspired with third-party biostatisticians to get unblinded data on two DiaPep277 phase III trials. They then manipulated the data to make it look more positive.
- The fall-out has been predictably negative for both companies. Hyperion is terminating development of DiaPep277 and Evotec is losing development of an important candidate, as well as anticipated royalties from the therapeutic.
Given the level of dishonesty and flagrant violation of clinical trial regulations, it would be almost impossible for Hyperion to continue development of DiaPep277. However, the company will allow the two phase III trials that are currently underway -- DIA-AID1 and DIA-AID2 -- to continue until completion.
At this point, the Hyperion's goal is to simply see is there are any “useful insights” into type 1 diabetes. Evotec will suffer financially. Not only did the company’s stock fall 23% on the day of the news, but the company is planning to take an $11.24 million charge. Unfortunately for Evotec, DiaPep277 was their only drug in phase III trials.
- pharmafile.com Trial misconduct halts Evotec/Hyperion drug