In a suit filed with the New Jersey state court John Arditi, Mannkind’s former senior director of regulatory affaires, said he has uncovered evidence of potentially fraudulent results at trials of the drug in Russia and Bulgaria.
Specifically, Arditi reports that, at one Russian site, data indicated that patients had the same blood pressure at each visit over several months which, he argues, is highly unlikely and may be an indication of fake results.
Arditi also alleges in the suit that he was sacked after he voiced these concerns and advocated disclosing his finding to the US Food and Drug Administration (FDA) which is due to its final decision on Afrezza next month.
MannKind said all the allegations have been assessed by an independent investigator which “concluded that MannKind is, and was, taking prudent measures under Good Clinical Practice regulations to meet the requirements of Good Clinical Practices, and that there was no evidence of any deception or intent on the part of MannKind to deceive the FDA. “
The firm, which also said that Arditi was fired for unrelated reasons, did not say whether the trials in question had been conducted by a contract research organisation (CRO) and was unable to respond to Outsourcing-pharma’s request for additional information ahead of publication.
CFO Matthew Pfeffer added that: "We believe that Mr Arditi's claims have no merit, and the company will vigorously defend the lawsuit in the normal course of business."
One big step back for Mannkind?
But, even so, some observers foresee the events having an impact on the US FDA’s review of Afrezza.
One such opinion came from Rodman & Renshaw analyst Simos Simeonidis who told Bloomberg that: “I assume the FDA will now dig through the data with a fine-tooth comb and it could lead to a delay if they request additional information about this specific data.”
John Newman from Oppenheimer & Co agreed, and predicted that the US regulator would now ask for additional clinical trials.