According to documents obtained by Reuters, Dendreon (NASDAQ:DNDN) analyzed the data in its key clinical trial for the prostate cancer treatment Provenge differently than their pre-specified goal stipulated.
The change artificially inflated the benefit of the cancer drug, and those results were published in the New England Journal of Medicine in 2010. However, Dendreon has said that the difference is unimportant because Provenge is still safe and effective treatment.
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Even though all companies seeking drug approval must tell the U.S. Food and Drug Administration how they will analyze trial data beforehand, the agency has not decided to withdraw its approval.
However the copy of Dendreon’s Statistical Analysis Plan, submitted to the FDA in 2008 and acquired by Reuters, shows that the pharmaceutical manufacturer did not follow its plan. According to the document, the trial was supposed to analyze the survival difference between those patients who received Provenge and those who took a placebo. The trial would also test whether age affected survival rates. But when results were published in 2010, the cut-point for the age-based study was not 65, as the company had told the FDA, but 71.
Harvard School of Public Health biostatistician Scott Evans told Reuters that such deviation indicated, “that they didn’t like what they saw and went looking for something better.”
If the company is found to have manipulated its data, Dendreon’s market share could be affected. Its market value has already decreased by 70 percent over the last 8 months due to low Provenge sales. The company also faces five lawsuits which accuse its management of insider trading and misleading shareholders.
But Dendreon is not the only pharmaceutical company in trouble. Piper Jaffray downgraded shares of Celgene (NASDAQ:CELG) from an overweight rating to a neutral rating and placed an $86 price target on the stock. Shares in the company closed at $78.42 on Friday.
The company’s stock price was depressed by a report from the European Medicines Agency on Wednesday, which indicated that more data is required before the cancer drug Revlimid can be considered as a front-line treatment.
Bloomberg reported that an updated study of 450 patients will be available by the year’s end.
As William Blair analyst John Sonnier wrote in a research note, “We believe this data could help clarify the potential for Revlimid as a front-line agent in multiple myeloma and could help define Celgene’s future regulatory plans with Revlimid in Europe.”