Intercept Pharma, Government Scientists Spar Over Negative Safety of Liver Drug, Emails Show

NEW YORK ( TheStreet) -- Intercept Pharmaceuticals ( ICPT) knew last January that abnormal cholesterol levels in patients contributed to the early stopping of a clinical trial involving its liver disease drug obeticholic acid, or OCA, but the company chose not to tell investors and lobbied government scientists conducting the trial to downplay the potentially worrisome safety finding, according to newly released emails.

These emails, made public through the Freedom of Information Act, provide a behind-the-scenes look at the days before Intercept's Jan. 9, 2014 announcement about the OCA clinical trial in patients with nonalcoholic steatohepatitis, or NASH.

In that announcement, Intercept said the clinical trial was stopped early after an interim analysis found a "highly statistically significant improvement" in the livers of patients treated with OCA compared to placebo. Intercept's stock price skyrocketed from $72 to $445 per share in two trading days following the Jan. 9 news release. In that same time period, the market value of Intercept increased six-fold to $8.4 billion.

But patients treated with OCA were also observed to have "significant lipid abnormalities" not seen in placebo patients, according to a written summary of a phone conversation between National Institutes of Health Program Director Dr. Averell Sherker and Intercept Chief Scientific Officer David Shapiro on Jan. 6.

On this call, Shapiro was told by Sherker that the decision made by the NIH's National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to stop the OCA trial early was based on positive efficacy and the negative safety signal.

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