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Idenix Drops After FDA Puts Hold on Another Hepatitis Drug

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US officials are concerned about potential heart risks of experimental drugs after threats detected in Bristol-Myers' hepatitis C treatment.

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MINYANVILLE ORIGINAL Shares of Idenix Pharmaceuticals (IDIX) are dropping after the drug developer said studies of a second experimental hepatitis C treatment are being halted by the government due to safety concerns.

Earlier this month, Idenix said the US Food and Drug Administration was putting a partial clinical hold on its lead medicine to treat hepatitis C. (See Idenix Shares Plunge After Hepatitis Drug Study Put on Hold.)

The reason for the actions for each drug relates to risks surrounding a similar therapy that was being developed by Bristol-Myers Squibb (BMY). Last week, Bristol-Myers said it is ending its program to test a hepatitis treatment after a patient in a company study died of heart failure. It earlier said study of the drug was being suspended.

"Based on our discussions with the FDA, we understand the clinical hold is a precautionary decision made by the FDA in light of the adverse events seen with" the Bristol-Myers' treatment, Idenix CEO Ronald Renaud says in a statement Monday.

After sliding 20% pre-market, shares of Idenix fell 10% to $5.40 in early trading Monday. The stock is down 28% this year and slid 2% over the past 12 months.

The suspending of clinical trials for Idenix's lead drug, known as IDX184, is more significant than Monday's news about the early stage therapy. IDX184 is in the second of three phases of human studies usually needed for US approval. The other drug, IDX19368, was not yet being tested on humans. Idenix hoped to begin the first phase of clinical trials of that drug in the third quarter. No trial will take place unless the FDA lifts its hold on the drug.

Idenix says the FDA asked for additional heart-risk testing of patients in the IDX184 study. More than 50 people in the study are scheduled for echocardiograms, the company says. A small number of patients already were tested and results were normal, Indenix says.

When Bristol-Myers announced in early August that there were safety concerns around its drug, other companies, including Idenix, Gilead Sciences (GILD) and Vertex Pharmaceuticals (VRTX) appeared to benefit from their rival's misfortune. (See Bristol-Myers' Hepatitis Stumble Boosts Gilead, Vertex.) But the risks associated with that drug appear to be damning for Idenix unless the company can demonstrate to the FDA that its drugs are safe.

The companies are all in competition to develop an effective, safe, and better-tolerated treatment for hepatitis C, a liver-destroying virus that affects millions of Americans as well as tens of millions of people around the world.

Twitter: @brettchase

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