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Novartis, Idenix Suspend Tests on Hepatitis C Drug NM283
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By Elizabeth Lopatto and Angela Zimm
July 13 (Bloomberg) -- U.S. regulators ordered Novartis AG and partner Idenix Pharmaceuticals Inc. to stop work on an experimental drug for hepatitis C because of the side effects. The shares of Idenix lost more than a third of their value.
The decision by the U.S. Food and Drug Administration on the drug valopicitabine may cause the companies to abandon the treatment, Jean-Pierre Sommadossi, chief executive officer of Cambridge, Massachusetts-based Idenix, said today.
Novartis, based in Basel, Switzerland, and Idenix are among at least a half-dozen companies racing to produce the first drug in a decade to treat hepatitis C, the main cause of liver cancer. About 3 million Americans are chronically infected with the virus that causes the disease.
``I am not optimistic about further development to valopicitabine in the future,'' Sommadossi said on a conference call. Novartis owns about 56 percent of Idenix's outstanding shares.
The failure was the second this week for a drug Novartis licensed after Antisoma Plc, a U.K. developer of cancer drugs, said July 12 one of its products failed to aid survival in ovarian cancer patients.
Idenix shares dropped $2.22, or 38 percent, to $3.57 at the close of Nasdaq Stock Market composite trading. Shares of Novartis fell 85 centimes, or 1.3 percent, to close at 66 Swiss francs in Zurich.
``The recent data suggested safety issues and very modest antiviral activity,'' said Ding Ding, an analyst with Maxim Group LLC in New York, in a telephone interview today. ``The FDA, because of the issues with side effects and the mild potency, thought that in the context of multiple choices, something else would come along that would be more attractive.''
Nausea, Vomiting
Risks included nausea and vomiting, Idenix said. The drug was in the second of three phases of testing generally required for U.S. approval.
``We believed the results from our triple combination trial showed improved efficacy and a good safety profile,'' Idenix spokeswoman Teri Dahlman said today in a telephone interview. ``The FDA's assessment was different than ours.''
Companies developing new hepatitis C medicines include Vertex Pharmaceuticals Inc., Roche Holding AG, Pfizer Inc. and Human Genome Sciences Inc. The newest experimental medicines target the hepatitis C virus similar to ways AIDS drugs attack HIV, by blocking proteins the virus uses to reproduce.
Valopicitabine is designed to block the protein polymerase. Roche has an experimental hepatitis C drug that also targets polymerase. Vertex's hepatitis C drug telaprevir blocks the protease enzyme the virus needs to reproduce.
Novartis bought rights to the Idenix drug a year ago for $455 million in milestone payments and $70 million in licensing fees. Both companies jointly market a medicine to treat hepatitis B called Tyzeka, or Sebivo.
``Milestone payments have been very low to date,'' Novartis spokesman John Gilardi said in an interview.
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