Massachusetts, US-based biotechnology firm Idenix Pharmaceuticals has put the development program for valopicitabine, its experimental drug for the treatment of hepatitis C, on clinical hold in the US, after an FDA review highlighted concerns over the risk/benefit profile observed to date in clinical testing of the treatment.
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In a press release regarding the decision to suspend the development of valopicitabine, Idenix said that it was disappointed with the FDA’s decision, and that the company would discuss the options remaining for the hepatitis drug with its partner and majority shareholder, Switzerland-based Novartis.
However, the outlook is bleak, and Retuers cited Jean-Pierre Sommadossi, CEO and chairman of Idenix, as stating: “I believe this drug will have no future in further clinical development,” during a conference call with analysts. Reuters said that this is the latest in a number of setbacks suffered by those companies trying to develop a treatment for hepatitis C.
Although the company remained optimistic about its future, citing other treatments currently in the pipeline, Reuters reported that Idenix’s shares plummeted 32% following the news about valopicitabine.
Idenix’s announcement attempted to reassure shareholders about the company’s future prospects. “Over the next few weeks, we will be taking a critical look at our expenses with the goal of investing in programs that we believe will create shareholder value,” said Ronald Renaud, CFO of Idenix.
“Our balance sheet is strong and we believe that we have enough cash to fund early clinical development of the pipeline,” Mr Renaud continued.