MINYANVILLE ORIGINAL Idenix Pharmaceuticals
(IDIX) shares tanked Thursday after the company said
the Food and Drug Administration was putting a partial hold on human studies of the company’s experimental hepatitis C treatment.
The FDA is concerned about potential heart risk in patients after a safety issue was discovered in a similar drug being developed by Bristol-Myers Squibb
(BMY). Initially, Bristol-Myers’ setback -- which led to the suspending of its drug trial -- seemed to be a positive for Idenix and other companies in the race for a better hepatitis treatment. (See Bristol-Myers’ Hepatitis Stumble Boosts Gilead, Vertex
Shares of Idenix dropped 29% to $5.91 in morning trading Thursday. The stock is still up almost 29% over the past 12 months.
Idenix CEO Ronald Renaud told investors on a conference call Thursday that the company hasn’t seen any evidence in studies so far that would suggest its drug, known as IDX184, poses a serious heart threat. The company will provide additional study data to the FDA as it tries to show that the drug is safe.
“We remain confident in the safety profile” of the drug, Renaud said on the call.
Evidence of heart failure is the type of risk that can kill an experimental drug even if there are only one or two cases among 10,000 patients, Leerink Swann analyst Howard Liang says in a recent note.
So far, the other leading companies developing similar hepatitis C drugs, including Gilead Sciences
(GILD) and Vertex Pharmaceuticals
(VRTX) have not indicated there are any heart safety issues related to their medicines.
Gilead shares dropped more than 1% to $57.12 Thursday morning, while Vertex rose 1% to $55.01.
Idenix, Gilead, Vertex, and Bristol-Myers have all been studying a class of drugs known as nucleotide polymerase inhibitors. The drugs target an enzyme needed for the hepatitis C virus to replicate. The goal of all these companies is to create an all-oral regimen for hepatitis patients that doesn’t include the injected therapy interferon, which can cause side effects such as fatigue and flu-like symptoms.
The government estimates as many as 3.9 million people in the US may be chronically infected with the liver-destroying virus. Worldwide, that figure is about 150 million, according to the World Health Organization.
No positions in stocks mentioned.
The information on this website solely reflects the analysis of or opinion about the performance of securities and financial markets by the writers whose articles appear on the site. The views expressed by the writers are not necessarily the views of Minyanville Media, Inc. or members of its management. Nothing contained on the website is intended to constitute a recommendation or advice addressed to an individual investor or category of investors to purchase, sell or hold any security, or to take any action with respect to the prospective movement of the securities markets or to solicit the purchase or sale of any security. Any investment decisions must be made by the reader either individually or in consultation with his or her investment professional. Minyanville writers and staff may trade or hold positions in securities that are discussed in articles appearing on the website. Writers of articles are required to disclose whether they have a position in any stock or fund discussed in an article, but are not permitted to disclose the size or direction of the position. Nothing on this website is intended to solicit business of any kind for a writer's business or fund. Minyanville management and staff as well as contributing writers will not respond to emails or other communications requesting investment advice.
Copyright 2011 Minyanville Media, Inc. All Rights Reserved.