Drugmaker Bristol-Myers Squibb Co. has scrapped a potential hepatitisC treatment after a patient participating in a test of the drug died of heartfailure.
The New York company said Thursday that it decided to discontinue developmentof the drug, labeled BMS-986094, in the interest of patient safety.
The patient's heart failure prompted Bristol-Myers to voluntarily suspend amid-stage study of the drug on Aug 1. The U.S. Food and Drug Administrationsubsequently placed the drug on a clinical hold.
"The decision to halt development of BMS-986094 has been guided by ouroverriding interest in protecting patients," Elliott Sigal, Bristol-Myers'chief scientific officer, said in a statement.
Nine patients, including the one who died, were hospitalized. Two remain underhospital care, the company said.
Bristol-Myers said it hasn't definitively established what caused patients tobecome ill, but identified heart and kidney toxicity as a key factor.
The company said it is working with the FDA to monitor the patients involved inthe study. It also said it would continue to investigate the potential cause ofthe drug's toxicity.
Cardiovascular problems can prove fatal to experimental drugs. The FDA has beenfocusing more on those risks since Merck & Co. took its painkiller Vioxxoff the market several years ago after a study showed the drug doubled the riskof heart attack or stroke.
Bristol Myers has been pushing to become a player in the hepatitis C drugmarket, which is expected to grow as baby boomers get older.
The discontinued drug was one of two main potential hepatitis C treatments fromBristol-Myers that investors are focused on. The other is a compound labeleddaclatasvir that has started late-stage testing, the last step beforedrugmakers submit a product to regulators for approval.
Bristol-Myers acquired BMS-986094 and some other potential treatments as partof a $2.5 billion acquisition of drug developer Inhibitex Inc. it completedearlier this year.
Hepatitis C is a virus that can lead to life-threatening liver damage and isthe main cause of liver transplants in the United States. Analysts say themarket for treatments is potentially lucrative for drugmakers. More people areexpected to be diagnosed with the tough-to-treat disease as the baby boomergeneration ages.
After a two-decade drought, the first two new hepatitis C drugs were approvedlast year: Victrelis from Merck & Co. and Incivek from VertexPharmaceuticals Inc. and Johnson & Johnson. Both significantly improve thecure rate over what has long been the standard of care, a mix of injections andpills with nasty, flu-like side effects that takes several months and still doesn'tcure many patients.
Bristol-Myers' shares tumbled when it first announced earlier this month thatit was suspending its trial of the hepatitis C drug. In aftermarket tradingThursday, they added 5 cents to $32.20. The stock ended the regular trading.