Thursday, August 2, 2012

Bristol-Myers suspends hepatitis C treatment study

Drugmaker Bristol-Myers Squibb Co. is suspending a midstage study of a potential hepatitis C treatment after at least one patient suffered heart failure.

The New York company hasn't determined the cause or whether it is tied to the potential treatment, so it is examining all patients who took the drug.

"We are working in close collaboration with clinical trial investigators and health authorities to ensure the appropriate steps are being taken to protect patient safety," spokeswoman Sonia Choi said Thursday in an email to The Associated Press.

Shares of Bristol-Myers plunged 7.6 percent, or $2.70, to $32.90 in midday trading Thursday.

The drugmaker is an important maker of medicines for viruses, including Baraclude for hepatitis B and several HIV drugs. It is searching for fresh sources of revenue because its top-selling product, the blood thinner Plavix, now faces competition in the United States from cheaper generic drugs. Plavix sales plummeted 60 percent to $741 million in the second quarter after several generic rivals debuted in May.

As part of that plan, Bristol-Myers is pushing to become a player in the hepatitis C drug market, which is expected to grow as baby boomers get older.

The drug, labeled BMS-986094, is one of two main potential hepatitis C treatments from Bristol-Myers that investors are focused on, Bernstein analyst Dr. Tim Anderson said in a research note. The other is a compound labeled daclatasvir that has started late-stage testing, the last step before drugmakers submit a product to regulators for approval.

Anderson said it seemed likely that BMS-986094 also would move to late-stage testing next year, but its prospects are now uncertain.

Cardiovascular problems can prove fatal to experimental drugs. The Food and Drug Administration has been focusing more on those risks since Merck & Co. took its painkiller Vioxx off the market several years ago after a study showed the drug doubled the risk of heart attack or stroke.

Bristol-Myers acquired BMS-986094 and some other potential treatments as part of a $2.5 billion acquisition of drug developer Inhibitex Inc. it completed earlier this year.

Analyst Erik Gordon, a professor at the University of Michigan's Ross School of Business, said the study suspension makes the Inhibitex acquisition look like a mistake for Bristol-Myers.

Hepatitis C is a virus that can lead to life-threatening liver damage and is the main cause of liver transplants in the United States. Analysts say the market for treatments is potentially lucrative for drugmakers. More people are expected to be diagnosed with the tough-to-treat disease as the baby boomer generation ages.

After a two-decade drought, the first two new hepatitis C drugs were approved last year: Victrelis from Merck & Co. and Incivek from Vertex Pharmaceuticals Inc. and Johnson & Johnson. Both significantly improve the cure rate over what has long been the standard of care, a mix of injections and pills with nasty, flu-like side effects that takes several months and still doesn't cure many patients.

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AP Business Writer Linda A. Johnson contributed to this report from Trenton, N.J.

Associated Press

Source: http://hosted2.ap.org/APDEFAULT/f70471f764144b2fab526d39972d37b3/Article_2012-08-02-US-Bristol-Myers-Study-Suspension/id-d74ea83d70f5443b9364ebba4425a089

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