PHARMACY

Bristol-Myers Squibb on Baraclude: Better efficacy than competitor

BY Alaric DeArment

BOSTON A Bristol-Myers Squibb drug used to treat hepatitis B kept viral load levels down more effectively than its competitor, according to study results announced by the company.

Bristol presented results in Boston Saturday at the American Association for the Study of Liver Disease’s annual meeting of a 48-week study comparing Baraclude (entecavir) with Gilead Sciences’ Hepsera (adefovir) in 191 patients with chronic hepatitis B infection with severe cirrhosis of the liver, also known as decompensated cirrhosis. Liver disease accounts for up to 25% of hepatitis B-related deaths.

Halfway through the study, 49% of 100 patients taking Baraclude had an undetectable viral load, compared with 16% of the 91 taking Hepsera. By the end of the study, 57% of Baraclude patients had an undetectable load, versus 20% of Hepsera patients.

“This study represents an important step in addressing an unmet medical need, as this is one of the first comparative studies to evaluate the safety and efficacy of antiviral therapy in this difficult-to-treat patient population,” said Hugo Cheinquer, study investigator and associate professor of gastroenterology and hepatology at the Universidade Federal do Rio Grande do Sul in Porto Alegre, Brazil. “Chronic hepatitis B is a lifelong disease, and these data suggest that treatment with Baraclude may offer chronic hepatitis B patients with decompensated cirrhosis a treatment option.”

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CAORC to host press briefing on organized retail crime

BY Alaric DeArment

WASHINGTON When most people think of organized crime, they imagine gun battles in the streets of Chicago during the Prohibition era, but some of its biggest victims are retail pharmacies.

The Coalition Against Organized Retail Crime announced that it would have a press conference at noon on Wednesday to discuss the role of federal law enforcement in combating organized retail crime. The conference will take place before a hearing of the House Judiciary Committee Subcommittee on Crime, Terrorism and Homeland Security on the subject.

Organized retail crime involves the theft of large quantities of goods from retailers and the sale of those goods through pawn shops, flea markets and online. It causes losses of tens of billions of dollars annually and puts consumers at risk of using mishandled and adulterated goods.

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FDA rejects expanded use of Pegintron

BY Alaric DeArment

KENILWORTH, N.J. The Food and Drug Administration has rejected an approval application for an additional use for a hepatitis C drug.

Schering-Plough Corp. announced Friday that it had received a complete response letter – an FDA notice of rejection – for Pegintron (pegylated interferon alfa-2b) as a treatment for stage 3 malignant melanoma. The FDA’s Oncologic Drugs Advisory Committee had recommended approval of the drug for the disease by vote of 6 to 4 in October.

Schering-Plough said it would work with the FDA to respond to the agency’s concerns. The drug is already approved for treating chronic hepatitis C in combination with Schering-Plough’s Rebetol (ribavarin).

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