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http://www.bloomberg.com/news/2011-04-02/bristol-myers-interferon-free-combo-cured-hepatitis-c-patients.html
Bristol-Myers Interferon-Free Combo Cured Hepatitis C Patients By Naomi Kresge - Apr 3, 2011 2:30 AM ET
Bristol-Myers Squibb Co. (BMY)’s cocktailof two experimental drugs cured four hepatitis C patients in thefirst success for a therapy that excludes often-toxic existingdrugs.
The combination had a higher rate of success when pairedwith the current standard treatment in the 21-person trial,curing nine of 10 patients, researchers said today at the Berlinmeeting of the European Association for the Study of the Liver.The study points to the next generation of drugs for the evasivevirus, said Mark Thursz, a professor of hepatology at ImperialCollege London and vice-secretary of EASL.
Bristol-Myers, based in New York, is among about a dozencompanies trying to make better drug combinations that eitherinclude interferon, a decades-old shot that causes flu-likesymptoms and only works in half of patients, or that replaceinterferon entirely. At stake is leadership in a market thatJefferies International Ltd. estimates may total $15 billion ayear by 2019.
“This is perhaps one of the most exciting developmentsthis year,” Thursz said in an interview. “For some patientswho are not going to tolerate interferon, this is the light atthe end of the tunnel.”
Bristol-Myers plans to begin the last trials required forregulatory approval this year, Douglas Manion, the drugmaker’shead of neuroscience and virology research, said in aninterview.
Toughest-to-Treat Today’s trial studied the Bristol-Myers drugs, BMS-790052and BMS-650032, in patients for whom existing therapies hadn’tbeen successful, “the toughest-to-treat population,” Manionsaid.
Ten patients got the two drugs together with interferon andgeneric ribavirin. All showed no sign of the virus 12 weeksafter the treatment was over. One patient had signs of virus at24 weeks and was again virus-free in another follow-up test 35days later.
Of 11 patients who took the Bristol-Myers combinationalone, five had cleared the virus from their bodies at the endof treatment. Four remained virus-free after 24 weeks.
Patients may start treatment earlier if they aren’t facedwith the toxic side effects of traditional hepatitis C drugs,said Howard Liang, a Boston-based analyst for Leerink Swann &Co., in an interview.
“If you have an interferon-free regimen, the marketexpands fairly dramatically,” Liang said.
Side Effects Side effects of the existing interferon regimen are oftensevere enough to force patients to take time off work, saidCharles Gore, president of the Geneva-based patient advocacygroup World Hepatitis Alliance.
Roche Holding AG (ROG) of Basel, Switzerland, sells a version ofinterferon under the brand name Pegasys, while Merck & Co. ofWhitehouse Station, New Jersey markets a form called PegIntron.
Merck, Vertex Pharmaceuticals Inc. (VRTX) and Johnson & Johnsonare expected to bring the first new hepatitis C drugs in adecade to the market this year. About 90 percent of patients whotook Johnson & Johnson (JNJ) and Vertex’s telaprevir were cured,Cambridge, Massachusetts-based Vertex said in two studies lastyear. Patients given Merck’s boceprevir showed similarly highcure rates in studies last year.
The Vertex and Merck trials included people who hadn’t yetbeen treated, an easier-to-cure group than those in today’ssmaller study. By comparison, about 30 percent of those whohadn’t responded to previous treatment were cured after tryingtelaprevir plus standard therapy, researchers said.
Seeking Partners Merck is seeking partnerships to gain its own hepatitis Cdrug combinations, Patrick Bergstedt, general manager of theinfectious diseases franchise, said in an interview.
“We’re behind the others,” Bergstedt said. “We need topartner to fill the gap.”
Bristol-Myers expects an “element of consolidation” ascompanies use acquisitions, partnerships and research anddevelopment collaborations to gain their own hepatitis C drugcombinations, Manion said. After signing a development deal withPrinceton, New Jersey-based Pharmasset Inc. (VRUS) in January, Bristol-Myers is “talking to pretty much every company out there,” hesaid.
“This is like trying to redesign a car as you’re rollingdown the road at 100 miles per hour, because the data are comingso fast,” he said. “What an exciting time.”
To contact the reporter on this story:Naomi Kresge in Frankfurt at [email protected]
To contact the editor responsible for this storyhil Serafino at [email protected]
Last update: 11:46 AM ET, Apr 2
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