Bristol-Myers’s Once-Daily Hepatitis C Drug Cures 83% of People in Study
Bristol-Myers Squibb Co. (BMY)’s experimental hepatitis C drug worked in combination with two established medicines to cure as many as 83 percent of patients, a study found.
The trial tested three doses of the drug, called BMS-790052, with peginterferon and ribavirin, the standard treatment. Pills with the two highest doses cured 83 percent of patients 24 weeks after the treatment was completed, compared with 25 percent for those on the current therapies and a placebo, the New York-based company said in a statement today at ICAAC, the Interscience Conference on Antimicrobial Agents and Chemotherapy, in Chicago.
Two hepatitis C drugs, Vertex Pharmaceuticals Inc. (VRTX)’s Incivek and Merck & Co.’s Victrelis, were approved in May by the U.S. Food and Drug Administration as the first for the illness in more than a decade. Those treatments are given three times a day; BMS-790052 is taken in one daily dose, said Douglas Manion, vice president of development and virology for Bristol-Myers.
“The new standard of care should be 60 to 80 percent cure rates,” Manion said in a telephone interview.
If approved, Bristol-Myers’s drug may generate sales of $125 million by the end of December 2015, according to Seamus Fernandez, an analyst with Leerink Swann & Co. in Boston. The treatment will advance into the final of three phases of trials usually required for U.S. regulatory approval, and be tested against the Vertex and Merck pills, Manion said.
About 170 million people worldwide, including 3.2 million in the U.S., have chronic hepatitis C, a blood-borne disease that can lead to liver cirrhosis and cancer, according to the Centers for Disease Control and Prevention in Atlanta. No vaccine exists for the virus, which is usually spread by sharing needles and can be transmitted sexually in rare cases.
Four Bristol Drugs
BMS-790052 is one of four Bristol-Myers drugs for the hepatitis C virus in human testing, including a treatment in the same class as the approved Merck and Vertex medicines and a new variant on interferon, he said.
The Bristol-Myers study released today tested 48 patients. Ribavirin and interferon were given plus BMS-790052 in 60- milligram, 10-milligram or 3-milligram doses.
Forty-two percent of patients given the lowest dose of the Bristol-Myers drug were cured of the virus after 24 weeks. Another group received the standard medicines and a placebo. Their results were measured after 48 weeks, the typical prescribed length of current treatment.
There were no increased side-effects beyond standard therapy in any of the patient groups, Bristol-Myers said in its statement.
Incivek from Cambridge, Massachusetts-based Vertex has been associated with rashes and anemia. Fatigue and anemia are side effects of Victrelis from Whitehouse Station, New Jersey-based Merck.
Incivek, which is marketed in Europe by Vertex and Johnson & Johnson (JNJ), is expected to have sales of $719 million in 2011, according to 10 analysts surveyed by Bloomberg. Victrelis revenue is expected to be $187 million, according to three analysts.
The new hepatitis C drugs have fewer side effects than the existing therapies, which fail in about half the patients, and work more quickly, according to the FDA.
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