Merck: Successor pill safer than Vioxx
Besieged firm will present findings of study next week
NEW YORK — Merck & Co., the US drug maker that recalled its Vioxx painkiller because of a link to heart disease, said short-term studies show the company’s planned successor pill, Arcoxia, is safer.
Merck will present safety findings on Arcoxia next week at the American College of Rheumatology’s annual meeting in San Antonio, said Peter S. Kim, the president of Whitehouse Station, N.J.-based Merck’s research laboratories, in a New York press conference. The company is seeking US regulatory approval to sell the new medication.
The company withdrew Vioxx after a study showed patients taking it for more than 18 months faced twice the risk of a heart attack compared with those on a placebo. The Sept. 30 recall, the biggest ever for a prescription medicine in the United States, wiped out $26.8 billion of Merck’s market value that day. Vioxx generated $2.5 billion, or 11 percent, of Merck’s sales last year.
‘‘We do have substantial safety data on Arcoxia,’’ Kim said during the press briefing. Merck officials said they don’t have safety findings for people taking the medicine as long as 18 months, when the Vioxx risk showed up.
Shares of Merck fell 78 cents to $30.07 in New York Stock Exchange composite trading.
Kim said he wouldn’t speculate whether the Food and Drug Administration may delay approval of Arcoxia because of the Vioxx withdrawal. An FDA decision on the application is due by Oct. 30.
Merck research on Arcoxia will be presented on Oct. 19 at the American College of Rheumatology’s annual meeting in San Antonio. Merck will present data about the study that confirmed Vioxx’s heart risk Oct. 18 at the same meeting.
Prudential Equity Group analyst Timothy Anderson and Sanford C. Bernstein analyst Richard Evans have published reports saying that the FDA probably will require more data on Arcoxia’s safety before approving it.
Arcoxia is sold in 47 countries. Kim said Merck is working with regulators around the world to see how the data from the Vioxx study apply to Arcoxia.
‘‘The data that we have around Arcoxia basically indicates that there are no safety issues,’’ said chief executive Raymond Gilmartin on CNBC. ‘‘That has been the basis of its approval in Europe and also in the other countries.’’
