Executives won't speculate on approval for Arcoxia
By Val Brickates Kennedy, CBS.MarketWatch.com
Last Update: 6:31 PM ET Oct. 13, 2004
BOSTON (CBS.MW) -- Merck managers repeatedly defended their actions Wednesday regarding the withdrawal of widely used arthritis and pain medication Vioxx and offered a cautious update on its prospective successor, Arcoxia.
During a lengthy conference call with reporters, executives for Whitehouse Station, N.J.-based Merck (MRK: news, chart, profile) answered questions about three large clinical studies that may link Vioxx to cardiovascular problems for long-term users.
"Any claim that Merck didn't react responsibly is in direct conflict with the facts," said Peter Kim, president of Merck Research Laboratories.
Shares of Merck, a Dow component, closed down 2.53 percent at $30.07 Wednesday.
On Sept. 30, the company shook the pharmaceutical sector by announcing that it was pulling Vioxx from the market immediately, on the advice of a safety panel overseeing a study that was testing the drug as a preventive against colon polyps. Merck's stock dropped more than 20 percent. See full story.
That study, called the "Approve" study, showed that patients who took Vioxx for over 18 months on a daily basis also were more likely to suffer a heart attack or stroke. The average age of the patient in the Approve study was 58, according to the company.
Merck said that it plans to present data from the Approve study on Oct. 18 at the annual scientific meeting of the American College of Rheumatology.
Asked how the fiasco will affect the company's chances of getting Arcoxia -- currently available in 47 nations -- approved by the U.S. Food and Drug Administration as a successor to Vioxx, Merck executives were reticent.
"I'm not in a position to speculate on what the FDA will do," said Dr. Kim during Wednesday's call.
Merck has said that it believes Arcoxia, chemically similar to Vioxx, is safe to take for at least 12 months. The company is currently working with foreign regulators about possible labeling changes for the drug.
Since Vioxx's withdrawal, questions have been raised as to Merck's handling of data from two earlier studies. One study, of particular interest Wednesday, tested Vioxx to see if it caused fewer gastrointestinal problems than naproxen, a popular over-the-counter pain reliever marketed under such names as Aleve. Merck had code-named that study "Vigor."
According to both Merck scientists and outside observers, the Vigor study showed an increased rate of cardiovascular problems in some Vioxx users compared with naproxen users. Merck executives said Wednesday that at the time, they attributed those results to naproxen possessing some sort of cardiovascular protective quality akin to that of aspirin.
Regardless, the Vigor data did result in the FDA requesting that Merck change Vioxx's labeling to include the cardiovascular data from the study. That labeling change took place in 2002.
'Numerous' lawsuits
Also Wednesday, Merck said that a third trial, which tested Vioxx to see if it could lessen the symptoms of Alzheimer's disease, was largely inconclusive as to the cardiac implications of the drug due to a high patient dropout rate.
Meanwhile, Kenneth Frazier, Merck's general counsel, confirmed that "numerous" lawsuits have been filed against Merck on behalf of Vioxx users claiming they have been injured by the drug.
Frazier refused to specify how many suits had been filed, stating only that the company anticipated more in the future.
Quelle
Interessanter Link zu Pressemeldungen aus der Pharma
Meine Meinung: Hoffen wir doch, daß die Merck durch die Berichte über beginnende Gerichtsverhandlungen vielleicht noch ein wenig nach unten gedrückt wird.