May1, 2000 - Does Merck Have A Problem With Vioxx?
Will the intense scrutiny of Merck's big selling arthritis drug Vioxx result in profit loss? A preliminary study of the drug, conducted by Merck last month, concluded that patients taking the drug suffered more cases of heart damage, like heart attacks and strokes, than those on an alternative drug called Naproxen. However, it is not clear if Vioxx actually puts patients at higher risk of adverse heart events or whether Naproxen confers heart-condition benefits.
Merck has a great interest in the success of Vioxx and their other new products. "Vioxx is Merck's big home run," says David Saks, manager of the Medical Sciences Fund at Gruntal & Co. "It's their Mickey Mantle, their Babe Ruth." "Perceptions about the prospects for Vioxx are the single most important factor in Merck's stock price."
Over the next two years five of Merck's big sellers will lose their patent protection, leaving them vulnerable to challenges from cheaper generics. In 1999, those five products generated $4.38 billion in U.S. sales and royalties. "Vioxx is critical to Merck's getting through the patent situation," says Larry Smith of Sutro & Co.
The drug was approved by the FDA in May to treat pain and osteoarthritis, the most common form of the disease. Susan Cruzan, speaking for the agency, said they will examine the study when Merck submits it in the next few months. The FDA, she added, continues to believe that Vioxx is "safe and effective for its labeled uses." Smith likes Pharmacia's (PHA2) rival drug Celebrex better. That drug, already approved for rheumatoid arthritis and osteoarthritis, but not pain, does not have dosage issues, he says. It retains a very good safety profile when given at doses of over twice the recommended levels. Last year, Celebrex produced sales of $1.5 billion. But Merck's aggressive marketing strategy and Vioxx's indication for pain have helped Vioxx gain a significant market share of new prescriptions. In the most recent quarter, Celebrex sales rose about 7% to $534 million, while Vioxx sales jumped 40% to $370 million.
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