Healthy Skepticism Library item: 9356
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Perrone M.
Wall Street Does Not Expect Blockbuster U.S. Sales From Merck's Vioxx Follow-Up, Arcoxia
Associated Press 2007 Apr 10
http://biz.yahoo.com/ap/070410/fda_arcoxia.html?.v=2
Full text:
Merck & Co. Inc. shares showed little reaction Tuesday to the release of government documents reviewing the pain-relieving drug Arcoxia.
The Food and Drug Administration posted the Arcoxia review to its Web site ahead of a Thursday meeting at which non-agency arthritis experts are expected to vote on whether the drug should be approved. The agency is not required to follow the panel’s recommendation, though it often does.
Arcoxia would be the first in the same class of drugs as Vioxx and Bextra to gain U.S. approval since those drugs were pulled from the market after showing links to heart attack and stroke in 2004 and 2005.
The prospect of FDA approval of a drug similar to Vioxx, which attained blockbuster status in its five years on the market, has attracted scrutiny from patients and physicians. But Wall Street seems unconcerned with the drug’s potential on speculation that safety concerns would limit sales.
“Our position has been that it won’t get approved, but even if it does, it will hardly make an impact,” said Kate Hohenberg, an analyst with pharmaceutical research firm Decision Resources.
Arcoxia is part of a class of drugs called cox-2 inhibitors, thought to be gentler on the stomach than over-the-counter medicines such as Tylenol and Advil. Pfizer, which made Bextra, still sells Celebrex, another cox-2 drug.
In its summary, FDA staff note that while Arcoxia had blood-clotting risks in line with another commonly prescribed pain reliever, it showed higher incidence of hypertension-related heart problems when compared with the same drug.
Hohenberg estimated Arcoxia sales could be limited by restrictive labeling that Celebrex does not have. In Europe, for example, Arcoxia was approved with a specific warning label indicating that it should not be used by patients with hypertension.
“Merck has not revealed why anyone would be compelled to use its drug over the one already available,” said Hohenberg.
Whitehouse Station, N.J.-based Merck also could find Arcoxia competing against cheaper generic versions of Celebrex after that drug loses patent protection, which could happen as early as 2013.
And Merck’s FDA application for Arcoxia seeks approval for use only in patients with osteoarthritis. While the osteoarthritic population in the United States is significant at 21 million, it is much smaller than the market had been for Vioxx, which was approved for osteoarthritis, rheumatoid arthritis and a variety of other chronic pain conditions.
Merck did not break out potential sales from Arcoxia in its 2007 guidance, instead lumping the product in with other drugs that are not considered major franchises. Together the group of more than a dozen products are expected to bring in sales of $5.2 to $5.6 billion for the year. By comparison, Merck’s top-selling allergy medication Singulair is expected to generate revenues between $3.7 and $4 billion next year.
Still, Dr. Patience White of the Arthritis Foundation says Arcoxia is likely to find a niche among arthritis sufferers who do not respond to more traditional pain relievers.
“There’s a percentage of patients out there who recognize that they face a greater risk from the disability associated with their pain than the reported risk of the drug,” said White, who is chief public health officer for the not-for-profit group.
Shares of Merck & Co. rose 21 cents to close at $45.86 on the New York Stock Exchange. Pfizer shares closed unchanged at $26, also on the NYSE.
