FDA panel says Vioxx can go back to market - Pharmaceuticals - General

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Vioxx gets FDA nod for comeback

Panel says it, Celebrex, Bextra can be sold on market

By I. Cohen & Val Brickates Kennedy, MarketWatch

Last Update: 4:02 PM ET Feb. 18, 2005

WASHINGTON (MarketWatch) - A U.S. Food and Drug Administration advisory

panel narrowly agreed that Merck's controversial drug Vioxx was safe enough

to be sold on the market, and gave the same nod to Pfizer's Celebrex and

Bextra.

The 17-15 ruling paves the way for Vioxx maker Merck (MRK: news, chart,

profile) to bring the painkiller back to pharmacies. On Thursday, the

company said it is considering a comeback for the drug, which was pulled

from shelves in September over concerns of heart risk.

The news sent Merck shares skyward, up 11.5 percent to $32.15.

Meeting for three days on whether Vioxx and other so-called -2 inhibitors

should be on the market, panelists voted 31-1 to keep Pfizer's Celebrex --

also in the same class of drugs -- on the market.

Voting was tighter on Bextra, 17-13 in favor of keeping it on the market.

The news sent shares of Pfizer (PFE: news, chart, profile) higher by more

than 6 percent to $26.62.

All three drugs, though, were determined to cause heart risk by the panel in

a unanimous vote.

Vioxx, Celebrex and Bextra all have come under fire recently for being

linked to a higher incidence of cardiac problems in some patients.

Merck pulled Vioxx from the market after a clinical study linked long-term

use to an increased rate of heart attack and stroke. The company currently

faces more than 600 lawsuits over Vioxx, ranging from personal injury suits

to an investigation by the Department of Justice. Analysts say Merck faced

$20 billion in liability over Vioxx.

While the advisory panel's vote is not a final decision by the FDA, the

agency generally always heeds the recommendations of its expert panels.

On Thursday, Merck researchers told FDA officials that it might consider

putting the drug back on the market if regulators determine that rival pain

medications such as Pfizer's Celebrex carry similar health risks.

Addressing the FDA panel on Thursday, Merck research chief Kim said:

" If the advisory committee and the FDA conclude that the benefits of this

class outweigh the risks in some patient populations, then we would have to

consider the implications of these new data given the unique benefits Vioxx

offers. "

Merck has maintained it believes Vioxx only causes problems after being

taken for at least 18 months or in very high doses. It also asserts that the

drug is of value to many pain sufferers as it doesn't cause the

gastrointestinal bleeding associated with other non-steroidal painkillers.

But analysts on Friday said on Friday that Vioxx's return to the market

would be difficult.

" We believe that there are likely to be multiple hurdles for Merck to

overcome should they decide to relaunch in addition to the possibility of a

positive committee outcome Friday, " said Lehman Brothers analyst

in a note midday Friday.

" We also note that if Merck were able to accomplish a renewal of Vioxx's

presence in the market, if would likely have the effect of minimizing the

liability in Vioxx litigation currently outstanding, " wrote.

Earlier Thursday, a leading FDA drug reviewer testified before that Vioxx

may be far more dangerous than previously believed.

Graham said that after reviewing data on both Vioxx and a similar

drug, Celebrex, he now believes Vioxx can trigger cardiovascular problems

even at low doses. Vioxx is also known as rofecoxib.

" Rofecoxib shows risks at all doses, " said Graham. He added that he suspects

that the drug can cause problems even within the first week of use.

Graham said he based his conclusions on a review of medical records of Vioxx

and Celebrex users from the state of California's Medicaid database.

I. Cohen is a reporter for MarketWatch based in Washington.

Val Brickates Kennedy is a reporter for MarketWatch in Boston.

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