CELEBREX SETS $25 MIL BLITZ DESPITE FDA SNAG

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Monsanto Co. and Pfizer are scheduled to launch one of the most eagerly anticipated direct-to-consumer pharmaceutical ad campaigns of the year this week -- for Celebrex, a wildly successful anti-arthritis drug.

The content of the estimated $25 million TV campaign remains unclear, however, due to concerns from the U.S. Food & Drug Administration about the branded TV spots, said an executive close to the situation. The co-marketers will proceed with the launch by using preplanned unbranded spots.

The FDA and Monsanto are engaged in negotiations about what to do about the drug's name, which the FDA said has caused confusion with Celexa, a medication for treating depression, and Cerebyx, used to treat epilepsy and seizures.

DELAY IN RUNNING ADS

The agency's reservations are believed to have led to the holdup in running the ads that mention Celebrex by name.

The branded ads are "up in the air," an executive said.

Mark Gleason, a spokesman for Monsanto's G.D. Searle & Co. pharmaceutical division, declined to comment on the company's plans. But in general, he said, the company voluntarily submits its ads to the FDA for approval before they are run.

"We want to do it in partnership with the FDA," Mr. Gleason said. "We want to make sure the FDA is comfortable with any message we have out there."

Drug marketers have two options: They can submit their ads to the FDA for a so-called pre-screening signoff or they can air them and run the risk of a warning from the agency.

The unbranded ads are believed to promote general arthritis-treatment awareness and will run on cable networks such as CNN and Lifetime, executives said. It was unclear whether they would also air on the broadcast networks.

The TV commercials were created by Leo Burnett USA with media planning by sibling Starcom USA, both Chicago; Young & Rubicam's Media Edge, New York, is buying media.

Monsanto and Pfizer have asked about print ads in several consumer magazines, two publishing executives said, but have yet to purchase space. Celebrex ads already are running in professional publications.

RELIEF WITHOUT SIDE EFFECTS

A six-page ad in Drug Topics, aimed at pharmacists, uses the tagline "Powerful relief. Safely delivered." Celebrex is the first in a category of drugs known as Cox-2 inhibitors, which relieve the pain and inflammation of both osteoarthritis and rheumatoid arthritis without causing widespread side effects, such as gastrointestinal problems.

The FDA began negotiations with Monsanto concerning the Celebrex name after it received more than 50 reports of name confusion from physicians and pharmacists, though only 10 of those resulted in incorrect prescriptions; no deaths or injuries resulted. The FDA said "all options are on the table" as far as a possible name change, though Mr. Gleason cited the expense of repackaging and remarketing the product.

Celebrex was introduced in January and became the second-most-successful new drug ever, trailing Pfizer's Viagra, introduced in 1998. Celebrex had $69.5 million in sales in its first two months, according to consultancy IMS Health.

But Celebrex's share could be threatened soon. An FDA advisory panel has recommended the agency approve Vioxx, a Cox-2 inhibitor from Merck & Co., which could be on the market this summer.

Vioxx also may be able to capitalize on negative publicity Celebrex has generated lately because, as with Viagra last year, the FDA has received reports of some deaths among people taking Celebrex.

An FDA spokeswoman said the agency has established "no cause and effect relationship" between the deaths and the drug.

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