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Ladies In Waiting For Merck's Gardasil

The FDA giveth and the FDA taketh away.

Yesterday the agencyhanded Merck a little bit of a break with what could be interpreted as an endorsement, of sorts, of the cholesterol drug Vytorin that MRK shares with Schering-Plough . Although financially, the pill is more important to SGP than it is to MRK.

But then this morning the Dow component announced that the FDAhas issued another delay in deciding whether to approve the company's Gardasil vaccine for sexually transmitted disease and cervical cancer for older women. The agency wants more data which Merck says won't be ready to turn over to regulators until the fourth quarter of this year.

Gardasil is approved for females nine to 26 years old. MRK wants permission to also sell it to women between the ages of 27 and 45 who the company says remain at risk for HPV- (Human Papillomavirus) related disease "throughout their lifetimes."

In addition, late last month Merck filed for FDA approval of the vaccine for males between the ages of nine and 26. Guys carry and transmit HPV. Both of those populations could help MRK spur Gardasil sales growth which has slowed over the past year or so. It's a blockbuster product and had been a new, key growth driver.

Nonetheless, Merck is reconfirming that it will still post overall 2009 sales of $23.7-$24.2 billion. And it isn't touching its earnings guidance either. However, the press release says, "The Company will update other elements of its 2009 guidance on its February 3, 2009 earnings conference call." I'm guessing that it might have to revise its 2009 Gardasil sales estimate of $1.4-$1.6 billion.

I'm off to San Francisco for the JPMorgan Healthcare Conference. I'll be reporting from there on Tuesday, all day long, with live interviews of nine executives representing a cross-section of the industry. Merck Chairman and CEO Dick Clark is not one of them.

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