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A Painless Advisory Panel Meeting

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Looks like Genzyme (Nasdaq: GENZ  ) might be getting a Christmas present from the Food and Drug Administration. An FDA advisory panel yesterday unanimously recommended approval for Genzyme's osteoarthritis pain drug Synvisc-One.

The drug, already approved for sale in European and Southeast Asian countries, is a refinement of the existing Synvisc, requiring only one injection instead of the original's three. Both versions collectively brought in only $68 million, or about 6% of Genzyme's revenue, last quarter, so an approval likely won't have a huge effect on Genzyme's earnings. Still, requiring only a single trip to the doctor's office, instead of three, should help Genzyme grab a slightly greater share of a market crowded with rival treatments, including Pfizer's (NYSE: PFE  ) Celebrex, Wyeth's (NYSE: WYE  ) Advil, and Johnson & Johnson's (NYSE: JNJ  ) Motrin.

It should be noted that Genzyme isn't guaranteed a fat present from the FDA before its PDUFA date on Dec. 23. Plenty of companies have gotten positive recommendations from advisory panels without a subsequent approval -- Dendreon (Nasdaq: DNDN  ) , anyone? Then again, I can't think of a time when a unanimous recommendation failed to lead to a drug's approval, so Genzyme's investors are probably safe to expect good news. Just don't be surprised if that gift is delayed; the FDA has been known to be a little late to the party.

Between Synvisc-One and bone marrow transplant drug Mozobil, which should also receive a decision from the FDA this month, Genzyme might have a pretty good December. With a P/E topping 40, the pharmaceutical hardly looks cheap right now -- especially in this market -- but high-growth stocks hardly ever do.

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Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. Pfizer and Johnson & Johnson are Income Investor recommendations. Pfizer is also an Inside Value selection and a Motley Fool holding. The Fool has a disclosure policy.


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Related Tickers

4/8/2011 3:59 PM
GENZ.DL $76.25 Down +0.00 +0.00%
Genzyme Corp CAPS Rating: ****
PFE $21.33 Up +0.03 +0.14%
Pfizer, Inc. CAPS Rating: ****
WYE.DL $0.00 Down +0.00 +0.00%
Wyeth CAPS Rating: ***
DNDN $13.99 Down -0.47 -3.25%
Dendreon Corp CAPS Rating: ***
JNJ $64.61 Down -0.07 -0.11%
Johnson & Johnson CAPS Rating: *****

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