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.
