Yesterday's FDA approval of Genzyme's (Nasdaq: GENZ) Lumizyme is either a sign the company is back from the dead or an anomaly in an otherwise disgraceful year. It kind of depends on whether your glass – or, in Genzyme's case, your 4,000-liter bioreactor -- is half-full or half-empty.

Lumizyme, which treats Pompe disease, is a scaled-up, 4,000-liter version of Myozyme, which treats the same disease but is made in 160-liter batches here in the U.S. Because of the high demand, Genzyme developed the larger manufacturing process, but the FDA said the drug was different enough that it needed a separate approval and even a different name.

Genzyme has been trying to get Lumizyme approved since November 2008. Since then, the company has been by far the worst performer of the midsized drugmakers.


Share Price Increase (Decrease)
Since First Lumizyme FDA Delay



Biogen Idec (Nasdaq: BIIB)


Amgen (Nasdaq: AMGN)


Eli Lilly (NYSE: LLY)


Bristol-Myers Squibb (NYSE: BMY)


S&P 500


Source: Capital IQ, a division of Standard & Poor's.

Is this the turning point? Ask me in another 18 months. The approval is certainly a good start, and the company's squaring away its consent decree with the FDA on Monday is another sign that it's trying to get manufacturing problems behind it. But Genzyme still has plenty to do before the FDA will let the company out of its grips. Call me middle-of-the-road cautiously optimistic.

We'll get a good idea whether investors agree when they vote in the proxy fight between the company and investor Carl Icahn at Genzyme's annual meeting next month. With CEO Henri Termeer up for re-election to the board, investors may ask for someone else to lead the turnaround despite Genzyme's 11th-hour heroics.

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Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. The Fool has a disclosure policy.