FDA Decisions Will Affect These Three Stocks
Genzyme General Corp.
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Transkaryotic Therapies
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BioMarin
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The FDA’s Endocrinologic and Metabolic
Drug Advisory Committee
met Monday to decide whether Genzyme’s
new drug to treat the potential fatal inherited Fabry disease had the potential
to be approved by the full FDA later in the year. The committee concluded with
an overwhelming vote that Genzyme’s drug did
show efficacy in treating the kidney pathology characteristic of this rare
disease. The committee did not recommend approval at this time. Despite this,
the news is good for Genzyme and should strengthen the company’s case when the
full FDA decides on the drug. Trading in the company’s stock was halted.
However, when it reopens expect the company’s stock to reflect this positive
judgment.
Unfortunately, Genzyme’s good news is bad for its competitor
Transkaryotic Therapies.
The same Advisory Committee will meet today (Tuesday) to make a judgment on whether
Transkaryotic’s competing drug (Replagal) is suitable for potential approval by
the full FDA later in the year. However, statements in documents released on the
FDA’s Web site do not bode well for Replagal. The statements conclude that
Replagal does not influence the renal pathology seen in Fabry disease. Trading
in Transkaryotic Therapies was also halted Monday and will be Tuesday while the
committee makes a recommendation.
Amongst all the excitement here, do not lose sight of
BioMarin
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last week’s column. The company quietly closed on Monday up 14% on heavy
volume and will continue to trade until Wednesday. With all the hype focused on Genzyme General and Transkaryotic Therapies, this company is a sleeper. On
Wednesday, the same Advisory Committee will continue its work and make a
judgment on Biomarin’s new drug (Aldurazyme) to treat MPS-I, a rare inherited
disease. So far, the data for Aldurazyme looks good and I suspect positive news
to come out of this final meeting. BioMarin is developing in collaboration with
Genzyme General.
As I said
earlier this week, biotechnology is never boring with the FDA.
Paul Ruggieri, MD FACS