Dendreon's (Nasdaq: DNDN) prostate cancer treatment Provenge has been on the market for about three months, and it's already gotten itself into trouble with the Food and Drug Administration. Late on Friday, the agency posted a letter telling Dendreon that its marketing materials for Provenge stepped over the line -- minimizing risk and overstating benefits.
It's tempting to say that the letter is a sign that Dendreon doesn't know what it's doing. But it's more likely the company knows exactly how to play this game: push the envelope until the FDA pushes back. Except for having to fix and reprint the promotional materials, there's no real punishment for getting such a letter from the FDA.
Dendreon has plenty of company. In the last year, Novartis (NYSE: NVS), Talecris Biotherapeutics (Nasdaq: TLCR), CSL Behring, and Genzyme (Nasdaq: GENZ) have all received letters from the FDA about their promotion of drugs, and that's just on the biologics side. For small molecules, there are too many to mention. On one day in April alone, the agency posted three letters to GlaxoSmithKline (NYSE: GSK), Novartis, and Astellas about their marketing of Arzerra, Voltaren, and Vesicare respectively.
Receiving a letter from the FDA is less severe than the headlines make it out to be, but that doesn't mean Dendreon is risk-free. The company is still new to the promotion and manufacturing of drugs. With only one drug, Dendreon is no Pfizer (NYSE: PFE) or Johnson & Johnson (NYSE: JNJ), which have extensive experience in both areas.
Of the two, I continue to think that manufacturing is the bigger risk for investors. The drug will mostly sell itself, but Provenge is complicated to make, because it uses the patient's own immune cells. So far, things seem to be moving smoothly, with Dendreon's only plant working at full capacity for two weeks in July. It remains to be seen how the newly-established practices will hold up when the company expands from one to three manufacturing plants.
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