Dendreon's (Nasdaq: DNDN ) Provenge was approved months ago, but the data from the clinical trial supporting the Food and Drug Administration's decision was finally published in the New England Journal of Medicine this week.
Being published in a well-respected journal certainly can't hurt, but despite the headlines on some articles, Dendreon doesn't need respect right now. It needs sales.
Ostensibly, more respect could lead to increased sales, but are there really that many doctors on the fence about whether to prescribe Provenge? Is the publication of data that's already been presented at a medical meeting really going to change anyone's mind?
The same goes for the accompanying editorial that criticized the data. Placebo might be hurting people; the drug is expensive; it's weird that the tumors don't shrink; yadda, yadda, yadda. We've heard it all before. Let's all just quiet down and see how sales pan out.
Dendreon will release second-quarter earnings next Tuesday, but I don't think investors should get too hung up on the first few months of sales. The magnitude of the sales ramp-up will matter most for Provenge's long-term future. With only one data point, you can't measure how fast sales are growing.
For comparison, here's how a few recent drug launches have panned out:
|
Drug
|
Company
|
Sales First Full Fiscal Year After U.S. Approval (in Millions)
|
|
Januvia
|
Merck (NYSE: MRK )
|
$668
|
|
Sutent
|
Pfizer (NYSE: PFE )
|
$581
|
|
Nexavar
|
Onyx Pharmaceuticals (Nasdaq: ONXX ) and Bayer
|
$165
|
|
Tykerb
|
GlaxoSmithKline (NYSE: GSK )
|
$189
|
|
Sprycel
|
Bristol-Myers Squibb (NYSE: BMY )
|
$158
|
Source: Company releases and FDA website.
Because of a manufacturing backlog, Provenge may not be able to ramp up quickly. But investors should keep a close eye on the drug's quarter-over-quarter sales growth next year, as more manufacturing plants come online.
Until that happens, gaining more potential prescribers won't matter much anyway.
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