It's nice to have your drug in high demand. Except, of course, if you can't actually meet demand.
Such is the life of ViroPharma
Metric |
2009 Q3 |
2009 Q4 |
2010 Q1 |
2010 Q2 |
---|---|---|---|---|
Cinryze sales (in millions) |
$29.1 |
$36.0 |
$34.9 |
$40.3 |
Sequential sales change from previous quarter |
13.7% |
23.7% |
(3.1%) |
15.5% |
Source: Company releases.
Increasing production using a process called parallel chromatography helped reaccelerate growth, but the ViroPharma really needs its industrial scale manufacturing to come online to reach the potential $250 million to $350 million in U.S. sales the company has guided for.
Investors are going to have to wait a little longer. ViroPharma announced today that the Food and Drug Administration has turned down, for now, its request to start selling Cinryze manufactured at an industrial scale. The agency wants answers to questions from observations made at the preapproval inspection and has additional questions about the technical processes of making Cinryze at the larger scale.
Issues with scaling up production are nothing new to the industry. Earlier this month, Onyx Pharmaceuticals
ViroPharma seems to think the issue is fairly minor. The company is pushing forward with production assuming the FDA will sign off and that it'll be able to sell the product once it does.
If ViroPharma is right, buying on today's dip could be a very well-timed move ahead of a reacceleration of sales.
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