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ViroPharma Loses Challenge to Generic Drug Rule

By Pharmaceutical Processing | April 19, 2011

EXTON, Pa. (AP) — Shares of biopharmaceutical company
ViroPharma Inc. fell Monday after the company said a U.S. District Court ruled
against it in a challenge to an FDA decision.

The stock fell $2.14, or 9.8 percent, to close at $19.67.

In 2009, a Food and Drug Administration panel of experts
voted unanimously that generic drug companies should not have to conduct costly
human trials before launching generic versions of Vancocin, ViroPharma’s key
product. The drug is aimed at antibiotic-associated gastrointestinal infection.

ViroPharma had argued that generic drug companies seeking
approval to market generic versions of Vancocin should be required to conduct
testing in patients with gastrointestinal infections before making a generic
version.

ViroPharma had filed a motion with the U.S. District Court
of the District of Columbia
challenging the FDA on the matter, and that motion was dismissed on a basis of
“lack of standing,” according to a Securities and Exchange Commission
filing from ViroPharma.

The company said it is considering alternatives following
the decision.

During the fourth quarter of 2010, sales of Vancocin climbed
31 percent to $67.8 million. Sales of Cinryze, ViroPharma’s other drug, grew 49
percent to $52.5 million. Cinryze treats hereditary angioedema, a genetic
disease that can cause dangerous swelling in the throat and extremities.

 

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