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Viropharma Loses Challenge to Generic Drug Rule

From Associated Press (April 18, 2011)

EXTON, Pa. -- 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.

Posted: April 2011

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