ViroPharma Inc. lost a bid for a court order temporarily blocking U.S. Food and Drug Administration marketing approval of generic forms of its biggest-selling drug, the antibiotic Vancocin.
U.S. District Judge Ellen Segal Huvelle in Washington yesterday denied the company’s bid for injunctive relief in a 42-page ruling, saying ViroPharma failed to show it was likely to prevail on its claim the government decision was arbitrary or that the restraint would be in the public interest.
“ViroPharma is evaluating potential legal options,” the company said today in a U.S. Securities and Exchange Commission filing disclosing Huvelle’s decision.
Vancocin, which the Exton, Pennsylvania-based company has described as a “drug of last resort” for people with gastrointestinal infections, accounted for about $289 million in sales last year, about half of ViroPharma’s revenue.
The drugmaker sued the FDA and the U.S. Department of Health and Human Services on April 13, three days after Akorn Inc. and Watson Pharmaceuticals Inc. announced they had gained government approval to market generic forms of Vancocin. ViroPharma sought injunctive relief and an order granting it exclusivity to market its drug through Dec. 15, 2014.
While not named as defendants in the complaint, Akorn and Watson were granted court permission to intervene in the case on the side of the government and then filed papers opposing ViroPharma’s request.
ViroPharma has fallen more than 25 percent since April 10. The shares rose 3 cents to $21.37 at 1:03 p.m. New York time in Nasdaq Stock Market trading.
The case is ViroPharma Inc. v. Hamburg, 12-cv-584, U.S. District Court for the District of Columbia (Washington).