BioCentury
ARTICLE | Regulation

"More is better": ViroPharma's ups and downs

August 10, 2009 7:00 AM UTC

ViroPharma Inc.'s investors have had a bumpy ride since the company received an FDA not-approvable letter for its common cold treatment, pleconaril, in 2002. The stock rebounded to about $22 in February 2006, gaining nearly 1,000% after the company received U.S. rights in 2004 to antibiotic Vancocin Pulvules from Eli Lilly and Co. (NYSE:LLY). The shares fell in March 2006 on concerns that FDA's Office of Generic Drugs would relax requirements for approval of generic versions.More than three years later, ViroPharma (NASDAQ:VPHM) was off 2% last week after an FDA panel voted 17-0 in favor of accepting the agency's recommendation that companies developing generic oral vancomycin capsules can use in vitro dissolution studies to establish bioequivalence to Vancocin capsules, essentially rejecting the company's claim that more arduous methods should be required. In between, the stock has been boosted by Cinryze for hereditary angioedema, obtained through the acquisition of Lev Pharmaceuticals Inc. But the shares also lost more than half their value on Feb. 9, when ViroPharma said that its maribavir oral anti-cytomegalovirus agent missed the primary endpoint in a Phase III trial to prevent CMV. A. 3/20/02 - ViroPharma drops $7.91 (59%) to $5.50 after FDA panel votes 15-0 that the safety and efficacy profile of pleconaril did not support its approval to treat viral respiratory infection (VRI) in adultsB. 5/10/02 - Drops $0.92 (22%) to $3.33 after the company says it will receive a not-approvable letter for pleconaril from FDA...