Vicuron Pharmaceuticals Inc., still smarting from the FDA's communication on anidulafungin that is, at best, delaying the product's launch, is cutting expenses through a staff reduction and operational maneuvers.
The plan, said George Horner, president and CEO of Vicuron, is to decrease expenses "by over $25 million" this year and "by an additional 25 million in 2005," via a "combination of operational and head count measures."
In a conference call, the company did not detail what those measures are or just how many employees will fall under the blade, but the moves are expected to give Vicuron a net loss in 2004 of $87 million to $92 million. For 2005's fiscal year, that loss should decrease to $65 million to $70 million.
Regarding anidulafungin, the company had little new information to offer.
"The discussions [with the FDA] have begun; we are very engaged in the process, and when we have more definitive information, we'll provide it," Horner said.
The FDA's approvable letter in May said the new drug application for anidulafungin did not support approval in esophageal candidiasis. The company's stock was crushed on the news, dropping $8.86, or 40.5 percent, closing at $13.04, the day it was released. But the FDA also said the company might get approval in invasive candidiasis/candidemia if the Phase III trial now under way provided positive results. That trial is expected to be complete by the end of 2004. (See BioWorld Today, May 25, 2004.)
The FDA's approvable letter was followed by several class-action lawsuits against Vicuron, of King of Prussia, Pa., alleging that the company misled investors.
In Thursday's conference call, the company was asked what might have been the deficiency in the initial filing, but Vicuron couldn't say.
"It's premature at this time to sort of second guess," said Dov Goldstein, the company's chief financial officer. "We had an initial meeting [with the FDA], which was very productive, but we don't have a definitive path or any further update on that."
Horner pointed out that Vicuron had said it would let the market know its managerial moves 30 days post-FDA communication, which now it has done.
"Thirty days is a short time" to be able to provide the answers investors and analysts are looking for, he said.
Vicuron is estimating cash reserves at the end of the second quarter of $142 million. The cost-cutting moves are meant to ensure that Vicuron has "sufficient money from a clinical standpoint to drive anidulafungin and dalbavancin to market," Horner said.
Dalbavancin is an intravenous antibiotic being developed to treat Gram-positive infections. It is in three Phase III trials in skin and soft-tissue infections, comparing the drug against vancomycin. Horner said the company is still "on track" to provide Phase III data in the third quarter and file an NDA by year's end.
Vicuron's stock (NASDAQ:MICU) dipped 27 cents Thursday to close at $12.47.