Dalbavancin has moved into the review process.
Vicuron Pharmaceuticals Inc. filed for FDA approval of the antibiotic, submitting a new drug application for its use in complicated skin and soft-tissue infections. The company released the news after the market closed.
"This is a very important milestone and represents a large amount of work," Dov Goldstein, Vicuron's chief financial officer, told BioWorld Today. "The endgame is to get an approval and sell the drug, and that's what this company is focused on doing."
With the NDA on file, Vicuron is that much closer to achieving those targets. The King of Prussia, Pa.-based company filed for priority review of the fast-track product, and the FDA has 60 days to determine whether to shorten its review time or evaluate the NDA under a standard timeline.
Dalbavancin is an intravenously delivered lipoglycopeptide for skin and soft-tissue infections caused by Gram-positive bacteria, including the most difficult-to-treat strains of methicillin-resistant Staphylococcus aureus (MRSA). Vicuron expects that it could offer an alternative to older agents such as vancomycin, a long-used antibiotic that is delivered twice a day.
"Dalbavancin is a drug that's highly potent against a broad spectrum of Gram-positive organisms," Goldstein said. "It's a reliably bactericidal drug during the entire treatment period, and it's administered once a week."
He said a convenient dosing schedule distinguishes dalbavancin from commonly used, standard-of-care agents for skin and soft-tissue infections such as vancomycin, linezolid and cefazolin. At the same time, he added, dalbavancin's consistent bactericidal profile is better.
The NDA is supported by data from three Phase III trials and includes results from more than 1,850 patients. The studies, which evaluated dalbavancin's safety and efficacy, met their primary and secondary endpoints of non-inferiority when compared to vancomycin, linezolid or cefazolin.
Upon releasing findings from the Phase III program four months ago, the company's stock gained more than 20 percent the day the news was released, closing at $12.63. On Tuesday, Vicuron's stock (NASDAQ:MICU) dropped 11 cents to close at $16.25.
Goldstein declined to forecast the market size in which dalbavancin could compete, though he noted that Vicuron plans to internally sell the drug in North America should it receive approval. The company, which owns dalbavancin's worldwide rights, has yet to determine an overseas commercialization strategy.
The drug was discovered by Biosearch Italia SpA, a company formerly based in Milan, Italy, before merging with Fremont, Calif.-based Versicor Inc. to form Vicuron. The transaction, which was completed more than two years ago, was valued at $225 million. (See BioWorld Today, Aug. 1, 2002.)
With the company moving dalbavancin down the regulatory pathway as planned, it will continue to negotiate the FDA process for another of its late-stage products, anidulafungin. An antifungal agent, it has received an approvable letter. The original NDA was filed about a year and a half ago, followed about a year later by the approvable letter that indicated concerns about a secondary endpoint associated with relapse rate after two weeks of follow-up. (See BioWorld Today, April 29, 2003, and May 25, 2004.)
An amendment to its NDA for esophageal candidiasis is scheduled to be submitted in the second quarter, with an additional NDA for invasive candidiasis/candidemia to be filed in the third quarter. Phase III findings on anidulafungin's use in the latter indication are expected to be released in the first half of next year. (See BioWorld Today, Sept. 22, 2004.)
The company also owns all rights to anidulafungin.
Earlier-stage programs at Vicuron are being conducted in partnerships. A relationship with Novartis AG, of Basel, Switzerland, has generated an antibiotic that is in Phase I studies. Another antibiotic collaboration, with New York-based Pfizer Inc., remains in late-stage preclinical studies.
On its own, Vicuron is committed to beginning Phase I studies next year for another antibiotic, an injectable product designed to treat anaerobic infections.