Vicuron Pharmaceuticals Inc has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for anidulafungin, a novel antifungal agent for the treatment of esophageal candidiasis, a painful and debilitating infection of the esophagus that commonly affects patients with compromised immune systems. Anidulafungin belongs to the first new class of antifungal agents, called echinocandins, introduced in more than 40 years.
"This is the most important corporate milestone achievement in our relatively brief history, and our development team has done an excellent job executing this filing expeditiously," said George F. Horner III, president and CEO of Vicuron. "Echinocandins such as anidulafungin promise to revolutionize the treatment of fungal infections, and represent a growing market opportunity in the United States and Europe. Drugs in this class are distinct due to their fungicidal activity, ability to treat a broad range of fungi, low potential for development of resistance and favorable side effect profile. Anidulafungin is further distinguished by its quicker achievement of steady state, strong in vitro potency, ability to be given at high doses and favorable drug interaction profile. We believe anidulafungin promises to become an important treatment for serious fungal infections and that these attributes should enable us to position it competitively within the new echinocandin class."
Vicuron's request for marketing clearance is based largely on the results of a pivotal Phase III trial that statistically showed intravenous anidulafungin is as effective as oral fluconazole, the current standard-of-care, in treating esophageal candidiasis. Based on results from this study, anidulafungin is well-tolerated with an adverse event and laboratory safety profile comparable to oral fluconazole. The file also includes safety and efficacy data from a large Phase II study with anidulafungin in invasive candidemia/candidiasis, as well as safety data from a Phase III trial studying anidulafungin in combination with a liposomal amphotericin for the treatment of invasive aspergillosis and a number of additional Phase I and Phase II clinical trials.
"The pivotal Phase III results in addition to positive data from our Phase II trial studying anidulafungin in invasive candidiasis and candidemia, a life-threatening fungal infection, form the basis of what we believe is a strong NDA submission," said Timothy J. Henkel, Vicuron's chief medical officer. "We look forward to working with the FDA to process this application as efficiently and quickly as possible. We plan to file for registration in Europe and Canada in the second half of this year."
Vicuron will present Phase II data with anidulafungin in invasive candidemia/candidiasis, the most common hospital-based fungal infection, at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) conference in the United Kingdom in May.
With the aging population and the growing number of immunocompromised patients, serious hospital-based fungal infections represent a large and growing market opportunity. The worldwide market for echinocandins is estimated to be $1.8 billion by the year 2008, according to Datamonitor.