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NDA Submitted to FDA for Anidulafungin, Treatment for Esophageal Candidiasis
KING OF PRUSSIA, Pa., April 28 /PRNewswire-FirstCall/ -- Vicuron Pharmaceuticals Inc. (Nasdaq: MICU; Nuovo Mercato) today announced that the company 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, M.D., Ph.D., 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.
Anidulafungin is a naturally occurring molecule that has been significantly improved through chemical modification. In vitro studies have demonstrated that anidulafungin combines both the potency and killing effects of the polyene class (e.g., amphotericin B) without the resistance problems found with the azole class (e.g., fluconazole). Anidulafungin is a broad-spectrum agent, and has been demonstrated to be highly potent in vitro against the fungi responsible for serious systemic infections. Preclinical studies have shown that a five-minute exposure to anidulafungin in vitro kills more than 99 percent of Candida, including fluconazole-resistant strains. Anidulafungin has no cross-resistance with azoles or amphotericin, and in the laboratory it has proven very difficult to develop resistance to anidulafungin. Anidulafungin also was well tolerated in the Phase I study when given in combination with cyclosporine, the leading chronic immunosuppressive drug.
Vicuron Pharmaceuticals Inc. is an international biopharmaceutical company focused on discovering, developing, manufacturing and commercializing vital medicine for seriously ill patients. The company's lead products are in Phase III clinical trials and include anidulafungin, a novel antifungal agent, and dalbavancin, a novel intravenous antibiotic for the treatment of serious Gram-positive infections. Vicuron's versatile research engine integrates industry-leading expertise in functional genomics, natural products discovery, mechanism-based drug design and combinatorial and medicinal chemistry. These approaches are yielding promising novel and next-generation compounds, many of which are in the later stages of preclinical development. In addition, Vicuron has research and development collaborations with leading pharmaceutical companies, such as Pfizer (formerly Pharmacia Corporation) and Novartis.
This news release contains forward-looking statements that predict or describe future events or trends. The matters described in these forward-looking statements are subject to known and unknown risks, uncertainties and other unpredictable factors, many of which are beyond Vicuron's control. Vicuron faces many risks that could cause its actual performance to differ materially from the results predicted by its forward-looking statements, including the possibilities that clinical trials and the results thereof might be delayed, that the timing of the filing of any new drug application might be delayed, that subsequent clinical trials might indicate that a product candidate is unsafe or ineffective, that ongoing proprietary and collaborative research might not occur or yield useful results, that competitors might develop superior substitutes for their products or market them more effectively, that a sales force may not be developed as contemplated and that one or more of its product candidates may not be commercialized successfully. The reports that Vicuron files with the U.S. Securities and Exchange Commission contain a fuller description of these and many other risks to which Vicuron is subject. Because of those risks, Vicuron's actual results, performance or achievements may differ materially from the results, performance or achievements contemplated by its forward- looking statement. The information set forth in this news release represents management's current expectations and intentions. Vicuron assumes no responsibility to issue updates to the forward-looking matters discussed in this news release.