July 17, 2014
Basilea reports that isavuconazole received QIDP designation from U.S. FDA for the treatment of invasive candidiasis
Basel, Switzerland, July 16, 2014 - Basilea Pharmaceutica Ltd. (SIX: BSLN) reports today that the U.S. Food and Drug Administration (FDA) designated isavuconazole as a Qualified Infectious Disease Product (QIDP) for the oral and intravenous treatment of invasive candidiasis, a life-threatening invasive fungal infection caused by Candida yeasts.
A QIDP designation, granted under the U.S. GAIN Act, provides priority review and a five-year extension of market exclusivity, should the product be approved in the United States. Isavuconazole was previously granted QIDP designation for the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis), which are severe mold infections. In addition, isavuconazole has FDA fast-track status and received U.S. and European Union orphan drug designations for invasive aspergillosis and mucormycosis.
Prof. Achim Kaufhold, Basilea's Chief Medical Officer, commented: "Invasive candidiasis is a nosocomial infection associated with high mortality, frequently occurring in critically ill patients, such as cancer patients undergoing chemotherapy, organ transplantation, and invasive surgical procedures. Moreover, the incidence of Candida infections has been increasing over past decades." He added: "We are very pleased that the FDA has granted this third QIDP designation to isavuconazole. QIDP designations are granted to antibacterial or antifungal drugs which are intended to treat serious or life-threatening infections caused by certain qualified pathogens, including Candida species, that have the potential to pose a serious threat to public health."
Isavuconazole is being co-developed with Astellas Pharma Inc. Basilea holds full rights to isavuconazole in markets outside of the U.S. and Canada where Astellas is the license holder.
Isavuconazole (drug substance: isavuconazonium sulfate) is an investigational once-daily intravenous and oral broad-spectrum antifungal for the potential treatment of severe invasive and life-threatening fungal infections, predominantly occurring in immunocompromised patients. Isavuconazole demonstrated in-vitro and in-vivo coverage of a broad range of yeasts (such as Candida species) and molds (such as Aspergillus species), including emerging and often fatal molds such as those that cause mucormycosis.
Basilea's partner Astellas has submitted a New Drug Application (NDA) to the FDA seeking approval of isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis. The NDA is supported by data from the SECURE and VITAL phase 3 studies. The SECURE study was a global double-blind randomized study that evaluated the safety and efficacy of once-daily isavuconazole versus twice-daily voriconazole in the primary treatment of invasive fungal disease caused by Aspergillus species or other filamentous fungi. The VITAL study was an open-label study of isavuconazole in the treatment of aspergillosis patients with pre-existing renal impairment or patients with invasive fungal disease caused by emerging and often fatal molds such as Mucorales, yeasts or dimorphic fungi.
The isavuconazole phase 3 program includes a third study, ACTIVE, which is currently enrolling patients and will evaluate the safety and efficacy of intravenously (i.v.) and orally administered isavuconazole versus i.v. caspofungin followed by oral voriconazole in the treatment of invasive Candida infections.
About invasive candidiasis
Infections by Candida yeasts are the most frequent invasive fungal infections in critically ill patients, accounting for 70% to 90% of all invasive mycoses.1 They are the fourth and seventh most common cause of bloodstream infections in the U.S. and Europe, respectively, and are associated with increased morbidity and mortality.2, 3 Estimates of the attributable mortality of Candida bloodstream infections (candidemia) range from 15% to 49%.4, 5, 6
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and listed on the SIX Swiss Exchange (SIX: BSLN). Through the fully integrated research and development operations of its Swiss subsidiary Basilea Pharmaceutica International Ltd., the company focuses on innovative pharmaceutical products in the therapeutic areas of bacterial infections, fungal infections and oncology, targeting the medical challenge of rising resistance and non-response to current treatment options.
This communication expressly or implicitly contains certain forward-looking statements concerning Basilea Pharmaceutica Ltd. and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
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| Peer Nils Schröder, PhD |
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| Barbara Zink, PhD, MBA |
Head Corporate Development
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This press release can be downloaded from www.basilea.com.
1 Lamagni T. L. et al. Emerging trends in the epidemiology of invasive mycoses in England and Wales (1990-9). Epidemiology & Infection 2001 (126), 397-414
2 Wisplinghoff H. et al. Nosocomial bloodstream infections in US hospitals: analysis of 24,179 cases from a prospective nationwide surveillance study. Clinical Infectious Diseases 2004 (39), 309-317
3 Marchetti O. et al. Epidemiology of candidemia in Swiss tertiary care hospitals: secular trends, 1991-2000. Clinical Infectious Diseases 2004 (38), 311-320
4 Morgan J. et al. Excess mortality, hospital stay, and cost due to candidemia: a case-control study using data from population-based candidemia surveillance. Infection Control and Hospital Epidemiology 2005 (26), 540-547
5 Zaoutis T. E. et al. The epidemiology and attributable outcomes of candidemia in adults and children hospitalized in the United States: a propensity analysis. Clinical Infectious Diseases 2005 (41), 1232-1239
6 Gudlaugsson O. et al. Attributable mortality of nosocomial candidemia, revisited. Clinical Infectious Diseases 2003 (37), 1172-1177