BASEL, Switzerland, July 17, 2014 (GLOBE NEWSWIRE) -- Basilea Pharmaceutica Ltd. (SIX: BSLN) reports today that it submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of isavuconazole for the treatment of invasive aspergillosis and mucormycosis (zygomycosis). Basilea's co-development partner Astellas Pharma Inc. also recently submitted a New Drug Application (NDA) for isavuconazole to the U.S. Food and Drug Administration (FDA).
Ronald Scott, Basilea's Chief Executive Officer, stated: "New antifungal therapies are urgently needed due to the increasing number of immunocompromised patients who are at risk for developing invasive fungal infections such as cancer patients undergoing chemotherapy. The isavuconazole regulatory submission in the EU is a major achievement for Basilea and complements the U.S. submission by our partner Astellas."
Isavuconazole (drug substance: isavuconazonium sulfate) is an investigational once-daily intravenous and oral broad-spectrum antifungal for the potential treatment of life-threatening invasive fungal infections which predominantly occur in immunocompromised patients. In the European Union (EU), isavuconazole was recently granted orphan drug status for the treatment of invasive aspergillosis and mucormycosis, providing ten years of market exclusivity independent of any existing patent protection should the product be approved in the EU. In the U.S., isavuconazole was granted FDA fast-track status and designated a Qualified Infectious Disease Product (QIDP) for invasive aspergillosis, mucormycosis and candidiasis under the U.S. GAIN Act. QIDP status provides priority review and, if the product is approved, a five-year extension of market exclusivity in the United States. In addition, isavuconazole received U.S. orphan drug designations for invasive aspergillosis and mucormycosis.
Basilea holds full rights to isavuconazole in markets outside of the U.S. and Canada where Astellas is the license holder. Basilea will be eligible to a milestone payment upon FDA acceptance of the U.S. NDA submission.
The MAA is supported by data from the SECURE and VITAL phase 3 studies. The SECURE study was a global double-blind randomized study that enrolled 516 patients (intent-to-treat population) and 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 (N=149 patients) 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.
In the invasive aspergillosis SECURE study, isavuconazole demonstrated non-inferiority to voriconazole on the primary endpoint of all-cause mortality at day 42. The treatment-emergent adverse events for isavuconazole were statistically fewer relative to voriconazole in the system organ classes of hepatobiliary, skin and eye disorders. In addition, isavuconazole showed statistically fewer study drug-related adverse events relative to voriconazole. In both treatment groups, the most common treatment-emergent adverse events were nausea, vomiting, pyrexia (fever) and diarrhea.1
The isavuconazole phase 3 program includes a third study, ACTIVE. It 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 aspergillosis and mucormycosis
Invasive aspergillosis is estimated to occur in 5-13% of bone marrow transplant recipients, 5-25% of patients who have received heart or lung transplants, and 10-20% of patients who have received intensive chemotherapy for leukemia.2 Mortality rates for transplant patients with invasive aspergillosis have been reported to be between 34% and 58%.3 Around 47% of solid organ transplant recipients who developed invasive aspergillosis had renal insufficiency and acute renal failure was reported for 43% of intensive care unit (ICU) patients with invasive aspergillosis, compared to 20% in the general ICU population.3, 4
Mucormycosis (also known as zygomycosis) is an often lethal fungal infection caused by certain emerging molds. Mucormycosis is associated with high morbidity and mortality rates in immunocompromised patients such as patients undergoing chemotherapy or bone marrow transplantation.5, 6 Left untreated, mucormycosis is almost always lethal, and even with appropriate medical management, mortality rates remain high.7
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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This press release can be downloaded from www.basilea.com.
1 J. Maertens et al. A phase 3 randomised, double-blind trial evaluating isavuconazole vs. voriconazole for the primary treatment of invasive fungal disease caused by Aspergillus spp. or other filamentous fungi (SECURE). European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) 2014, oral presentation O230a
2 E. M. Harman. Medscape Reference, Drugs, Diseases & Procedures, Aspergillosis Clinical Presentation, http://emedicine.medscape.com/article/296052-overview
3 J. W. Baddley et al. Factors associated with mortality in transplant patients with invasive aspergillosis. Clinical Infectious Disease 2010 (50), 1559-1567
4 K. H. Vandewoude et al. Invasive aspergillosis in critically ill patients: attributable mortality and excesses in length of ICU stay and ventilator dependence. Journal of Hospital Infection 2004 (56), 269-276
5 F. Lanternier et al. A global analysis of mucormycosis in France: the RetroZygo study (2005-2007). Clinical Infectious Diseases 2012 (54), S35-S43
6 J. Ambrosioni et al. Emerging invasive zygomycosis in a tertiary care center: epidemiology and associated risk factors. International Journal of Infectious Diseases 2010 (14S), e100-e103
7 J. Wingard. Zygomycosis: Epidemiology and treatment options. Proceedings 2006, (6), S526-S530
Press release (PDF) http://hugin.info/134390/R/1828093/633582.pdf
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