Basilea reports recruitment completion of phase 3 pivotal study of isavuconazole, an agent for the potential primary treatment of invasive and life-threatening fungal infections

14 december 2012 Basilea Pharmaceutica AG / Basilea reports recruitment completion of phase 3 pivotal study of isavuconazole, an agent for the potential primary treatment of invasive and life-threatening fungal infections . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement. Basel, Switzerland, December 14, 2012 - Basilea Pharmaceutica Ltd. ("Basilea", SIX:BSLN) and its partner Astellas Pharma Inc. ("Astellas") announced today that patient recruitment for the isavuconazole phase 3 registration study SECURE has been completed. Isavuconazole is an investigational intravenous (i. v.) and oral broad-spectrum antifungal being jointly developed by Basilea and Astellas. The SECURE study is a global double-blind randomized phase 3 study, designed to evaluate the safety and efficacy of once-daily isavuconazole versus twice-daily voriconazole for up to 84 days of therapy in the primary treatment of invasive fungal disease caused by Aspergillus species or other filamentous fungi. Five hundred and twenty-seven (527) patients were enrolled in the study. Acute invasive fungal infections are serious, life-threatening diseases associated with high mortality. The primary endpoint of this non-inferiority study is all- cause mortality through day 42. Basilea and Astellas expect that results of this study will be available in the second half of 2013. In addition, enrollment into the VITAL study, an open-label phase 3 study of isavuconazole in the treatment of aspergillosis patients with pre-existing renal impairment or patients with invasive fungal disease caused by rare but often fatal molds, yeasts or dimorphic fungi has achieved the targeted recruitment of 100 patients and will continue to recruit to further expand the data base on the use of isavuconazole in the treatment of the diverse rare mold infections. The ACTIVE study, a double-blind randomized phase 3 study evaluating the use of isavuconazole i. v. and oral versus caspofungin i. v. followed by oral voriconazole for the treatment of candidemia and other invasive Candida infections, will likely continue to recruit into 2014. "Invasive Aspergillus infections cause life-threatening disease in patients undergoing chemotherapy, bone marrow transplantation and other immunocompromised patients. Current pre-clinical and clinical data suggest that isavuconazole may have the potential to overcome certain limitations of current treatment options. We are pleased to have achieved this important milestone together with our partner Astellas, of completing recruitment in the SECURE study, the largest aspergillosis trial ever conducted," said Prof. Achim Kaufhold, Chief Medical Officer at Basilea. About isavuconazole Isavuconazole is an investigational intravenous and oral broad-spectrum antifungal. In collaboration with Astellas Pharma Inc., isavuconazole is being investigated in phase 3 clinical studies for the treatment of severe invasive fungal infections. The drug demonstrated excellent in-vitro and in-vivo coverage of a broad range of yeasts (such as Candida species) and molds (such as Aspergillus species) as well as in-vitro activity against less prevalent but often fatal molds such as Mucorales spp. In clinical studies, isavuconazole achieves predictable drug levels allowing reliable dosing and a switch from intravenous administration to a convenient once-daily oral dose. About Basilea 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. Disclaimer 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. For further information, please contact: +-----------------------------+--------------------------------+ | Media Relations | Investor Relations | +-----------------------------+--------------------------------+ | Peer Nils Schröder, Ph.D. | Barbara Zink, Ph.D., MBA | | Head Public Relations & | Head Corporate Development | | Corporate Communications |   | | +41 61 606 1102 | +41 61 606 1233 | | media_relations@basilea.com | investor_relations@basilea.com | +-----------------------------+--------------------------------+ This press release can be downloaded from www.basilea.com. Press release (PDF): http://hugin.info/134390/R/1664857/540108.pdf This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients. The owner of this announcement warrants that: (i) the releases contained herein are protected by copyright and other applicable laws; and (ii) they are solely responsible for the content, accuracy and originality of the information contained therein. Source: Basilea Pharmaceutica AG via Thomson Reuters ONE [HUG#1664857]