Basilea's antifungal isavuconazole passed phase III clinical trial futility analysis
(Thomson Reuters ONE) - Basilea Pharmaceutica AG / Basilea's antifungal isavuconazole passed phase III clinical trial futility analysis processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement. Basel, Switzerland, January 29, 2010 - Basilea Pharmaceutica Ltd. (SIX:BSLN)announces that based on a futility analysis of the isavuconazole phase III trialfor the treatment of invasive Aspergillus infections, the Independent DataSafety Monitoring Board (IDSMB) has recommended the continuation of the study.The primary goal of this phase III study is to demonstrate statisticalnon-inferiority of isavuconazole versus the comparator, current standard-of-carevoriconazole in the treatment of invasiveAspergillus infections. The futilityanalysis was included in the clinical trial design to ensure that the trialcould be stopped early if it appeared that the study would be eventually unableto demonstrate non-inferiority for isavuconazole. In life-threatening infectionssuch as invasive fungal infections it is standard to ensure that patientsreceive the most effective treatment at the earliest stage and are notunnecessarily exposed to potentially ineffective investigational drugs. TheIDSMB recommendation was based on the analysis of the primary efficacy endpointof 180 patients."Since the data remains blinded, the efficacy results will not be known untilthe study is completed, however, we are very pleased that the study hassuccessfully passed this important interim assessment point. Regular assessmentsof safety parameters by the IDSMB have not revealed any major or unexpectedsafety concerns. With numerous differentiating features over current therapies,isavuconazole has the potential for a best-in-class antifungal," said Dr.Anthony Man, CEO Basilea Pharmaceutica Ltd. "The recruitment of new patientsinto the phase III clinical program is expected to resume in the first half of2010 and topline data are anticipated to be available in 2011."About isavuconazolePre-clinical and clinical data generated to date indicate that isavuconazole hasthe potential to overcome many of the key limitations of current therapies forthe treatment of invasive fungal infections. Isavuconazole shows highbioavailability and provides for a seamless intravenous-oral step-down option.The drug has predictable, linear pharmacokinetics with no relevant food effect,and the potential for fewer drug-drug interactions. The ability to rapidlyachieve adequate plasma and tissue concentrations and to maintain these levelslong enough to avoid recurrence is essential for the successful treatment ofthese life-threatening invasive fungal infections. In addition, isavuconazole ishighly water-soluble circumventing the need to add potentially kidney-damagingsolubulizing agents to the i.v. formulation.There are three phase III trials currently open investigating isavuconazole, onetargeting yeast infections (candidemia and other invasive candida infections),one targeting mold infections (invasive aspergillosis) and a third trialtargeting rare molds and renally impaired patients with aspergillosis.About invasive fungal infectionsInvasive fungal infections are life-threatening. Immunocompromized individualslike cancer or transplant patients are at special risk of acquiring fungalinfections, mainly caused byCandida and Aspergillus species and associated withmortality rates between 30% and 90%. It has been shown that early treatment withhighly effective antifungals reduces patient mortality.About BasileaBasilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed onthe SIX Swiss Exchange (SIX:BSLN). Basilea's integrated research and developmentoperations are currently focused on new antibacterial, antifungal and oncologyagents to fight drug resistance and on the development of dermatology drugs.Basilea's products are targeted to satisfy high medical and patient needs in thehospital and specialty care setting.The company owns a diversified portfolio including two commercialized drugs(Toctino®, ZEFTERA(TM)/ Zevtera(TM)) and one investigational drug(isavuconazole) in phase III clinical development. Toctino® (alitretinoin) ismarketed in Denmark, France, Germany, Switzerland and the United Kingdom and isapproved in Austria, Belgium, Canada, Finland, Luxemburg, the Netherlands andSpain. Toctino® has been recommended for approval in 16 European countries.Furthermore, a phase III clinical trial on alitretinoin forthe treatment ofsevere chronic hand eczema is ongoing in the U.S.Ceftobiprole is marketed in Canada under the brand name ZEFTERA(TM) and inSwitzerland under Zevtera(TM). Basilea has set up commercial organizations inCanada, France, Germany, the Nordics, Switzerland and the United Kingdom, whileit is building sales and marketing organizations in other countries tocommercialize alitretinoin and to co-promote ceftobiprole, subject to approval.DisclaimerThis communication expressly or implicitly contains certain forward-lookingstatements concerning Basilea Pharmaceutica Ltd. and its business. Suchstatements involve certain known and unknown risks, uncertainties and otherfactors, which could cause the actual results, financial condition, performanceor achievements of Basilea Pharmaceutica Ltd. to be materially different fromany future results, performance or achievements expressed or implied by suchforward-looking statements. Basilea Pharmaceutica Ltd. is providing thiscommunication as of this date and does not undertake to update anyforward-looking statements contained herein as a result of new information,future events or otherwise.For further information, please contact:+----------------------------------------+-------------------------------------+|Media Relations |Investor Relations |+----------------------------------------+-------------------------------------+|Adesh Kaul |Barbara Zink, Ph.D., MBA ||Head Public Relations & |Head Corporate Development ||Corporate Communications | ||+41 61 606 1460 |+41 61 606 1233 ||media_relations(at)basilea.com |investor_relations(at)basilea.com ||
P.O Box Basel SwitzerlandWKN: A0B9GA;ISIN: CH0011432447; Press release (PDF): http://hugin.info/134390/R/1378471/338988.pdf
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Datum: 29.01.2010 - 01:16 Uhr
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