Initiation of first isavuconazole study centers foreseen around year-end
Basel, Switzerland, September 10, 2010 - Basilea Pharmaceutica Ltd. (SIX:BSLN) announced today that, in agreement with its partner Astellas, the initiation of study centers in the isavuconazole phase III clinical program will be deferred to year-end or early 2011. Availability of phase III data continues to be anticipated by 2013.
Astellas and Basilea have obtained approvals from local authorities to allow restart of patient recruitment at first sites but have decided to use drug product from the commercial-scale production line, which covers the estimated demand for clinical trial material at all sites globally and allows for added buffer stock.
This decision will defer initiation of first sites to year-end or early 2011. This is expected to cause only minor delays in the initiation of the majority of sites because of the planned staggered global initiation of sites. The availability of phase III results continues to be expected in 2013.
Pre-clinical and clinical data generated to date indicate that isavuconazole has the potential to overcome many limitations of current therapies for the treatment of invasive fungal infections. Isavuconazole is given by intravenous infusion or oral capsules with high oral bioavailability that provides an option for intravenous-oral step-down. The drug has predictable and dose proportional pharmacokinetics that are important to ensure adequate therapeutic drug levels in patients with life-threatening fungal infections. The intravenous dose form has the potential to be given safely to patients with renal impairment.
The clinical program includes three international phase III trials with centers in the U.S., Europe and other regions that target respectively, yeast infections (candidemia/invasive Candida infections), mold infections (invasive aspergillosis) and finally rare molds and aspergillosis in renally impaired patients.
Earlier this year, an Independent Data Safety Monitoring Board recommended continuation of the phase III clinical trial of isavuconazole for the treatment of invasive Aspergillus infections based on a futility analysis of the first 180 patients.
Isavuconazole has been granted fast track designation by the U.S. Food and Drug Administration (FDA).
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange (SIX:BSLN). Its fully integrated research and development operations are currently focused on antibiotics, antifungals and oncology drugs, as well as on the development of dermatology drugs, targeting the medical challenge of resistance and non-response to current treatment options in the hospital and specialty care setting.
Basilea is marketing Toctino® (alitretinoin), the only approved treatment for severe chronic hand eczema unresponsive to potent topical corticosteroids, in Denmark, France, Germany, Switzerland and the United Kingdom and has appointed distributors for Toctino® in other selected European markets, Canada and Mexico. Furthermore, a phase III clinical program on alitretinoin for the treatment of severe chronic hand eczema is ongoing in the U.S. The company has entered into a global partnership with Astellas Pharma Inc. for its phase III compound isavuconazole, a potential best-in-class azole antifungal, for the treatment of life-threatening invasive fungal infections. Full rights to ceftobiprole for the treatment of potentially life-threatening resistant bacterial infections, are being transferred back to Basilea from Cilag GmbH International, a Johnson & Johnson company.
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
Head Public Relations &
+41 61 606 1460
[email protected] Barbara Zink, Ph.D., MBA
Head Corporate Development
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This press release can be downloaded from www.basilea.com