Basilea provides update on phase III program for the antifungal isavuconazole
Basel, Switzerland, June 25, 2010 - Basilea Pharmaceutica Ltd. (SIX:BSLN) announced today that its partner Astellas Pharma Inc. (TSE:4503) has initiated the formal process to allow continuation of patient recruitment into the phase III clinical studies of isavuconazole for the treatment of life-threatening invasive fungal infections. Certain study protocol amendments have been implemented and the phase III program will be expanded to include more patients.
Following transfer completion of the Investigational New Drug (IND) application and clinical trial sponsorship internationally to Astellas, the process to re-open phase III clinical sites for the isavuconazole trials has commenced. The safety, tolerability and efficacy of isavuconazole is being investigated in three phase III studies, one targeting yeast infections (candidemia and other invasive Candida infections), one mold infections (invasive aspergillosis) and a third trial including rare molds infections and renally impaired patients with aspergillosis.
Following the review of the phase III clinical program, Astellas and Basilea have implemented certain study protocol amendments to the invasive aspergillosis study in order to account for changes in clinical practice, the evolving regulatory environment and ongoing advancements in clinical diagnostics. The joint development program envisages increasing the proportion of patients to be recruited with probable and proven Aspergillus infections as well as more extensive use of the galactomannan diagnostic test.
Subject to local Ethic Committees' approvals, treatment of first new patients in the phase III program is anticipated in Q3 2010. Given the anticipated timing for initiation of all clinical sites and estimated recruitment rates, patient recruitment is anticipated to be completed in 2012 and first trial results from the phase III program are expected in 2013.
"The implementation of these protocol amendments that allow for a swift continuation of patient recruitment and the anticipated expansion of patient numbers underscore Astellas' and our strong commitment to pursue the best development path for this innovative treatment," said Professor Achim Kaufhold, M.D., Chief Medical Officer, Basilea Pharmaceutica International Ltd. "Despite the change to the initially anticipated timelines, we believe that the envisaged changes will further strengthen the competitive positioning of isavuconazole in an evolving medical field."
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. Human studies to-date suggest a lesser potential for some specific drug interactions. 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 renally impaired patients with aspergillosis.
Recently, an Independent Data Safety Monitoring Board recommended the 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).
About invasive fungal infections
Invasive fungal infections are life-threatening. Immunocompromised individuals like cancer or transplant patients are at special risk of acquiring fungal infections, mainly caused by Candida and Aspergillus species and associated with mortality rates between 30% and 90%. It has been shown that early treatment with highly effective antifungals reduces patient mortality.
Basilea Pharmaceutica Ltd. invites you to participate in a conference call on Friday, June 25, 4 p.m. (CEST), during which the company will discuss today's press release.
Dial-in numbers are:
+41 (0) 91 610 56 00 (Europe and ROW)
+1 (1) 866 291 4166 (USA)
+44 (0) 207 107 0611 (UK)
A playback will be available 1 hour after the conference call until Tuesday, June 29, 6 p.m. (CEST).
Participants requesting a digital playback may dial:
+41 (0) 91 612 4330 (Europe)
+1 (1) 866 416 2558 (USA)
+44 (0) 207 108 6233 (UK)
and will be asked to enter the ID 16662 followed by the # sign.
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange (SIX:BSLN). Basilea's products are targeted to satisfy high medical and patient needs in the hospital and specialty care setting. Its integrated research and development operations are currently focused on antibiotics and antifungals, as well as on the development of dermatology and oncology drugs, all areas in which the medical challenge of rising resistance or non-response to current treatment options is commonly encountered.
The company owns a broad and diversified portfolio. Basilea is marketing Toctino® (alitretinoin), for the treatment of severe chronic hand eczema, in Denmark, France, Germany, Switzerland and the United Kingdom. The drug is approved in 15 additional European countries as well as in Canada and has been recommended for approval in seven further European countries. Basilea has appointed Almirall S.A. as its distributor for Toctino® in selected European markets and Mexico. Furthermore, a phase III clinical trial on alitretinoin for the treatment of severe chronic hand eczema is ongoing in the U.S. Basilea has entered into a license, co-development and co-promotion agreement with Astellas Pharma Inc. for its phase III compound isavuconazole for the treatment of life-threatening invasive fungal infections on a worldwide basis, including an option for Japan. Full rights to a third late-stage product, ceftobiprole for the treatment of potentially life-threatening resistant bacterial infections, will be transferred from Cilag GmbH International, a Johnson & Johnson company, back to Basilea.
Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals. Astellas has approximately 15,000 employees worldwide. The organization is committed to becoming a global category leader in urology, immunology & infectious diseases, neuroscience, DM complications & metabolic diseases and oncology. For more information on Astellas Pharma Inc., please visit our website at http://www.astellas.com/en.
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
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+41 61 606 1460
[email protected] Barbara Zink, Ph.D., MBA
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This press release can be downloaded from www.basilea.com