Basilea provides update on phase III program for the antifungal isavuconazole
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Basilea Pharmaceutica AG / Basilea provides update on phase III program for the antifungal isavuconazole processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
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."
About isavuconazole
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.
Conference call
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.
About Basilea
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.
About Astellas
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.
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 |
+-----------------------------+--------------------------------+
| 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 |
+-----------------------------+--------------------------------+
This press release can be downloaded from www.basilea.com
[HUG#1427190]
--- End of Message ---
Basilea Pharmaceutica AG
Grenzacherstrasse 487
P.O Box Basel Switzerland
ISIN: CH0011432447;
Listed: Freiverkehr in Börse Stuttgart,
Freiverkehr in Börse Berlin,
Open Market (Freiverkehr) in Frankfurter Wertpapierbörse,
Freiverkehr in Bayerische Börse München;
Press release (PDF): http://hugin.info/134390/R/1427190/374845.pdf
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(ii) they are solely responsible for the content, accuracy and originality of the information contained therein.
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Source: Basilea Pharmaceutica AG via Thomson Reuters ONE
Unternehmensinformation / Kurzprofil:
Datum: 25.06.2010 - 07:16 Uhr
Sprache: Deutsch
News-ID 23005
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contact information:
Town:
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Kategorie:
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