Initiation of first isavuconazole study centers foreseen around year-end
(Thomson Reuters ONE) -
Basilea Pharmaceutica AG / Initiation of first isavuconazole study centers foreseen around year-end processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
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.
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. 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).
About Basilea
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.
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#1443702]
--- End of Message ---
Basilea Pharmaceutica AG
Grenzacherstrasse 487
P.O Box Basel Switzerland
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Freiverkehr in Börse Berlin,
Open Market (Freiverkehr) in Frankfurter Wertpapierbörse,
Freiverkehr in Bayerische Börse München;
Press Release (PDF):
http://hugin.info/134390/R/1443702/387661.pdf
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Source: Basilea Pharmaceutica AG via Thomson Reuters ONE
Unternehmensinformation / Kurzprofil:
Datum: 10.09.2010 - 07:15 Uhr
Sprache: Deutsch
News-ID 41971
Anzahl Zeichen: 0
contact information:
Town:
Basel
Kategorie:
Business News
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