Basilea provides update on isavuconazole phase 3 program

Basilea provides update on isavuconazole phase 3 program 
BASEL, SWITZERLAND -- (Marketwired) -- 07/17/13 --  Basilea
Pharmaceutica AG / Basilea provides update on isavuconazole phase 3
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* On track for first data from the SECURE and VITAL phase 3 studies
in the 
second half of this year 
* Primary efficacy assessment in the ACTIVE phase 3 study moved to
the end of     intravenous treatment 
* Recruitment into VITAL study completed after enrollment of 150
* Pediatric Investigation Plans agreed by EMA 
Basilea Pharmaceutica Ltd. (SIX: BSLN) provided an update today on
the phase 3 program with the novel antifungal isavuconazole that is
being developed in collaboration with Astellas Pharma Inc.
data from the SECURE and VITAL phase 3 studies are on track to be
available in the second half of 2013. The SECURE registration study
the safety and efficacy of once-daily isavuconazole versus
twice-daily voriconazole for the primary treatment of life-threatening
invasive fungal disease caused by Aspergillus species. The VITAL
study is an open-label phase 3 study in the treatment of
aspergillosis patients with pre-existing renal impairment or with
invasive fungal disease caused by emerging and often fatal
With 150 patients enrolled, the VITAL study has now completed
recruitment, which was extended beyond its initial target to further
expand the
database on the use of isavuconazole in the primary
treatment of emerging fungal
infections for which currently only
limited treatment options exist. The data
from the SECURE and VITAL
studies could form the basis of an initial filing in
the first part
of 2014. 
The ACTIVE phase 3 study is evaluating the safety and efficacy of
(i.v.) and orally administered isavuconazole versus
i.v. caspofungin followed by oral voriconazole in the treatment of
invasive Candida infections. The study's
primary efficacy endpoint of
overall response will be moved to the end of intravenous treatment
and assessed by a Data Review Committee. The previous assessment at
two weeks after i.v. and oral treatment will remain a
efficacy endpoint. There are no changes in the overall
operational study conduct. The protocol change will facilitate the
comparison to data obtained
from previous registration trials in
invasive Candida infections. The study is
expected to continue to
recruit in 2014. 
Prof. Achim Kaufhold, Basilea's Chief Medical Officer, commented: "We
are on
track to provide the first data from the SECURE and VITAL phase
3 studies in the second half of this year. The move of the ACTIVE
study outcome assessment time
point will facilitate the comparison of
the efficacy of isavuconazole to the
data from previous registration
trials investigating echinocandins. It reflects
the most recent
thinking of health authorities on the design and analysis of
phase 3
clinical trials investigating antifungals for the treatment of
yeast infections." 
In addition, the European Medicines Agency has agreed to the
Pediatric Investigation Plans (PIP) of isavuconazole for the treatment
of invasive aspergillosis, mucormycosis and Candida infections in
About isavuconazole 
Isavuconazole is an investigational intravenous and oral
broad-spectrum antifungal. In collaboration with Astellas Pharma Inc.,
isavuconazole is being
investigated in phase 3 clinical studies for
the treatment of severe invasive
fungal infections. The drug
demonstrated in-vitro and in-vivo coverage of a broad range of yeasts
(such as Candida species) and molds (such as Aspergillus
species) as
well as in-vitro activity against emerging and often fatal
including those that cause mucormycosis. In clinical studies to
date, isavuconazole achieved predictable drug levels supporting
reliable dosing and a switch from once-daily intravenous to oral
administration. The intravenous formulation of isavuconazole, which
is water-soluble, does not contain possibly
kidney damaging
solubilizers and has the potential to be given to patients
pre-existing renal impairment. In the U.S. isavuconazole has
fast-track status
and was granted orphan drug designation for the
treatment of invasive aspergillosis. 
About Basilea 
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland,
and listed on the SIX Swiss Exchange (SIX: BSLN). Through the fully
integrated research and
development operations of its Swiss
subsidiary Basilea Pharmaceutica International Ltd., the Company
focuses on innovative pharmaceutical products in the therapeutic
areas of bacterial infections, fungal infections and
targeting the medical challenge of rising resistance and
non-response to current
treatment options. 
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
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. 
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Source: Basilea Pharmaceutica AG via Thomson Reuters ONE 
Media Relations
Peer Nils Schroder, PhD
Head Public Relations &
Corporate Communications
+41 61 606 1102 
Investor Relations
Barbara Zink, PhD, MBA
Head Corporate Development
+41 61 606 1233
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