Basilea Pharmaceutica AG : Basilea provides update on isavuconazole phase 3 program

 Basilea Pharmaceutica AG : Basilea provides update on isavuconazole phase 3

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 patients
  *Pediatric Investigation Plans agreed by EMA

Basel, Switzerland, July 17, 2013 - 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. Topline 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 evaluates
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
fungi. 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
intravenously (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 secondary 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 invasive 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 children.

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 molds
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 with 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
oncology, 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 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
Peer Nils Schröder, PhD       Barbara Zink, PhD, MBA
Head Public Relations &       Head Corporate Development
Corporate Communications
+41 61 606 1102               +41 61 606 1233

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