Basilea reports recruitment completion of phase 3 pivotal study

Basilea reports recruitment completion of phase 3 pivotal study of
isavuconazole, an agent for the potential primary treatment of
invasive and life-threatening fungal infections 
BASEL, SWITZERLAND -- (Marketwire) -- 12/14/12 --  Basilea
Pharmaceutica AG / Basilea reports recruitment completion of phase 3
pivotal study of isavuconazole, an agent for the potential primary
treatment of invasive and life-threatening fungal infections .
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solely responsible for the content of this announcement. 
Basilea Pharmaceutica Ltd. ("Basilea", SIX:BSLN) and its partner
Astellas Pharma Inc. ("Astellas") announced today that
recruitment for the isavuconazole phase 3 registration study SECURE
been completed. Isavuconazole is an investigational intravenous
(i. v.) and oral
broad-spectrum antifungal being jointly developed by
Basilea and Astellas. 
The SECURE study is a global double-blind randomized phase 3 study,
designed to evaluate the safety and efficacy of once-daily
isavuconazole versus twice-daily voriconazole for up to 84 days of
therapy in the primary treatment of invasive fungal disease caused by
Aspergillus species or other filamentous fungi. Five
hundred and
twenty-seven (527) patients were enrolled in the study. Acute
invasive fungal infections are serious, life-threatening diseases
with high mortality. The primary endpoint of this
non-inferiority study is all-cause mortality through day 42. Basilea
and Astellas expect that results of this study will be available in
the second half of 2013. 
In addition, enrollment into the VITAL study, an open-label phase 3
study of
isavuconazole in the treatment of aspergillosis patients with
pre-existing renal
impairment or patients with invasive fungal disease
caused by rare but often
fatal molds, yeasts or dimorphic fungi has
achieved the targeted recruitment of 100 patients and will continue
to recruit to further expand the data base on the use of
isavuconazole in the treatment of the diverse rare mold infections.
ACTIVE study, a double-blind randomized phase 3 study evaluating
the use of isavuconazole i. v. and oral versus caspofungin i. v.
followed by oral voriconazole for the treatment of candidemia and
other invasive Candida infections, will likely continue to recruit
into 2014. 
"Invasive Aspergillus infections cause life-threatening disease in
patients undergoing chemotherapy, bone marrow transplantation and
other immunocompromised
patients. Current pre-clinical and clinical
data suggest that isavuconazole may
have the potential to overcome
certain limitations of current treatment options.
We are pleased to
have achieved this important milestone together with our partner
Astellas, of completing recruitment in the SECURE study, the
aspergillosis trial ever conducted," said Prof. Achim
Kaufhold, Chief Medical
Officer at Basilea. 
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 excellent 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 less prevalent
often fatal molds such as Mucorales spp. In clinical studies,
isavuconazole achieves predictable drug levels allowing reliable
dosing and a switch from intravenous administration to a convenient
once-daily oral dose. 
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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