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2014-05-14

Basilea Pharmaceutica AG: Basilea reports additional data on positive isavuconazole phase 3 SECURE study at ECCMID

Basilea Pharmaceutica AG / Basilea reports additional data on positive
isavuconazole phase 3 SECURE studyat ECCMID . Processed and transmitted by
NASDAQ OMX Corporate Solutions.The issuer is solely responsible for the
content of this announcement.
Basel,
Switzerland, May 14, 2014

- Basilea Pharmaceutica Ltd. (SIX: BSLN) reported today that detailed efficacy
and safety data of the isavuconazole invasive aspergillosis study (SECURE)
were presented at the European Congress of Clinical Microbiology and
Infectious Diseases (ECCMID) in Barcelona, Spain.

Treatment emergent adverse events for isavuconazole were statistically fewer
relative to the study comparator voriconazole in the System Organ Classes of
hepatobiliary (8.9% vs. 16.2%), skin (33.5% vs. 42.5%) and eye disorders
(15.2% vs. 26.6%). In addition, isavuconazole (42.4%) showed statistically
fewer study drug-related adverse events relative to voriconazole (59.8%). In
both treatment groups, the most common treatment emergent adverse events for
isavuconazole and voriconazole respectively were nausea (27.6% vs. 30.1%),
vomiting (24.9% vs 28.2 %), pyrexia (fever) (22.2% vs 30.1%) and diarrhea
(23.7% vs 23.2%).

Basilea's antifungal agent isavuconazole is being co-developed with Astellas
Pharma Inc.

Prof. Achim Kaufhold, Basilea's Chief Medical Officer, stated: "There is an
unmet medical need for new antifungals that have a broad spectrum of activity
and a favorable safety profile. Based on its activity against bothAspergillus
spp. and emerging molds, such as mucormycetes, along with its safety profile,
isavuconazole may play an important role in the treatment of invasive,
potentially life-threatening mold infections." He added: "The results from
the SECURE and VITAL phase 3 studies will support regulatory submissions in
Europe and in the U.S., which are planned for mid-2014."

Previously announced topline data showed that the randomized, double-blind
SECURE study met the primary objective of demonstrating non-inferiority of
isavuconazole versus voriconazole for the primary treatment of invasive
fungal disease caused byAspergillus
species or certain other filamentous fungi. Baseline characteristics of the
severely ill patient population enrolled in this trial were balanced between
treatment groups and were reflective of patients at risk for invasive fungal
disease (mean age 51 years, 84% hematologic malignancies, 66% neutropenic and
20% allogeneic haematopoietic stem-cell transplantation).

The primary endpoint of all-cause mortality through day 42 in the
intent-to-treat population (ITT, N=516) was 18.6% in the isavuconazole (ISA)
treatment group and 20.2% in the voriconazole (VRC) group. The upper limit of
the 95% confidence interval of the adjusted treatment group difference was
5.7% which is below the pre-specified 10% non-inferiority margin. All-cause
mortality through day 42 in patients with proven/probable invasive fungal
disease (modified intent-to-treat population, mITT) was 19.6% (ISA) and 23.3%
(VRC).

Overall response (a composite of clinical, mycological and radiological
responses) at end-of-therapy in the mITT population assessed by the
independent data review committee was 35.0% for isavuconazole versus 36.4%
for the comparator voriconazole.

---------------------------------------------------------------------------------
|Isavuconazole posters and presentations at ECCMID 2014 |
| * A phase 3 randomised, double-blind trial evaluating isavuconazole vs. |
| voriconazole for the primary treatment of invasive fungal disease caused by |
| Aspergillus spp. or other filamentous fungi (SECURE) - J. Maertens, T. |
| Patterson, G. Rahav, D. Kontoyiannis, K. Marr, R. Maher, M. Lee, B. Zeiher, |
| A. Ullmann; Oral presentation O230a |
| * Pharmacodynamics of the new azole isavuconazole (ISA) in an Aspergillus |
| fumigatus mouse infection model - S. Seyedmousavi, J. F. Meis, R. J. M. |
| Brüggemann, W. J. G. Melchers, P. E. Verweij, J. W. Mouton; Poster P1698 |
| * In vivo efficacy of isavuconazole and amphotericin B in a non-neutropenic |
| murine model of disseminated Absidia corymbifera - P. Warn, A. Sharp; |
| Poster P0106 |
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For further information please visitwww.eccmid.org.

About isavuconazole

Isavuconazole (drug substance: isavuconazonium sulfate) is an investigational
once daily intravenous and oral broad-spectrum antifungal for the potential
treatment of severe invasive and life-threatening fungal infections. It is
currently in phase 3 of clinical development. Isavuconazole
demonstratedin-vitro
andin-vivo
coverage of a broad range of yeasts (such asCandida
species) and molds (such asAspergillus
species) as well as activity inin-vitro
studies and in animal models against emerging and often fatal molds including
those that cause mucormycosis. In the U.S., isavuconazole was granted FDA
fast-track status and received QIDP and orphan drug designation for invasive
aspergillosis and mucormycosis (zygomycosis). Isavuconazole is being
co-developed with Astellas Pharma Inc.

About the isavuconazole phase 3 program

The phase 3 program with isavuconazole includes three studies, SECURE, VITAL
and ACTIVE. 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 in the primary treatment of
invasive fungal disease caused byAspergillus
species or other filamentous fungi. The VITAL study is 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 emerging and often fatal molds, yeasts or dimorphic fungi. 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 invasiveCandida
infections. Topline data from the SECURE study as well as VITAL study results
were reported in September 2013 and February 2014, respectively.

About invasive aspergillosis infections

Invasive aspergillosis is estimated to occur in 5-13% of recipients of bone
marrow transplants, 5-25% of patients who have received heart or lung
transplants, and 10-20% of patients who are receiving intensive chemotherapy
for leukemia.[1] Mortality rates for transplant patients with invasive
aspergillosis have been reported to be between 34% and 58%.[2] Around 47% of
solid organ transplant recipients who developed invasive aspergillosis had
renal insufficiency and acute renal failure was reported for 43% of intensive
care unit (ICU) patients with invasive aspergillosis, compared to 20.5% in
the general ICU population.[2],[3]

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.

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 |
|Peer Nils Schröder, PhD Barbara Zink, PhD, MBA |
| |
|Head Public Relations& Head Corporate Development |
|Corporate Communications |
|+41 61 606 1102 +41 61 606 1233 |
|media_relations@basilea.com investor_relations@basilea.com |
-------------------------------------------------------------
This press release can be downloaded fromwww.basilea.com.

References

[1] E. M. Harman, Medscape Reference, Drugs, Diseases&Procedures,
Aspergillosis Clinical
Presentation,http://emedicine.medscape.com/article/296052-overview

[2] J. W. Baddley et al. Factors associated with mortality in transplant
patients with invasive aspergillosis. Clinical Infectious Disease 2010 (50),
1559-1567

[3] K. H. Vandewoude et al. Invasive aspergillosis in critically ill patients:
attributable mortality and excesses in length of ICU stay and ventilator
dependence. Journal of Hospital Infection 2004 (56), 269-276

Press release (PDF)
http://hugin.info/134390/R/1785161/611992.pdf

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This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Basilea Pharmaceutica AG via Globenewswire

HUG#1785161

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