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Basilea Pharmaceutica AG: Basilea launching antifungal CRESEMBA® (isavuconazole) in Germany

Basilea Pharmaceutica AG / Basilea launching antifungal CRESEMBA®
(isavuconazole) in Germany. Processed and transmitted by NASDAQ OMX Corporate
Solutions. The issuer is solely responsible for the content of this
Basel, Switzerland, March 04, 2016

- Basilea Pharmaceutica Ltd. (SIX: BSLN) hosts a symposium to support the
launch of the new azole antifungal CRESEMBA®(isavuconazole) in Germany. The
symposium will be held on March 5 and 6, 2016 in Berlin. The symposium is
co-chaired by Prof. Oliver A. Cornely, Department of Internal Medicine I,
University of Cologne, Germany; and Prof. Andrew J. Ullmann,
Julius-Maximilians-University, Department of Internal Medicine II, Infectious
Diseases, Würzburg, Germany. The focus of the symposium will be on current
challenges and recent developments in the management of invasive mold

David Veitch, Basilea's Chief Commercial Officer, commented: "We are excited
to be launching CRESEMBA in Germany. The symposium provides an opportunity
for clinicians to discuss important clinical data and share their experiences
in relation to the treatment of potentially life-threatening invasive mold
infections. CRESEMBA addresses an important medical need of immunocompromised
patients. We are focused on rolling out CRESEMBA in our core European markets
this year."

CRESEMBA®(isavuconazole) was approved by the European Commission in October
2015 for the treatment of adults with invasive aspergillosis and the
treatment of adults with mucormycosis for whom amphotericin B is
inappropriate. Invasive aspergillosis and mucormycosis are life-threatening
fungal infections that often affect immunocompromised patients, such as
patients with cancer and after transplantation. Invasive aspergillosis is
often fatal. Mucormycosis (also known as zygomycosis) is a rapidly
progressive and life-threatening invasive fungal infection, often affecting
the nose and sinuses with high mortality.

Prof. Andrew J. Ullmann stated: "Clinicians have with isavuconazole a new
antifungal agent with a broad spectrum activity against invasive fungal
diseases and an improved safety profile. The combination of these features
demonstrates clearly that isavuconazole is an improvement for the care of our
patients with severe invasive fungal diseases."

About CRESEMBA® (isavuconazole)

Isavuconazole is an intravenous and oral azole antifungal and the active agent
of the prodrug isavuconazonium sulfate. Isavuconazole was co-developed with
Astellas Pharma Inc. under an agreement granting Astellas a license to
commercialize isavuconazole in the U.S. Basilea holds full isavuconazole
rights in markets outside the United States. Isavuconazole is marketed under
the trade name CRESEMBA®. The drug was approved in March 2015 by the U.S. FDA
for the use for patients 18 years of age and older in the treatment of
invasive aspergillosis and invasive mucormycosis. The European Commission
granted marketing authorization in October 2015 to isavuconazole for the
treatment of adult patients with invasive aspergillosis and for the treatment
of adult patients with mucormycosis for whom amphotericin B is inappropriate.
The European marketing authorization is valid in all 28 European Union (EU)
member states, as well as in Iceland, Liechtenstein and Norway. Isavuconazole
has orphan drug designation for the treatment of invasive aspergillosis and
mucormycosis in Europe and the U.S.

About the isavuconazole invasive aspergillosis and mucormycosis studies

The approval of CRESEMBA®is based on results from the isavuconazole
development program. The safety and efficacy profile of isavuconazole in
adult patients with invasive aspergillosis was demonstrated based on data
from two phase 3 clinical studies: SECURE, a randomized, double-blind,
active-control study in 516 patients (intent-to-treat population, ITT) with
invasive aspergillosis, and VITAL, an open-label non-comparative 146-patient
study (ITT) of isavuconazole in the treatment of invasive aspergillosis
patients with renal impairment, or invasive fungal disease (IFD) caused by
rare molds, yeasts or dimorphic fungi, including invasive mucormycosis.

In the SECURE study, isavuconazole was non-inferior to voriconazole based on
the primary endpoint of all-cause mortality at Day 42 in the intent-to-treat
population. All-cause mortality through Day 42 was 19% in the isavuconazole
treatment group and 20% in the voriconazole treatment group.1

In the SECURE study, similar rates of non-fatal adverse events were observed
for isavuconazole and the comparator, voriconazole. Further, the percentage
of study drug-related adverse events in invasive aspergillosis patients was
42% for isavuconazole and 60% for voriconazole. In addition, the percentage
of treatment-emergent adverse events in the system organ classes of
hepatobiliary disorders was 9% for isavuconazole versus 16% for voriconazole;
skin or subcutaneous tissue disorders was 33% for isavuconazole versus 42%
for voriconazole; and eye disorders was 15% for isavuconazole versus 27% for

The safety and efficacy profile of isavuconazole in patients with mucormycosis
was demonstrated based on data from the VITAL study, which included a
subpopulation of 37 patients with proven or probable mucormycosis, of whom 21
received isavuconazole as primary treatment for their infection. All-cause
mortality at Day 42 was 38% which is similar to mortality rates reported in
literature for the treatment of mucormycosis. In this trial the rate of
overall response against mucormycosis at the end of therapy was 31%, with an
additional 29% exhibiting a stable response. For patients receiving
isavuconazole as primary therapy, this number was 32%, with an additional 32%
having stable disease. The efficacy of isavuconazole for the treatment of
mucormycosis has not been evaluated in concurrent, controlled clinical

The most frequent adverse events for patients treated with isavuconazole in
clinical phase 3 studies were nausea (26%), vomiting (25%), diarrhea (22%),
headache (17%), elevated liver chemistry tests (17%), hypokalemia (14%),
constipation (13%), dyspnea (12%), cough (12%), peripheral edema (11%), and
back pain (10%).

About aspergillosis and mucormycosis

Aspergillosis is the name given to a wide variety of diseases caused by the
airborne fungusAspergillus
. CommonAspergillus
infections include invasive aspergillosis, allergic bronchopulmonary
aspergillosis, chronic pulmonary aspergillosis and aspergilloma. Mucormycosis
is the name for fungal infections caused by numerous fungi found in soil and
mouldy bread.

About Basilea

Basilea Pharmaceutica Ltd. is a biopharmaceutical company developing products
that address increasing resistance and non-response to current treatment
options in the therapeutic areas of bacterial infections, fungal infections
and cancer. The company uses the integrated research, development and
commercial operations of its subsidiary Basilea Pharmaceutica International
Ltd. to discover, develop and commercialize innovative pharmaceutical
products to meet the medical needs of patients with serious and potentially
life-threatening conditions. Basilea Pharmaceutica Ltd. is headquartered in
Basel, Switzerland and listed on the SIX Swiss Exchange (SIX: BSLN).
Additional information can be found at Basilea's


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:

| Peer Nils Schröder, PhD |
|Head Public Relations&Corporate Communications |
|+41 61 606 1102 |
| |
| |
| |
This press release can be downloaded


| 1 J. A. Maertens, I. I. Raad, K. A. Marr et al. Isavuconazole versus |
| voriconazole for primary treatment of invasive mould disease caused |
| byAspergillus |
| and other filamentous fungi (SECURE): a phase 3, randomised-controlled, |
| non-inferiority trial. The Lancet 2016 (387), 760-769 |

Press release (PDF)


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


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