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2015-10-12

Basilea Pharmaceutica AG: Basilea announces that Health Canada approved ZEVTERA® for the treatment of bacterial lung infections

Basilea Pharmaceutica AG / Basilea announces that Health Canada approved
ZEVTERA® for the treatment ofbacterial lung infections . Processed and
transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely
responsible for the content of this announcement.
Basel,

Switzerland, October 12, 2015

- Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that Health Canada
has approved ZEVTERA®(ceftobiprole medocaril) for the treatment of patients
18 years of age and older with hospital-acquired pneumonia (HAP), excluding
ventilator-associated pneumonia (VAP), and for the treatment of
community-acquired pneumonia (CAP).

ZEVTERA®is a broad-spectrum antibiotic with bactericidal activity against
susceptible Gram-positive bacteria, including
methicillin-resistantStaphylococcus aureus
(MRSA), and Gram-negative bacteria associated with pneumonia.1ZEVTERA®is not
yet launched in Canada.

Prof. Achim Kaufhold, Basilea's Chief Medical Officer, said: "We are very
pleased that ZEVTERA has received regulatory approval in Canada. As a
bactericidal cephalosporin with broad-spectrum activity against relevant
pathogens causing pneumonia, ZEVTERA may potentially offer a valuable new
treatment option in the empiric treatment setting for life-threatening lung
infections."

David Veitch, Basilea's Chief Commercial Officer, stated: "The approval by
Health Canada is a significant achievement for Basilea and demonstrates our
commitment to expand the availability of ZEVTERA around the world."

About hospital-acquired and community-acquired pneumonia

Hospital-acquired pneumonia (HAP) is one of the most common hospital-acquired
infections and has been shown to have among the highest mortality rates of
all hospital-acquired infections.2 Methicillin-resistant Staphylococcus
aureus (MRSA) is a frequent cause of hospital-acquired pneumonia.3 In a study
involving Canadian hospitals, MRSA pneumonia infections were associated with
significant morbidity and an all-cause 30-day mortality of 28%.4
Community-acquired pneumonia (CAP) is a common condition with up to 60% of
the patients requiring hospital admission and intravenous antibiotics.5
Prompt empiric intervention with an appropriate broad-spectrum antibiotic
treatment is considered a best medical practice. The increasing incidence of
bacteria resistant to many established antibiotics is a major concern.

About ZEVTERA®

ZEVTERA®(ceftobiprole medocaril) is a broad-spectrum antibiotic for
intravenous administration with bactericidal activity against Gram-positive
and Gram-negative bacteria associated with pneumonia, including
methicillin-resistantStaphylococcus aureus
(MRSA) and susceptiblePseudomonas
spp.6

Ceftobiprole has received national licenses in 13 European countries7for the
treatment of adult patients with CAP and HAP (excluding VAP) and has been
launched in Germany, France, Italy and the United Kingdom. Ceftobiprole
received Qualified Infectious Disease Product (QIDP) designation from the
U.S. Food and Drug Administration for the potential treatment of
community-acquired bacterial pneumonia and acute bacterial skin and skin
structure infections. Ceftobiprole is not approved in the United States.

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 websitewww.basilea.com.

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 ZEVTERA®(Ceftobiprole medocaril powder for injection) Health Canada Product |
| Monograph. Date of Revision: September 24, 2015 |
| 2 C. Rotstein et al. Clinical practice guidelines for hospital-acquired |
| pneumonia and ventilator-associated pneumonia in adults. Canadian Journal of |
| Infectious Diseases&Medical Microbiology 2008 (19), 19-53 |
| 3 R. N. Jones. Microbial etiologies of hospital-acquired bacterial pneumonia and |
| ventilator-associated bacterial pneumonia. Clinical Infectious Diseases 2010 |
| (51), S81-S87 |
| 4 M. Tadros et al. Epidemiology and outcome of pneumonia caused by |
| methicillin-resistant Staphylococcus aureus (MRSA) in Canadian hospitals. |
| PLOS ONE 2013 (8), e75171 |
| 5 W. I. Sligl et al. Severe community-acquired pneumonia. Critical Care Clinics |
| 2013 (29), 563-601 |
| 6 Y. Y. Syed. Ceftobiprole medocaril: A review of its use in patients with |
| hospital- or community-acquired pneumonia. Drugs 2014 (74), 1523-1542 |
| 7 Ceftobiprole (European trade name Zevtera®or Mabelio®, depending on the |
| country) has received national licenses in 13 European countries for the |
| treatment of adult patients with community- and hospital-acquired pneumonia |
| (CAP, HAP), excluding ventilator-associated pneumonia (VAP): Austria, |
| Belgium, Denmark, Finland, France, Germany, Italy, Luxembourg, Norway, Spain, |
| Sweden, Switzerland and the United Kingdom. |
-------------------------------------------------------------------------------------

Press release (PDF)
http://hugin.info/134390/R/1958087/713489.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#1958087

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