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Basilea's Antibiotic Ceftobiprole Obtains Regulatory Approval In Europe For Pneumonia

BASEL, Switzerland, Oct. 23, 2013 (GLOBE NEWSWIRE) --
Basilea Pharmaceutica Ltd. (SIX: BSLN)
announced today the approval of its antibiotic ceftobiprole in Europe.
Ceftobiprole is indicated for the treatment of hospital-acquired pneumonia
(excluding ventilator-associated pneumonia) and community-acquired pneumonia in
adults. Ceftobiprole has broad-spectrum activity against many pathogens that
cause pneumonia including Gram-positive pathogens such as penicillin-resistant
Streptococcus pneumoniae (PRSP), methicillin-resistant Staphylococcus aureus
(MRSA) and various Gram-negative pathogens including Pseudomonas species.

Basilea submitted the ceftobiprole Marketing Authorization Application under the
Decentralized Procedure (DCP) initially in 12 European Union Member States
including the major markets in Europe. In accordance with the DCP, each of the
involved Member States are expected to grant national authorizations within the
coming months.

"Basilea is committed to develop new medicines that fight the increasing threat
of resistance," stated Basilea's Chief Executive Officer Ronald Scott. "The
European approval of ceftobiprole in pneumonia marks another significant
milestone for our company. Ceftobiprole has the broadest spectrum of activity of
any approved anti-MRSA agent. It is the first broad-spectrum anti-MRSA
cephalosporin monotherapy for both hospital- and community-acquired pneumonia.
We will work with authorities, hospital formularies, clinicians and potential
partners to bring this new antibiotic to patients as soon as possible."

Basilea's Chief Medical Officer Prof. Achim Kaufhold added: "Ceftobiprole has
broad-spectrum activity against many pathogens that cause pneumonia. Its
spectrum extends to isolates resistant to other commonly used antibiotics like
penicillin-resistant Streptococcus pneumoniae (PRSP), methicillin-resistant
Staphylococcus aureus (MRSA) or Staphylococcus aureus strains resistant to
vancomycin or linezolid. In the phase 3 pneumonia studies ceftobiprole was
comparable to a standard-of-care regimen consisting of two drugs. Ceftobiprole
may simplify physicians' treatment choice when the causative organism of an
infection is not known and offers coverage over a broad range of bacteria right
from the start of empiric therapy."

The European authorities' positive decision will support additional regulatory
submissions in many markets around the world. In Switzerland, a ceftobiprole
Marketing Authorization Application for the treatment of hospital- and
community-acquired pneumonia in adults is currently under review by the
regulatory authority Swissmedic.

About ceftobiprole

Ceftobiprole medocaril (ceftobiprole) is a broad-spectrum intravenous antibiotic
from the cephalosporin class for the treatment of hospital-acquired pneumonia
(excluding ventilator-associated pneumonia) and community-acquired pneumonia.
Ceftobiprole has demonstrated broad-spectrum activity against Gram-positive
bacteria including methicillin-resistant and vancomycin-resistant Staphylococcus
aureus (MRSA, VRSA) and penicillin- and ceftriaxone-resistant Streptococcus
pneumoniae (PRSP, CRSP) as well as Gram-negative pathogens including strains of
Enterobacteriaceae and Pseudomonas species.

About hospital-acquired and community-acquired pneumonia

Hospital-acquired pneumonia is one of the most common infections in the
hospital, accounting for approximately 25% of all intensive care unit (ICU)
infections, and is associated with significant mortality.[1],[2] Community-
acquired pneumonia is a common condition with up to 60% of the patients
requiring hospital admission and intravenous antibiotics.[3] Prompt empiric
intervention with an appropriate broad-spectrum antibiotic treatment is accepted
as best medical practice. The increasing incidence of bacteria resistant to many
established antibiotics is a major concern.

Conference call

Basilea Pharmaceutica Ltd. invites you to participate in a conference call on
Wednesday, October 23, 2013, 4 p.m. (CEST), during which the company will
discuss today's press release.

Dial-in numbers are:

 +41 (0) 58 310 50 00   (Europe and ROW)

 +1 (1) 631 570 5613    (USA)

 +44 (0) 203 059 5862   (UK)



A playback will be available 1 hour after the conference call until Friday,
October 25, 2013, 6 p.m. (CEST). Participants requesting a digital playback may
dial:

 +41 (0) 91 612 4330    (Europe and ROW)

 +1 (1) 866 416 2558    (USA)

 +44 (0) 207 108 6233   (UK)

and will be asked to enter the ID 15072 followed by the # sign.

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 from www.basilea.com.

References

[1] Torres A, Ferrer M and Badia JR. Treatment guidelines and outcomes of
    hospital-acquired and ventilator-associated pneumonia. Clinical Infectious
    Diseases 2010; 51: S48-S53.

[2] Barbier F, Andremont A, Wolff M, Bouadma L. Hospital-acquired pneumonia and
    ventilator-associated pneumonia: recent advances in epidemiology and
    management. Current Opinion in Pulmonary Medicine 2013; 19: 216-228.

[3] Sligl WI, Marrie TJ. Severe community-acquired pneumonia. Critical Care
    Clinics 2013; 29:
    563-601.




Press release (PDF): http://hugin.info/134390/R/1737484/582542.pdf

[HUG#1737484]

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