Basilea Pharmaceutica AG : Swissmedic accepts for review Basilea's ceftobiprole Marketing Authorization Application for the

      Basilea Pharmaceutica AG : Swissmedic accepts for review Basilea's
    ceftobiprole Marketing Authorization Application for the treatment of

Basilea Pharmaceutica AG / Swissmedic accepts for review Basilea's
ceftobiprole Marketing Authorization Application for the treatment of
pneumonia . Processed and transmitted by Thomson Reuters ONE. The issuer is
solely responsible for the content of this announcement.

Basel, Switzerland, September 16, 2013 - Basilea Pharmaceutica Ltd. (SIX:
BSLN) announced today that the Swiss regulatory authority Swissmedic has
accepted the ceftobiprole Marketing Authorization Application for review.
Ceftobiprole is an investigational broad-spectrum anti-MRSA
(methicillin-resistant Staphylococcus aureus) antibiotic. The intended
indication of ceftobiprole is for the treatment of hospital-acquired
(nosocomial) pneumonia and community-acquired pneumonia in adults.

Ronald Scott, Chief Executive Officer of Basilea, stated: "We are very pleased
that Swissmedic will begin its review of our Marketing Authorization
Application for ceftobiprole in pneumonia. Severe pneumonia is a condition
associated with morbidity and mortality which is significantly increased when
MRSA is a causative organism. Data has shown that ceftobiprole provides broad
antibacterial coverage including MRSA and Gram-negative pathogens such as
Pseudomonas. We are focused on working with Swissmedic to support their review
of ceftobiprole."

Basilea's submission dossier includes data from two international
double-blind, randomized, controlled phase 3 studies in hospital-acquired
pneumonia and community-acquired pneumonia. These studies compared the
efficacy and safety of empiric ceftobiprole use versus standard-of-care single
or combination antibiotic therapy.

Ceftobiprole in pneumonia is currently under review with European regulatory
authorities, with a decision anticipated in the second half of 2013.

About ceftobiprole

Ceftobiprole is an investigational broad-spectrum intravenous antibiotic for
the potential first-line empiric treatment of severe bacterial infections.
Ceftobiprole has demonstrated broad-spectrum activity against Gram-positive
bacteria, including methicillin-resistant and vancomycin-resistant
Staphylococcus aureus (MRSA, VRSA) and penicillin-resistant Streptococcus
pneumoniae (PRSP) as well as Gram-negative pathogens, including
Enterobacteriaceae and Pseudomonas aeruginosa.

About pneumonia treated in the hospital

Community-acquired pneumonia is a common condition with up to 60% of the
patients requiring hospital admission and intravenous antibiotics.[1]
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.[2],[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 antibiotics is a major concern.

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.


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

This press release can be downloaded from


[1] Sligl WI, Marrie TJ. Severe community-acquired pneumonia. Critical Care
    Clinics 2013; 29:
[2] 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.
[3] 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.

Press release (PDF)


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Source: Basilea Pharmaceutica AG via Thomson Reuters ONE

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