Ceftobiprole shows high cure rates in patients hospitalized with
community-acquired pneumonia
Basel, Switzerland, May 20, 2008 - Basilea Pharmaceutica Ltd.
(SWX:BSLN) highlights the presentation of positive phase III results
on ceftobiprole in the treatment of community-acquired pneumonia
(CAP) requiring hospitalization at the International Conference of
the American Thoracic Society (ATS). The detailed analysis of
previously announced top line results demonstrate high cure rates in
patients at risk for poor outcomes.
The randomized, double-blind phase III study compared clinical
outcomes following the treatment with ceftobiprole versus ceftriaxone
with or without linezolid in patients hospitalized with
community-acquired pneumonia. The clinical cure rate in the
clinically evaluable patient population with moderate to severe
pneumonia was 87% for ceftobiprole and 88% for the comparator arm. In
patients infected with Streptococcus pneumoniae, the most common
pathogen in CAP, high cure rates were achieved with ceftobiprole
(93%) and the comparator (89%). In the overall study population
ceftobiprole met non-inferiority with a margin (delta) of 10%.
Ceftobiprole achieved high cure rates in patients at risk for poorer
outcomes such as elderly patients, patients with severe pneumonia,
with systemic inflammatory response or with concomitant bloodstream
infection. Ceftobiprole was effective in 93% of the clinically
evaluable patients at age 75 or older (vs. 86% for the comparator).
The cure rate in patients with class IV and V severity (PORT score)
was 90% for ceftobiprole vs. 85% for the comparator. Patients with
systemic inflammatory response syndrome were cured in 85% and 87% for
ceftobiprole and comparator respectively, and 86% of patient with
concomitant bloodstream infection were cured in both treatment arms.
Ceftobiprole was generally well tolerated, with an adverse event
profile consistent with that previously reported.
"The results of this study confirm that ceftobiprole as a single drug
was effective as a first-line therapy in the treatment of CAP
requiring hospitalization, including those patients at risk of poorer
outcome. We believe that ceftobiprole has the potential to become an
important therapeutic option to treat patients with bacterial lung
infections", commented Dr. Anthony Man, CEO of Basilea.
Ceftobiprole is being co-developed with Johnson & Johnson
Pharmaceutical Research & Development, L.L.C. and it is currently
under review by regulatory authorities in the US, the EU, Canada,
Australia and in Switzerland for the treatment of complicated skin
and skin structure infections.
Ceftobiprole posters presented at ATS on Tuesday, May 20th 2008
Efficacy of Ceftobiprole compared to Ceftriaxone +/- Linezolid for
the Treatment of Patients Hospitalized with Community-Acquired
Pneumonia. SC Nicholson and co-authors.
Efficacy of Ceftobiprole for the Treatment of Severely Ill Patients
Hospitalized with Community-Acquired Pneumonia. SC Nicholson and
co-authors.
To view poster abstracts please visit www.abstracts2view.com/ats08/.
About community-acquired pneumonia requiring hospitalization
Community-acquired pneumonia is associated with high morbidity and
mortality, with at least one fifth of cases requiring
hospitalization. Despite a large number of antimicrobials available,
it remains a significant cause of death in industrialized countries.
CAP is caused by a variety of pathogens with their order of
importance dependent on the location and population studied,
Streptococcus pneumonia being the predominant pathogen with
increasing incidence of CAP caused by multidrug-resistant
Streptococcus pneumoniae (MDRSP).
About ceftobiprole
Ceftobiprole, Basilea's lead antibacterial product, is a
first-in-class anti-MRSA broad-spectrum cephalosporin antibiotic. It
is specially designed to inhibit penicillin-resistant targets in many
Gram-positive cocci, resulting in potent bactericidal activity
towards methicillin-resistant Staphylococcus aureus (MRSA) and
penicillin-resistant Streptococcus pneumoniae (PRSP). In clinical
trials, ceftobiprole has demonstrated a broad-spectrum profile
targeting other Gram-positive and Gram-negative pathogens with potent
activity against common bacterial respiratory pathogens including
MDRSP. In addition, it has demonstrated a low potential to select
resistance in vitro. In the trials, ceftobiprole was generally well
tolerated with a safety profile consistent with the cephalosporin
class of antibiotics.
Ceftobiprole is being developed through an exclusive worldwide
collaboration between Basilea Pharmaceutica International Ltd. and
Cilag GmbH International. When approved, Ortho-McNeil, Division of
Ortho-McNeil-Janssen Pharmaceuticals, will market ceftobiprole in the
U.S. and Janssen-Cilag companies will market the product in Europe
and Asia. Basilea has exercised its co-promotion rights for
ceftobiprole in North America and major European countries, and
maintains an option to co-promote the drug in Japan and China.
About Basilea
Basilea Pharmaceutica Ltd. is an independent biopharmaceutical
company headquartered in Basel, Switzerland, and listed on the SWX
Swiss Exchange (SWX:BSLN). Basilea's integrated research and
development operations are currently focused on new antibacterial and
antifungal agents to fight drug resistance and on the development of
dermatology drugs. Basilea's products are targeted to satisfy high
medical and patient needs in the hospital and specialty care setting.
The company owns a diversified portfolio including two
pre-registration drugs and one phase-III investigational drug. The
company is currently building its sales and marketing organization to
promote alitretinoin and to co-promote ceftobiprole, subject to
approval.
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:
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