Ceftobiprole shows high cure rates in patients hospitalized with community-acquired pneumonia
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BASEL, SWITZERLAND, May 20 (MARKET WIRE) --
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
includingMDRSP. 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 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
futureresults, 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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| General Information | Investor Relations |
|--------------------------------+--------------------------------|
| information@basilea.com | Dr. Barbara Zink |
| | investor_relations@basilea.com |
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This press release can be downloaded from www.basilea.com
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Hugin AS 2008. All rights reserved.
Copyright 2008, Market Wire, All rights reserved.
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