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Janssen-Cilag AG

New Antibiotic Against Serious Infections

Beerse, Belgium, November 21 (ots/PRNewswire)

- European Authority Recommends Approval of ZEVTERA(TM)
BEERSE, Belgium, November 21 /PRNewswire/ --
- A Broad-spectrum, Anti-MRSA Cephalosporin Antibiotic to Treat
Complicated Skin and Soft Tissue Infections
BEERSE, Belgium, November 21 /PRNewswire/ --
The Committee for Medicinal Products for Human Use (CHMP) has
recommended approval for the antibiotic, ZEVTERA(TM) (ceftobiprole
medocaril) for the treatment of complicated skin and soft tissue
infections. The CHMP's positive opinion is now referred for final
action to the European Commission.
Ceftobiprole is the first, broad-spectrum, anti-MRSA
cephalosporin antibiotic with activity against a range of
difficult-to-treat Gram-positive and Gram-negative hospital- and
community-acquired infections including methicillin-resistant
Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa.
In clinical trials, ceftobiprole has demonstrated high cure rates
in patients with complicated skin infections, including those with
deep wound and diabetic foot infections, and in infections caused by
the potentially deadly MRSA.
Data from the European Antimicrobial Resistance Surveillance
System (EARSS) show that the prevalence of MRSA - a difficult to
treat cause of hospital-and- community acquired infections - while
varying considerably among countries, has been rising across Europe
for the past six years(1).
The use of ceftobiprole in adults for the treatment of
complicated soft tissue infections is under regulatory review in the
United States, and Australia, among other countries. Ceftobiprole was
approved in Switzerland in November 2008. In Canada, it was approved
and launched in August 2008, and is marketed under the trade name
ZEFTERA.
Ceftobiprole is licensed from and co-developed with Swiss based
Basilea Pharmaceutica Ltd. Janssen-Cilag AG, and Basilea
Pharmaceutica Ltd will co-promote the drug in North America and key
European markets and in North America subject to approval.
About Complicated Skin Infections
Complicated skin and soft tissue infections are among the most
common infections in the hospital setting. Staphylococcus aureus is
the predominant pathogen in these infections. In recent years,
resistant strains (MRSA) have become increasingly common and have
been associated with increased morbidity and mortality. There is a
high unmet medical need for new antibiotics such as ceftobiprole that
cover resistant bacteria including MRSA, but also clinically
important and problematic Gram-negative pathogens.
Patients with chronic wounds or those who have recently received
antibiotics may also be infected by Gram-negative pathogens. This is
frequently the case for diabetic patients with foot infections.
Adequate treatment of diabetic foot infections can require
hospitalization, surgery and broad-spectrum intravenous antibiotics.
About Ceftobiprole
Ceftobiprole is an intravenous antibiotic that belongs to the
class of antibacterial drugs known as cephalosporins, which are used
to treat serious infections caused by a broad range of bacteria,
characterized as Gram-negative and Gram-positive, based on a
classification process that is used to identify the specific type of
bacteria.
Ceftobiprole is licensed from and co-developed with Basilea
Pharmaceutica Ltd through an exclusive worldwide collaboration.
Janssen-Cilag AG, will market ceftobiprole in Europe under the trade
name ZEVTERA(TM). Basilea will co-promote ceftobiprole in the major
European markets and in the U.S. with the respective Janssen-Cilag
companies, and in Canada with Janssen-Ortho, Inc.
Notes
The Janssen-Cilag companies have a long and successful track
record in developing and marketing treatments for a wide variety of
conditions such as fungal and bacterial infections, HIV, pain
management, multiple myeloma, gastroenterological disorders,
epilepsy, Alzheimer's disease, schizophrenia, acute bipolar mania,
behavioural psychological symptoms of dementia, disruptive behaviour
disorders and autism. More information can be found at
http://www.janssen-cilag.com. The Janssen-Cilag companies are part of
the Johnson & Johnson family of companies.
This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995.
These statements are based on current expectations of future events.
If underlying assumptions prove inaccurate or unknown risks or
uncertainties materialize, actual results could vary materially from
Janssen-Cilag's expectations and projections. Risks and uncertainties
include general industry conditions and competition; economic
conditions, such as interest rate and currency exchange rate
fluctuations; technological advances and patents attained by
competitors; challenges inherent in new product development,
including obtaining regulatory approvals; domestic and foreign health
care reforms and governmental laws and regulations; and trends toward
health care cost containment. A further list and description of these
risks, uncertainties and other factors can be found in Exhibit 99 of
Johnson & Johnson's Annual Report on Form 10-K for the fiscal year
ended December 30, 2007. Copies of this Form 10-K, as well as
subsequent filings, are available online at http://www.sec.gov,
http://www.jnj.com or on request from Johnson & Johnson.
Janssen-Cilag does not undertake to update any forward-looking
statements as a result of new information or future events or
developments.
(1) European Antimicrobial Resistance Surveillance System (EARSS)
2005 Annual Report. Available at: http://www.rivm.nl/en/
For further information, please contact:
    Jennifer Tear,
    Tel: +32-14-60-26-38,
    Pharmaceutical Communications EMEA,
    Turnhoutsweg 30,
    B-2340 Beerse 2340 Belgium.

Contact:

For further information, please contact: Jennifer Tear, Tel:
+32-14-60-26-38, Pharmaceutical Communications EMEA, Turnhoutsweg 30,
B-2340 Beerse 2340 Belgium.

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