BEERSE, Belgium, November 21 /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.
For further information, please contact: Jennifer Tear, Tel: +32-14-60-26-38, Pharmaceutical Communications EMEA, Turnhoutsweg 30, B-2340 Beerse 2340 Belgium.
