CHMP Delays European Commission Decision Process To Approve ZEVTERATM

February 24, 2009 at 2:00 pm Leave a comment


Janssen-Cilag announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has decided to delay the European Commission decision process on ZEVTERATM (ceftobiprole medocaril) pending completion of a Good Clinical Practice (GCP) inspection.




ZEVTERA is in the final stage of approval for the treatment of complicated skin and soft tissue infections. This application for approval was based on the results of two, large, Phase III trials that demonstrated ZEVTERA was not inferior to comparator regimens as a treatment for complicated skin and soft tissue infections.




ZEVTERA was well tolerated with the most common treatment-emergent adverse events including nausea, taste disturbance, diarrhoea and vomiting. ZEVTERA received a positive opinion from the CHMP in November 2008 for the treatment of complicated skin and soft tissue infections.




ZEVTERA 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 pathogens including methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa.




The regulatory review process is ongoing in the United States, and Australia, among other countries for the use of ceftobiprole in adults for the treatment of complicated skin and skin structure infections. Ceftobiprole was approved in Switzerland in November 2008, in Ukraine in December 2008 and in Canada, in June 2008, where it is marketed under the trade name ZEFTERA™ (ceftobiprole medocaril I.V).




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 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.



About ZEVTERA




ZEVTERA 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 ZEVTERATM. 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 and/or Johnson & Johnson’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 28, 2008. 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. Neither Janssen-Cilag nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.



The Janssen-Cilag

[Via http://www.medicalnewstoday.com]

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