BEERSE, Belgium, February 19, 2010 /PRNewswire/ -- Janssen-Cilag International NV announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a negative opinion on its Marketing Authorisation Application (MAA) for the antibiotic ZEFTERA(TM) (ceftobiprole medocaril), for the treatment of complicated skin and soft tissue infections.
Cilag GmbH International has given Basilea Pharmaceutica Ltd. notice of termination of the worldwide License , Development and Co-Promotion Agreement between the parties. The compound, including pending applications and in-market products, will be transitioned back to Basilea under the terms of the License Agreement.
Janssen-Cilag International NV and Cilag GmbH International are Johnson Johnson 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 International NV and 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 International NV nor Johnson Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.
For further information, please contact: Media: Karen Manson - Office: +44-1737-644-690or Investor Relations: Stan Panasewicz - Office: +1-732-524-2524
SOURCE: Janssen-Cilag International NV
CONTACT: For further information, please contact: Media: Karen Manson -Office: +44-1737-644-690, Mobile: +32-479-89-47-99 or Investor Relations: StanPanasewicz - Office: +1-732-524-2524