Chmp Adopts Negative Opinion For Zeftera(tm)

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20th February 2010, 06:10am - Views: 928





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MEDIA RELEASE PR38431



CHMP Adopts Negative Opinion for ZEFTERA(TM)


BEERSE, Feb. 19/ PRNewswire-AsiaNet/ --



    

    - Cilag GmbH International to Terminate Collaboration


    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


& 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.


     SOURCE: Janssen-Cilag International NV


    CONTACT:  Media: 

Business Company Janssen-Cilag International NV 3 image

              Karen Manson

              Office: +44-1737-644-690 or 


              Investor Relations:

              Stan Panasewicz 

              Office: +1-732-524-2524





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