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:
Karen Manson
Office: +44-1737-644-690 or
Investor Relations:
Stan Panasewicz
Office: +1-732-524-2524
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