BASEL, SWITZERLAND--(Marketwire - September 09, 2010) -
Basilea Pharmaceutica AG / Discontinuation of sale of ceftobiprole in
Switzerland processed and transmitted by Hugin AS. The issuer is solely
responsible for the content of this announcement.
Basilea Pharmaceutica Ltd. (SWISS: BSLN)
announces that Janssen-Cilag AG, a Johnson & Johnson company, will be
discontinuing sale of ceftobiprole (Zevtera™) for the treatment of
complicated skin and soft tissue infections (cSSTI) in Switzerland.
Janssen-Cilag AG, the holder of the Marketing Authorization in Switzerland,
has
requested Swissmedic to withdraw the marketing authorization of Zevtera™
and
will discontinue sale of Zevtera™ as of September 17, 2010. This action
is
being taken based on the unfavorable assessments of the marketing
authorization
applications for ceftobiprole in the United States and the European Union.
Physicians are advised to allow all patients on Zevtera™ to complete
their
course of therapy and not to initiate treatment of new patients.
Zevtera™ was
authorized in Switzerland in November 2008 for the treatment of cSSTI.
There
have been no safety observations that would be in conflict with the
approved
label of Zevtera™.
The decision to discontinue sale of the product in the Swiss market does
not
preclude the submission of a new application for marketing authorization in
the
future.
Corresponding requests for the withdrawal of Marketing Authorizations are
being
submitted to health authorities by a respective Janssen-Cilag company
holding
the Marketing Authorization in Russia, Ukraine and Azerbaijan, the
remaining
countries in which ceftobiprole is currently approved.
About Basilea
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and
listed on
the SIX Swiss Exchange (SWISS: BSLN). Its fully integrated research and
development
operations are currently focused on antibiotics, antifungals and oncology
drugs,
as well as on the development of dermatology drugs, targeting the medical
challenge of resistance and non-response to current treatment options in
the
hospital and specialty care setting.
Basilea is currently marketing Toctino® (alitretinoin), the only
approved
treatment for severe chronic hand eczema unresponsive to potent topical
corticosteroids, in Denmark, France, Germany, Switzerland and the United
Kingdom
and has appointed distributors for Toctino® in other selected European
markets,
Canada and Mexico. Furthermore, a phase III clinical program on
alitretinoin for
the treatment of severe chronic hand eczema is ongoing in the U.S. The
company
has entered into a global partnership with Astellas Pharma Inc. for its
phase
III compound isavuconazole, a potential best-in-class azole antifungal, for
the
treatment of life-threatening invasive fungal infections. Full rights to
ceftobiprole for the treatment of potentially life-threatening resistant
bacterial infections, are being transferred back to Basilea from Cilag GmbH
International, a Johnson & Johnson company.
Disclaimer
This communication expressly or implicitly contains certain forward-looking
statements concerning Basilea Pharmaceutica Ltd. and its business. Such
statements involve certain known and unknown risks, uncertainties and other
factors, which could cause the actual results, financial condition,
performance
or achievements of Basilea Pharmaceutica Ltd. to be materially different
from
any future results, performance or achievements expressed or implied by
such
forward-looking statements. Basilea Pharmaceutica Ltd. is providing this
communication as of this date and does not undertake to update any
forward-looking statements contained herein as a result of new information,
future events or otherwise.
For further information, please contact:
+-----------------------------+--------------------------------+
| Media Relations | Investor Relations |
+-----------------------------+--------------------------------+
| Adesh Kaul | Barbara Zink, Ph.D., MBA |
| Head Public Relations & | Head Corporate Development |
| Corporate Communications | |
| +41 61 606 1460 | +41 61 606 1233 |
| media_relations@basilea.com | investor_relations@basilea.com |
+-----------------------------+--------------------------------+
This press release can be downloaded from www.basilea.com
[HUG#1443360]
Ceftobiprole Discontinuation SWI:
http://hugin.info/134390/R/1443360/387537.pdf
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Source: Basilea Pharmaceutica AG via Thomson Reuters ONE
