Discontinuation of sale of ceftobiprole in Switzerland
(Thomson Reuters ONE) -
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.
Basel, Switzerland, September 09, 2010 - Basilea Pharmaceutica Ltd. (SIX:BSLN)
announces that Janssen-Cilag AG, a Johnson & Johnson company, will be
discontinuing sale of ceftobiprole (Zevtera(TM)) 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(TM) and
will discontinue sale of Zevtera(TM) 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(TM) to complete their
course of therapy and not to initiate treatment of new patients. Zevtera(TM) 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(TM).
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 (SIX: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(at)basilea.com | investor_relations(at)basilea.com |
+-----------------------------+--------------------------------+
This press release can be downloaded from www.basilea.com
[HUG#1443360]
--- End of Message ---
Basilea Pharmaceutica AG
Grenzacherstrasse 487
P.O Box Basel Switzerland
Listed: Freiverkehr in Börse Stuttgart,
Freiverkehr in Börse Berlin,
Open Market (Freiverkehr) in Frankfurter Wertpapierbörse,
Freiverkehr in Bayerische Börse München;
Ceftobiprole Discontinuation SWI:
http://hugin.info/134390/R/1443360/387537.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Basilea Pharmaceutica AG via Thomson Reuters ONE
Unternehmensinformation / Kurzprofil:
Datum: 09.09.2010 - 07:15 Uhr
Sprache: Deutsch
News-ID 41821
Anzahl Zeichen: 0
contact information:
Town:
Basel
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 168 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Discontinuation of sale of ceftobiprole in Switzerland"
steht unter der journalistisch-redaktionellen Verantwortung von
Basilea Pharmaceutica AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
