Discontinuation of sale of ceftobiprole in Canada
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Basilea Pharmaceutica AG / Discontinuation of sale of ceftobiprole in Canada processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
Basel, Switzerland, April 9, 2010 - Basilea Pharmaceutica Ltd. (SIX:BSLN)
announces that Janssen-Ortho Inc., a Johnson & Johnson company, has in
consultation with Health Canada decided to discontinue sale of ceftobiprole
(ZEFTERA(TM)) for the treatment of complicated skin and skin structure
infections (cSSSI) in Canada.
Janssen-Ortho Inc., the holder of the Market Authorization in Canada, is
discontinuing sale of ZEFTERA(TM) effective April 16, 2010. This action is being
taken by Janssen-Ortho Inc. following discussions with Health Canada in response
to recent regulatory recommendations in the United States and European Union to
not approve ZEFTERA(TM) for cSSSI due to concerns regarding the conduct of
clinical trials.
ZEFTERA(TM) was authorized in Canada in June 2008 for the treatment of cSSSI.
There have been no safety observations that would be in conflict with the
approved label of ZEFTERA(TM) in Canada. The decision to discontinue sale of the
product in the Canadian market does not preclude the submission of a new
application for market authorization in the future.
Recently, the European Committee for Medicinal Products for Human Use (CHMP)
indicated that, although the study results suggested that ceftobiprole is
beneficial to patients, it was concerned about how reliable the trial results
were. The Committee therefore recommended that, in light of the uncertainty
surrounding the results, ceftobiprole should not be granted marketing
authorization for the treatment of complicated skin and soft tissue infections
at this time. The sponsor Janssen-Cilag International NV, a Johnson & Johnson
company, submitted a request for re-examination of the negative opinion by the
CHMP.
In December 2009, the U.S. Food and Drug Administration (FDA) issued to the
sponsor of the US filing, Johnson & Johnson Pharmaceutical Research and
Development, L.L.C., a Complete Response Letter on ceftobiprole for the
treatment of cSSSI, indicating that the Agency cannot approve the New Drug
Application in its present form. The Agency determined that data from the phase
III clinical trials could not be relied upon because of concerns regarding the
overall data integrity for both studies.
About Basilea
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on
the SIX Swiss Exchange (SIX:BSLN). Its integrated research and development
operations are currently focused on antibiotics and antifungals, as well as on
the development of dermatology and oncology drugs, all areas in which the
medical challenge of rising resistance or non-response to current treatment
options is commonly encountered. Basilea's products are targeted to satisfy high
medical and patient needs in the hospital and specialty care setting.
The company owns a broad and diversified portfolio. Basilea is marketing
Toctino® (alitretinoin), for the treatment of severe chronic hand eczema, in
Denmark, France, Germany, Switzerland and the United Kingdom. The drug is
approved in ten additional European countries as well as in Canada and has been
recommended for approval in 12 further European countries. Furthermore, a phase
III clinical trial on alitretinoin for the treatment of severe chronic hand
eczema is ongoing in the U.S. Basilea has entered into a license, co-development
and co-promotion agreement with Astellas Pharma Inc. for its phase III compound
isavuconazole for the treatment of life-threatening invasive fungal infections
on a worldwide basis, including an option for Japan. Full rights to a third
late-stage product, ceftobiprole for the treatment of potentially
life-threatening resistant bacterial infections, will be transferred from Cilag
GmbH International, a Johnson & Johnson company, back to Basilea.
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 1233 |
| | |
|+41 61 606 1460 | |
| | |
|media_relations(at)basilea.com |investor_relations(at)basilea.com |
|
+----------------------------------------+-------------------------------------+
This press release can be downloaded from www.basilea.com
The press release can also be downloaded from the following link:
[HUG#1401931]
--- End of Message ---
Basilea Pharmaceutica AG
Grenzacherstrasse 487
P.O Box Basel Switzerland
WKN: A0B9GA;ISIN: CH0011432447;
Press release (PDF): http://hugin.info/134390/R/1401931/356785.pdf
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Datum: 09.04.2010 - 11:33 Uhr
Sprache: Deutsch
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