Request for re-examination of ceftobiprole submitted to CHMP
(Thomson Reuters ONE) -
Basilea Pharmaceutica AG / Request for re-examination of ceftobiprole submitted to CHMP processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
Basel, Switzerland, March 11, 2010 - Basilea Pharmaceutica Ltd. (SIX:BSLN)
announces that the Applicant Janssen-Cilag International NV (Janssen-Cilag), a
Johnson & Johnson company, has submitted a request for re-examination of the
negative opinion by the European Committee for Medicinal Products for Human Use
(CHMP) on the Marketing Authorization Application (MAA) for ceftobiprole for the
treatment of complicated skin and soft tissue infections (cSSTI).
On February 18, 2010, the CHMP adopted a negative opinion on the MAA for
ceftobiprole for the treatment of cSSTI. The Applicant Janssen-Cilag has given
written notice to the Agency that it requests a re-examination of the negative
opinion under standard procedures. According to current CHMP guidelines, a final
opinion on the re-examination could be issued by the Agency within four to five
months.
About Basilea
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on
the SIX Swiss Exchange (SIX:BSLN). Basilea's integrated research and development
operations are currently focused on new antibacterial, antifungal and oncology
agents to fight drug resistance and on the development of dermatology drugs.
Basilea's products are targeted to satisfy high medical and patient needs in the
hospital and specialty care setting.
The company owns a diversified portfolio including two commercialized drugs
(Toctino®, ZEFTERA(TM)/ Zevtera(TM)) and one investigational drug
(isavuconazole) in phase III clinical development. Basilea has entered into a
license, co-development and co-promotion agreement with Astellas Pharma Inc. for
isavuconazole for the treatment of life-threatening invasive fungal infections
on a worldwide basis, including an option for Japan. Toctino® (alitretinoin) is
marketed in Denmark, France, Germany, Switzerland and the United Kingdom. It is
approved in six additional European countries as well as in Canada and has been
recommended for approval in 15 European countries. Furthermore, a phase III
clinical trial on alitretinoin for the treatment of severe chronic hand eczema
is ongoing in the U.S.
Ceftobiprole is marketed in Canada under the brand name ZEFTERA(TM) and in
Switzerland under Zevtera(TM). Basilea has set up commercial organizations in
Canada, France, Germany, the Nordics, Switzerland and the United Kingdom, while
it is building sales and marketing organizations in other countries to
commercialize alitretinoin.
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#1392772]
--- 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/1392772/350221.pdf
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Datum: 11.03.2010 - 01:15 Uhr
Sprache: Deutsch
News-ID 1011190
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