European CHMP concludes re-examination of ceftobiprole
Basilea Pharmaceutica AG / European CHMP concludes re-examination of ceftobiprole processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
Basel, Switzerland, June 25, 2010 - Basilea Pharmaceutica Ltd. (SIX:BSLN)
announces that following a request for re-examination from the Applicant
Janssen-Cilag International NV (Janssen-Cilag), a Johnson & Johnson company, the
European Committee for Medicinal Products for Human Use (CHMP) confirmed its
previous negative opinion on the Marketing Authorization Application (MAA) for
ceftobiprole for the treatment of complicated skin and soft tissue infections
The CHMP has confirmed its previous negative opinion on the use of ceftobiprole
for the treatment of cSSTI. The CHMP indicated that, although the study results
suggested that the medicine was beneficial to patients, it was concerned about
the reliability of the results. The Committee therefore recommended that, in
light of the uncertainty surrounding the results, ceftobiprole should not be
granted marketing authorization.
In February 2010, the CHMP issued a negative opinion on ceftobiprole in cSSTI
stating that inspections had shown that the phase III studies supporting the MAA
had not been conducted in compliance with good clinical practice in some sites.
Following the Applicant Janssen-Cilag's request for a re-examination of the
negative opinion under standard procedures, the Agency has reassessed the MAA.
Ceftobiprole is an anti-MRSA broad-spectrum cephalosporin antibiotic exhibiting
activity against a wide spectrum of Gram-positive bacteria, including the
'superbug' methicillin-resistant Staphylococcus aureus (MRSA) and
penicillin-resistant Streptococcus pneumonia as well as many clinically
important Gram-negative bacteria, including Pseudomonas.
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on
the SIX Swiss Exchange (SIX:BSLN). Basilea's products are targeted to satisfy
high medical and patient needs in the hospital and specialty care setting. 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.
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 15 additional European countries as well as in Canada and has been
recommended for approval in seven further European countries. Basilea has
appointed Almirall S.A. as its distributor for Toctino® in selected European
markets and Mexico. 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.
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 |
| email@example.com | firstname.lastname@example.org |
This press release can be downloaded from www.basilea.com
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Basilea Pharmaceutica AG
Grenzacherstrasse 487 P.O Box Basel Switzerland
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Freiverkehr in Börse Berlin,
Open Market (Freiverkehr) in Frankfurter Wertpapierbörse,
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