Published:
Zevtera(TM) (ceftobiprole medocaril), the novel anti-MRSA broad-spectrum antibiotic, receives a positive opinion from the CHMP
Basilea Pharmaceutica Ltd.
announces that Zevtera(TM) (ceftobiprole medocaril), the
first-in-class anti-MRSA broad-spectrum cephalosporin, received a
positive opinion from the Committee for Medicinal Products for Human
Use (CHMP) for the treatment of complicated skin and soft tissue
infections.
Dr. Anthony Man, CEO of Basilea Pharmaceutica Ltd. said, "This
positive opinion represents a transforming landmark for Basilea and a
major validation for Zevtera(TM) in the treatment of severe skin
infections. Zevtera(TM) is now a step closer to being available for
healthcare professionals and patients in Europe to fight against
potentially deadly infections, including methicillin-resistant
Staphylococcus aureus (MRSA) infections. The announcement from the
CHMP reflects our conviction that Zevtera(TM) is an innovative
broad-spectrum antibiotic that can be used as first-line treatment
for a wide range of serious skin infections before knowing the exact
bacteria causing an infection."
As per the CHMP positive opinion, "Zevtera(TM) is indicated in adults
for the treatment of complicated skin and soft tissue infections."
The CHMP's positive opinion is now referred for final action to the
European Commission. Subject to approval by the European Commission,
the positive CHMP opinion on Zevtera(TM) will apply in all 27 EU
Member States plus Iceland and Norway.
Ceftobiprole is marketed in Canada under the trade name ZEFTERA(TM)
through co-promotion with Janssen-Ortho Inc., a Johnson & Johnson
company. Ceftobiprole is approved for the treatment of complicated
skin and soft tissue infections including diabetic foot infections in
Switzerland and currently under review for this indication by
regulatory authorities in the U.S. and other countries.
Conference Call
Basilea Pharmaceutica Ltd. invites you to participate in a conference
call on November 21, 2008, 4 p.m. (CET), during which the company
will discuss today's press release.
Dial-in numbers are:
+41 (0) 91 610 56 00 (Europe and ROW)
+1 (1) 866 291 4166 (USA)
+44 (0) 207 107 0611 (UK)
The playback will be available 1 hour after the conference call for
48 hrs. Participants requesting a digital playback may dial:
+41 (0) 91 612 4330 (Europe)
+1 (1) 866 416 2558 (USA)
+44 (0) 207 108 6233 (UK)
and will be asked to enter the ID 10303 followed by the # sign.
About Zevtera(TM)
Zevtera(TM) (ceftobiprole medocaril for injection), Basilea's lead
antibacterial product, is the first approved broad-spectrum anti-MRSA
antibiotic belonging to the cephalosporin class. Ceftobiprole as a
single intravenous agent has demonstrated broad-spectrum activity
against a wide range of difficult-to-treat Gram-positive and
Gram-negative hospital- and community-acquired infections including
methicillin-resistant Staphylococcus aureus (MRSA). In the trials,
ceftobiprole was generally well tolerated with a safety profile
consistent with the cephalosporin class of antibiotics.
Ceftobiprole is being developed through an exclusive worldwide
collaboration between Basilea Pharmaceutica International Ltd. and
Cilag GmbH International. Basilea Pharmaceutica Ltd. has also
exercised its option to co-promote ceftobiprole in the U.S. and in
the major European markets together with Ortho-McNeil, Division of
Ortho-McNeil-Janssen Pharmaceuticals, Inc. in the U.S. and the
respective Janssen-Cilag companies in Europe. Basilea maintains an
option to co-promote the drug in Japan and China.
About complicated skin infections
Complicated skin and soft tissue infections are among the most common
infections in the hospital setting. Staphylococcus aureus, a
Gram-positive microbe, is the predominant pathogen in skin
infections. In recent years methicillin-resistant strains of S.
aureus (MRSA) have become increasingly common and have been
associated with increased morbidity and mortality. Patients with
chronic wounds or those who have recently received antibiotics may
also be infected by Gram-negative microbes. This is frequently the
case for diabetic patients with foot infections. Treatment of
diabetic foot infections requires broad-spectrum intravenous
antibiotics and may include hospitalization and surgery.
Broad-spectrum antibiotics that cover resistant bacteria are often
needed for the treatment of more severe skin infections.
About Basilea
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland,
and listed on the SIX Swiss Exchange (SWISS: BSLN). Basilea's integrated
research and development operations are currently focused on new
antibacterial and antifungal 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 (alitretinoin, ceftobiprole) and
one investigational drug in phase III (isavuconazole). Alitretinoin
(Toctino®) is marketed in the United Kingdom, in Denmark and in
Germany and is approved in Finland and France. Alitretinoin has been
recommended for approval in six additional EU Member States and is
under regulatory review in Canada and Switzerland. Ceftobiprole is
marketed in Canada and approved in Switzerland. Ceftobiprole received
a positive opinion from the CHMP and is under review by regulatory
authorities in the U.S. and in several other countries. The company
has set up commercial organizations in UK, Denmark, Germany and
Canada, while it is building sales and marketing organizations to
commercialize alitretinoin and to co-promote ceftobiprole in the U.S.
and in other European countries, subject to approval.
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:
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| Media Relations | Investor Relations |
|---------------------------------+---------------------------------|
| Jean-Christophe Britt, Ph.D. | Barbara Zink, Ph.D., MBA |
| Corporate Communication & | Head Corporate Development |
| Public Relations | +41 61 606 1233 |
| +41 61 606 1354 | investor_relations@basilea.com |
| media_relations@basilea.com | |
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Press release (PDF): http://hugin.info/134390/R/1271976/282249.pdf
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Tags: ,Pharmaceuticals and Biotech:Drugs, Chemicals:SpecialtyChemicals, ,GA,BASEL, SWITZERLAND
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