BASEL, SWITZERLAND -- 06/30/08 --
Basel, Switzerland, June 30, 2008 - Basilea Pharmaceutica Ltd.
announces that ceftobiprole (ZEFTERA(TM)), the first-in-class
anti-MRSA broad-spectrum cephalosporin, has obtained regulatory
approval from Health Canada authorizing the marketing of ceftobiprole
for the treatment of complicated skin and soft tissue infections
including diabetic foot infections. In addition, Basilea announces
further organizational changes in preparation of product
commercialization.
Dr. Anthony Man, CEO of Basilea said, "The availability of
ZEFTERA(TM) is an important advance in the fight against infections
due to potentially deadly bacteria, including MRSA and we are
delighted by this first regulatory approval in Canada. The labeling
reflects our conviction that ZEFTERA(TM) is an innovative
broad-spectrum, first-line treatment which may be used before knowing
the exact bacteria causing the infection. This marketing
authorization signals the start of a new era for Basilea as we
commercialize the first of a number of innovative compounds in our
pipeline."
Basilea Pharmaceuticals Corp. will co-promote the drug in Canada
under the trade name ZEFTERA(TM) with its local partner
Janssen-Ortho, Inc. Ceftobiprole is currently under review by
regulatory authorities in the U.S., the European Union, Australia,
Russia, South Africa and Switzerland.
About ZEFTERA(TM)
ZEFTERA(TM) (ceftobiprole medocaril for injection) is the first
approved broad-spectrum anti-MRSA antibiotic belonging to the
cephalosporin class. It is specially designed to bind the
penicillin-resistant targets in many Gram-positive bacteria of the
cocci-type, resulting in bactericidal activity towards MRSA and
penicillin-resistant Streptococcus pneumoniae. Ceftobiprole as a
single intravenous agent has demonstrated broad-spectrum activity
against many other Gram-positive as well as Gram-negative bacteria,
frequently associated with community and hospital-acquired
infections.
Health Canada has indicated ZEFTERA(TM) for: "The treatment of the
following infections when caused by susceptible strains of the
designated microorganisms in patients 18 years of age and older:
Complicated skin and skin structure infections (cSSSI), including
non-limb threatening diabetic foot infections without concomitant
osteomyelitis caused by: Enterobacter cloacae, Escherichia coli,
Klebsiella pneumoniae, Proteus mirabilis, Staphylococcus aureus
(including methicillin-resistant isolates), and Streptococcus
pyogenes."
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 germ 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 food 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.
Organizational Changes
Basilea Pharmaceutica Ltd. also announces organizational changes in
preparation of anticipated international product commercialization
including expansion of Drug Safety, Medical Information, Medical
Affairs, Market Access, Supply Chain Distribution, and Global Quality
Management.
To support Basilea's transition to a fully integrated company, Dr.
Dieter Götte joins as Chief Medical Officer and replaces Dr. Rienk
Pypstra on the Basilea Management Committee. Dr. Götte has over
twenty years of industry experience with Hoechst, Aventis and
Novartis across multiple therapeutic areas including anti-infectives
and dermatology. His previous senior management roles have included
Vice President of Regulatory & Medical Affairs including Drug Safety
at Aventis Pharma and Global Head of Corporate Medical Services at
Hoechst. Dr. Götte also was Chief Scientific Officer with Novartis
Germany and Chairman of the Novartis Foundation for Therapeutic
Research.
Dr. Rienk Pypstra takes on the role of Head of Portfolio Development
to focus on expansion and consolidation of Basilea's R&D portfolio.
About Basilea
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and
listed on the SWX Swiss Exchange (SWX: 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 one approved product (ZEFTERA(TM)), one pre-registration
drug (alitretinoin) and one phase-III investigational drug
(isavuconazole). The company is currently building its sales and
marketing organization to commercialize alitretinoin and to
co-promote ZEFTERA(TM) in North America and major 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. |
| Corporate Communication & Public | Head Corporate Development |
| Relations | +41 61 606 1233 |
| +41 61 606 1354 | investor_relations@basilea.com |
| media_relations@basilea.com | |
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