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Basilea
Pharmaceutica Ltd.
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Swiss Exchange (SWX:
BSLN)
Basilea Pharmaceutica is
a biotechnology company focusing on discovery and development of novel
drugs for high unmet medical needs in the fields of anti-bacterials, anti-fungals
and dermatology.
Annual General Meeting of Shareholders
of Basilea Pharmaceutica Ltd.
Basel, Switzerland, March 19, 2008
- Basilea Pharmaceutica Ltd. (SWX:BSLN) shareholders
approve all Board of Directors' proposals at the Annual General Meeting.
Today, the shareholders of Basilea approved
the annual report, the statutory and consolidated financial statements
for the financial year 2007, as well as the release of the members of the
Board of Directors and management. Shareholders also approved a partial
release from the legal reserve to the free reserve as well as offsetting
the free reserve with the accumulated loss. Dr. Anthony Man and Mr. Ronald
Scott were re-elected as members of the Board of Directors, both for a
term of three years. Dr. Walter Fuhrer, Prof. Daniel Lew, and Prof. Peter
van Brummelen were re-elected as members of the Board of Directors for
a term of one year, while Mr. Steven Skolsky was elected as a new member
of the Board for a term of three years, replacing Dr. Gottlieb Keller.
In addition, shareholders re-elected PricewaterhouseCoopers AG, Basel,
as statutory auditor and group auditor for the business year 2008, and
approved changes to the Articles of Association to permit the implementation
of a holding structure to support the potential future distribution of
Basilea products. In the meeting of the Board of Directors, Mr. Werner
Henrich was confirmed as Chairman of the Board of Directors, and Dr. Andreas
Wicki as Vice-Chairman.
The Annual General Meeting for the financial
year 2007 was attended by shareholders who represented 40.3% of the total
share capital of the company
Marketing
Authorization Application for Alitretinoin Accepted by European Health
Authorities
Basel,
Switzerland, October 11, 2007 - Basilea Pharmaceutica Ltd. (SWX:BSLN) announced
today that the Marketing Authorization Application (MAA) for alitretinoin
submitted to various EU Member States was accepted for review under the
decentralized procedure. This application supports the proposed use of
oral alitretinoin in patients with severe refractory chronic hand eczema.
The
Marketing Authorization Application (MAA) seeks approval for oral alitretinoin
for the treatment of severe refractory chronic hand eczema (CHE) and is
based on a clinical program comprising almost 2000 patients. Recently,
a market authorization application for alitretinoin in severe refractory
CHE has been submitted with the Swiss health authority Swissmedic.
Swiss
Regulatory Authority Accepts Marketing Authorization Application for Ceftobiprole
for Assessment
Basel,
Switzerland, October 8, 2007 - Basilea Pharmaceutica Ltd. (SWX:BSLN) announced
today that Swissmedic has accepted for assessment the marketing authorization
application of ceftobiprole for the treatment of complicated skin and soft
tissue infections (cSSTI) including diabetic foot infections. The application
is subject to an accelerated review. The regulatory dossier was submitted
by Basilea's license partner Janssen-Cilag AG, a Johnson & Johnson
company.
Swissmedic
had previously granted accelerated assessment of the marketing authorization
application ("Beschleunigtes Zulassungsverfahren") for ceftobiprole for
the treatment of complicated skin and soft tissue infections.
Ceftobiprole
is currently under review by regulatory authorities in the U.S., Canada
and the European Union.
Ceftobiprole
is being developed through an exclusive worldwide collaboration between
Basilea Pharmaceutica Ltd. and Cilag GmbH International.
Basilea
Reports 2007 Interim Results
Basel,
Switzerland, August 22, 2007 - Basilea Pharmaceutica Ltd. (SWX:BSLN) announces
its 2007 interim financial results - Basilea prepares to commercialize
its product candidates.
Basilea
Pharmaceutica Ltd. announced today its 2007 interim financial results reflecting
its activities in establishing an international sales and marketing organization
and in manufacturing registration and commercialization material for its
product candidates. Basilea continued to achieve major milestones in the
first half of 2007 announcing positive phase III clinical trial results
for ceftobiprole and alitretinoin and regulatory filings of ceftobiprole
in the U.S., Europe and Canada together with its partner Johnson &
Johnson. Regulatory filings for alitretinoin are expected for the second
half of 2007.
Financial
Summary
Combined
cash and short-term investments amounted to CHF 366.0 million as of June
30, 2007, compared to CHF 176.6 million at year-end 2006. In addition,
the Company held long-term bank deposits of CHF 105.0 million. The increase
in available funds results mainly from net proceeds in the amount of CHF
310.1 million from a secondary offering, that was completed in March 2007.
Research
and development expenses amounted to CHF 60.6 million in the first half
of 2007 compared to CHF 39.0 million in the prior year period. This increase
resulted primarily from initiation of the phase III clinical program for
isavuconazole, as well as from expenses of CHF 10.6 million related to
the manufacturing of alitretinoin commercialization material. General and
administrative expenses amounted to CHF 10.8 million in the first six months
of 2007 reflecting initial set up costs for an international sales and
marketing organization. The net loss in the first half of 2007 consequently
amounted to CHF 64.4 million compared to CHF 39.8 million in the respective
period in 2006. Basic and diluted loss per share amounted to CHF 7.40 for
the first six months in 2007 as compared to CHF 5.24 in the first half
of 2006.
The
decrease in net cash used for operating activities compared to the prior
year period is mainly the result of a CHF 24.5 million milestone payment
received related to the regulatory filing of ceftobiprole in the U.S.,
as well as from changes in working capital.
Key
Figures
(in
CHF million), except per share data H1 2007 H1 2006
Revenues
3.4 3.9
Expenses
Research
& Development (60.6) (39.0)
General
& Administrative (10.8) (5.9)
Operating
Loss (68.1) (41.0)
Net
Loss (64.4) (39.8)
Cash
Flow from Operating Activities (28.0) (33.8)
Basic
and Diluted Loss per Share in CHF (7.40) (5.24)
Notes:
Unaudited consolidated figures in conformity with US GAAP
Basilea
Announces the Submission to U.S. Authorities of a New Drug Application
for Ceftobiprole, a Novel anti-MRSA Broad-spectrum Cephalosporin
Basel,
Switzerland, May 18, 2007 - Basilea Pharmaceutica Ltd. (SWX:BSLN) announced
today the submission of a New Drug Application (NDA) to the U.S. Food and
Drug Administration (FDA) for ceftobiprole by its co-development partner
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. This
submission is for the use of ceftobiprole in the treatment of complicated
skin and skin structure infections (cSSSI) including diabetic foot infections.
Submissions to other health authorities around the world will follow. Ceftobiprole
is a novel anti-MRSA broad-spectrum cephalosporin antibiotic.
This
submission of ceftobiprole for the treatment of complicated skin and skin
structure infections includes the data from two pivotal phase III trials
(STRAUSS 1 and STRAUSS 2). These trials comprise data from over 1600 patients
including those with diabetic foot infections caused by Gram-negative and
Gram-positive pathogens and with methicillin-resistant Staphylococcus aureus
(MRSA) infections. In both of these large, multinational, double-blind,
randomized phase III clinical studies, ceftobiprole was effective, demonstrated
by achievement of the non-inferiority endpoint to single drug or two-drug
combination comparators, respectively. Ceftobiprole was well tolerated
with a safety profile consistent with the cephalosporin class of antibiotics.
Dr.
Anthony Man, CEO of Basilea commented, "We and our partners at Johnson
& Johnson Pharmaceutical Research and Development, L.L.C. are delighted
to have been able to prepare and submit this first NDA package in a timely
fashion. We believe the compelling clinical results in this package confirm
the profile of ceftobiprole as an innovative anti-MRSA drug providing coverage
of a broad range of common Gram-positive and Gram-negative pathogens associated
with complicated skin and skin structure infections."
The
NDA filing triggers a milestone payment of approximately CHF 24 million
from Cilag GmbH International, the Johnson & Johnson company with which
ceftobiprole is being developed through an exclusive worldwide collaboration.
Ceftobiprole
is currently in clinical phase III testing in hospital-acquired pneumonia
(HAP) including ventilator-associated pneumonia (VAP) and in hospitalized
patients with community-acquired pneumonia (CAP) with anticipated completion
in the second half of the year. |