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Basilea Pharmaceutica Ltd.
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. 

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