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Basilea Pharmaceutica AG (VTX:BSLN) Basel, Switzerland, November 13, 2008 - Basilea Pharmaceutica Ltd. announces that ceftobiprole (Zevtera(TM)), the first-in-class anti-MRSA broad-spectrum cephalosporin, has obtained regulatory approval from Swissmedic for the treatment of complicated skin and soft tissue infections including diabetic foot infections.
Dr. Anthony Man, CEO of Basilea said, "We are delighted by this approval of ceftobiprole by Swissmedic. This is an important moment for our company and brings a novel and effective treatment against resistant bacteria to patients and physicians here in Switzerland."
The Swiss marketing authorization certificate may be used to facilitate regulatory approval and market entry in other countries including Asia and South America.
The regulatory dossier to Swissmedic was submitted by Basilea's license partner Janssen-Cilag AG, a Johnson & Johnson company, who will commercialize ceftobiprole in Switzerland under the trade name Zevtera(TM).
Ceftobiprole is marketed in Canada and is currently under regulatory review by regulatory authorities in the U.S., the European Union and in other countries. Subject to approval, Basilea will co-promote ceftobiprole in the U.S. and in the major European markets together with the respective Janssen-Cilag companies.
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 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.
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. It is 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. In the trials, ceftobiprole was generally well tolerated with a safety profile consistent with the cephalosporin class of antibiotics.
Swissmedic has indicated Zevtera(TM) for the treatment of complicated skin and soft tissue infections, including diabetic foot infections without concomitant osteomyelitis caused by susceptible gram-positive pathogens (e.g. MRSA) and/or gram-negative bacteria.
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 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 two commercialized drugs (alitretinoin, ceftobiprole) and one investigational drug (isavuconazole) in phase III. 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 is approved in Switzerland. Ceftobiprole is under review by regulatory authorities in the U.S., in the EU and in several other countries. The company has set up commercial organizations in UK, Denmark and in Germany while it is building sales and marketing organizations to commercialize alitretinoin and to co-promote ceftobiprole in North America 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.
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+-------------------------------------------------------------------+ | Media Relations | Investor Relations | |----------------------------------+--------------------------------| | Jean-Christophe Britt, Ph.D. | Barbara Zink, Ph.D., MBA | | 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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