ceftobiproleTreatment for Skin and Structure Infection
U.S. FDA and European EMEA Accept Registration Applications for Ceftobiprole, Novel Anti-MRSA Broad-Spectrum Cephalosporin
BASEL, Switzerland, July 18, 2007 - Basilea Pharmaceutica Ltd. (SWX:BSLN) announced today that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) have accepted the New Drug Application (NDA) and Marketing Authorization Application (MAA), respectively, of ceftobiprole for the treatment of complicated skin and skin structure infections (cSSSI) including diabetic foot infections. Both applications will be subject to standard review. The regulatory dossiers were submitted by Basilea's co-development partner Johnson & Johnson Pharmaceutical Research & Development, L.L.C., in the U.S. and in Europe by its license partner Janssen-Cilag International NV.
The regulatory application for ceftobiprole is based on data from two multinational, double blind pivotal phase III trials (STRAUSS 1 and STRAUSS 2) which enrolled over 1600 patients with infections caused by Gram-negative and Gram-positive pathogens including MRSA. STRAUSS 2 included patients with diabetic foot infections. In both pivotal studies, ceftobiprole achieved high clinical cure rates that were comparable to either a single drug or to a two-drug comparator combination. Ceftobiprole was well tolerated with a safety profile consistent with the cephalosporin class of antibiotics.
Dr. Anthony Man, CEO of Basilea commented, "We are delighted that the two major health authorities have accepted the applications for ceftobiprol. This underscores the potential of this new antibiotic in the treatment of complicated skin and skin structure infections in which MRSA or gram-negative pathogens are a concern. In addition, we plan to report topline data for the pneumonia program, including hospital-acquired and community-acquired pneumonia requiring hospitalization, later this year. Assuming positive study outcomes, subsequent filings are expected."
Ceftobiprole (BAL5788), Basilea's lead antibacterial product, is the first of a new class of anti-MRSA broad-spectrum cephalosporin antibiotics. It is specially designed to inhibit penicillin-resistant targets in many Gram-positive cocci, resulting in potent bactericidal activity towards MRSA and penicillin-resistant Streptococcus pneumoniae (PRSP). In clinical trials, ceftobiprole has demonstrated a broad-spectrum profile targeting other Gram-positive and Gram-negative pathogens. In addition, it has shown a low potential to select resistance in vitro. In the trials, ceftobiprole was well tolerated with a safety profile consistent with the cephalosporin class of antibiotics.
FDA granted ceftobiprole fast track designation for the treatment of complicated skin and skin structure infections due to methicillin-resistant Staphylococcus species and for a second indication in the treatment of hospital-acquired (nosocomial) pneumonia, including ventilator-associated pneumonia due to suspected or proven MRSA.
Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica Ltd. and Cilag GmbH International. Ortho-McNeil, Inc., will market ceftobiprole in the U.S. and Janssen-Cilag companies will market the product in Europe and Asia. Basilea has exercised its co-promotion rights for ceftobiprole in North America and major European countries, and maintains an option to co-promote the drug in Japan and China.
Basilea Pharmaceutica Ltd. is an independent biopharmaceutical company headquartered in Basel, Switzerland, and listed on the SWX Swiss Exchange (SWX:BSLN). Basilea's fully 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 three investigational phase III drugs of which two have shown positive pivotal phase III results. The company is integrating commercialization into its organization, in a first step through co-promoting ceftobiprole with its partner Cilag GmbH International.
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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Posted: July 2007
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