BASEL, Switzerland, Oct. 11, 2005 (PRIMEZONE) -- Basilea Pharmaceutica Ltd. (SWX:BSLN) today announced the start of an additional pivotal Phase III trial with its development partner Johnson & Johnson Pharmaceutical Research and Development, L.L.C. for ceftobiprole (BAL5788), the first cephalosporin in late stage development with potent activity against methicillin resistant Staphylococcus aureus (MRSA).
After successful completion of enrollment into the first STRAUSS trial (Study of Resistant Staphylococcus Aureus Skin and Skin Structure Infections), focusing on Gram-positive infections, Basilea and its development partner Johnson & Johnson Pharmaceutical Research and Development, L.L.C. now plan to study ceftobiprole in a second complicated skin infection trial by targeting both Gram-positive and Gram-negative bacterial infections, including patients with diabetic foot infections.
"Our joint development plan to maximize the potential of ceftobiprole is being executed as intended. It confirms the high commitment of both parties to this product and the effectiveness of the partnership between our two companies," commented Anthony Man, M.D., Basilea's CEO.
"We want as many patients as possible to benefit from the broad-spectrum and cidal activity of ceftobiprole, which is particularly useful in clinical situations such as diabetic patients with foot infections. Successful completion of this trial would clearly demonstrate the unique spectrum of ceftobiprole, covering not only resistant Gram-positive infections but also Gram-negative bacterial infections, such that ceftobiprole may replace a traditional combination treatment of two antibiotics. We wish ceftobiprole to become available as soon as possible, in particular for diabetic patients with difficult to treat foot infections," said Rienk Pypstra, M.D., Chief Development Officer of Basilea.
Foot ulcers develop in 15% of people suffering from diabetes mellitus, which may evolve to uncontrolled infections requiring lower leg amputation. In the U.S., 81,000 lower leg amputations occur per year in diabetic patients, and associated health care cost are very significant. Typically diabetic foot infections are caused by staphylococci (including MRSA) and streptococci, and very often involve also Gram-negative and anaerobic bacteria. Adequate treatment of diabetic foot infections requires hospitalization, urgent surgery and broad-spectrum intravenous antibiotics.
About Ceftobiprole
Ceftobiprole (BAL5788) is the first of a new class of broad-spectrum anti-MSRA cephalosporin antibiotics that was specially designed to bind to the penicillin-resistant targets in Gram-positive cocci, resulting in potent bactericidal activity towards methicillin-resistant Staphylococcus aureus (MRSA) and penicillin-resistant Streptococcus pneumoniae (PRSP). Ceftobiprole not only has maintained a broad-spectrum profile targeting other Gram-positive as well as Gram-negative pathogens, but has also shown a low potential to induce resistance in vitro.
In March 2003, the FDA granted Ceftobiprole a fast track designation for the treatment of complicated skin and skin structure infections due to methicillin-resistant Staphylococcus species. In June 2004, the FDA granted a fast track designation for a second indication for the treatment of hospital-acquired (nosocomial) pneumonia, including ventilator-associated pneumonia due to suspected or proven methicillin-resistant Staphylococcus aureus (MRSA). Ceftobiprole is currently in Phase III clinical trials in complicated skin and skin structure infections and hospital-acquired pneumonia.
Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica Ltd. and Cilag AG International, a Johnson & Johnson company. Ortho-McNeil Pharmaceutical, Inc., another Johnson & Johnson company, will market ceftobiprole in the U.S. and its affiliate company, Janssen-Cilag, will market the product in Europe, Japan and China. Basilea has retained an option to co-promote ceftobiprole in North America, major European countries, Japan and China.
About Basilea
Basilea Pharmaceutica Ltd. (BSLN) is a biopharmaceutical company headquartered in Basel, Switzerland, and listed on the SWX Swiss Exchange. Basilea was founded in October 2000 to discover, develop and bring innovative medicines to the market. The company's fully integrated research and development operations are focused on new anti-bacterial and anti-fungal agents to fight drug resistance as well as on dermatology drugs.
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.
The press release can be downloaded from www.basilea.com.
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