Basel, Switzerland, April 8, 2005 (PRIMEZONE) -- Basilea Pharmaceutica AG announced today the start of its international phase III program for BAL5788, a novel broad spectrum, anti-methicillin resistant Staphylococcus aureus (MRSA) antibiotic, in hospital-acquired pneumonia with its development partner Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Basilea, with its development partner Johnson & Johnson Pharmaceutical Research and Development, L.L.C., initiated enrolment in its CHOPIN study (Ceftobiprole in Hospital acquired Pulmonary Infections), an international randomized controlled phase III study in hospital-acquired pneumonia including ventilator-associated pneumonia.
"The timely start of this study reflects our high level of commitment to bring this important molecule to patients and the medical community as rapidly as possible and our continued delivery on our planned milestones," commented Anthony Man, Chief Executive Officer of Basilea.
Hospital-acquired pneumonia is one of the most common infections in intensive care units and accounts for some 15% of all hospital infections. The mortality rate exceeds 30% and is highest among mechanically ventilated patients and patients infected with methicillin-resistant Staphylococcus aureus (MRSA). Recent studies confirmed that initial choice of the right antibiotic is essential for a positive clinical outcome.
"We are pleased to announce the advancement of BAL5788 into phase III clinical trials for the second indication of nosocomial pneumonia in addition to the earlier commenced phase III clinical trials in complicated skin and skin structure infections. Based on its broad Gram-positive and Gram-negative antibiotic profile, including activity on MRSA, its low probability of inducing resistance and its expected cephalosporin-like safety profile, BAL5788 has the potential to become a drug of choice in hospital-acquired pneumonia. Basilea commenced these studies as planned with our partner Johnson & Johnson Pharmaceutical Research and Development, L.L.C., continuing the consistent delivery on our clinical milestones" said Rienk Pypstra, M.D., Chief Development Officer of Basilea.
BAL5788 is being developed through an exclusive worldwide collaboration between Basilea 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 companies, known as Janssen-Cilag, will market the product in major European countries, Japan and China. Basilea has retained an option to co-promote ceftobiprole in North America, in major European countries, Japan and China.
About BAL5788
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). BAL5788 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 BAL5788 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 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).
BAL5788 is currently also in phase III clinical trials in complicated skin and skin structure infections.
About Basilea
Basilea Pharmaceutica AG (BSLN) is an independent biopharmaceutical company headquartered in Basel, Switzerland, that is actively engaged in the discovery and development of innovative medicines for the treatment of unmet medical needs. Basilea is 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 currently focused on new anti-bacterial and anti-fungal agents to fight drug resistance as well as on dermatology drugs. In the recent months, Basilea announced major company milestones including the entry of ceftobiprole (BAL5788) into phase III in complicated skin and skin structure infections; the entry of alitretinoin (BAL4079) for severe chronic hand dermatitis into phase III; the entry of BAL8557 in severe fungal infections into phase II; the advancement of a novel topical antibiotic for acne into preclinical testing; and an alliance with Johnson & Johnson's affiliated company, Cilag AG International, to globally develop and commercialize ceftobiprole.
Disclaimer
This communication expressly or implicitly contains certain forward-looking statements concerning Basilea Pharmaceutica AG 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 AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica AG 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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