BASEL, Switzerland, March 3, 2004 (PRIMEZONE) -- Basilea Pharmaceutica AG today announced positive phase II results for BAL5788 in the indication of complicated skin and skin structure infections (cSSSI). BAL5788 is the first of a new class of broad-spectrum cephalosporin antibiotics also active against multi-resistant Gram-positive pathogens such as methicillin-resistant Staphylococcus aureus (MRSA). In March 2003 the FDA awarded BAL5788 Fast Track review status in recognition of its therapeutic potential to treat severe infections.
"We believe BAL5788 offers significant advantages over existing therapy, and as the first of a new generation of anti-MRSA cephalosporins has the potential to become a leading product. The positive phase II results we released today confirm Basilea's position as an innovator and R&D leader in anti-infectives. We plan to initiate a phase III program being fully committed to making BAL5788 available to physicians and patients as soon as possible," said Anthony Man MD, Basilea CEO.
The phase II study investigated the safety and efficacy of BAL5788 in patients hospitalised for complicated skin infections requiring surgical intervention. Most patients were suffering from deep muscle and/or fascia infections caused by streptococci and staphylococci, including patients with MRSA.
All of the 35 evaluable study patients were cured and rapid clinical improvement was typically observed within the first days of treatment. No treatment failures occurred and the safety of BAL5788 was consistent with the established safety profile of the cephalosporin class, with mild to moderate nausea/vomiting being the most frequent side effect observed.
"A beta-lactam antibiotic with potent anti-MRSA activity and a safety profile typical of this class should be an excellent agent for the treatment of severe infections where MRSA is a likely pathogen," commented Professor Henry Chambers, Head of Infectious Diseases at San Francisco General Hospital.
About Antibiotic Resistance
The growing incidence of serious infections caused by antibiotic-resistant bacteria is a matter of increasing global medical concern. BAL5788 offers potent bactericidal activity against MRSA, penicillin-resistant Streptococcus pneumoniae (PRSP) and other major Gram-positive bacterial pathogens as well as against Gram-negative bacteria, similar to that of third-generation cephalosporins.
About Basilea
Basilea Pharmaceutica AG 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. The company's fully integrated research and development operations are currently focused on new anti-bacterial and anti-fungal agents to overcome the problem of drug-resistance in bacterial infections and fungal infections, as well as skin diseases all of which are associated with high unmet medical needs and growth potential. Basilea was founded in October 2000 with significant resources to discover, develop and bring innovative medicines to market.
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