Results of Ceftobiprole Phase III Program for the Treatment of Complicated Skin Infections Presented Today at ICAAC
BASEL, Switzerland, September 18, 2007 Basilea Pharmaceutica Ltd. (SWX:BSLN) today announced that previously unpublished data on ceftobiprole were presented in 23 posters at the Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Chicago. The detailed clinical and microbiological results of the phase III program demonstrate ceftobiprole's potential breadth of activity in complicated skin infections involving Gram-positive and Gram-negative pathogens.
Ceftobiprole is an investigational, broad-spectrum cephalosporin with activity against methicillin-resistant Staphylococcus aureus (MRSA), that is being co-developed with Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Of particular importance are the detailed analyses of various aspects of the second pivotal study of patients with complicated skin and skin structure infections (cSSSI), STRAUSS II, included in posters E-282, C2-185, L-1145, L-1143 and K-1092 and the slide presentation A-590. Ceftobiprole demonstrated non-inferiority within the 10% non-inferiority margin in the clinically evaluable, intent-to-treat and microbiologically evaluable populations of patients. Clinical cure rates were 91% for Gram-positive infections and 87% for patients with Gram-negative infections.
A comprehensive microbiological analysis of the two pivotal studies STRAUSS I and II, respectively, demonstrated ceftobiprole's activity against infections that involved a broad spectrum of pathogens ranging from MRSA to Pseudomonas aeruginosa. Resistant pathogen subsets, particularly for Pseudomonas and Enterobacteriaceae, are fully described. Microbiological eradication for ceftobiprole alone was comparable to that of the combination therapy for both Gram-positive and Gram-negative pathogens, with 88% eradication for ceftobiprole compared to 89% with vancomycin and ceftazidime.
E. coli, Enterobacter spp., P. aeruginosa, Proteus mirabilis and Klebsiella pneumoniae were the most frequent isolates among the Gram-negative pathogens and which play a significant role in cSSSI. Staphylococci, particularly S. aureus, and Streptococci, which are major pathogens involved in complicated skin infections, were eradicated by ceftobiprole, as was Enterococcus faecalis (Poster E-282).
MRSA can be grouped by SCCmec genotypes. In the combined pathogen panel of the STRAUSS I and II trials, all major global clones were represented. Ceftobiprole was active against all isolates regardless of genetic subtype (Poster C2-185).
The Panton-Valentine Leukocidin (PVL) toxin is a marker for disease severity of S. aureus infections. PVL-positive S. aureus strains have been identified worldwide, particularly in community-acquired MRSA isolates. The frequency and clinical outcome of patients infected with PVL-positive staphylococci were examined with pooled data from the STRAUSS I and II studies. Clinical cure rates in ceftobiprole-treated patients with cSSSI due to PVL-positive S. aureus exceeded 90%, demonstrating activity against these aggressive bacteria. (Posters K-1092 and L-1143).
Irrespective of infection type (diabetic foot infection, wound, abscess or cellulitis) and severity markers, ceftobiprole demonstrated activity in all infection types (Poster L-1145).
The time of drug concentrations above inhibitory levels (T> MIC) at the infection site is the pharmacological determinant of activity for beta-lactams in general, and for ceftobiprole specifically. The PK/PD rationale was discussed in more detail showing pharmacodynamic coverage of greater than or equal to 90% of Gram-positive pathogens, with a clear correlation of the pharmacokinetic properties associated with the eradication of Gram-negative pathogens (Slide Session A-590).
About Basilea Basilea Pharmaceutica Ltd. is an integrated biopharmaceutical company headquartered in Basel, Switzerland, listed on the SWX Swiss Exchange (SWX:BSLN). We focus on the discovery, development and commercialization of innovative medicines to satisfy high medical and patient needs in the hospital and specialty pharmaceutical setting. Basilea has a diversified product portfolio including novel treatments for resistant bacterial infections, systemic fungal infections and severe skin diseases. The highly competitive product pipeline comprises three late-stage product candidates and substantial early-stage programs. Basilea is currently building its sales and marketing organization in the U.S. and major European markets to promote alitretinoin and co-promote ceftobiprole upon 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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Dr. Barbara Zink
Posted: September 2007