Basel, Switzerland, April 18, 2008 - Basilea Pharmaceutica Ltd. highlighted today that new research and preclinical data on two late-stage product candidates ceftobiprole and isavuconazole will be presented at the upcoming European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). Poster and oral presentations reflect the advanced stage of development of the broad-spectrum anti-MRSA antibiotic ceftobiprole. Additionally, publications on isavuconazole present further research results confirming the differentiated profile of the compound.
In preparation of the potential launch, ceftobiprole presentations focus on key surveillance data from multicenter trials describing the in vitro activity of ceftobiprole in European countries (poster #613 and #578). Ceftobiprole demonstrated sustained Gram-positive activity (vs. Staphylococcus aureus, coagulase-negative staphylococci and Streptococcus pneumoniae) as well as comparable activity to cefepime against Gram-negative isolates (Enterobacteriaceae and Pseudomonas aeruginosa). This dataset supports the potential empirical treatment choice and positioning of ceftobiprole in the clinical setting.
Ceftobiprole posters
In vitro activity of ceftobiprole against select Gram-positive and Gram-negative pathogens isolated from Europe in 2006-2007. M.K. Torres and co-authors. Poster #613.
Antimicrobial activity of ceftobiprole tested against leading European bacterial pathogens: Results from an international surveillance program. T.R. Fritsche and co-authors. Poster #578.
Genetic relatedness among European methicillin-susceptible and -resistant Staphylococcus aureus isolates from ceftobiprole clinical trials. T.A. Davies and co-authors. Poster #1428.
Ceftobiprole is superior to cefepime against a Klebsiella pneumoniae strain in experimental meningitis. M. Cottagnoud and co-authors. Poster #1933.
To view poster abstracts please visit www.akm.ch/eccmid2008.
Ceftobiprole is currently under review by regulatory authorities in the U.S., Canada, the European Union, Australia and Switzerland. It is being co-developed with Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Isavuconazole is currently in phase III testing for first-line treatment against invasive aspergillus and candida bloodstream infections.
Data presented at ECCMID confirm that the broad-spectrum of activity in vitro translates into effective treatment in animal models of Candida tropicalis and Candida krusei, difficult pathogens with some resistance to fluconazole (Poster #1914). Additionally, in vitro susceptibility testing of numerous clinical yeast isolates indicate that isavuconazole could become a useful therapeutic option for fluconazole-resistant yeast infections (Poster #2176).
Potent fungicidal activity of isavuconazole was shown in animal models of disseminated aspergillosis (Poster #1915). A sustained post-antibiotic effect has been demonstrated in mice models (Poster #2177).
Isavuconazole posters
Efficacy of isavuconazole, voriconazole and fluconazole in neutropenic murine models of disseminated Candida tropicalis and Candida krusei. J.B. Majithiya and co-authors. Poster #1914.
Correlation of in vitro MIC and MFC against isavuconazole, voriconazole and amphotericin B of Aspergillus with in vivo outcome in mice with disseminated aspergillosis. J.B. Majithiya and co-authors. Poster #1915.
Comparison between Isavuconazole and other azoles against characterised clinical isolates and recombinant yeast model systems. D. Sanglard and co-authors. Poster #2176.
In vitro post antibiotic effect of isavuconazole, voriconazole and amphotericin B against a strain of C. albicans with concentration-dependent pharmacokinetics in a murine model and susceptibility of strains from mouse kidneys post infection. P.A. Warn and co-authors. Poster #2177.
To view poster abstracts please visit www.akm.ch/eccmid2008.
About Basilea
Basilea Pharmaceutica Ltd. is an independent biopharmaceutical company headquartered in Basel, Switzerland, and listed on the SWX Swiss Exchange (SWX:BSLN). Basilea's 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 two pre-registration drugs and one phase III investigational drug. The company is currently building its sales and marketing organization to commercialize alitretinoin and to co-promote ceftobiprole.
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
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