BASEL, Switzerland, June 16, 2004 (PRIMEZONE) -- Basilea Pharmaceutica AG announced today that it received a second fast track designation from the U.S. Food and Drug Administration (FDA) for its novel broad-spectrum, first-in-class antibiotic BAL5788. The additional fast track designation covers hospital-acquired pneumonia including ventilator-associated pneumonia due to suspected or proven methicillin-resistant Staphylococcus aureus (MRSA). Fast track designation is designed to expedite the availability of treatments that address unmet medical needs for serious and life-threatening diseases. The growing incidence of serious infections caused by antibiotic-resistant bacteria is a matter of increasing global medical concern.
"BAL5788 has already shown excellent clinical activity in complicated skin infections and is also highly active in pneumonia and septicaemia preclinical models. We believe BAL5788 offers significant advantages over existing therapies for MRSA. This second fast track designation acknowledges the potential of BAL5788 in treating these infections. We are fully committed to working with regulatory authorities and moving forward into our phase III program with these indications as soon as possible," said Anthony Man MD, Basilea CEO.
About BAL5788
BAL5788 is the first of a new class of broad-spectrum cephalosporin antibiotics that has a unique combination of features resulting in potent bactericidal activity towards MRSA and penicillin-resistant Streptococcus pneumoniae (PRSP), in addition to a broad-spectrum profile towards other Gram-positive and Gram-negative pathogens.
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. BAL5788 has completed phase II clinical development and is anticipated to enter phase III development in second half of 2004.
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.
The company's fully integrated research and development operations are currently focused on new anti-bacterial, anti-fungal and dermatology drugs. Basilea was founded in October 2000 with significant resources to discover, develop and bring innovative medicines to market. Basilea is listed on the SWX Swiss Exchange.
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. For further information, please contact the following:
General Information Investor Relations
information@basilea.com Sean Wells
sean.wells@basilea.com
The press release can be downloaded from the following link: http://hugin.info/134390/R/949205/134308.pdf