Healthcare Industry News:  ceftobiprole 

Biopharmaceuticals Regulatory

 News Release - May 30, 2007

Swiss Regulatory Authority Grants Accelerated Assessment of Planned Market Authorization Application for Ceftobiprole

BASEL, SWITZERLAND--(Healthcare Sales & Marketing Network)--May 30, 2007 -- Basel, Switzerland, May 30, 2007 - Basilea Pharmaceutica Ltd. (Swiss:BSLN.SW ) announced today that Swissmedic granted Janssen-Cilag AG, a Johnson & Johnson company, accelerated assessment of the planned market authorization application ("Beschleunigtes Zulassungsverfahren") for ceftobiprole for the treatment of complicated skin and soft tissue structure infections.

Swissmedic accelerated assessment designation is designed to expedite the availability of treatments that address high medical needs and is granted provided all of the following criteria are fulfilled: the therapy must have promising potential for the treatment of a severely debilitating or life-threatening disease, existing therapies are insufficient or not available, and a high therapeutic benefit is expected through the use of the drug.

Dr. Anthony Man, CEO of Basilea said, "We want to make ceftobiprole available to patients and prescribers around the world as quickly as possible, and are pleased that ceftobiprole has met the requirements to receive accelerated assessment designation in Switzerland."

About ceftobiprole

ceftobiprole (BAL5788), Basilea's lead antibacterial product is specially designed to bind the penicillin-resistant targets in many Gram-positive cocci, resulting in bactericidal activity towards methicillin-resistant Staphylococcus aureus (MRSA) and penicillin-resistant Streptococcus pneumoniae (PRSP). ceftobiprole has demonstrated a broad-spectrum profile targeting other Gram-positive as well as Gram-negative pathogens. In addition it has shown a low potential to select resistance in vitro.

ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica Ltd. and Cilag GmbH International, a Johnson & Johnson company. Ortho-McNeil, Inc., another Johnson & Johnson company, will market ceftobiprole in the U.S. and its affiliate Janssen-Cilag companies will market the product in Europe and Asia. Basilea has exercised its co-promotion rights for ceftobiprole in North America and major European countries, and maintains an option to co-promote the drug in Japan and China.

About Basilea

Basilea Pharmaceutica Ltd. is an independent biopharmaceutical company headquartered in Basel, Switzerland, and listed on the SWX Swiss Exchange (Swiss:BSLN.SW ). Basilea's fully 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 three investigational phase III drugs of which two have shown positive pivotal phase III results. The company is integrating commercialization into its organization, in a first step through co-promoting ceftobiprole with its partner Cilag GmbH International.


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. This communication is not for promotional purposes but specifically released to fulfill SWX Swiss Exchange ad hoc publicity requirements.

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Source: Basilea Pharmaceutica

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