Healthcare Industry News:  fast track designation 

Biopharmaceuticals Regulatory

 News Release - June 18, 2007

Basilea Announces Submission of Marketing Authorization Application in Europe by Janssen-Cilag International NV for Ceftobiprole, a Novel Anti-MRSA Broad-spectrum Cephalosporin

BASEL, SWITZERLAND--(Healthcare Sales & Marketing Network)--Jun 18, 2007 -- Basel, Switzerland, June 18, 2007 - Basilea Pharmaceutica Ltd. (Swiss:BSLN.SW ) announced today the submission of a Marketing Authorization Application to the European Medicines Agency (EMEA) for ceftobiprole by its license partner Janssen-Cilag International NV, a Johnson & Johnson company. This submission is for the use of ceftobiprole in the treatment of complicated skin and soft tissue infections (cSSTI) including diabetic foot infections. Ceftobiprole is the first anti-MRSA broad-spectrum cephalosporin antibiotic to complete Phase III clinical trials.

This Marketing Authorization Application (MAA) of ceftobiprole for the treatment of complicated skin and soft tissue infections includes the data from two pivotal phase III trials (STRAUSS 1 and STRAUSS 2). These trials comprise data from over 1600 patients including those with diabetic foot infections caused by Gram-negative, Gram-positive and methicillin-resistant Staphylococcus aureus (MRSA) pathogens. In both multinational, double-blind, randomized phase III studies, ceftobiprole achieved a high clinical cure rate compared to single drug or two-drug combination comparators, respectively. Ceftobiprole was well tolerated with a safety profile consistent with the cephalosporin class of antibiotics.

Dr. Anthony Man, CEO of Basilea commented, "We have been delighted at the exciting, robust clinical data we have seen in the pivotal clinical trials for these complicated skin infections. Today's MAA submission as well as the recent NDA filing in the USA reflect our view that ceftobiprole could play an important role globally in the future management of important medical problems posed by MRSA".

A milestone payment of approximately CHF 12 million is associated with the MAA filing acceptance.

Ceftobiprole is currently in clinical phase III testing in hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP) and in hospitalized patients with community-acquired pneumonia (CAP) with anticipated completion in the second half of the year.

About Ceftobiprole

Ceftobiprole (BAL5788), Basilea's lead antibacterial product, is the first of a new class of broad-spectrum anti-MSRA cephalosporin antibiotics. It is specially designed to bind the penicillin-resistant targets in many Gram-positive cocci, resulting in potent 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.

The U.S. Food and Drug Administration (FDA) granted ceftobiprole fast track designation for the treatment of complicated skin and skin structure infections due to methicillin-resistant Staphylococcus species and for a second indication in the treatment of hospital-acquired (nosocomial) pneumonia, including ventilator-associated pneumonia due to suspected or proven methicillin-resistant Staphylococcus aureus (MRSA). A New Drug Application (NDA) to the U.S. FDA has been filed for the use of ceftobiprole in the treatment of complicated skin and skin structure infections (cSSSI) including diabetic foot infections.

Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica Ltd. and Cilag GmbH International. Ortho-McNeil, Inc., 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.

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Source: Basilea Pharmaceutica

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