SOURCE: Basilea Pharmaceutica AG

March 18, 2008 02:21 ET

FDA issues Approvable Letter for ceftobiprole, a new anti-MRSA broad-spectrum antibiotic

BASEL, SWITZERLAND--(Marketwire - March 18, 2008) -


Basel, Switzerland, March 18, 2008 - Basilea Pharmaceutica Ltd. announces that the U.S. Food and Drug Administration (FDA) issued an Approvable Letter for ceftobiprole, a first-in-class anti-MRSA broad-spectrum cephalosporin, for the treatment of complicated skin and skin structure infections including diabetic foot infections.

The Approvable Letter indicates that the ceftobiprole application is approvable, subject to completion and assessment of clinical study site inspections; assessment of clinical and microbiological data provided but not yet reviewed; and further characterization of patients with diabetic foot infections.

Dr. Anthony Man, CEO of Basilea said, "We are closely working together with our development partner Johnson & Johnson Pharmaceutical Research and Development, L.L.C., to quickly address the questions from the FDA."

The New Drug Application (NDA) was submitted to the FDA by Basilea's co-development partner Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Ceftobiprole is currently under review by regulatory authorities in Canada, the European Union and in Switzerland.

The NDA submission of ceftobiprole for the treatment of complicated skin and skin structure 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 and Gram-positive pathogens and with methicillin-resistant Staphylococcus aureus (MRSA) infections. In both of these large, multinational, double-blind, randomized phase III clinical studies, ceftobiprole was effective, demonstrated by achievement of the non-inferiority endpoint to single drug or two-drug combination comparators, respectively. Ceftobiprole was well tolerated with a safety profile consistent with the cephalosporin class of antibiotics.

Conference Calls

Basilea Pharmaceutica Ltd. will hold two conference calls on March 18, 2008, one at 8:30 a.m. (CET) and one at 4 p.m. (CET) to discuss today's press release.

The Company invites you to participate in the conference call on March 18, 2008, 8:30 a.m. (CET).

Dial-in numbers are:
+41 (0) 91 610 56 00      (Europe and ROW)
+44 (0) 207 107 0611     (UK)
+1 (1) 866 291 4166       (USA)

The playback will be available 1 hour after the conference call for 48 hrs. Participants requesting a digital playback may dial:

+41 (0) 91 612 4330       (Europe)
+44 (0) 207 108 6233     (UK)
+1 (1) 866 416 2558       (USA)

and will be asked to enter the ID 12592 followed by the # sign.

A second conference call is scheduled on March 18, 2008, 4 p.m. (CET).

Dial-in numbers are:
+41 (0) 91 610 56 00      (Europe and ROW)
+44 (0) 207 107 0611     (UK)
+1 (1) 866 291 4166       (USA)

The playback will be available 1 hour after the conference call for 48 hrs. Participants requesting a digital playback may dial:

+41 (0) 91 612 4330       (Europe)
+44 (0) 207 108 6233     (UK)
+1 (1) 866 416 2558       (USA)

and will be asked to enter the ID 12592 followed by the # sign.

About Basilea

Basilea Pharmaceutica Ltd. is an integrated biopharmaceutical company headquartered in Basel, Switzerland, listed on the SWX Swiss Exchange (SWX: BSLN). The company focuses on the discovery, development and commercialization of innovative medicines for resistant bacterial infections, systemic fungal infections, and severe skin diseases.

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.


For further information, please contact:

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| General Information            | Investor Relations             |
|--------------------------------+--------------------------------|
| information@basilea.com        | Dr. Barbara Zink               |
|                                | investor_relations@basilea.com |
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This press release can be downloaded from www.basilea.com


The press release can also be downloaded from the following link:

http://hugin.info/134390/R/1201851/245931.pdf



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