SOURCE: Basilea Pharmaceutica AG

February 26, 2009 01:33 ET

Basilea Confirms Its Press Release of February 24, 2009

BASEL, SWITZERLAND--(Marketwire - February 26, 2009) - Basilea Pharmaceutica Ltd. (SWISS: BSLN) announces that Johnson&Johnson PRD received confirmation from the European Medicines Agency (EMEA) that it has halted the European Commission decision process on Zevtera™ (ceftobiprole) for the treatment of complicated skin and soft tissue infections (cSSTI) pending completion of Good Clinical Practice (GCP) inspections.

In November 2008 Zevtera™ received a positive benefit-risk opinion and recommendation for approval from the EU Committee for Medicinal Products for Human Use (CHMP). Basilea announced on February 24, 2009 that it had been verbally informed that the EMEA would conduct GCP inspections and had halted the EU commission decision process until review of the inspection outcome is completed. Basilea now received written confirmation provided to Johnson&Johnson Pharmaceutical Research and Development, L.L.C (Johnson&Johnson PRD) that the EMEA has halted the EU Commission decision process on ceftobiprole pending EU led GCP inspections. Basilea anticipates that the final report from the EMEA GCP inspections will be available to the CHMP in the second half of this year.

Ceftobiprole showed in two large multinational, double-blind, randomized phase III clinical studies, that it was effective in treating cSSTI, as demonstrated by meeting the primary endpoint using a 10% non-inferiority margin. A safety profile consistent with the cephalosporin class of antibiotics was demonstrated. Ceftobiprole has been approved and is marketed in Canada (ZEFTERA™) and Ukraine for the treatment of complicated skin and skin structure infections (cSSSI), including non-limb threatening diabetic foot infections without concomitant osteomyelitis; and Switzerland (Zevtera™) for the treatment of cSSTI including diabetic foot infections.

About Basilea

Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange (SIX: BSLN). Basilea's integrated research and development operations are currently focused on new antibacterial, antifungal and oncology 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 commercialized drugs (alitretinoin, ceftobiprole) and one investigational drug in phase III (isavuconazole). Toctino® (alitretinoin) is marketed in the United Kingdom, Denmark and Germany and is approved in Finland and France. Alitretinoin has been recommended for approval in six additional EU Member States and is under regulatory review in Canada and Switzerland. Furthermore a phase III clinical trial on alitretinoin for the treatment of severe chronic hand eczema is ongoing in the U.S. Marketing applications for ceftobiprole (ZEFTERA™/Zevtera™) were submitted in the U.S., the EU and several other countries. The company has set up commercial organizations in UK, Denmark, Germany and Canada, while it is building sales and marketing organizations in other countries to commercialize alitretinoin and to co-promote ceftobiprole, subject to approval.


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:

| Media Relations                  | Investor Relations             |
| Jean-Christophe Britt, Ph.D.     | Barbara Zink, Ph.D., MBA       |
| Corporate Communication & Public | Head Corporate Development     |
| Relations                        | +41 61 606 1233                |
| +41 61 606 1354                  | |
|      |                                |

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