FDA issues Warning Letter to Johnson & Johnson Pharmaceutical Research and Development related to ceftobiprole

BASEL, SWITZERLAND--(Marketwire - August 18, 2009) -

Basel, Switzerland, August 18, 2009 - Basilea Pharmaceutica Ltd.
announces that the company was notified today that the U.S. Food and
Drug Administration (FDA) issued to Johnson & Johnson Pharmaceutical
Research and Development, L.L.C. (J&JPRD) a Warning Letter related to
clinical trials for ceftobiprole for the treatment of complicated
skin and skin structure infections.

The Warning Letter to Johnson&Johnson PRD relates to observations
from FDA sponsor and clinical site inspections conducted during the
first part of 2008.

Consistent with Basilea's earlier press releases, the Warning Letter
asserts that there was a failure to ensure proper monitoring of the
studies as well as deficiencies in study conduct.

The FDA has posted the Warning Letter at www.fda.gov.

Ceftobiprole is an anti-MRSA broad-spectrum cephalosporin antibiotic.
It is marketed in Canada (ZEFTERAT) for the treatment of
complicated skin and skin structure infections (cSSSI), including
non-limb threatening diabetic foot infections without concomitant
osteomyelitis and in Switzerland (ZevteraT) for the treatment of
complicated skin and soft tissue infections (cSSTI) including
diabetic foot infections without concomitant osteomyelitis.

Ceftobiprole is being developed through an exclusive worldwide
collaboration between Basilea Pharmaceutica International Ltd. and
Cilag GmbH International, a Johnson & Johnson company.

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 (Toctino®,
ZEFTERAT/ZevteraT) and one investigational drug in phase III
(isavuconazole).

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:

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

This press release can be downloaded from www.basilea.com

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

Attachments: Press release (PDF):
R/1335700/317529.pdf">http://hugin.info/134390/R/1335700/317529.pdf

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