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Basilea's Toctino® receives marketing authorization in Austria

Basel, Switzerland, March 17, 2009 - Basilea Pharmaceutica Ltd.
(SIX:BSLN) announces that Toctino® (alitretinoin), a new once-daily
oral treatment for adults with severe chronic hand eczema (CHE)
unresponsive to potent topical corticosteroids, has been approved by
the Austrian Agency for Health and Food Safety (AGES).

Subsequent to the recommendation for regulatory approval under the
European decentralized procedure, Basilea received the marketing
authorization for Toctino® in Austria. Following the regulatory
approval of Toctino® in Austria, Basilea will submit a pricing and
reimbursement dossier to the country authorities.

Chronic hand eczema - a debilitating skin disease
Hand eczema is a common inflammatory skin disease and is often
chronic and relapsing. Hand eczema is reported to affect up to ten
percent of the general population. The more severe, chronic form of
the condition is thought to affect five to seven percent of these
patients, causing impaired use of their hands and a considerable
impact on their ability to perform everyday activities.

Toctino® (alitretinoin), the only therapy approved for severe chronic
hand eczema unresponsive to potent topical corticosteroids
Toctino® (alitretinoin) was developed by Basilea Pharmaceutica
International Ltd.

The AGES approved Toctino® for the use in adults who have severe CHE
that is unresponsive to treatment with potent topical
corticosteroids.

Toctino® is a once-daily oral therapy for the treatment of adults
that is given for 12 to 24 weeks, depending on patient response. In
the six-month post-treatment observation in the pivotal phase III
clinical trials, patients who responded to Toctino® experienced long
periods free from relapse and improved patient satisfaction. Toctino®
has been launched in Denmark, Germany and the United Kingdom and has
also received marketing authorization in Belgium, Finland, France and
Luxemburg. It has also been recommended for approval in three
additional EU Member States and is under regulatory review in Canada
and Switzerland.

In the largest ever phase III clinical trial program in CHE, Toctino®
was the first treatment able to show effective clearing of severe CHE
unresponsive to potent topical corticosteroids, with clear or almost
clear hands achieved in nearly 50 percent of patients treated with 30
mg Toctino®.

Toctino® is a known teratogen (a substance that can cause birth
defects when women are exposed during pregnancy). Strict pregnancy
prevention one month before, during, and one month after cessation of
treatment as well as monthly pregnancy testing are required for women
of childbearing age. A comprehensive pregnancy prevention program for
Toctino® has been developed and implemented. In clinical trials,
Toctino® was well tolerated and demonstrated a safety profile overall
consistent with the retinoid class. Overall, the most frequently
reported adverse events in the phase III clinical trials were
headache and increased levels of blood lipids. Side effects were
dose-dependent.

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 Austria,
Belgium, Finland, France and Luxemburg. Alitretinoin has been
recommended for approval in three 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(TM)/Zevtera(TM)) 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.

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., MBA |
| 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:


This announcement was originally distributed by Hugin. The issuer is
solely responsible for the content of this announcement.
Copyright © Hugin AS 2009. All rights reserved.



 
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