Basilea's Toctino(R) receives marketing authorization in Netherlands

BASEL, SWITZERLAND, Apr 29 (MARKET WIRE) --

Basel, Switzerland, April 29, 2009 - Basilea Pharmaceutica Ltd. (SIX:
BSLN) announces that Toctino(R) (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 Dutch
Medicines Evaluation Board (MEB).

Subsequent to the recommendation for regulatory approval under the
European decentralized procedure, Basilea received the marketing
authorization for Toctino(R) in Netherlands. Following the regulatory
approval of Toctino(R) in Netherlands, 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(R) (alitretinoin), the only therapy approved for severe chronic
hand eczema unresponsive to potent topical corticosteroids Toctino(R)
(alitretinoin) was developed by Basilea Pharmaceutica International Ltd..
The MEB approved Toctino(R) for the use in adults who have severe CHE
that is unresponsive to treatment with potent topical corticosteroids.
Toctino(R) 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(R) experienced long periods
free from relapse and improved patient satisfaction. Toctino(R) has been
launched in Denmark, Germany and the United Kingdom, and has also
received marketing authorization in Austria, Belgium, Finland, France and
Luxemburg. In addition, Toctino(R) has been recommended for approval in
two additional EU Member States and is under regulatory review in
Switzerland, Canada and 15 additional European countries. In the largest
ever phase III clinical trial program in CHE, Toctino(R) was the first
treatment to show effective clearing of severe CHE, with clear or almost
clear hands achieved in nearly 50 percent of patients treated 30 mg
Toctino(R). Toctino(R) 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(R) has been developed and implemented. In clinical trials,
Toctino(R) 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. A
phase III clinical trial on alitretinoin for the treatment of severe
chronic hand eczema is ongoing in the U.S.

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(R) (alitretinoin) is marketed
in the United Kingdom, Denmark and Germany and is approved in Austria,
Belgium, Finland, France, Luxemburg and Netherlands. Alitretinoin has
been recommended for approval in two additional EU Member States and is
under regulatory review in Canada, Switzerland and 15 additional European
countries. Furthermore a phase III clinical trial on alitretinoin for the
treatment of severe chronic hand eczema is ongoing in the U.S.
Ceftobiprole is marketed in Canada and Ukraine under the brand name
ZEFTERA(TM) and in Switzerland under Zevtera(TM). Marketing applications
for ceftobiprole 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 | |
+-------------------------------------------------------------------+

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