Published: April 29, 2009
Basilea's Toctino® receives marketing authorization in Netherlands
Basel, Switzerland, April 29, 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 Dutch Medicines Evaluation Board (MEB).
Subsequent to the recommendation for regulatory approval under the
European decentralized procedure, Basilea received the marketing
authorization for Toctino® in Netherlands. Following the regulatory
approval of Toctino® 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® (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 MEB 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 Austria,
Belgium, Finland, France and Luxemburg. In addition, Toctino® 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®
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®.
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.
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® (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:
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| 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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