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Basilea's Toctino® receives marketing authorization in Spain |
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Basel, Switzerland, May 5, 2009 - Basilea Pharmaceutica Ltd.
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 Spanish Drugs and Health Products Agency (Agencia Española de
Medicamentos y Productos Sanitarios, AEMPS).
Following the recommendation for regulatory approval under the
European decentralized procedure, Toctino® has received national
regulatory approval in Spain. Basilea will submit a pricing and
reimbursement dossier to the Spanish authorities based on the
approval.
"We are pleased by the AEMPS approval of Toctino, the first
authorized oral treatment for patients suffering from severe chronic
hand eczema who do not respond to potent steroid therapy," said Hans
Christian Rohde, Chief Commercial Officer, Basilea Pharmaceutica
International Ltd. "The disease heavily burdens patients' ability to
perform day-to-day activities and their psychological well-being. We
look forward to bring this novel and effective treatment to patients
and physicians in Spain."
Toctino® has been launched in Denmark, Germany and the United Kingdom
for the treatment of adults with severe chronic hand eczema
unresponsive to potent topical corticosteroids. Launches in other
European countries are expected during 2009. Toctino® has also
received marketing authorization in Austria, Belgium, Finland,
France, Luxemburg and Netherlands. Further, Toctino® has been
recommended for approval in Italy. Alitretinoin is under regulatory
review in Canada, Switzerland and 15 additional European countries.
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® was developed by Basilea Pharmaceutica International Ltd.
The AEMPS approved Toctino® for the use in adults who have severe CHE
that is unresponsive to treatment with potent topical
corticosteroids.
Patients whose CHE is predominantly characterized by fissured, thick
scaly skin are more likely to respond than those in whom the eczema
is mainly characterized by blisters.
Toctino® (alitretinoin) is a once-daily capsule to be taken with
food. The recommended starting dose is 30 mg in most patients and a
treatment course lasts up to 24 weeks depending on response.
Alitretinoin is a naturally occurring, physiologic retinoid that is
thought to work in CHE through anti-inflammatory and immunomodulatory
effects.
Alitretinoin 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 has
been developed and implemented. In clinical trials alitretinoin was
well tolerated and has a safety profile overall consistent with the
retinoid class. Side effects were generally 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, Luxemburg, the Netherlands and Spain.
Alitretinoin has been recommended for approval in Italy 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 | |
+-------------------------------------------------------------------+
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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