Basilea's Toctino® included in expert consensus for management of chronic hand eczema in France
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Basel, Switzerland, April 28, 2010 - Basilea Pharmaceutica Ltd. (SIX:BSLN)
announces the integration of alitretinoin (Toctino®) for state-of-the-art
management of chronic hand eczema in France. The position paper, recently
published in the organ of the French Society of Dermatology (Société Française
de Dermatologie), was elaborated by an expert panel and recommends Toctino® as
the treatment of choice when clinical signs of chronic hand eczema persist under
topical corticosteroids.
The comprehensive review provides a practice-oriented expert opinion for the
management of chronic hand eczema in France and recommends prompt intervention
with oral alitretinoin therapy, the first systemic treatment authorized for the
management of severe chronic hand eczema that is unresponsive to topical
corticosteroids. The document is published in Annales de dermatologie et de
vénéréologie (B. Halioua, M.-A. Richard; Vol 137, No. 4: pp. 315-327; April
2010).
"The inclusion of Toctino as treatment of choice for chronic hand eczema
unresponsive to topical corticosteroids into this expert consensus indicates
that Toctino has a clear role to play in the management of this very
debilitating and painful skin disease," said Hans Christian Rohde, Chief
Commercial Officer, Basilea Pharmaceutica International Ltd. "This
state-of-the-art guideline supports optimal management of a condition that
severely impacts patients' quality of life and their ability to perform everyday
activities."
For accessing the position paper Mise au point sur l'eczéma chronique des mains,
please visit:http://www.em-consulte.com/showarticlefile/249912/main.pdf
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®, the only therapy approved for severe chronic hand eczema unresponsive
to potent topical corticosteroids
Toctino® was developed by Basilea Pharmaceutica International Ltd. To date,
Toctino® is launched in Denmark, France, Germany, Switzerland and the United
Kingdom for the treatment of severe chronic hand eczema. The drug is approved in
11 additional European countries as well as in Canada and has been recommended
for approval in 11 further 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®.
The once-daily oral therapy is given for 12 to 24 weeks, depending on patient
response, and six-month post-treatment observations in patients who responded to
Toctino® indicate that treatment can provide long periods free from relapse and
improve patient satisfaction.
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). Its integrated research and development
operations are currently focused on antibiotics and antifungals, as well as on
the development of dermatology and oncology drugs, all areas in which the
medical challenge of rising resistance or non-response to current treatment
options is commonly encountered. Basilea's products are targeted to satisfy high
medical and patient needs in the hospital and specialty care setting.
The company owns a broad and diversified portfolio. Basilea is marketing
Toctino® (alitretinoin), for the treatment of severe chronic hand eczema, in
Denmark, France, Germany, Switzerland and the United Kingdom. The drug is
approved in 11 additional European countries as well as in Canada and has been
recommended for approval in 11 further European countries. Furthermore, a phase
III clinical trial on alitretinoin for the treatment of severe chronic hand
eczema is ongoing in the U.S. Basilea has entered into a license, co-development
and co-promotion agreement with Astellas Pharma Inc. for its phase III compound
isavuconazole for the treatment of life-threatening invasive fungal infections
on a worldwide basis, including an option for Japan. Full rights to a third
late-stage product, ceftobiprole for the treatment of potentially
life-threatening resistant bacterial infections, will be transferred from Cilag
GmbH International, a Johnson & Johnson company, back to Basilea.
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 |
+-----------------------------+--------------------------------+
| Adesh Kaul | Barbara Zink, Ph.D., MBA |
| Head Public Relations & | Head Corporate Development |
| Corporate Communications | |
| +41 61 606 1460 | +41 61 606 1233 |
| media_relations(at)basilea.com | investor_relations(at)basilea.com |
+-----------------------------+--------------------------------+
This press release can be downloaded fromwww.basilea.com
The press release can also be downloaded from the following link:
[HUG#1409028]
--- End of Message ---
Basilea Pharmaceutica AG
Grenzacherstrasse 487
P.O Box Basel Switzerland
ISIN: CH0011432447;
Listed: Freiverkehr in Börse Stuttgart,
Freiverkehr in Börse Berlin,
Open Market (Freiverkehr) in Frankfurter Wertpapierbörse,
Freiverkehr in Bayerische Börse München;
Press release (PDF): http://hugin.info/134390/R/1409028/361629.pdf
Unternehmensinformation / Kurzprofil:
Datum: 28.04.2010 - 07:15 Uhr
Sprache: Deutsch
News-ID 19794
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contact information:
Town:
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Kategorie:
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