Basilea's Toctino® receives marketing authorization in Italy
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Basilea Pharmaceutica AG / Basilea's Toctino® receives marketing authorization in Italy processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
Basel, Switzerland, May 03, 2010 - 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 Italian Drug Agency (Agenzia Italiana del Farmaco [AIFA]).
Following the recommendation for regulatory approval under the European
decentralized procedure, Toctino® has received national regulatory approval in
Italy and was accepted for reimbursement.
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 treatments
Toctino® was developed by Basilea Pharmaceutica International Ltd.
The AIFA approved Toctino® for the use in adults who have severe CHE that is
unresponsive to treatment with potent topical corticosteroids.
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 and
reversible.
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 13 additional European countries as well as in Canada and has been
recommended for approval in nine 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 from www.basilea.com
The press release can also be downloaded from the following link:
[HUG#1410853]
--- 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/1410853/363205.pdf
Unternehmensinformation / Kurzprofil:
Datum: 03.05.2010 - 07:15 Uhr
Sprache: Deutsch
News-ID 20110
Anzahl Zeichen: 0
contact information:
Town:
Basel
Kategorie:
Business News
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