Data on Basilea's ToctinoÂ® in daily medical practice in Germany presented at dermatology congress
Basilea Pharmaceutica AG / Data on Basilea's ToctinoÂ® in daily medical practice in Germany presented at dermatology congress processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
Basel, Switzerland, July 30, 2010 - Basilea Pharmaceutica Ltd. (SIX:BSLN)
announced today that first results from the TOCCATA observational study were
presented at the 22nd Fortbildungswoche fÃ¼r praktische Dermatologie und
Venerologie in Munich, Germany. TOCCATA was designed to investigate the clinical
profile of ToctinoÂ® (alitretinoin) under daily practice conditions in severe
chronic hand eczema (CHE) patients in Germany.
Prof. Thomas Diepgen (UniversitÃ¤tsklinikum Heidelberg) presented first results
from the non-interventional TOCCATA study. TOCCATA was designed to investigate
the efficacy and safety profile of ToctinoÂ® under daily practice conditions in
Germany in a sample of 680 severe CHE patients. The planned maximum treatment
duration was 24 weeks with visits and documentation of efficacy and safety
parameters to be conducted every four weeks.
After an average treatment duration of five months with ToctinoÂ® 57% of patients
achieved clear or almost clear hands as determined by Physician's Global
Assessment (PGA). Patient compliance was excellent and the reported safety
profile was consistent with the approved label. The presented conclusions of
this first large prospective observational study since registration confirm in a
real-life setting the clinical profile of ToctinoÂ® as seen in the clinical study
More insight into remission and potential retreatment under daily practice
conditions will be collected in the follow-up study TOCCATA-N, which will
include up to 200 responders from TOCCATA. These patients will be observed over
a period of up to 12 months. If CHE reverts to a severe rating and retreatment
with ToctinoÂ® is initiated the course of disease will be documented.
In addition, data from the first 515 patients from the German patient registry
CARPE (Chronisches Handekzem Register zum Patienten-Langzeitmanagement), aiming
at collecting long-term data for a better understanding of the prognosis and
course of disease were presented. The data suggest that a significant number of
patients not responding to topical treatments are still not being moved to
systemic therapies such as ToctinoÂ® as would be recommended by the treatment
guidelines issued by the German Society of Dermatology (Deutsche Dermatologische
Gesellschaft, DDG), leaving room for further improvement in the treatment of
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.
ToctinoÂ® (alitretinoin), the only therapy approved for severe chronic hand
eczema unresponsive to potent topical treatments
ToctinoÂ® was developed by Basilea Pharmaceutica International Ltd.
To date, ToctinoÂ® is marketed in Denmark, France, Germany, Switzerland and the
United Kingdom for the treatment of severe chronic hand eczema (CHE). The drug
is approved in 16 additional European countries as well as in Canada and has
been recommended for approval in six further European countries.
In the largest ever phase III clinical trial program in CHE, ToctinoÂ® 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 with 30 mg
ToctinoÂ®. 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 ToctinoÂ® indicate that treatment can provide long periods free from
relapse and improve patient satisfaction.
ToctinoÂ® 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 ToctinoÂ® has been developed and implemented.
In clinical trials, ToctinoÂ® 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
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on
the SIX Swiss Exchange (SIX:BSLN). Its fully integrated research and development
operations are currently focused on antibiotics, antifungals and oncology drugs,
as well as on the development of dermatology drugs, targeting the medical
challenge of resistance and non-response to current treatment options in the
hospital and specialty care setting.
Basilea is currently marketing ToctinoÂ® (alitretinoin), the only approved
treatment for severe chronic hand eczema unresponsive to potent topical
steroids, in Denmark, France, Germany, Switzerland and the United Kingdom and
has appointed Almirall, S.A. as its distributor for ToctinoÂ® in other selected
European markets and Mexico. Furthermore, a phase III clinical trial on
alitretinoin for the treatment of severe chronic hand eczema is ongoing in the
U.S. The company has entered into a global partnership with Astellas Pharma Inc.
for its phase III compound isavuconazole, a potential best-in-class azole
antifungal, for the treatment of life-threatening invasive fungal infections,
including an option for Japan. Full rights to ceftobiprole, the first approved
anti-MRSA broad-spectrum cephalosporin antibiotic, for the treatment of
potentially life-threatening resistant bacterial infections, will be transferred
from Cilag GmbH International, a Johnson & Johnson company, back to Basilea.
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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 |
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This press release can be downloaded from www.basilea.com
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