Titel Data on Basilea's Toctino® in daily medical practice in Germany presented at dermatology congress Autor/Erfasser/Quelle Basilea Pharmaceutica Firmenportrait Basilea Pharmaceutica AG System powered by HELP.ch Headline Basilea Pharmaceutica Ltd. (SIX:BSLN) announced today that first results from the TOCCATA observational study were presented at the 22nd Fortbildungswoche für praktische Dermatologie und Venerologie in Munich, Germany. TOCCATA was designed to investigate the clinical profile of Toctino® (alitretinoin) under daily practice conditions in severe chronic hand eczema (CHE) patients in Germany.

Prof. Thomas Diepgen (Universitätsklinikum Heidelberg) presented first results from the 
non-interventional TOCCATA study. TOCCATA was designed to investigate the efficacy and 
safety profile of Toctino® 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 Toctino® 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 Toctino® as seen in the clinical study program.

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 Toctino® 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 Toctino® 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 severe CHE.
 
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. 
To date, Toctino® 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, 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 with 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.

Contact
Adesh Kaul
Head Public Relations & 
Corporate Communications
+41 61 606 1460
media_relations@basilea.com
www.basilea.com

Basilea Pharmaceutica AG hat ihren Hauptsitz in Basel, Schweiz und ist an der 
Schweizer Börse SIX Swiss Exchange kotiert (SIX:BSLN). Der vollständig 
integrierte Forschungs- und Entwicklungbereich konzentriert sich zurzeit auf die 
Entwicklung von Antibiotika und Antimykotika sowie auf dermatologische 
Arzneimittel und Wirkstoffe gegen Krebs. In all diesen medizinischen Gebieten 
stellt zunehmende Resistenz beziehungsweise Nicht-Ansprechen gegenüber aktuellen
Behandlungsmöglichkeiten ein Problem dar. Basileas Produkte zielen auf den 
dringenden medizinischen Bedarf und die Patientenbedürfnisse im Krankenhaus- und 
Facharztumfeld ab.

Das Unternehmen besitzt ein breites und diversifiziertes Produktportfolio. 
Basilea vertreibt Toctino® (Alitretinoin) für die Behandlung des schweren 
chronischen Handekzems in Dänemark, Deutschland, Frankreich, Grossbritannien und 
der Schweiz. Toctino® ist in 11 weiteren europäischen Ländern und in Kanada 
zugelassen sowie in 11 weiteren europäischen Ländern zur Zulassung empfohlen. 
Zudem wird derzeit in den USA ein klinisches Phase-III-Programm zu Alitretinoin 
für die Behandlung von schwerem chronischem Handekzem durchgeführt. Basilea
hat mit Astellas Pharma Inc. eine Lizenzvereinbarung zur gemeinsamen Entwicklung 
und Vermarktung für Isavuconazol abgeschlossen. 

Die weltweite Vereinbarung umfasst auch eine Option für Japan. Isavuconazol 
befindet sich derzeit in Phase III der klinischen Entwicklung zur Behandlung 
lebensbedrohlicher invasiver Pilzinfektionen. Die Rechte für ein drittes Produkt 
in der fortgeschrittenen Entwicklung, Ceftobiprol zur Behandlung potenziell 
lebensbedrohlicher resistenter bakterieller Infektionen, werden von Cilag GmbH 
International, einer Johnson & Johnson Gesellschaft, an Basilea rückübertragen.