BASEL, SWITZERLAND, Jul 30, 2010 (MARKETWIRE via COMTEX) — Basilea Pharmaceutica AG / Data on Basilea’s Toctino(R) 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. (SWISS: BSLN) announced today that first results from the TOCCATA observational study were presented at the 22nd Fortbildungswoche fuer praktische Dermatologie und Venerologie in Munich, Germany. TOCCATA was designed to investigate the clinical profile of Toctino(R) (alitretinoin) under daily practice conditions in severe chronic hand eczema (CHE) patients in Germany.
Prof. Thomas Diepgen (Universitaetsklinikum Heidelberg) presented first results from the non-interventional TOCCATA study. TOCCATA was designed to investigate the efficacy and safety profile of Toctino(R) 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(R) 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(R) 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(R) 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(R) 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.