Sandoz' Alzheimer's Drug; International Data Revealed

Sandoz has reported confirmatory clinical data from its ADENA clinical trials program for Exelon (ENA-713), a new-generation acetylcholinesterase inhibitor for Alzheimer's disease. The new results, which come primarily from centers in Europe, backs up US data reported earlier this year (Marketletter August 5).

The ADENA program is made up of eight clinical trials, including four Phase III studies; two in the USA (B351 and B352) and two in other, mainly European countries (B303 and B304). In all, the program involves 3,800 patients and is believed to be largest-ever clinical program for a dementia drug. On the strength of the data, Sandoz intends to file for approval with a single dossier worldwide early next year.

B303 Study Results Ravi Anand, medical director of central nervous system clinical research at Sandoz, presented data from study B303, a six-month trial involving 723 patients which was conducted in Austria, Canada, Switzerland, Germany, France and the USA. Placebo was compared to a low-dose Exelon arm (1-4mg/day) and a high-dose arm (6-12mg/day). Exelon demonstrated a positive effect on all three of the key aspects of AD, noted Dr Anand, namely cognition (measured by the ADAS-cog scale), global functioning (measured by CIBIC-plus) and activities of daily living (measured by PDS).