Novartis To File Exelon Worldwide This Month

20 March 1997

Novartis is planning to file marketing applications for its Alzheimer'sdisease treatment, Exelon (ENA-713), in the European Union, the USA and other world health authorities in the next few weeks.

Exelon is a acetylcholinesterase inhibitor which offers improved efficacy and tolerability over the lead drug in this category, Warner-Lambert's Cognex (tacrine). The dossier is based on the ADENA clinical trials program, which enrolled over 4,000 patients with Alzheimer's disease. ADENA also included the first-ever predominantly European Phase III study to demonstrate significant efficacy in the disease (Marketletter December 2, 1996).

Novartis maintains that Exelon has shown the largest effect on patients' cognitive abilities, such as memory, attention and orientation, than all other Alzheimer's drug studies to date. The drug has not been associated with hepatic, cardiovascular or pulmonary adverse events, or neuromuscular leg cramps, as seen with some other compounds. The most common side effects are nausea, vomiting and diarrhea, which occur most frequently during titration dosing. Exelon can also be taken concurrently with other drugs used in Alzheimer's patients, according to Novartis.

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