Neurim Pharmaceuticals reported good results in its Phase III study of insomnia drug Circadin.
The study showed long term efficacy and safety in elderly patients. The company said that the drug was found to improve sleep quality and next day alertness in the study of 790 insomnia patients. There were minor side effects which are not expected to hold back registration with the US Food and Drug Administration (FDA).
Neurim CSO Prof. Nava Zisapel founded the company on the basis of her research at Tel Aviv University. She is the wife of entrepreneur Yehuda Zisapel, the chairman of RAD Group.
Besides Teva Pharmaceutical Industries Ltd.'s (Nasdaq: TEVA; TASE: TEVA) Copaxone, Circadin is the first drug to be brought all the way to market by an Israeli company.
The drug is already marketed in Europe by Danish company H. Lundbeck A/S. Lundbeck is engaged in the research and development, production, marketing and sale of drugs for the treatment of psychiatric and neurological disorders.
Circadin has already been included in the drug baskets of several European countries, and holds respectable market share in the sleep disorder treatment market even outside of Europe.
Neurim is in the process of obtaining FDA authorization. Launching the drug in the US is somewhat more complicated, because melatonin, on which Circadin is based, is already sold there as a food supplement to treat sleep disorders, while in Europe the sale of melatonin is more limited.
Published by Globes [online], Israel business news - www.globes-online.com - on June 11, 2009
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