BioWorld International Correspondent

LONDON - CeNeS Pharmaceuticals plc made further progress with its restructuring, agreeing to a US$4.5 million licensing deal with Swiss company Addex Pharmaceuticals SA for CEE 03-310 in the treatment of substance abuse.

Neil Clark, CeNeS' chief operating officer, told BioWorld International, "We are happy to have reached agreement with Addex. Addex specializes in drug dependence, and is strongly focused on doing something with the asset."

The $4.5 million splits into $100,000 up front and a series of clinical milestone payments. CeNeS, of Cambridge, UK, also would receive royalties on any product sales.

CEE 03-310, a selective antagonist of dopamine D1 receptors, has reached Phase II in the treatment of sleep disorders. In a Phase II study in health volunteers, reported in May 2000, the compound had a significant effect on sleep patterns, specifically rapid eye movement (REM). REM sleep patterns are affected in a range of psychiatric disorders, such as depression, schizophrenia and narcolepsy.

However, the mechanism of action also is relevant to control of substance abuse, and Addex intends to develop CEE 03-310 for alcohol abuse.

Clark said, "While we have gone further in sleep [disorders], we always were running with drug abuse as well. The existing IND for the compound will be a useful starting point in addiction studies."

He added that Geneva-based Addex is well-connected with U.S. public bodies involved in the research and control of substance abuse and may be eligible for support with clinical development. It is expected to be easiest to get proof of principle by showing CEE 03-310 can be used to limit alcohol intake, but the compound could be relevant to the control of cocaine and nicotine addiction as well.

CeNeS acquired CEE 03-310 from Novo Nordisk A/S in 1999. Novo retains an interest in the compound but no payments are triggered immediately as a result of this deal.

Clark said the $100,000 up-front payment will be useful, but it is not sufficient to allow CeNeS to pay for Phase III trials of its lead compound, M6G, a morphine derivative. It is partnered with Elan Pharmaceutical plc, of Dublin, Ireland, which is not expected to fund further trials.

"We are still focusing on M6G, and progressing [discussions] with Elan [on the future of the joint venture]. We still aim to have M6G in Phase III next year," said Clark.