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Merck/Sumitomo Antipsychotic Lurasidone To Enter Phase III In 2006

This article was originally published in The Pink Sheet Daily

Executive Summary

Merck and Sumitomo will begin Phase III studies of the atypical antipsychotic lurasidone in 2006

Merck and Sumitomo will begin Phase III studies of the atypical antipsychotic lurasidone in 2006.

The companies signed an agreement for lurasidone (SM-13496) in late June. The deal, announced by Merck on July 5, includes an up front payment and milestones, in addition to royalties on net sales.

Lurasidone is currently in Phase II studies for the treatment of schizophrenia. Under the terms of the deal, Merck gains rights in all countries except Japan, China, Korea and Taiwan. Tokyo-based Sumitomo retains the right to co-promote the drug in the U.S.

Lurasidone is Merck's first atypical antipsychotic in late-stage development. Merck has used licensing deals to enter new R&D areas in the past, such as its February 2004 agreement with Lundbeck for the selective extrasynaptic GABA-A agonist gaboxadol for the treatment of insomnia.

If approved, lurasidone, a dopamine D-2/serotonin 5HT-2A receptor antagonist, would compete in a crowded atypical antipsychotic market.

However, Merck and Sumitomo believe lurasidone may have fewer side effects than other atypical antipsychotics.

"This compound is expected to be effective in ameliorating...symptoms of schizophrenia with fewer extra pyramidal symptoms than conventional therapeutic agents," Sumitomo said.

- Kate Rawson

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