Lundbeck/Takeda Advance Novel Anxiety Candidate To Phase III

H. Lundbeck and Takeda Pharmaceutical have initiated Phase III trials of their novel mood and anxiety disorders candidate Lu AA21004 roughly four months after inking a co-development deal, the firms announced Dec. 18.

The Phase III program includes several international studies with a goal of enrolling more than 2,000 patients, the firms said. In a Phase II study, Lu AA21004 "showed highly significant improvements on the primary endpoints for both 5 and 10 mg doses compared to placebo and had an attractive safety profile," according to a release.

Under the terms of their September agreement, Copenhagen, Denmark-based H. Lundbeck is set to receive a $40 million milestone payment from Takeda, based in Osaka, Japan. The agreement also includes potential additional milestones of up to $345 million.

A second compound covered by the agreement, Lu AA24530, is in Phase II development. The companies have predicted filing timelines of 2009 or later for both candidates.

The novel antidepressants are derived from a group of bis-aryl-sulphanyl amine psychotropics, which act as serotonin enhancers and could address unmet needs for patients over currently marketed antidepressants, both in fast onset of action and increased efficacy, according to H. Lundbeck.

The development and commercialization deal covers a portfolio of antidepressants discovered by H. Lundbeck. It also offers both companies an opportunity to expand their presence in the U.S. and gives Lundbeck access to the Japanese market ("The Pink Sheet" DAILY, Sept. 6, 2007).

H. Lundbeck is partnered with Forest Labs on the antidepressant Lexapro (ecitalopram). The companies recently announced they would seek an indication in adolescents in 2008 ("The Pink Sheet" DAILY, Nov. 29, 2007).

-Shirley Haley (s.haley@elsevier.com)

This article is reprinted from "The Pink Sheet" DAILY – Dec. 18, 2007.

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