GSK, Actelion Dream in Billions for Insomnia Drug

GlaxoSmithKline (GSK) may pay Actelion up to $2.7 billion in milestone payments for the right to jointly develop and commercialize the Swiss biopharma company’s insomnia drug almorexant.

The two companies have agreed on exclusive worldwide collaboration, excluding Japan, on the orexin receptor antagonist now in Phase III clinical trials that has first-in-class potential. Orexins, previously referred to as hypocretins, are proteins produced by the hypothalamus that play a role in controlling the sleep-wake cycle.

Actelion will receive an upfront payment of $147.6 million and will be eligible for milestone payments of up to $408.4 million if almorexant is successfully developed and approved for treating primary insomnia. The $2.7 billion figure would depend on the drug’s approval for two other indications for which it has not yet undergone clinical trials.

The RESTORA Phase III clinical trial of almorexant for primary insomnia in adult and elderly patients began late last year; first findings are expected in the second half of 2009. Pivotal studies required for registration in the U.S. are scheduled to start later this year.