GSK signs $1.5 billion insomnia collaboration

pharmafile | July 16, 2008 | News story | Sales and Marketing Actelion, GSK, insomnia 

 

GlaxoSmithKline has joined forces with Swiss biopharmaceutical company Actelion to bring a new insomnia treatment to market.

The deal could be worth up to £1.5 billion to Actelion and will see the two companies co-develop and co-commercialise Actelion’s almorexant, a potential first-in-class orexin receptor antagonist currently in phase III trials for primary insomnia.

An oral therapy, almorexant works by penetrating the blood-brain barrier and inducing a transient and reversible blockade of receptors for the orexin – proteins produced by the hypothalamus that influence the sleep-wake cycle.

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GSK’s head of R&D Dr Moncef Slaoui says orexin receptor antagonists have tremendous potential.

“By targeting orexin, which is known to help regulate the sleep-wake cycle, these novel molecules could help to reduce or even eliminate some of the side-effects associated with current sleep treatments,” he added.

GSK will contribute 40% of the development costs for almorexant in primary insomnia, but the programme will continue to be led by Actelion. Costs relating to studies of almorexant in other orexin-related disorders will then be shared equally.

Actelion’s chief executive Jean-Paul Clozel said: “Almorexant has the potential to fundamentally change the treatment of sleep disorders. GSK, with its strong track record of successful worldwide commercialisation, is the ideal partner to work with Actelion to rapidly bring this novel medicine – with the potential to restore normal physiological sleep – to insomnia patients all around the globe.

“In addition, this alliance allows Actelion and GSK to create significant additional value by rapidly expanding clinical development of almorexant beyond primary insomnia.”

Almorexant could be ready for market by 2011 and it is predicted to reach peak annual sales of £600 million.

The deal will give further momentum to Actelion, which is one of the fastest growing specialist pharma companies after just 11 in existence.

The company will receive CHF 150 million (£66 million) from GSK up front, and additional milestone payments of up to CHF 415 relating to the successful development and approval of almorexant.

Actelion could also benefit from further milestone payments of up to CHF 2.7 billion (£1.2 billion) if two additional indications are approved and sales targets for all three indications are met.

Analysts Datamonitor predict the demand for insomnia treatments in the world’s seven largest markets will increase in value from $6.1 billion in 2006 to $7.7 billion in 2016.

The biggest players in the insomnia treatment market are Sanofi-Aventis’ Ambien (known as Stilnoct in the UK) and Sepracor’s Lunesta. But there are a number of new and emerging challengers, including Takeda’s Rozerem, Pfizer’s Indiplon and Organon’s phase III compound esmirtazapine (ORG50081).

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