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GlaxoSmithKline and Actelion enter into exclusive collaboration to realise the full potential of almorexant in sleep disorders and beyond


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GlaxoSmithKline and Actelion to potentially co-develop and co-commercialise other orexin receptor antagonists

Issued – July 2008, London, UK & Allschwil, Switzerland

GlaxoSmithKline (GSK) and Actelion Ltd (SWX: ATLN) announced today that they have entered into an exclusive worldwide collaboration (excluding Japan) for Actelion’s almorexant, an orexin receptor antagonist in phase III development with first-in-class potential as a treatment for primary insomnia.

Under the terms of the agreement, GSK will receive exclusive worldwide rights to co-develop and co-commercialise almorexant. Actelion will continue to lead the ongoing development programme and potential registration for almorexant in the first indication, primary insomnia, with GSK contributing 40 per cent of the costs. Almorexant will also be studied in other orexin-related disorders and all costs related to these programmes will be shared equally.

Actelion will receive an upfront payment of CHF 150 million (approximately £66 million) and will be eligible for additional potential milestone payments of up to CHF 415 million in regards to the successful development and approval of almorexant in primary insomnia. In addition, Actelion will be eligible to receive additional milestone payments, pending successful development of two other major indications for almorexant yet to be evaluated through clinical investigation. If all three indications were successfully registered, approved and commercialised, and exceptional sales targets met for all these indications, Actelion would be eligible to receive additional potential milestone payments of up to CHF 2.735 billion. Also, costs and profits resulting from this collaboration will be shared equally between the two companies.

Dr Moncef Slaoui, Chairman of Research and Development, GSK, commented, “GSK and Actelion both share the vision – based on our individual research efforts - that 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.“

Jean-Paul Clozel, MD and Chief Executive Officer of Actelion commented: "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.”

Collaboration to realise full potential of orexin antagonism

At the end of 2007, Actelion initiated Phase III development for almorexant, with the pivotal studies required for registration in the U.S. scheduled to commence later in 2008. The RESTORA (REstore normal physiological Sleep with The Orexin Receptor antagonist Almorexant) programme is evaluating the safety and efficacy of almorexant in adult and elderly patients diagnosed with primary insomnia.

Actelion and GSK will equally share costs and profit in key pharmaceutical markets worldwide where they will co-commercialise almorexant. In these markets Actelion will book all sales and GSK will book its share of profit. GSK will grant Actelion the right to assist in the commercialisation - as a paid-for sales force – of a GSK product in certain countries and for a limited period of time. In emerging markets, GSK will commercialise the product exclusively, with Actelion receiving a share of profit.

The two companies will continue their important independent efforts in the field of orexin research and under the agreement can exercise the option to jointly select, develop and promote additional new antagonists targeting the orexin system.

Every night, insomnia – or sleeplessness – affects or impairs an estimated 150 million patients worldwide, resulting in significant negative health consequences. Patients with insomnia tend to have higher rates of mental health problems, drug and alcohol abuse, and cardiac morbidity. In the United States alone, the direct and indirect economic costs of sleep disorders are estimated to be in the range of USD 35 billion annually.1,2


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