Partnerships

Actelion develops projects as far as possible within the company, but where a compound's benefit for patients can be further optimized, strategic partnerships are considered. Actelion seeks to work closely with committed partners to progress compounds discovered in Actelion’s laboratory as quickly as possible from bench to patients, supported by comprehensive development.

Actelion / GlaxoSmithKline collaboration
Actelion and GlaxoSmithKline (GSK) entered into an exclusive worldwide (excluding Japan) collaboration in July 2008 to jointly develop and commercialize Actelion’s first-in-class orexin receptor antagonist almorexant, a new and targeted treatment approach for insomnia with the potential to restore normal physiological sleep. The compound is currently being developed in the Phase III RESTORA program. The two companies plan to jointly develop and commercialize this novel compound for the treatment of sleep disorders and other orexin-related disorders. Actelion will continue to lead the ongoing Phase III program with almorexant in primary insomnia, with GSK contributing 40 percent of the RESTORA costs. All future costs involving almorexant development and the discovery and development of additional orexin receptor antagonists will be shared equally. In key pharmaceutical markets worldwide, the two companies will both actively promote almorexant, with Actelion booking sales and the two companies sharing profit equally. In emerging markets where Actelion does not plan to build a primary care presence, GSK will promote almorexant on their own, and book sales with Actelion receiving its 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.

GSK made an upfront payment of CHF 150 million to Actelion in July 2008 and Actelion will be eligible for additional potential milestone payments of up to CHF 415 million contingent on 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 commercialized, 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.

Actelion / Merck & Co., Inc. alliance
Actelion and Merck & Co., Inc. formed an exclusive worldwide alliance in December 2003 to discover, develop and market new classes of orally available renin inhibitors, initially discovered by Actelion, for patients suffering from cardio-renal diseases. Through a joint committee of the Merck Actelion global renin alliance organization, the parties are collaborating on the development of these products.

Pursuant to the agreement, Actelion granted Merck & Co., Inc. an exclusive worldwide license to develop, manufacture and sell any renin inhibitor to which Actelion has rights or which results from the alliance, as well as any products containing the compound. Under the agreement, Actelion is responsible for funding all preclinical research and Phase I clinical trials until two compounds have successfully completed these phases. Merck & Co., Inc. will fund these costs for subsequent compounds. Costs for Phase II clinical trials will be shared equally, and Merck & Co., Inc. will fund Phase III and clinical outcome trials. Merck & Co., Inc. will also lead and fund commercialization. Actelion retains a worldwide option to use its sales force to co-promote any product resulting from this alliance and to be reimbursed by Merck & Co., Inc., for these services.

Merck & Co., Inc. paid Actelion an upfront payment of USD 10 million and a further USD 15 million following the completion of technology transfer to Merck & Co., Inc. Following these payments, Actelion received the first milestone payment from Merck & Co., Inc. of USD 5 million in March 2005. In July 2006, the alliance entered its first compound into Phase I, which triggered a second milestone payment of USD 7 million. The entry of the lead compound into Phase IIa in December 2007 triggered a USD 10 million milestone payment to Actelion. In addition, Actelion will be eligible to receive further research, development and approval milestone payments of up to USD 225 million for the successful development and commercialization of the first collaboration product. Certain milestone payments for the successful development and commercialization of additional products are also included in the agreement. Merck & Co., Inc. will pay Actelion royalties on the sale of all products resulting from the renin inhibitor alliance.