Amgen and GlaxoSmithKline have announced a collaboration inwhich the companies will share commercialization of Amgen’s monoclonalantibody denosumab for postmenopausal osteoporosis (PMO) in Europe, Australia,New Zealand and Mexico once the product is approved in these countries. Amgenwill commercialize the drug for PMO and oncology in the United States (U.S.)and Canada and for all oncology indications in Europe and specified markets.GlaxoSmithKline will register and commercialize denosumab for allindications in countries where Amgen does not currently have a commercialpresence, including China, Brazil, India and South Korea. The structure ofthe collaboration allows Amgen the option of an expanded role incommercialization in both Europe and certain emerging markets in the future.Financial terms of the partnership include an initial payment andnear-term commercial milestones to Amgen totaling $120 million, and ongoingroyalties. In Europe, Amgen and GlaxoSmithKline will share profits afteraccounting for expenses associated with the partnership. In emerging markets,GlaxoSmithKline will be responsible for all commercialization expenses andpurchase denosumab from Amgen to meet demand. The companies’ combined commercialization activities will expand access todenosumab, once approved, to patients worldwide who are afflicted byosteoporosis and other bone loss conditions. “Our collaboration with GlaxoSmithKline will help Amgen bring the promiseof denosumab to patients in Europe and other parts of the world moreeffectively than if we commercialized the drug globally on our own,” saidAmgen CEO Kevin Sharer. “Amgen and GlaxoSmithKline together are uniquelypositioned to help medical providers and patients understand the clinicalpromise and economic value of denosumab.” “This pioneering treatment that Amgen has developed will be a strongaddition to our biopharmaceuticals portfolio,” commented Andrew Witty, CEO ofGlaxoSmithKline. “The data for denosumab is very encouraging and we believeit will provide significant benefit and value to patients with postmenopausalosteoporosis and other bone disease conditions. Together with Amgen we arecommitted to increasing worldwide access to this medicine.” In July 2007, Amgen granted Daiichi Sankyo exclusive rights to develop andcommercialize denosumab in Japan in PMO and oncology with the potential foradditional indications. This arrangement remains in place.
