Amgen and GlaxoSmithKline to collaborate on Denosumab for postmenopausal osteoporosis

Amgen and GlaxoSmithKline (GSK) today announced a collaboration in which the companies will share commercialization of Amgen's monoclonal antibody denosumab for postmenopausal osteoporosis (PMO) in Europe, Australia, New Zealand and Mexico once the product is approved in these countries.

Amgen will 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 all indications in countries where Amgen does not currently have a commercial presence, including China, Brazil, India and South Korea. The structure of the collaboration allows Amgen the option of an expanded role in commercialization in both Europe and certain emerging markets in the future.

Financial terms of the partnership include an initial payment and near-term commercial milestones to Amgen totaling $120 million, and ongoing royalties. In Europe, Amgen and GlaxoSmithKline will share profits after accounting for expenses associated with the partnership. In emerging markets, GlaxoSmithKline will be responsible for all commercialization expenses and purchase denosumab from Amgen to meet demand.

The companies' combined commercialization activities will expand access to denosumab, once approved, to patients worldwide who are afflicted by osteoporosis and other bone loss conditions.

In July 2007, Amgen granted Daiichi Sankyo exclusive rights to develop and commercialize denosumab in Japan in PMO and oncology with the potential for additional indications. This arrangement remains in place. and


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