Amgen and GSK to Commercialize Denosumab in Europe for Postmenopausal Osteoporosis

Amgen (Thousand Oaks, CA) and GlaxoSmithKline (GSK, London, UK) 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 US and Canada and for all oncology indications in Europe and specified markets.

Denosumab is a fully human monoclonal antibody that targets RANK Ligand and is being investigated for its potential to prevent and treat a broad range of bone disease conditions including osteoporosis, bone metastases and their consequences, cancer treatment-induced bone loss caused by hormone ablative therapy, multiple myeloma, and bone erosions in rheumatoid arthritis. Denosumab is the first late-stage investigational therapy that specifically inhibits RANK Ligand, an essential mediator of the cells that break down bone.

GSK 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 GSK will share profits after accounting for expenses associated with the partnership. In emerging markets, GSK will be responsible for all commercialization expenses and purchase denosumab from Amgen to meet demand.