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GSK to market Amgen's next blockbuster hope

30.07.2009

London/Thousand Oaks – GlaxoSmithKline has obtained the right to sell Amgen's investigational monoclonal antibody denosumab for postmenopausal osteoporosis (PMO) in Europe and various other countries, including emerging markets. U.S. based Amgen will commercialise the drug for PMO and oncology in the United States and Canada and for all oncology indications in the major markets. GSK will pay Amgen an initial payment and near-term commercial milestones totalling $120 million, in addition to ongoing royalties. Given that denosumab could be a potential EUR 1.5 billion blockbuster, analysts consider the deal a bargain for British GSK.
GlaxoSmithKline will register and commercialise 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 commercialisation in both Europe and certain emerging markets in the future.
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 due to hormone ablative therapy, multiple myeloma and bone erosions in rheumatoid arthritis. Amgen has submitted marketing applications for denosumab in the United States, the European Union, Canada, Switzerland, and Australia.
Denosumab will complement GSK's PMO treatment Boniva/Bonviva (ibandronate sodium), which it co-markets with Roche in several territories, particularly as its patent expires in the EU in 2011 and the following year in the US. Sales of the drug fell by 2% in the second quarter to £66 million.

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