Amgen and GlaxoSmithKline (GSK) 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 (US) and Canada and for all oncology indications in Europe and specified markets.

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 totalling $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.

"Our collaboration with GlaxoSmithKline will help Amgen bring the promise of denosumab to patients in Europe and other parts of the world more effectively than if we commercialized the drug globally on our own," said Amgen CEO Kevin Sharer. "Amgen and GlaxoSmithKline together are uniquely positioned to help medical providers and patients understand the clinical promise and economic value of denosumab."

"This pioneering treatment that Amgen has developed will be a strong addition to our biopharmaceuticals portfolio," commented Andrew Witty, CEO of GSK. "The data for denosumab is very encouraging and we believe it will provide significant benefit and value to patients with postmenopausal osteoporosis and other bone disease conditions. Together with Amgen we are committed to increasing worldwide access to this medicine."

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.

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 discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient.