GlaxoSmithKline (GSK) negotiated a $120 million deal to obtain commercial rights in certain regions to Amgen’s lead candidate, denosumab, which is currently under FDA review for postmenopausal osteoporosis (PMO). Amgen is also seeking to get denosumab approved to prevent bone loss in patients undergoing hormone therapy for breast or prostate cancer and to prevent bone metastasis in prostate cancer.
The payment includes an up-front fee and near-term commercial milestones. Under the terms of the agreement, Amgen and GSK will share commercialization of denosumab for PMO in Europe, Australia, New Zealand, and Mexico. Additionally GSK will register and commercialize denosumab for all other indications in countries where Amgen does not currently have a commercial presence, including China, Brazil, India, and South Korea. Denosumab is also in Phase II rheumatoid arthritis trials.
The deal allows Amgen the option of an expanded role in commercialization in both Europe and certain emerging markets in the future. Amgen retains commercialization rights for PMO and oncology in the U.S. as well as Canada and for oncology in Europe and other specified markets. The company will receive ongoing royalties.
Two years ago Daiichi Sankyo paid $20 million up front for Japanese rights to denosumab in PMO and oncology with the potential to expand into other indications. The firm is not only responsible for development costs in Japan but also agreed to pay $150 million toward worldwide development.