Amgen/GSK teaming up on Denosumab marketingAmgen and GlaxoSmithKline (GSK) announced plans to share commercialization of Amgen's osteoporosis drug denosumab, in Europe, Australia, New Zealand and Mexico once they win approval in those countries.
Amgen will commercialize the drug for postmenopausal osteoporosis and oncology in the US and Canada and for all oncology indications in Europe and specified markets. GSK said it will register and commercialize denosumab for all indications in countries where Amgen does not currently have a commercial presence. Those countries include: China, Brazil, India and South Korea.
The nature of the collaboration allows Amgen the option of an expanded role in commercialization in both Europe and other emerging markets in the future.
Financial terms of the partnership include an initial payment and near-term commercial milestones to Amgen totaling $120 million, as well as 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.
In a statement, Amgen CEO Kevin Sharer said the collaboration will help Amgen bring the promise of denosumab to patients in Europe and other parts of the world more effectively than if Amgen commercialized the drug globally on its own.
Andrew Witty, GSK CEO, said that the pioneering treatment that Amgen has developed will be a strong addition to GSK's biopharmaceuticals portfolio.
In July 2007, Amgen entered into an agreement with Daiichi Sankyo which it granted exclusive rights to develop and commercialize denosumab in Japan in postmenopausal osteoporosis and oncology.
The FDA approved denosumab for the treatment of osteoporosis in postmenopausal women. However, in August, an FDA advisory committee did not recommend the drug for preventive use in postmenopausal osteoporosis until more long-term data becomes available.