AstraZeneca (AZN) recently entered into an agreement with Daiichi Sankyo for the co-promotion of denosumab in Japan. Denosumab, which has been developed by biotech major Amgen (AMGN), is currently under regulatory review in Japan.
AstraZeneca will be responsible for co-promoting denosumab for the treatment of bone disorders stemming from bone metastasis. Financial terms of the deal were not disclosed.
Daiichi Sankyo had acquired exclusive rights from Amgen in July 2007 for the development and commercialization of denosumab for postmenopausal osteoporosis (PMO), oncology and certain other indications in Japan. Daiichi Sankyo filed for Japanese approval in Aug 2010.
Denosumab is already approved in the US under the trade name Xgeva for the prevention of SREs in patients with bone metastases from solid tumors. EU approval should come in the next 2-3 months.
Denosumab is also available under the trade name Prolia for the treatment of osteoporosis in postmenopausal women at increased risk of fractures or patients who have failed or are intolerant to other osteoporosis treatments.
Besides Japan, Amgen is seeking approval for denosumab in other territories including Australia, Mexico, Russia, and Switzerland. While Daiichi Sankyo is Amgen’s licensing partner in Japan, Amgen has a collaboration agreement with GlaxoSmithKline (GSK) in countries where it does not have a commercial presence.
Our Take
AstraZeneca should be a strong co-promotion partner given its presence in Japan. Japan was the second largest market for AstraZeneca with 2010 sales coming in at $2.6 billion, up 4%. The launch of products like Crestor, Losec and Symbicort Turbuhaler in 2010 helped drive sales. The agreement with Daiichi Sankyo is in-line with AstraZeneca’s strategy of strengthening its presence in Japan.
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