For distribution and marketing of biosimilar Denosumab in Japan
Lupin announced that it has entered into an exclusive licensing agreement with I'rom Group Co. (I'rom), a leading pharmaceutical company in Japan. Under the terms of the Agreement, I'rom will conduct clinical trials along with Lupin, register, distribute and market biosimilar Denosumab in Japan on an exclusive basis.Denosumab is indicated for the treatment of postmenopausal women with osteoporosis at high risk of fracture and prevention of skeletal-related events in patients with bone metastases from solid tumors among other indications.
Following the completion of the clinical trial and receipt of marketing authorization from PMDA in Japan, I'rom will exclusively commercialize the product in Japan. As part of the agreement, Lupin will receive multiple milestone payments. Currently, Denosumab is available under two brands, Pralia and Ranmark, with a market size of approximately USD 500 million in Japan.
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