Hungarian pharmaceutical company Gedeon Richter on Thursday said it entered into an exclusive licence agreement with UK-headquartered Hikma Pharmaceuticals to commercialise its drug denosumab, used to treat osteoporosis and fractures due to bone metastasis, in the United States.
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Denosumab comprises two biosimilar products referencing the brands Prolia and Xgeva.
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Under the agreement, Richter is responsible for the development of the products,
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conducting both Phase 1 and Phase 3 global clinical studies, and will supply the products for the US market.
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Hikma will be responsible for registering the products with the US Food and Drug Administration (FDA) and will have exclusive rights to commercialise them in the United States.
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Richter is eligible for an upfront payment and milestone payments totalling “a double-digit million USD figure” under the financial terms of the agreement.
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