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.
Denosumab comprises two biosimilar products referencing the brands Prolia and Xgeva.
Under the agreement, Richter is responsible for the development of the products,
conducting both Phase 1 and Phase 3 global clinical studies, and will supply the products for the US market.
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.
Richter is eligible for an upfront payment and milestone payments totalling “a double-digit million USD figure” under the financial terms of the agreement.