Richter, Hikma ink deal for proposed biosimilars Prolia, Xgeva

Richter and Hikma have entered into an exclusive license agreement to commercialise Richter’s denosumab, comprising biosimilar Prolia and Xgeva.

The products are used for the treatment of osteoporosis and fractures due to bone metastasis respectively and are currently in global Phase 1 and Phase 3 clinical studies.

According to the agreement, Richter is responsible for the development of the products (to conduct both Phase 1 and Phase 3 global clinical studies) and will supply finished commercial products for the U.S. market. Hikma is responsible for registering the products with the Food and Drug Administration and will have exclusive rights to commercialize them in the United States.

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Under the financial arrangements of the licensing agreement, Richter is eligible for an upfront payment upon signature as well as certain milestone payments linked to reaching defined development stages totalling a double-digit million U.S. figure.

“We are looking forward to collaborating with Hikma on this important biosimilar project targeting the U.S. market,” said Gábor Orbán, CEO of Richter. “Extending our partnership with a highly respected company having a strong US presence further increases our confidence in the viability of our specialty pharma strategy.”

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“Biosimilars are a growing area of interest for Hikma and we are delighted to add two new products to our portfolio, building on our position as one of the leading suppliers of sterile injectable medicines in the U.S.,” said Siggi Olafsson, Hikma CEO. “This key collaboration is highly complementary and strengthens our US oncology and auto-immune offerings. Gedeon Richter brings strong technical capabilities for biological products which, combined with our well-established commercial presence in the US market makes for a partnership with exciting potential.”