9th Dec 2021 09:25
(Alliance News) - Hikma Pharmaceuticals PLC said Thursday it has signed an exclusive license agreement with Hungarian multinational pharmaceutical and biotechnology firm Gedeon Richter PLC to commercialise denosumab.
The licence will cover Gedeon's two biosimilar products with Prolia and Xgeva in the US.
"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," Hikma said.
It added: "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 US market. Hikma is responsible for registering the products with the US Food & Drug Administration and will have exclusive rights to commercialise them in the US."
As part of the deal, Gedeon will make upfront payment, as well as certain milestone payments linked to reaching defined development stages, totalling a double-digit million US dollar figure.
Hikma Chief Executive Siggi Olafsson said: "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 US.
"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."
Shares in Hikma Pharmaceuticals were trading flat in London on Thursday morning at 2,267.00 pence each.
By Paul McGowan; [email protected]
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