Ipsen SA (OTC: IPSEY) has entered into a long-term strategic partnership to develop, manufacture, and commercialize and Genfit SA's (NASDAQ: GNFT) elafibranor for Primary Biliary Cholangitis (PBC).
Under the agreement, Ipsen will pay Genfit up to €480 million, including an upfront cash payment of €120 million and milestone payments up to €360 million, plus tiered double-digit royalties of up to 20%.
Ipsen will also invest €28 million via equity, representing 8% post-issuance in Genfit.
Genfit remains responsible for the Phase 3 ELATIVE trial until completing the double-blind period.
Ipsen will assume responsibility for all additional clinical development, including completion of the long-term extension period of the ELATIVE trial and global commercialization.
The ELATIVE is evaluating the safety and efficacy of elafibranor in 150 PBC patients who have an inadequate response or intolerance to ursodeoxycholic acid (UDCA).
Topline data is expected in early 2023.
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