07 December 2023 | Thursday | News
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Cyprium received $4.5 million payment upon closing and remains eligible to receive royalties and up to $129 million in aggregate development and sales milestones
Cyprium will retain 100% ownership over any FDA priority review voucher that may be issued at NDA approval for CUTX-101
Cyprium Therapeutics, Inc. (“Cyprium”), a Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) subsidiary company, today announced that it executed an Assignment and Assumption Agreement (the “Agreement”) with Sentynl Therapeutics, Inc. (“Sentynl”), a U.S.-based specialty pharmaceutical company wholly owned by the Zydus Lifesciences Ltd., in which, Cyprium completed the transfer of its proprietary rights and assigned its FDA documents pertaining to CUTX-101, Copper Histidinate product candidate for the treatment of Menkes disease, to Sentynl.
Cyprium received $4.5 million at closing and remains eligible to receive up to $129 million in aggregate development and sales milestones under the Agreement, in addition to royalties on net sales of CUTX-101 as follows: (i) 3% of annual net sales up to $75 million; (ii) 8.75% of annual net sales between $75 million and $100 million; and (iii) 12.5% of annual net sales in excess of $100 million. Cyprium will retain 100% ownership over any FDA priority review voucher that may be issued at NDA approval for CUTX-101.
“We are pleased to complete the CUTX-101 asset transfer with Sentynl. Cyprium has made progress with the CUTX-101 rolling NDA submission, and we expect that Sentynl will complete the filing in 2024. The transfer of the CUTX-101 program to Sentynl will result in a reduction in Cyprium’s development-related spend, while potentially expediting commercialization upon FDA approval. The drug has demonstrated a compelling safety and efficacy profile for the treatment of Menkes disease and, if approved, CUTX-101 will fill a significant unmet need for children suffering from this rare, fatal pediatric disease,” said Fortress’ Chairman, President and Chief Executive Officer and Cyprium’s Chairman, Lindsay A. Rosenwald, M.D.
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