Cyprium Therapeutics, a Fortress Biotech Partner Company, and Sentynl Therapeutics, a Wholly-owned Subsidiary of the Zydus Group, Sign Development and Asset Purchase Agreement for Cyprium Therapeutics’ Copper Histidinate Product Candidate for Treatment of

Sentynl acquires CUTX-101, Copper Histidinate, for $20 million in upfront and regulatory milestone payments through NDA approval, as well as potential sales milestones plus royalties

Cyprium will retain 100% ownership over any FDA priority review voucher that may be issued at NDA approval for CUTX-101

Rolling submission of New Drug Application to the FDA for CUTX-101 on track to begin in the third quarter of 2021 and to be completed during the fourth quarter of 2021

NEW YORK and SOLANA BEACH, Calif., Feb. 24, 2021 (GLOBE NEWSWIRE) -- Cyprium Therapeutics, Inc. (“Cyprium”), a Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) partner company, and Sentynl Therapeutics, Inc. (“Sentynl”), a U.S.-based specialty pharmaceutical company owned by the Zydus Group, today announced the execution of an asset purchase agreement to commit development funding for and acquire Cyprium’s proprietary rights to CUTX-101, its Copper Histidinate product candidate for the treatment of Menkes disease. Under the terms of the agreement, Sentynl will make an upfront cash payment to Cyprium, provide additional cash payments upon the achievement of certain regulatory milestones, and pay royalties and commercial milestone payments based on the net sales of CUTX-101. Cyprium will retain development responsibility of CUTX-101 through approval of the New Drug Application (“NDA”) by the U.S. Food and Drug Administration (“FDA”), and Sentynl will be responsible for commercialization of CUTX-101 as well as progressing newborn screening activities. Continued development of CUTX-101 will be overseen by a Joint Steering Committee consisting of representatives from Cyprium and Sentynl.

“We are very pleased to partner with Sentynl to potentially expedite the development and commercialization of CUTX-101. The drug has demonstrated a compelling safety and efficacy profile in topline analysis for the treatment of Menkes disease. We look forward to working with Sentynl to begin the rolling submission of the NDA to the FDA this year. If approved, CUTX-101 will provide a major breakthrough and fill a significant unmet need for children suffering from this rare, fatal pediatric disease,” said Lung S. Yam, M.D., Ph.D., President and Chief Executive Officer of Cyprium.