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.
Matt Heck, Co-founder, President & Chief Executive Officer of Sentynl, commented, "Our mission, at the Zydus Group, has been to provide healthcare professionals with access to innovative treatment solutions that enable them to meet the needs of individual patients. We are excited to collaborate with Cyprium in order to broaden our pediatric rare disease portfolio and commercialize CUTX-101, a potentially transformative product, for children with Menkes disease, an unmet healthcare need."
Fortress' Chairman, President and Chief Executive Officer, Lindsay A. Rosenwald, M.D., added, "This transaction with Sentynl further validates the Fortress business model of identifying and developing promising treatments for patients, while pursuing partnership opportunities that potentially maximize shareholder value. We are thrilled with the progress Cyprium has made developing this treatment for Menkes disease and look forward to working with Sentynl to make CUTX-101 available to patients."
Under the agreement, Cyprium is eligible to receive up to $20 million in upfront development and regulatory cash milestones through NDA approval, as well as potential sales milestones. Royalties on CUTX-101 net sales ranging from the mid-single digits up to the mid-twenties are also payable. Cyprium will retain 100% ownership over any FDA priority review voucher that may be issued at NDA approval for CUTX-101.
Torreya Partners advised Cyprium on this transaction.
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