Zydus Cadila-owned US-based specialty pharmaceutical company Sentynl Therapeutics Inc and Cyprium Therapeutics Inc have inked a development and asset purchase agreement for latter's Copper Histidinate product candidate that is used for treatment of Menkes disease. Cyprium Therapeutics Inc is a partner company of Nasdaq-listed Fortress Biotech Inc.

As per the official statement, Sentynl has acquired CUTX-101 - Copper Histidinate - for $20 million in upfront and regulatory milestone payments through approval of the New Drug Application (NDA), as well as potential sales milestones plus royalties. The 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.

Under the terms of 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 US Food and Drug Administration (USFDA) 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.

The rolling submission of NDA to the USFDA for CUTX-101 is on track and is slated to begin in the third quarter of 2021 and to be completed during the fourth quarter of 2021, the statement said adding that Torreya Partners advised Cyprium on this transaction.

"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, "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."

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