RenaMed Biologics Inc. and Genzyme Corp. entered a collaboration to develop and commercialize RenaMed's Bio-Replacement Therapy for acute renal failure in a deal that could bring RenaMed $43 million.
The agreement calls for an even split of costs and profits. Genzyme will contribute funding of about $23 million through the third quarter of 2006 to support clinical development and is scheduled to make additional payments to RenaMed, of Lincoln, R.I., for achieved milestones. In all, those payments could equal $20 million.
After that, the deal requires shared program funding, but with more potential milestone payments by Genzyme at approval.
Genzyme also made an equity investment in RenaMed's June private financing of an undisclosed amount.
The Bio-Replacement Therapy uses physiologically active renal epithelial cells administered ex vivo in a hollow-fiber cartridge.
The therapy is intended to treat a sudden loss of kidney function and is meant to improve survival rate. The technology is designed to isolate and expand ex vivo human progenitor cells in the hope that they direct and orchestrate the body's response to stress, infections and inflammatory states by providing metabolic, endocrine and immunologic functions, it said.
RenaMed grows specific renal stem cell isolates in monolayers on its hollow fiber systems. It has done so with both xenogeneic and human-sourced cells in preclinical studies but now uses only human cells.
The hollow fibers provide support for the cellular system, RenaMed said, allow transport of essential cell products and nutrients, and prevent the cells from entering the circulatory system.
RenaMed recently completed a Phase II trial in acute renal failure patients. Data from that trial are scheduled to be presented at the annual American Society for Nephrology meeting in Philadelphia in November.
Acute renal failure is the sudden loss of kidney function that can lead to multi-organ failure, systemic inflammatory response syndrome and death.
The most common causes of acute renal failure are sepsis, blood loss during major surgery or injury, medications and contrast agents.