Alliance to Develop Renal Failure Therapy

(Cambridge, MA, USA) and RenaMed Biologies, Inc. (Lincoln, RI, USA).

The product, under development by RenaMed, utilizes physiologically active renal epithelial cells, administered ex vivo in a hollow-fiber cartridge to treat a sudden loss of kidney function, with the goal of improving the survival rate. The two companies will collaborate on clinical development, manufacturing, and commercialization on a worldwide basis, sharing costs and profits. Genzyme will contribute funding of about U.S.$23 million to support the next stage of clinical development and additional payments of up to $20 million. Genzyme also made an equity investment in a private financing completed by RenaMed in June 2005.

Acute renal failure (ARF) can lead to multi-organ failure, systemic inflammatory response syndrome, and death. The most common causes are sepsis, blood loss during major surgery or injury, medications, and contrast agents. The bio-replacement therapy is designed to work in conjunction with existing hemofiltration systems to provide comprehensive kidney function support. ARF occurs in about 5% of all hospitalized patients. Severe ARF, about 20% of all cases, is treated in the intensive care unit with renal replacement therapy, and the mortality rate is 55-70%.

"Genzyme is a leading medical innovator, has a strong commitment to advancing renal disease treatments, and has proven expertise in developing and commercializing similar biologic therapies,” noted Greg Phelps, chairman and CEO of RenaMed Biologics. The company recently completed a Phase II trial of its therapy in patients with ARF. The data from this trial are scheduled to be presented at the annual meeting of the American Society for Nephrology in Philadelphia (PA, USA) in November 2005.





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