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FibroGen, AstraZeneca Partner on Kidney-Based Anemia Therapy

Red blood cell (

Red blood cell (

The global pharmaceutical company AstraZeneca is licensing a therapy for anemia caused by kidney disease made by FibroGen, a biotechnology company in San Francisco. The deal is valued initially at $815 million, and covers the U.S., China, and other markets not covered by an earlier FibroGen license to Astellas Pharma for commercialization in Europe, Japan, former Soviet republics, Middle East, and South Africa.

FibroGen’s therapy, code-named FG-4592 regulates a protein called hypoxia-inducible factor that responds to variations in oxygen levels in cells by inducing erythropoiesis, a process for meeting the body’s need for oxygen by producing red blood cells. Kidneys detect low levels of oxygen in the blood, and respond by releasing erythropoietin, a hormone that stimulates bone marrow to produce more red blood cells. Chronic kidney disease, a result of conditions like high blood pressure and diabetes, impairs the kidneys’ ability to perform this function leading to anemia, as well as the potential for kidney failure, also known as end-stage renal disease.

Current therapies for anemia from kidney disease consist of erythropoiesis-stimulant injections and iron supplements. In intermediate-stage clinical trials among 117 patients with chronic kidney disease, says FibroGen, patients not on dialysis and taking FG-4592 were able to correct their anemia, while patients on dialysis taking FG-4592 maintained their hemoglobin levels as well as corrected their anemia. In both cases, patients did not need iron supplements. The company reports the drug showed an acceptable safety profile in those trials.

Under the deal, AstraZeneca and Fibrogen will conduct late-stage clinical trials in the U.S. and China, aiming for regulatory submissions in 2015 in China and 2017 in the U.S. The companies will co-commercialize FG-4592 in China. AstraZeneca will make an initial payment of $350 million, with FibroGen eligible for development milestone payments of up to $465 million. FibroGen can also qualify for later sales and royalty payments.

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Hat tip: FirstWord Pharma

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