AstraZeneca Plc is eyeing the anemia drug it licensed from FibroGen Inc. as its next blockbuster to help fight erosion of revenue from its best-selling drugs whose patents expire over the next three years.
AstraZeneca will pay closely held FibroGen $350 million up front and as much as $465 million in future payments tied to development goals for the compound called FG-4592, the London-based drugmaker said in a statement today. The companies will test the treatment for anemia in patients with chronic kidney disease and end-stage renal disease in pivotal clinical trials in the U.S. and China. If successful, they will file for market approval in China in 2015 and the U.S. in 2017.
The deal comes as the U.K.’s second-biggest drugmaker tries to license or acquire treatments to boost its pipeline as its main products face generic competition. The company has said it expects profit to decline “significantly” more than revenue this year.
“The market opportunity in China alone is very significant,” Christoph Pittius, vice president of business development in cardiovascular and metabolic disease, said in a phone interview.
Patients with chronic kidney disease can develop anemia, a condition where there are too few red blood cells, because they have a low supply of erythropoietin, a hormone made by healthy kidneys to signal red blood cell production, according to the National Kidney Foundation.
The current standard of care is a combination of iron supplements and injectable erythropoiesis-stimulating agents, which tell the bone marrow to produce more red blood cells and decrease the need for blood transfusions. The U.S. Food and Drug Administration has said the agents carry the risk of causing cardiovascular events such as heart attacks and strokes.
The FibroGen drug is a small molecule inhibitor of the hypoxia-inducible factor which signals the body’s cellular “oxygen-sensing” system to help produce red blood cells. For example, when a person is at high altitude, where oxygen levels are low, the body reacts by producing more red blood cells.
China has an estimated 125 million chronic kidney disease patients, which is about five times as many as in the U.S., the company said. The FibroGen drug already has priority review status in China, which “played an important role in this deal,” Pittius said. The anemia drug is a good fit with the company’s cardiovascular portfolio and AstraZeneca may test the treatment for other anemia-related illnesses, he said.
AstraZeneca has said it expects to file for three marketing approvals of drugs in its pipeline by 2016. The U.K. drugmaker will also pay FibroGen royalties in the “low” 20 percentage range.