AstraZeneca signs deal potentially worth more than $815 million to develop FibroGen's anaemia therapy FG-4592

AstraZeneca will pay potentially more than $815 million under an agreement to develop and commercialise FibroGen's late-stage therapy FG-4592 for the treatment of anaemia associated with chronic kidney disease (CKD) and end-stage renal disease (ESRD), the companies announced Wednesday. AstraZeneca CEO Pascal Soriot commented that the collaboration "is an important addition to [our] growing late-stage portfolio in cardiovascular and metabolic disease, one of our core therapy areas."

The oral drug, which inhibits hypoxia-inducible factor (HIF), is designed to work through the body’s oxygen-sensing and response system to help produce red blood cells. FibroGen CEO Thomas Neff said FG-4592 potentially offers patients with anaemia a "therapy that provides coordinated erythropoiesis, that increases natural erythropoietin within the normal physiological range, and that is effective without intravenous iron supplementation and without an increased risk for hypertension." In Phase II studies, the compound met its main goals of demonstrating anaemia correction in treatment-naïve CKD patients not on dialysis, as well as maintenance of haemoglobin levels and anaemia correction in patients on dialysis.

AstraZeneca and FibroGen are planning Phase III trials of the therapy in China and the US, and anticipate regulatory filings in the two countries in 2015 and 2017, respectively. Neff remarked that "we are especially pleased that AstraZeneca will share our commitment to making China the first-to-launch country for FG-4592." The companies noted that the agreement is focused on the development of FG-4592 to treat anaemia in CKD and ESRD in the US, China and all major markets, excluding Japan, Europe, CIS countries, the Middle East and South Africa, which are covered by an existing deal between FibroGen and Astellas. AstraZeneca and FibroGen noted that the deal may be extended to other anaemia indications.

Under the agreed terms, AstraZeneca will make upfront and subsequent non-contingent payments to FibroGen totalling $350 million, plus pay potential development milestones of up to $465 million. The deal also includes potential sales-related milestones and tiered royalty payments on future sales in the low 20-percent range. AstraZeneca noted that it will be responsible for the US commercialisation of FG-4592, with FibroGen undertaking certain promotional activities in the ESRD segment of that market. The companies will jointly market FG-4592 in China, with FibroGen responsible for clinical trials, regulatory matters, manufacturing and medical affairs, while AstraZeneca will oversee promotional activities and commercial distribution.

Other companies developing similar drugs include GlaxoSmithKline and Akebia Therapeutics, with both therapies in mid-stage testing.

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