AstraZeneca has entered into an agreement to develop and sell FibroGen’s first-in-class late-stage oral compound for anaemia in a deal that could be worth over $815 million to the latter.
Under the terms of the deal, AstraZeneca will pay $350 million upfront for the drug, known as FG-4592, as well as potential future development related milestone payments of up to $465 million, plus royalties in the low 20% range. The agreement covers the USA and China, and some other markets, excluding Japan, Europe, the Commonwealth of Independent States, the Middle East and South Africa, which are covered by an existing agreement between FibroGen and Astellas Pharma.
AstraZeneca and FibroGen will focus on developing FG-4592 to treat anaemia in chronic kidney disease and end-stage renal disease and may also explore other anaemia indications. The drug is a small molecule inhibitor of hypoxia-inducible factor (HIF), a protein that responds to oxygen changes in the cellular environment and meets the body’s demands for oxygen by inducing erythropoiesis, the process by which red blood cells are produced. At present, treatment options involve a combination of injectable erythropoiesis-stimulating agents (ESAs) and iron supplements.
In Phase II studies, FG-4592 met its primary objective of demonstrating anaemia correction in treatment-naive CKD patients not on dialysis as well as maintenance of haemoglobin levels and anaemia correction in patients on dialysis. After an extensive Phase III programme, the companies hope to file in China in 2015 and in the USA in 2017.
Pascal Soriot, AstraZeneca’s chief executive, said that “we know from our research into complications of renal disease that anaemia continues to be a challenge for patients with CKD, due in part to the inconvenience and complexity of existing injectable and intravenous therapies and the safety concerns associated with them”. He added that “the science behind this compound is compelling [and] we aim to offer a first-in-class, convenient treatment option”.
