AstraZeneca signs $350m kidney deal
pharmafile | August 1, 2013 | News story | Sales and Marketing | AstraZeneca, CKD, fibrogen, kidney
AstraZeneca has signed a deal with private biotech company FibroGen to develop a novel compound aimed at treating anaemia associated with chronic kidney disease (CKD) and end-stage renal disease (ESRD).
The Anglo-Swedish group will pay $350 million upfront plus milestones of up to $465 million, with tiered royalty payments on future sales ‘in the low 20% range’.
FG-4592 was impressive in Phase II, meeting its primary objective of demonstrating anaemia correction in treatment-naïve CKD patients not on dialysis while maintaining haemoglobin levels and anaemia correction in those on dialysis – all with no safety issues.
The agreement does not include Europe, which is already wrapped up – along with Japan, former Soviet states, the Middle East and South Africa – in a licensing deal FibroGen has with Astellas Pharma: instead it will focus on the US and China.
The companies are masterminding a Phase III development programme in both countries, and plan to file in China in 2015 and the US in 2017. AstraZeneca will take charge of commercialisation activities in the US, with FibroGen doing some promotional activities related to ESRD there.
In China, AstraZeneca is to oversee promotion and distribution, leaving FibroGen’s remit as clinical trials, regulatory matters, manufacturing and medical affairs.
If successful, the oral drug would be a more convenient option for patients: current regimes are a combination of injectable erythropoiesis-stimulating agents (ESAs) and iron supplements – and an important point is that FG 4592 achieved anaemia correction without intravenous iron supplementation.
FG-4592 interacts with hypoxia-inducible factor (HIF), a protein transcription factor which induces erythropoiesis – the process by which the body produces red blood cells.
“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,” said AstraZeneca chief executive Pascal Soriot.
“The science behind this compound is compelling,” he concluded.
FibroGen chief executive Thomas Neff said: “We are especially pleased that AstraZeneca will share our commitment to making China the first-to-launch country for FG-4592.”
He went on: “This agreement secures proper development and commercialisation resources for FG-4592, and ensures US clinical trial efforts are fully funded.”
Adam Hill
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