AstraZeneca CEO Pascal Soriot has taken another step forward in his turnaround campaign, committing $350 million in cash and up to $465 million in milestones to partner up with FibroGen as it positions a lead anemia drug for late-stage trials.
The pharma giant is grabbing U.S. commercialization rights to FG-4592, which has produced mid-stage proof-of-concept data to demonstrate its first-in-class potential for patients suffering from chronic kidney disease. The drug is designed to kick-start the production of red blood cells by mimicking the body's response to high altitudes. And it fits into AstraZeneca's R&D strategy, which has included a careful focus on the cardiovascular and metabolic fields.
For AstraZeneca, the move beefs up one of the weakest late-stage pipelines in Big Pharma. Even before Soriot took over, the company was wheeling and dealing its way around the world. But only a handful of deals have focused on Phase III, raising concerns among analysts that the CEO is taking the long road back to financial health. In its release today, AstraZeneca says it is on track to file for U.S. regulatory approval of 4592 in 2017--and its progress will be closely watched. China is included in the deal, where the companies could file as early as 2015.
AstraZeneca is taking the lead in the deal, but FibroGen is hanging on to U.S. commercialization rights for end stage renal disease, hoping to muscle into a market dominated by ESAs. Astellas landed European and Japanese rights to the drug years ago. Just yesterday Astellas and FibroGen announced that they were launching a Phase II study for FG-4592 in Japan, triggering a $12.5 million milestone payment for the San Francisco-based biotech. That study will focus on patients on dialysis and later this year Astellas plans another Phase II for non-dialysis patients.
AstraZeneca is entering a drug development race. A week ago Akebia began a Phase IIb study of AKB-6548, which is designed to act the same way as FibroGen's drug. And GlaxoSmithKline has a rival program as well.
"The science behind this compound is compelling," says Soriot in a statement. "Through our collaboration with FibroGen we aim to offer a first-in-class, convenient treatment option for doctors and patients."
- here's the press release
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