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Aug 12, 2013
 |  BioCentury  |  Strategy

FibroGen's globetrotting

How FibroGen, AstraZeneca aim to bring anemia compound to U.S., China patients

Seven years after its last major deal, FibroGen Inc. has now carved up worldwide rights to FG-4592 via its new deal with AstraZeneca plc. A key task for FibroGen is now to execute in China, where the biotech's deals give it development, regulatory and manufacturing responsibility for the oral anemia compound.

Meanwhile, its new pharma partner needs to help FibroGen navigate a U.S. regulatory system on heightened alert and sell a product in China where infrastructure for anemia drugs has been lacking.

FibroGen's first significant deal was in 2004, when Yamanouchi Pharmaceutical Co. Ltd. licensed Japanese rights to the biotech's hypoxia-inducible factor prolyl hydroxylase (HIF-PH; EGLN) inhibitor program. The economics included $27.5 million up front, a $30.5 million equity investment and up to $140 million in milestones.

Two years later, Astellas Pharma Inc. re-upped with FibroGen. The Japanese pharma, created in 2005 through the merger of Yamanouchi and Fujisawa Pharmaceutical Co. Ltd., added rights to FG-4592, along with FG-2216 and other HIF-PH inhibitors in Europe, the Commonwealth of Independent States, the Middle East and South Africa.

That deal included $300 million up front, a $50 million equity investment and up to $465 million in milestones.

It also put a stake in the ground for how much an anemia compound in Phase II testing was worth. Two months after the Astellas deal, Takeda Pharmaceutical Co. Ltd. expanded its anemia deal with Affymax Inc. beyond Japan for $105 million up front and up to $430 million in milestones (see BioCentury, July 3, 2006).

Shifting landscape

At the time, FibroGen told BioCentury that Astellas' willingness to leave North American rights in the biotech's hands was the primary reason for doing the deal (see BioCentury, May 1, 2006).

FibroGen had planned to develop its compounds mainly for pre-dialysis chronic kidney disease (CKD) patients under the care of a primary physician. Dialysis patients were already largely taken care of by erythropoiesis-stimulating agents (ESAs).

However, the landscape changed soon after the Astellas deal,

A host of safety issues for ESAs raised the regulatory bar for compounds aimed at boosting red blood cell production (see BioCentury, March 12, 2007). That left FibroGen with...

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