FibroGen - 2013 Fierce 15

FibroGen pioneers new class of anemia drugs

Based: San Francisco
Founded: 1993
CEO: Thomas Neff
Clinical focus: Anemia, pulmonary fibrosis

The scoop: After two decades of research, FibroGen leads one of the most competitive contests in pharma to develop new oral anemia drugs with blockbuster sales potential. AstraZeneca ($AZN) recently grabbed rights to the biotech group's late-stage contender FG-4592 in China and the U.S., following FibroGen's deals that gave Astellas Pharma dibs on the candidate in Europe, Japan and other international markets. Up against rival programs from GlaxoSmithKline ($GSK) and Akebia Therapeutics, FibroGen's candidate acts on a mechanism that is involved in how the body boosts red blood cell production in response to high altitudes. And FibroGen also features an experimental antibody for treating idiopathic pulmonary fibrosis, a high-priority target for many major biopharma outfits.

What makes FibroGen fierce: FibroGen's lead candidate could revive a wounded market for anemia treatments and deliver a badly needed new product for AstraZeneca and Astellas. The oral compound has provided signs of boosting red blood cell production in anemia patients with chronic kidney disease (CKD) without the cardiovascular side effects that have hurt sales of injected erythropoiesis-stimulating agents (ESAs).

In an understated fashion, FibroGen has become an innovator in the field of hypoxia-inducible factor (HIF) biology, from which its oral anemia candidates FG-4592 and FG-2216 emerged. The candidates are designed to block HIF-PH enzymes, an entirely different mechanism for boosting red blood cell production from Amgen's injected ESA products Epogen and Aranesp, and one that acts along the natural pathway that increases red blood cell creation at high altitudes.

The compounds have also shown antitumor activity. FibroGen, which discovered its lead compound, has licenses to HIF technology from Dana-Farber Cancer Institute. And the biotech company touted a U.S. patent board decision in December 2009 against patents on similar technology from Isis Pharmaceuticals ($ISIS) that had been licensed to Amgen ($AMGN), which was clearly seeking a piece of the action.

FibroGen and its partners AstraZeneca and Astellas face plenty of competition from HIF-PH inhibitors under development at the British drug giant GlaxoSmithKline and Cincinnati, OH-based startup Akebia. Yet those rivals have programs in midstage development, potentially years behind FibroGen's FG-4592. FibroGen has also reduced its own risk from the major program through the alliances with Astellas and AstraZeneca, which stepped up after analysts pondered potential toxicity issues.  

This summer AstraZeneca forked over $350 million in upfront cash and up to $465 million in milestones for the China and U.S. rights to the candidate for treating anemia in patients with CKD and end-stage renal disease. In the AstraZeneca deal, for example, FibroGen gets a tidy 20% royalty on U.S. sales, splits profits equally with AZ for sales in China, and stands to gain other sales-related milestones.

"The partnership means that, in combination with our Astellas collaborations, we expect that the future costs of FG-4592 development and commercialization for the treatment of anemia in CKD patients in the U.S., Europe, China, and Japan should be fully funded," FibroGen spokesman Greg Mann said in an email to FierceBiotech. "We expect to receive substantial cash payments from AstraZeneca during the pre-NDA submission phase for FG-4592."

In 2011 the FDA warned that use of ESAs such as Amgen's Epogen and Aranesp has been linked to increased risk of heart problems in anemia patients, hurting sales in the biotech giant's blockbuster anemia franchise. Many patients with kidney disease take ESAs in combination with intravenous iron supplements. FibroGen has produced midstage data showing that FG-4592 combats anemia without iron supplements.

"A HIF-based oral therapy like FG-4592 may increase access to anemia therapy for the largely underserved population of patients with anemia of chronic kidney disease who are not yet on dialysis as well as successfully treat dialysis patients who do not respond adequately to existing therapies," Mann noted.

Led by CEO Thomas Neff, FibroGen's first taste of major pharma product revenue could be just around the corner. With financial firepower from AstraZeneca, FibroGen's lead product is on schedule for new approval applications in 2015 in China and 2017 in the U.S. 

The 250-person company has been building a pipeline beyond the HIF program too. FibroGen has a clinical-stage antibody candidate known as FG-3019, a connective tissue growth factor inhibitor that could provide a first-in-class therapy for a deadly lung disease known as idiopathic pulmonary fibrosis as well as cancers and other diseases.

Investors: Adage Capital Management, Apothecary Capital, Astellas Pharma, Brookside Capital Partners/Bain Capital, BankInvest Biomedical Development, Bio Fund Ventures II OY, Corriente Biotechnology Partners, Credit Suisse London Nominees, Duquesne Capital Management, Franklin Fairview, Franklin Templeton, Goldman Sachs, IBELIN PTE Investments, Janus Capital Group, New Ventures, Och-Ziff Capital Management, Peninsula Group, Pictet Bank, Privat Kredit Bank, Ridgeback Capital, The Rosewood Corporation, Sedgefield Investments, SITRA, SMBC Capital, Taisho Pharmaceutical, Three Arch Bay Health Science Fund I, T. Rowe Price, VCFA Holdings and Wagner & Brown

For more:
AstraZeneca commits $815M to partner with FibroGen on anemia drug
Pharma giants' oral EPO alternatives could cater to dopers

-- Ryan McBride

FibroGen - 2013 Fierce 15

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