Akebia Prevails in Additional European Patent Dispute

Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company focused on delivering innovative therapies to patients with kidney disease through the biology of hypoxia inducible factor (HIF), today announced that the Opposition Division (OD) of the European Patent Office (EPO) has revoked another of FibroGen, Inc.’s HIF-related patents. The patent, EP 1 633 333 (the ‘333 patent), claimed various compounds that were purported to stabilize HIFα for treating or preventing various conditions, including iron deficiency and specific forms of anemia. This ruling follows Akebia’s challenge to FibroGen’s earlier European patent, EP 1 463 823, which was revoked in its entirety by the OD earlier this year.

“While we believe that this patent would not have impacted our ability to commercialize in Europe, we are pleased that the EPO has confirmed that another of FibroGen’s patents associated with HIF is invalid,” stated John P. Butler, President and Chief Executive Officer of Akebia. “Our focus continues to be advancing our Phase 3 program for vadadustat, while progressing our discussions with potential partners regarding a geographic collaboration for vadadustat in regions not currently partnered.”

In August 2014, the EPO granted the ‘333 patent to FibroGen, Inc. In order to preserve the right to challenge this patent, on May 20, 2015, Akebia filed an opposition to the ‘333 patent requesting that the ‘333 patent be revoked in its entirety. In an oral proceeding on December 8 and 9, 2016, the OD ruled that the patent as granted did not meet the requirements for patentability under the European Patent Convention and, therefore, revoked the patent in its entirety. The written decision consistent with the oral ruling is expected within a couple of months.

In other news today, Akebia provided details related to its December 2, 2016 press release. The company noted that the option to purchase 130,000 shares of Akebia’s common stock with a per share exercise price of $8.61, the closing price on the grant date, was granted to Karen Tubridy, an executive recently hired as Senior Vice President and Chief Development Officer. The stock options were inducements material to the new employee entering into employment with the company, and issued in reliance on NASDAQ Listing Rule 5635(c)(4).

About Akebia Therapeutics

Akebia Therapeutics, Inc. is a biopharmaceutical company headquartered in Cambridge, Massachusetts, focused on delivering innovative therapies to patients with kidney disease through hypoxia-inducible factor biology. Akebia’s lead product candidate, vadadustat, is an oral therapy in development for the treatment of anemia related to chronic kidney disease in both non-dialysis and dialysis patients. Akebia has commenced its vadadustat Phase 3 Program, which includes the PRO2TECT studies for non-dialysis patients with anemia secondary to chronic kidney disease and the INNO2VATE studies for dialysis-dependent patients. For more information, please visit our website at www.akebia.com.

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