Affymax and Takeda Terminate Omontys Agreement

Takeda Pharmaceutical Company Ltd announced in a press release that it and Affymax have agreed to terminate their collaboration and license agreement regarding Omontys (peginesatide). Effective September 10, 2014, the two companies will end their partnership on the injection for patients with anemia due to chronic kidney disease. Takeda stated that it will also withdraw the New Drug Application (NDA) for Omontys.

Affymax and Takeda Partnership Dissolution

During discussions with Takeda on Omontys, Affymax decided not to move forward. In other words, it decided not to exercise its rights regarding development for the drug. Takeda agreed to work with the Food and Drug Administration (FDA) on withdrawing the Omontys NDA. Affymax stated that it will review its options concerning the partnership dissolution.

Omontys Concerns

In February 2013, the FDA issued a safety alert warning patients and healthcare professionals that Omontys may have serious adverse effects including life-threatening or fatal anaphylaxis. The warning was due to post-marketing studies that revealed adverse reactions in about 0.02 percent of patients, a third of which were serious in nature. Some patients required immediate intervention and hospitalization. The hypersensitivity reactions occurred within 30 minutes of the first Omontys administration. In subsequent dosing, no adverse events were reported. No reactions were reported in patients who completed their dialysis session. The drug was studied on over 25,000 patients in the post-marketing setting. Ten days after the FDA safety warning, Takeda and Affymax announced in a press release that they would recall all lots of Omontys.

Omontys

Omontys (peginesatide) is packaged in 10 mg and 20 mg multi-dose vials. The erythropoiesis-stimulating agent (ESA) treats chronic kidney disease (CKD) patients on dialysis who develop anemia. It is not indicated for patients not on dialysis, cancer patients, or patients with anemia not due to CKD. It is also not indicated as a substitute for red blood cell (RBC) transfusions. Omontys was studied in over 1,600 dialysis patients in the EMERALD studies. Patients at 172 sites in the U.S. and Europe took either epoetin or Omontys and investigators took several measurements, which they stated have unknown clinical significance. Robert Provenzano, MD, Chair, Division of Nephrology at St. John Hospital & Medical Center in Detroit and the presenter of the EMERALD analyses said, "The observations of these post-hoc analyses from the EMERALD studies may warrant further scientific evaluation."