Anemia in the News

Pharmaceutical manufacturers Affymax and Takeda announced they will suspend co-development of Hematide^TM to treat chemotherapy-induced anemia (CIA) and focus all efforts on developing the erythropoiesis-stimulating agent for treatment of anemia associated with chronic kidney disease.

The decision by Affymax and joint partner Takeda will suspend enrollment in a Phase I clinical trial of Hematide^TM in patients with CIA, and allow them to focus on four concurrent Phase 3 trials in kidney disease patients called PEARL 1 & 2 and EMERALD 1 & 2.

Affymax CEO Arlene Morris told reporters in an August 28th conference call that the strategic decision reflected the “changing dynamics and continued uncertainty in regulatory requirements” for oncology indications. She also cited recent U.S. Food and Drug Administration (FDA) restrictions on ESA use for cancer patients and reimbursement limits imposed by the Centers for Medicare and Medicaid (CMS) as contributing factors leading to their decision to end the drug’s oncology program.

Hematide^TM is an erythropoiesis-stimulating agent (ESA) used to treat anemia by stimulating red blood cell production. The synthetic pegylated peptide-based agent differs from other recombinant ESAs in manufacturing and physical properties that are expected to allow a less-frequent dose requirement for patients when compared with currently available products in this class of medicines.

Last Updated: October 1, 2008