Takeda and Affymax provide update for Hematide in chemotherapy-induced anemia

Takeda Pharmaceutical Company Limited and Affymax, Inc. today announced their agreement to suspend co-development of Hematide to treat chemotherapy-induced anemia and to focus all development efforts for Hematide on the treatment of chronic kidney disease related anemia.

Takeda and Affymax continue to be encouraged by the potential of bringing Hematide, a convenient, once monthly treatment option, to the millions of chronic kidney disease patients suffering from anemia and believe this represents a significant opportunity for the two companies.

Takeda has been conducting Phase I clinical studies of Hematide for the treatment of chemotherapy-induced anemia in the U.S. and Japan. However, the companies have decided to suspend development of Hematide in oncology and not to enroll new patients in the ongoing Phase I clinical trial of the product in chemotherapy-induced anemia given the uncertain regulatory landscapes for erythropoiesis-stimulating agents in oncology indications, despite the potential for Hematide in this indication.

Takeda and Affymax are continuing to investigate Hematide for the treatment of anemia related to chronic renal failure. Registrational Phase III trials are ongoing in the United States and Europe, with Phase I/Phase II trials ongoing in Japan. Enrollment for one of the four Phase III trials has been completed and enrollment for the remaining Phase III trials is expected to be completed within this year.

Hematide is a novel, synthetic pegylated peptide-based erythropoiesis stimulating agent (ESA) that acts on the erythropoietin receptor to stimulate the production of red blood cells.