Japan’s Takeda Pharmaceutical has expanded a licensing agreement with US biotechnology company Affymax for Hematide, a peptide drug that could mount a strong challenge in the multibillion dollar market for anaemia treatments if its early promise is fulfilled.
Takeda originally licensed Japanese rights to Hematide in February, paying $17 million upfront, buying $10 million of Affymax stock and committing up to $75 million in clinical and regulatory milestone payments.
The Japanese drugmaker now wants exclusive, worldwide control of Hematide, and the new terms call for an upfront payment of $105 million, $280 million in clinical and regulatory milestone payments and up to $150 million in sales milestone payments.
Hematide is currently undergoing Phase II clinical trials in the USA and Europe. Like erythropoietin, it is designed to treat anaemia in patients with chronic kidney disease and cancer, but could have significant benefits over EPO including once-monthly dosing, a rapid onset of action and no potential to cause pure red cell aplasia, a rare but serious disease that can be caused by recombinant EPO treatment.
Other potential advantages of Hematide compared to EPO include uncomplicated chemical synthesis which could reduce its price, greater stability than currently marketed products, room temperature storage and a low tendency to immunogenicity.
Under the terms of the revised agreement, Takeda will pay all the development and commercialisation costs outside the US market, while Affymax will manufacture and supply the drug to Takeda. The two companies will jointly promote the drug in the US.
That profile could allow it to gain a sizeable chunk of the market for recombinant EPO products. Together these drugs account for a multibillion dollar market worldwide; for example, in Europe alone sales of EPO products for anaemia of chronic kidney disease and chemotherapy-induced anaemia total approximately $3 billion a year. Key players in the market are Amgen's Epogen (epoetin alfa) and Aranesp (darbepoetin alfa), as well as Roche's NeoRecormon (epoetin beta).
Meanwhile, there are a number of other EPO-like drugs in the pipeline, including Roche’s CERA, currently filed for approval in Europe and the USA but under fire from Amgen for patent infringement,. Orally-active drugs are also coming through development, though these are further back in development. They include Astellas’ FG-2216 and FG-5592, two hypoxia-inducible factor prolyl hydroxylase inhibitors recently licensed from US firm FibroGen that are in early-stage clinical testing.