Affymax Inc. and Takeda Pharmaceutical Company Limited have entered into an exclusive agreement to develop and commercialise Affymax's lead product candidate, Hematide, in Japan for the treatment of anaemia.
Hematide, a synthetic, peptide-based, next-generation erythropoiesis- stimulating agent (ESA), is designed to stimulate the production of red blood cells. It is currently being evaluated in four phase 2 clinical trials in the United States and Europe to treat anaemia in chronic kidney disease (CKD) and cancer patients.
Pursuant to the agreement, Takeda will pay to Affymax USD 17 million as an up-front payment and will also purchase USD 10 million of Affymax's stock. In addition, Affymax is eligible to receive clinical and regulatory milestone payments totaling USD 75 million, informs the company release.
After the launch of Hematide in Japan, Affymax would receive a double-digit royalty on Hematide sales in the territory. Takeda is responsible for all development and commercialisation costs in Japan, and Affymax is responsible for the manufacture and supply of drug substance to Takeda. Takeda then will manufacture the final commercial product for use in Japan.
"With this agreement, Affymax has delivered on a key corporate goal. This major milestone achievement will allow us to focus our own now considerable resources on developing Hematide in the United States and Europe, while Takeda focuses on the significant market in Japan" said Arlene M. Morris, Affymax's president and chief executive officer.
ESAs, which have been used successfully to manage anaemia in patients with CKD and cancer-related anaemia, represent a $12 billion market worldwide, of which Japan is about $1 billion and growing. ESA therapy has dramatically reduced the need for blood transfusions and the frequency and severity of anaemia-associated morbidity, resulting in an improved quality of life for patients.
Affymax, Inc. is a clinical-stage pharmaceutical company that is developing a rich pipeline of synthetic peptide-based drugs against clinically validated targets for the treatment of kidney diseases and cancer.
Takeda, located in Osaka, Japan, is a research-based global company with its main focus on pharmaceuticals.