Date: 2016-12-20
Type of information: Development agreement
Compound: vadadustat
Company: Akebia Therapeutics (USA - MA) Otsuka Pharmaceuticals (Japan)
Therapeutic area: Kidney diseases - Renal diseases
Type agreement: development commericalisation
Action mechanism: hypoxia-inducible factor (HIF) stabilizer. Vadadustat is an oral hypoxia-inducible factor (HIF) stabilizer. The compound exploits the same mechanism of action used by the body to adapt naturally to lower oxygen availability associated with a moderate increase in altitude. At higher altitudes, the body responds to lower oxygen availability with increased production of HIF, which coordinates the interdependent processes of iron mobilization and erythropoietin production to increase red blood cell production and, ultimately, improve oxygen delivery.
Disease: anemia associated with chronic kidney disease (CKD)
Details: * On December 20, 2016, Akebia Therapeutics and Otsuka Pharmaceutical announced they have entered into a collaboration and license agreement in the U.S. for vadadustat, an oral hypoxia-inducible factor (HIF) stabilizer currently in development for the treatment of anemia associated with chronic kidney disease. The collaboration provides capital for the global development program for vadadustat, and commercial resources for a U.S. launch of vadadustat upon approval by the FDA. Akebia will continue to lead the ongoing global Phase 3 development program for vadadustat. The companies intend to contribute equally to commercialization efforts and share equally all costs and revenue in the U.S., where sales of erythropoiesis stimulating agents (ESAs), the current standard of care, are estimated to be $3.5 billion. In addition to the collaboration with Otsuka, Akebia has established a collaboration with Mitsubishi Tanabe Pharma Corporation for the development and commercialization of vadadustat in Japan, Taiwan, South Korea, Indonesia, India and other countries in Asia.
Financial terms: Under the terms of the agreement, Akebia will receive $265 million in committed funds plus development and commercial milestones. Under the terms of the agreement, Otsuka will pay $265 million or more in committed capital. This includes a payment of $125 million upon signing and a payment of approximately $35 million in the first quarter of 2017. The agreement also provides for Otsuka to pay $105 million or more of the costs of the global development program for vadadustat. Additionally, Otsuka will pay potential development and commercial milestones up to $765 million.
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