Pharma Focus Asia

Akebia Therapeutics and Otsuka Pharmaceutical Expand Relationship with Collaboration to Develop and Commercialise Vadadustat

Wednesday, April 26, 2017

Akebia Therapeutics, Inc. and Otsuka Pharmaceutical Co., Ltd. announced that they have expanded their collaboration for vadadustat by entering into a collaboration and license agreement for Europe, China and other territories. Vadadustat is an oral hypoxia-inducible factor (HIF) stabiliser currently in Phase 3 development for the treatment of anaemia associated with chronic kidney disease (CKD). Anaemia related to CKD arises from the kidney’s failure to produce adequate amounts of erythropoietin, a key hormone stimulating the production of red blood cells. Left untreated, anaemia significantly accelerates patients' overall deterioration of health with increased morbidity and mortality.

This agreement follows a previously announced collaboration between the companies in which they equally share the costs of developing and commercialising vadadustat in the U.S., as well as the profits from potential future sales of vadadustat in the $3.5 billion renal anaemia market. The total committed development funding from all vadadustat collaborations, combined with Akebia’s cash, is expected to exceed $600 million.

Under the terms of this collaboration agreement, Akebia will receive $208 million or more in committed capital from Otsuka, including $73 million upon signing and $135 million or more of development funding. In addition, Akebia is eligible to receive up to $657 million in milestone payments, representing a total transaction value of approximately $865 million. Otsuka will also make tiered, double-digit royalty payments of up to 30% on net sales of vadadustat in Otsuka’s territory, which includes Europe, Russia, China, Canada, Australia and the Middle East, but excludes Latin America and other previously licensed countries. In the five major markets in the European Union, sales of erythropoiesis stimulating agents (ESAs), the current standard of care for the treatment of renal anaemia, were approximately $1.5 billion.

Mr. Tatsuo Higuchi, president and representative director of Otsuka Pharmaceutical Co., Ltd., commented, “Thanks to Akebia’s expertise in developing vadadustat, we anticipate that it holds significant promise for renal anaemia. We are also convinced that by strengthening our cardio-renal portfolio with a drug candidate like this, following our own tolvaptan, we can contribute to changing the standard of care worldwide for patients with complex kidney diseases."

We are very pleased to expand our strategic relationship with Otsuka, a company who shares our vision to improve the lives of patients with kidney disease, stated John P. Butler, President and Chief Executive Officer of Akebia. We now have a single, strong collaborator for the two largest markets, the U.S. and Europe. This simplifies governance and decision making, maximising the efficiency of our global Phase 3 development programme and ultimately the commercialisation of vadadustat. We are able to accomplish this while obtaining substantial funding for our vadadustat development programme and retaining significant long-term value for Akebia.

Akebia has established three significant collaborations for vadadustat in a little over a year, which together total more than $2.2 billion in potential value and include $573 million or more in upfront payments and committed development funding. In addition to this agreement and the U.S. collaboration with Otsuka, Akebia has established a collaboration with Mitsubishi Tanabe Pharma Corporation for the development and commercialisation of vadadustat in Japan, Taiwan, South Korea, Indonesia, India and select other countries in Asia.

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