Mitsubishi Tanabe Pharma will pay Akebia $40 million upfront to license vadadustat for the Asian market. The Japanese drug maker will also contribute another $60 million towards the costs of Akebia'a global phase III program for vadadustat, according to the partnership terms announced Monday.
With Mitsubishi on board, Akebia CEO John Butler said the vadadustat phase III study in non-dialysis, chronic kidney disease patients will start enrollment in the next few weeks.
"We had $157 million in the bank and an active At-The-Market [equity financing program] with approximately $30 million available at the end of the last quarter. Now, we have a $100 million commitment from Mitsubishi. We have also said publicly that we are looking for a European partner. Using the Asian deal as a value benchmark, all those pieces together would support the cost of the phase III studies in non-dialysis and dialysis-dependent patients," said Butler, in an email response Sunday night.
Vadadustat is designed to stimulate the production of red blood cells (and the oxygen-carrying molecule hemoglobin) by mimicking the body's reaction to high altitudes. Fibrogen (FGEN) - Get FibroGen, Inc. Report is developing a similar pill.
Both Akebia and Fibrogen intend their respective pills to treat patients with chronic kidney disease, including dialysis patients. If approved, the drugs are taking aim at replacing less convenient, injectable anemia drugs like Amgen's Epogen.
Fibrogen already has two, deep-pocketed partners, Astellas and AstraZeneca helping to fund ongoing phase III studies for its anemia pill. Akebia is playing catch up, so Monday's Mitsubishi partnership is a boost.
In addition to the $100 million, Akebia is eligible to receive approximately $250 million in additional milestone payments from Mitsubishi, based upon achievement of certain development and sales milestones. Mitsubishi will also make tiered royalty payments to Akebia ranging from low teens up to 20%, on sales of vadadustat, if the drug is approved in Japan, Taiwan, South Korea, Indonesia, India and other Asian countries.
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