Akebia Therapeutics Regaining Rights to Vadadustat in the United States, Europe, China and Access Consortium Countries upon Termination of Collaboration and License Agreements with Otsuka & More News Here

• Companies finalize termination with an agreed-upon settlement payment of $55M to be paid to Akebia
• Akebia to assume accountability for regulatory evaluate processes beforehand led by Otsuka

CAMBRIDGE, Mass., June 30, 2022 /PRNewswire/ — Akebia Therapeutics^®, Inc. (Nasdaq: AKBA), a biopharmaceutical firm with the goal to higher the lives of folks impacted by kidney illness, at this time introduced that it has executed an settlement to terminate the U.S. and ex-U.S. vadadustat Collaboration and License Agreements with Otsuka Pharmaceutical Co., Ltd. (Otsuka). As half of the termination, Otsuka has agreed to pay Akebia a settlement payment of $55 million.

As a consequence of the termination of the agreements, Akebia is regaining the rights from Otsuka for vadadustat, an investigational oral hypoxia-inducible issue prolyl hydroxylase inhibitor, in the United States, Europe, China, Russia, Canada, Australia, the Middle East, and sure different territories.

“We continue to believe in the potential of vadadustat as an oral treatment for patients with anemia due to chronic kidney disease, and we are pleased to be regaining the full rights to the product in these important markets,” mentioned John Butler, Chief Executive Officer of Akebia. “Otsuka has been a strong partner for many years, and we appreciate their desire to have an efficient transfer of the responsibilities back to Akebia. We plan to continue to pursue approval for vadadustat to make it available to patients in these territories, and we are excited about the potential additional value this brings to Akebia, as we continue to work to build the company into the future.”

In October 2021, Otsuka submitted an preliminary advertising authorization software (MAA) to the European Medicines Agency (EMA) for vadadustat for the remedy of anemia related with persistent kidney illness (CKD) in adults. The evaluate is in progress. Otsuka and Akebia will coordinate to switch the MAA to Akebia via processes outlined by the EMA. Vadadustat can be below evaluate in the United Kingdom, Switzerland, and Australia via the Access Consortium. Responsibilities for that evaluate will switch to Akebia as properly at a date to be agreed upon.

In the U.S., Akebia obtained a Complete Response Letter from the U.S. Food & Drug Administration (FDA) for vadadustat. Akebia plans to consider and decide potential subsequent steps for vadadustat in the U.S. following the finish of evaluate convention with the FDA.

In the U.S., Akebia individually has a distribution settlement in place with Vifor Pharma, offering potential entry to up to 60% of U.S. dialysis sufferers via present Vifor Pharma relationships. Mitsubishi Tanabe Pharma Corporation owns growth and commercialization rights to vadadustat in Japan and sure different Asian counties.

About Akebia Therapeutics

Akebia Therapeutics, Inc. is a completely built-in biopharmaceutical firm with the goal to higher the lives of folks impacted by kidney illness. The Company was based in 2007 and is headquartered in Cambridge, Massachusetts. For extra data, please go to our web site at www.akebia.com, which doesn’t type a component of this launch.

About Vadadustat

Vadadustat is an oral hypoxia-inducible issue prolyl hydroxylase inhibitor designed to mimic the physiologic impact of altitude on oxygen availability. At larger altitudes, the physique responds to decrease oxygen availability with stabilization of hypoxia-inducible issue, which may lead to elevated crimson blood cell manufacturing and improved oxygen supply to tissues. Vadadustat is an investigational new drug and shouldn’t be authorised by the U.S. Food and Drug Administration (FDA). On March 29, 2022, the FDA issued an entire response letter to Akebia’s New Drug Application for vadadustat for the remedy of anemia due to persistent kidney illness (CKD). Vadadustat is at the moment below evaluate by the European Medicines Agency for the remedy of anemia due to CKD in adults. In Japan, vadadustat is authorised as a remedy for anemia due to CKD in each dialysis-dependent and non-dialysis dependent grownup sufferers.

About Anemia due to Chronic Kidney Disease (CKD)

Anemia is a situation in which an individual lacks sufficient wholesome crimson blood cells to carry satisfactory oxygen to the physique’s tissues. It generally happens in folks with CKD as a result of their kidneys don’t produce sufficient erythropoietin (EPO), a hormone that helps regulate manufacturing of crimson blood cells. Anemia due to CKD can have a profound affect on an individual’s high quality of life as it could possibly trigger fatigue, dizziness, shortness of breath and cognitive dysfunction. Left untreated, anemia leads to deterioration in well being and is related with elevated morbidity and mortality in folks with CKD.

Forward Looking Statement

Statements in this press launch relating to Akebia Therapeutics, Inc.’s (“Akebia’s”) technique, plans, prospects, expectations, beliefs, intentions and targets are forward-looking statements inside the which means of the U.S. Private Securities Litigation Reform Act of 1995, as amended, and embody, however aren’t restricted to, statements relating to:  Akebia’s perception in vadadustat as an oral remedy for sufferers with anemia due to persistent kidney illness; Akebia’s plans to pursue approval for vadadustat to make it accessible to sufferers in the U.S., Europe, China, Russia, Canada, Australia, the Middle East and sure different territories and the related worth that may convey to Akebia; Akebia’s future plans with respect to its strategic progress and working plans, together with as they relate to subsequent steps for regulatory submissions outdoors of the U.S. and plans to consider and decide potential subsequent steps for vadadustat in the U.S. following the finish of evaluate convention with the U.S. Food and Drug Administration (“FDA”); and the quantity of U.S. dialysis sufferers that could possibly be accessed in consequence of the distribution settlement in place with Vifor Pharma. The phrases “believe,” “plan,” “potential,” “will,” “continue,” derivatives of these phrases, and related references are supposed to establish forward-looking statements, though not all forward-looking statements comprise these figuring out phrases. Actual outcomes, efficiency or expertise might differ materially from these expressed or implied by any forward-looking assertion in consequence of varied dangers, uncertainties and different elements, together with, however not restricted to, dangers related with: the implementation of the provisions of the termination settlement with Otsuka, together with the skill of Akebia to pursue regulatory approval outdoors the U.S.; choices made by well being authorities, corresponding to the FDA and the European Medicines Agency, with respect to regulatory filings, together with the New Drug Application for vadadustat; the potential therapeutic advantages, security profile, and effectiveness of vadadustat; the affect of the workforce discount on Akebia’s enterprise; the skill of Akebia to entice and retain certified personnel; Akebia’s skill to implement value avoidance measures and scale back overhead prices; the direct or oblique affect of the COVID-19 pandemic on regulators and Akebia’s enterprise, operations, and the markets and communities in which Akebia and its companions, collaborators, distributors and prospects function. Other dangers and uncertainties embody these recognized below the heading “Risk Factors” in Akebia’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, and different filings that Akebia might make with the U.S. Securities and Exchange Commission in the future. These forward-looking statements (besides as in any other case famous) converse solely as of the date of this press launch, and, besides as required by legislation, Akebia doesn’t undertake, and particularly disclaims, any obligation to replace any forward-looking statements contained in this press launch.

Akebia Therapeutics^® is a registered trademark of Akebia Therapeutics, Inc.

Akebia Therapeutics Contact   
Mercedes Carrasco  
[email protected] 

SOURCE Akebia Therapeutics

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