GENE ONLINE|News &
Opinion
Blog

2022-07-04| Licensing

Akebia Therapeutics Gains $55M Following Deal Termination by Otsuka Pharmaceutical

by Fujie Tham
Share To

Otsuka Pharmaceutical agreed to pay Cambridge, Massachusetts-based Akebia Therapeutics $55 million for terminating the vadadustat oral anemia drug’s licensing deal following rejection by the FDA.

As a result of the termination, the biotech is regaining rights from Otsuka for vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor inside and outside the US. Earlier this May, the FDA issued a complete response letter in response to vadadustat’s safety concerns, deeming the drug is not ready for approval.

Related article: FDA Halts Sanofi’s $3.7B Multiple Sclerosis Investment

 

Otsuka Terminates Deal Following Safety Issues 

 

FDA concluded that the data in vadadustat’s New Drug Application (NDA) showed increased risk of cardiovascular issues (thromboembolic events) and drug-induced liver injury. FDA said that Akebia could explore ways to potentially demonstrate a favorable benefit-risk assessment through new clinical trials.

A few weeks later, Otsuka decided to drop the medicine, causing disputes between both companies. Otsuka alleged breaches that could lead to a premature termination of the partnership, while Akebia denies said claims.

“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,” said John Butler, Akebia CEO.

Vadadustat is currently under review by the European Medicines Agency (EMA) for treating anemia due to chronic kidney disease in adults. In Japan, the drug is approved for chronic kidney disease anemia in both dialysis and non-dialysis dependent adults.

For Akebia, this cash injection is a significant sum, making the smaller biotech better funded than competitors on a similar scale. Following the news, Akebia’s share price jumped 50%, crossing the $0.50 mark.

 

©www.geneonline.com All rights reserved. Collaborate with us: service@geneonlineasia.com
Related Post
Ascendis’ Hormone Drug Hits Another FDA Roadblock on Path to Approval
2023-05-02
Sun Pharma Temporarily Pauses Shipments from Mohali Following FDA’s Mandate for Corrective Actions
2023-04-24
Mesoblast’s Resubmission Brings First-of-its-Kind Therapy One Step Closer to Approval
2023-03-09
LATEST
Should People Looking to Lose Weight Skip Sugar Substitutes?
2023-05-30
Advancing Next-Generation Cancer Metabolic Therapy by Targeting Critical Amino Acid Metabolic Pathways: An Interview with Brian A. Van Tine, MD, PhD
2023-05-26
Rona Therapeutics, Keymed Biosciences Team Up To Develop siRNA Drugs For Kidney Disease
2023-05-25
CDC Calls an End to J&J’s COVID-19 Vaccine in the U.S.
2023-05-25
A Close Look at the Evolution of ESG in Biopharma
2023-05-22
Scientists Identified Potential New Drugs to Combat Blindness
2023-05-21
FDA Approves Astellas’ Non-hormonal Menopause Treatment After Extended Review
2023-05-19
EVENT
2023-05-16
The 2nd International Healthcare Week
Hong Kong , China
2023-06-02
2023 ASCO annual meeting
Chicago, USA
2023-07-26
BIO Asia-Taiwan 2023
Taipei, Taiwan
2023-09-06
2023 Bio Asia Pacific
Bangkok, Thailand
Scroll to Top