Otsuka to end licensing agreements with Akebia after FDA turns down anemia drug
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Otsuka Pharmaceutical Co. Ltd. recently announced it is terminating agreements with Akebia Therapeutics for development of vadadustat in the U.S. market.
The announcement from Otsuka comes 6 weeks after the FDA declined to approve the anemia drug because of concerns about vascular access complications and liver toxicity.
Vadadustat is an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor for the treatment of anemia due to chronic kidney disease.
Under the Otsuka U.S. agreement and the Otsuka international agreement, Otsuka funds 80% of the global development costs for vadadustat, Akebia said in a recent Securities and Exchange Commission filing.
“ ... [I]n March this year, Akebia received a complete response letter (CRL) from the [FDA]. As a result, Otsuka has decided to terminate its co-development of vadadustat and has notified Akebia of the termination of its global license agreements,” Otsuka said in a press release.
“Otsuka is expanding globally in the cardiovascular and renal therapeutic areas as one of its priority therapeutic areas. Otsuka will continue its vigorous research programs on new treatments for patients with unfulfilled medical needs who eagerly await new treatment choices,” according to the press release.
The company said termination will be effective on May 13, 2023.
European review
In a statement provided to Healio, Akebia CEO John Butler said, “As Akebia had not been in previous discussions with Otsuka about the termination, we are quickly working through the grounds of the termination and relevant, associated ongoing activity.
“Vadadustat is currently under review by the European Medicines Agency for the treatment of anemia due to CKD in adults. The review process remains on track, and we will continue to collaborate closely with Otsuka through the review,” Butler said.
Otsuka submitted a marketing authorization application for vadadustat for the treatment of anemia due to CKD in adults on dialysis and not on dialysis to the European Medicines Agency in October 2021 and submitted applications for regulatory approval in the United Kingdom, Switzerland and Australia in March 2022.
US approval
Akebia submitted the new drug application for vadadustat in April 2021, saying it included data from more than 8,000 patients from 36 clinical trials. “We are extremely disappointed to receive a CRL for vadadustat, a therapy that has the potential to help patients with anemia due to CKD,” Butler said in March after the FDA decision. “We continue to believe the data are supportive of a positive benefit-risk assessment of vadadustat for patients with anemia due to CKD, particularly in dialysis patients.”
After the FDA decision to not approve the drug for the U.S. market, the board of directors of Akebia approved a 42% reduction in workforce; that was later expanded to include “several members of management,” the company said in a press release on its first-quarter earnings.
Akebia said it received a notice on May 12 from Nasdaq indicating that the drop in its stock price to below $1 per share for 30 consecutive business days was in violation of maintaining the company’s listing. Akebia has been provided a period of 180 calendar days or until Nov. 8, 2022, to regain compliance with the bid price requirement, according to the company.
Akebia also manufacturers Auryxia (ferric citrate), a drug which helps control phosphorus levels in patients on dialysis. The company reported in its first-quarter report for 2021 that revenue from Auryxia was $41.4 million, a 36% increase over the first quarter of 2021.
“There has been significant effort made since our CRL in March to streamline our operations with a goal of funding operations from the cash flows of Auryxia as well as funds from our collaboration partners,” David A. Spellman, chief financial officer of Akebia, said in a press release. “There is still work to do, and we are focused on delivering increased revenue and greater cost savings.
“If we are successful in implementing cost avoidance measures, we believe we will have cash flows to support the business through at least the next [12] months and do not anticipate a near-term requirement to further finance the company to execute our operating plan,” Spellman said.
References:
Akebia Therapeutics reports first-quarter 2022 financial results and business update. https://ir.akebia.com/news-releases/news-release-details/akebia-therapeutics-reports-first-quarter-2022-financial-results. Published May 9, 2022. Accessed May 18, 2022.
Announcement of termination of global license agreements for renal anemia treatment with Akebia Therapeutics Inc. www.otsuka.co.jp/en/company/newsreleases/2022/20220513_1.html Published May 13, 2022. Accessed May 17, 2022.
SEC filings: Report of unscheduled material events or corporate events. https://ir.akebia.com/financial-and-filings/sec-filings. Published May 13, 2022. Accessed May 18, 2022.
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