Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
New member
Sign up for FREE
New customer
Discover our services
Settings
Settings
Dynamic quotes 
OFFON
  1. Homepage
  2. Equities
  3. Japan
  4. Japan Exchange
  5. Otsuka Holdings Co., Ltd.
  6. News
  7. Summary
    4578   JP3188220002

OTSUKA HOLDINGS CO., LTD.

(4578)
  Report
SummaryChartsNewsRatingsCalendarCompanyFinancialsConsensusRevisions 
SummaryMost relevantAll NewsOther languagesPress ReleasesOfficial PublicationsSector news

Otsuka : and Akebia Announce Submission of New Drug Application to the FDA for Approval of Akebia's Vadadustat

03/30/2021 | 06:04am EDT

March 30, 2021

Company Name

Otsuka Holdings Co., Ltd.

Name of Representative

Tatsuo Higuchi

President and Representative Director, CEO

Code Number

4578, First Section of the Tokyo Stock

Exchange

Contact

Yuji Kogure

Director, Investor Relations Department

(Phone: +81-3-6361-7411

Otsuka and Akebia Announce Submission of New Drug Application to the FDA for Approval of Akebia's Vadadustat

Indications for renal anemia associated with chronic kidney disease in both dialysis-dependent and non-dialysis-dependent adult patients

Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that its U.S.-based collaborator Akebia Therapeutics, Inc. (Akebia) has submitted a New Drug Application (NDA) to the Food and Drug Administration in the U.S. (FDA) seeking approval for Akebia's investigational drug vadadustat as an oral medication for the treatment of renal anemia due to chronic kidney disease (CKD) in adult patients who receive dialysis and those who do not receive dialysis.

Kabir Nath, senior managing director, Global Pharmaceutical Business, Otsuka Pharmaceutical Co., Ltd., noted, "Kidney-related diseases were long a dormant area for drug research, but this has changed in the past decade and thankfully drug candidates such as vadadustat are now emerging from the R&D process. We look forward to continuing the journey to strengthen our nephrology portfolio and honor our commitment to changing the standard of care worldwide for people living with chronic kidney diseases."

In 2016, Otsuka and Akebia signed a collaboration and license agreement for vadadustat in the U.S. The two companies subsequently signed a collaboration and license Agreement in 2017 for vadadustat in certain other areas. The two companies share development rights in Europe. Contingent on regulatory approvals, Otsuka has exclusive rights to market this drug in Europe, Canada, Australia and China and certain other areas, but excluding Japan and Latin America.

About Akebia's Vadadustat

Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. At higher altitudes, the body responds to lower oxygen availability with stabilization of hypoxia-inducible factor, which can lead to increased red blood cell production and improved oxygen delivery to tissues.

Vadadustat recently completed its global Phase 3 development program for the treatment of anemia due to CKD. Vadadustat is not approved by the U.S. Food and Drug Administration or any regulatory authority with the exception of Japan's Ministry of Health, Labour and Welfare. In Japan, vadadustat is approved and marketed under the trade name Vafseo™, as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis-dependent adult patients.

Disclaimer

Otsuka Holdings Co. Ltd. published this content on 30 March 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 30 March 2021 10:02:01 UTC.


© Publicnow 2021
All news about OTSUKA HOLDINGS CO., LTD.
06/09OTSUKA  : Complete Introduction of CO2-free Electricity for All 23 Manufacturing..
AQ
06/09Japanese electronics retailer Yamada to fully acquire furniture shop Otsuka K..
RE
06/08OTSUKA  : Complete Introduction of CO2-free Electricity for All 23 Manufacturing..
PU
06/02Decibel Therapeutics Names New Board Chairman
MT
06/01Akebia, Otsuka Say FDA Accepts New Drug Application for Anemia Drug Vadadusta..
MT
06/01OTSUKA  : and Akebia Announce U.S. FDA Acceptance for Filing of New Drug Applica..
PU
04/28OTSUKA  : Notice Concerning Completion of Payment for Disposal of Treasury Share..
PU
04/14NIKKEI 225  : Down 0.4% Amid Pandemic, Monthly Decline in Private Sector Core Ma..
MT
04/14Otsuka Holdings to Continue Phase III Trial of Brexpiprazole; Shares Fall 5%
MT
04/13H LUNDBECK A/S  : Lundbeck, Otsuka to Push Through With Recruitment in Late-Stag..
MT
More news
Financials
Sales 2021 1 428 B 12 954 M 12 954 M
Net income 2021 149 B 1 352 M 1 352 M
Net cash 2021 282 B 2 556 M 2 556 M
P/E ratio 2021 17,0x
Yield 2021 2,14%
Capitalization 2 551 B 23 138 M 23 144 M
EV / Sales 2021 1,59x
EV / Sales 2022 1,50x
Nbr of Employees 33 151
Free-Float 75,8%
Chart OTSUKA HOLDINGS CO., LTD.
Duration : Period :
Otsuka Holdings Co., Ltd. Technical Analysis Chart | 4578 | JP3188220002 | MarketScreener
Technical analysis trends OTSUKA HOLDINGS CO., LTD.
Short TermMid-TermLong Term
TrendsBullishNeutralNeutral
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus HOLD
Number of Analysts 12
Average target price 4 637,50 JPY
Last Close Price 4 704,00 JPY
Spread / Highest target 14,8%
Spread / Average Target -1,41%
Spread / Lowest Target -10,7%
EPS Revisions
Managers and Directors
NameTitle
Tatsuo Higuchi President, CEO & Representative Director
Yuko Makino Chief Financial Officer & Director
Ichiro Otsuka Chairman
Yukitakeshi Matsutani Independent Outside Director
Yasushi Sekiguchi Independent Outside Director
Sector and Competitors