Daiichi Sankyo Explained

Daiichi Sankyo Company, Limited
Native Name:第一三共株式会社
Native Name Lang:ja
Romanized Name:Daiichi Sankyō kabushiki gaisha
Type:Public KK
Traded As:
TOPIX Large 70 Component
TOPIX 100 Component
Nikkei 225 Component
Foundation:Tokyo, Japan (by merger)
Location:Daiichi Sankyo Building A/B 3-5-1, Nihonbashi-honcho, Chūō-ku, Tokyo 103–8426, Japan
Num Employees:17,435 (as of May 2023)[1]
Homepage:http://www.daiichisankyo.com
Industry:Pharmaceutical
Revenue: $ 9.44 billion USD (FY 2022) (¥ 1,278 billion JPY) (FY 2022)
Net Income: $ 812 million USD (FY 2022) (¥ 109.2 billion JPY) (FY 2022)[2]
Footnotes:[3]

is a global pharmaceutical company and the second-largest pharmaceutical company in Japan. It achieved JPY 1,278 billion in revenue in 2022.[2] The company owns the American pharmaceutical company American Regent.

Daiichi Sankyo, Inc. (DSI) began operating in the U.S. in 2006. It is the U.S. subsidiary of Daiichi Sankyo Company, Limited, and a member of the Daiichi Sankyo Group. The organization, which includes U.S. commercial operations and global clinical development (Daiichi Sankyo Pharma Development), is headquartered in Basking Ridge, New Jersey.

Daiichi Sankyo Europe, GmbH (DSE), the European subsidiary, is headquartered in Munich, Germany. The organization is responsible for development and manufacturing for 12 European countries.

Daiichi Sankyo Company, Limited is a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA) and of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).

History

Daiichi Sankyo was established in 2005 through the merger of and, which were century-old pharmaceutical companies based in Japan.

Sankyo Co., Ltd. was founded by Jokichi Takamine, who patented the isolation of adrenaline.[4] [5] Takamine was president of Sankyo Co., Ltd from March 1913 until July 1922.[6]

In 1990, Sankyo acquired the German Luitpold-Werk Group, a pharmaceutical company based in Munich.[7] In 2019, Luitpold renamed itself after its American Regent brand.[8] American Regent, now based in the United States, is a subsidiary of Daiichi Sankyo.[9] [10]

Acquisitions

In 2006, Daiichi Sankyo acquired Zepharma, the OTC drugs unit of Astellas Pharma. On June 10, 2008, the company agreed to take a majority (64%) stake in Indian generic drug maker Ranbaxy, with a deal valued at about $4.6 billion.[11] [12]

It acquired U3 Pharma in June 2008, contributing a therapeutic anti-HER3 antibody to the company's anticancer portfolio.[13] The company closed U3 Pharma in 2015.[14]

The acquisition of Plexxikon, a Berkeley, California-based pharmaceutical start-up company, was completed on April 4, 2011, for $805 million and an additional $130 million in milestone payments, pending on the success of Vemurafenib (Plexxikon's lead program) an oral, novel drug that targets the oncogenic BRAF mutation present in about half of melanoma cancers and about eight percent of all solid tumors. Daiichi Sankyo is retaining US co-promotion right of the (Roche licensed) drug.[15] The shutdown of Plexxikon was announced in 2022[16] as Daiichi Sankyo pivots to focus on more antibody-drug conjugate therapies.[17]

On April 7, 2014, Daiichi Sankyo announced it had agreed to vote its shares in Ranbaxy in favor of Sun Pharma's acquisition of 100% of Ranbaxy through the merger process which entailed a share swap. On September 29, 2014, Daiichi Sankyo agreed to acquire Ambit Biosciences for approximately $410 million, the deal enabled Daiichi to gain the cancer compound quizartinib.[18] On April 20, 2015, the company announced it had sold off the 8.9% stake in Sun Pharmaceutical Industries it acquired when acquiring Ranbaxy, raising $3.2 billion.[19]

It transferred 41 of its products in Japan to Alfresa Holdings Corporation for JPY 4.2 billion in 2018 in order to focus on oncology.[20] The company acquired ramosetron, nicardipine and barnidipine from Astellas Pharma in October 2019.[21]

In January 2020, the company's market value rose above JPY 5 trillion after the U.S. Food and Drug Administration approval and release of Enhertu, an antibody-drug conjugate for cancer treatment.[22] Daiichi Sankyo developed Enhertu in cooperation with AstraZeneca,[23] which agreed in March 2019 to pay up to $6.9 billion to Daiichi Sankyo in exchange for a share of Enhertu's sales.[24] [25]

The following is an illustration of the company's major mergers and acquisitions and historical predecessors (this is not a comprehensive list):

Kickbacks, 2015

As of 2015, Daiichi Sankyo was being "closely monitored" after settling charges concerning payment of remuneration to physicians in the form of speaker fees as part of company's Physician Organization and Discussion program, in violation of the False Claims Act, an anti-kickback statute.[26]

Daiichi Sankyo agreed to pay the United States and state Medicaid programs $39 million to settle allegations by the United States Department of Justice over kickbacks to doctors. As part of the company's Physician Organization and Discussion program which ran from 2005 through 2011, Daiichi Sankyo paid physicians improper kickbacks in the form of speaker fees to induce physicians to prescribe Daiichi Sankyo's drugs, including Azor, Benicar, Tribenzor and Welchol. Allegedly, payments were made to physicians even when physician participants in PODs took turns “speaking” on duplicative topics over Daiichi-paid dinners, the recipient spoke only to members of his or her own staff in his or her own office, or the associated dinner was so lavish that its cost exceeded Daiichi Sankyo's own internal cost limitation of $140 per person.

“Schemes such as this are particularly abhorrent,” said Inspector General Daniel R. Levinson for the U.S. Department of Health and Human Services. “Manufacturers and physicians who engage in them are cheating Medicare and Medicaid out of millions of dollars and threatening programs upon which many elderly and disabled Americans rely. My office will take whatever steps necessary to guard against improper alliances between manufacturers of drugs and those who prescribe them. Through our corporate integrity agreement we will be closely monitoring Daiichi Sankyo.”

Products

This list is not comprehensive.[27]

Oncology
Cardiovascular
Other

Pipeline candidates

Select mid-stage and late-stage investigational candidates in Daiichi-Sankyo's pipeline include:

References

External links

Notes and References

  1. Web site: About Us . Daiichi Sankyo . 15 May 2023.
  2. News: Consolidated Financial Results for Year Ended March 31, 2023 (Fiscal 2022) . 18 May 2023 . Daiichi Sankyo . 27 April 2023.
  3. News: Value Report 2020 . 30 November 2020 . Daiichi Sankyo Group . 31 March 2020 . 45.
  4. Web site: Bennett. Joan. The Time Line: Adrenalin and cherry trees. pubs.acs.org. 24 January 2016.
  5. Book: Kawakami. K. K.. Jokichi Takamine: A Record of his American Achievements. 1928. William Edwin Rudge. New York.
  6. Web site: 13th Takamine Memorial Daiichi Sankyo Prize Winner Announced - Media & Investors - Daiichi Sankyo. www.daiichisankyo.com. 24 January 2016.
  7. News: Sankyo Buys Drug Maker . 17 December 2020 . The New York Times . 19 January 1990.
  8. News: Luitpold Pharmaceuticals Renamed American Regent . 17 December 2020 . American Pharmaceutical Review . 2 January 2019.
  9. News: Daiichi Sankyo creates new biz unit for oncology . 17 December 2020 . BioSpectrum Asia . 13 November 2020.
  10. News: Leadership Transitions Upcoming at Daiichi Sankyo, American Regent . 17 December 2020 . PharmaLive . 7 December 2020.
  11. News: Ranbaxy-Daiichi marriage: Implications for Indian pharma . June 11, 2008 . April 29, 2014.
  12. News: Ranbaxy promoters to sell stake to Japan's Daiichi . June 11, 2008 . April 29, 2014.
  13. News: Daiichi Sankyo Intends to Purchase U3 Pharma for Roughly $236M . . . May 21, 2008 . July 6, 2008.
  14. News: White . Victoria . Daiichi Sankyo to close research subsidiary U3 Pharma . 1 December 2020 . Drug Target Review . 1 December 2015 . https://web.archive.org/web/20210520180934/https://www.drugtargetreview.com/news/8043/daiichi-sankyo-to-close-research-subsidiary-u3-pharma/ . 2021-05-20 . live.
  15. Web site: Daiichi Sankyo To Acquire Plexxikon . February 28, 2011 . April 29, 2014 . Plexxikon . https://web.archive.org/web/20110306091816/https://www.plexxikon.com/view.cfm/88/Press-Releases . 2011-03-06 . dead.
  16. Web site: Madeline. Wells . 2022-01-12. South SF company bought for $800 million is being shut down. SFGATE. en-US . https://web.archive.org/web/20220112185128/https://www.sfgate.com/local/article/South-SF-Plexxikon-to-shut-down-16770179.php . 2022-01-12 . live.
  17. News: Daiichi axes 60-person Plexxikon R&D facility in California to free up cash for ADC development. Nick P.. Taylor . 2022-01-12. Fierce Biotech. en . https://web.archive.org/web/20220112175425/https://www.fiercebiotech.com/biotech/daiichi-axes-60-person-plexxikon-r-d-facility-california-to-free-up-cash-for-adc . 2022-01-12 . live.
  18. Web site: GEN - News Highlights:Daiichi Sankyo to Acquire Ambit Biosciences for Up to $410M. GEN. 2014-09-29.
  19. Web site: GEN - News Highlights:Daiichi Sankyo Sells Off Stake in Sun Pharma. GEN. 2015-04-21.
  20. News: Daiichi Sankyo splits to offload old assets and focus on oncology ambition . 1 December 2020 . The Pharma Letter . 1 August 2018.
  21. News: Daiichi Sankyo buys three drugs to boost presence in Asia . 1 December 2020 . The Pharma Letter . 15 October 2019.
  22. News: Matsuyama . Kanoko . Drug devised to replace chemotherapy may reshape cancer care . 1 December 2020 . The Japan Times . 16 June 2019.
  23. News: Takada . Noriyuki . Kawana . Yukihiro . Sakabe . Yoshinaru . Daiichi Sankyo harnesses 'old' R&D to strike cancer drug gold . 1 December 2020 . Nikkei Asia . 28 January 2020.
  24. News: Terry . Mark . AstraZeneca and Daiichi Sankyo Sign $6.9 Billion Deal for a Single Cancer Drug . 1 December 2020 . BioSpace . 29 March 2019.
  25. News: Tatelbaum . Julianna . Global pharma giant AstraZeneca strikes $6.9 billion deal to expand cancer portfolio . 1 December 2020 . CNBC . 29 March 2019.
  26. Web site: Daiichi Sankyo Inc. Agrees to Pay $39 Million to Settle Kickback Allegations Under the False Claims Act. 2015-01-09. Office of Public Affairs. U.S. Department of Justice. 2016-04-06.
  27. Web site: Products - Daiichi Sankyo. Daiichi Sankyo. June 15, 2021.
  28. News: AZ, Daiichi Sankyo get early okay for DS-8201, now named Enhertu . 3 December 2020 . PMLive . 23 December 2019.
  29. News: Dual EZH1 and EZH2 inhibitor Ezharmia launched in Japan . 13 April 2023 . The Pharma Letter . 20 December 2022.
  30. News: Taylor . Phil . Daiichi Sankyo's pexidartinib is first FDA-approved drug for rare tumour . 3 December 2020 . Pharma Phorum . 5 August 2019.
  31. News: Idrus . Amirah Al . FDA nixes Daiichi's blood cancer drug quizartinib after Japanese regulators wave it through . 3 December 2020 . Fierce Biotech . 21 June 2019.
  32. Web site: VANFLYTA (quizartinib), FDA Approved in the U.S. for Newly Diagnosed FLT3-ITD Positive Acute Myeloid Leukemia, Available at Biologics by McKesson McKesson . 2023-08-07 . www.mckesson.com.
  33. News: 18 August 2011. First-in-class skin cancer drug approved. en. PMLive. 13 May 2021.
  34. Web site: Products. 2 December 2020. Daiichi Sankyo.
  35. News: Daiichi Sankyo says prasugrel hits goals in thrombotic stroke study . 3 December 2020 . The Pharma Letter . 21 July 2020.
  36. News: Weinberg . Ido . FDA approves edoxaban to reduce stroke risk, treat DVT and PE . 3 December 2020 . Healio . 9 January 2015.
  37. News: FDA approves Daiichi Sankyo bloodthinner Savaysa . 3 December 2020 . PharmaTimes . 9 January 2015.
  38. News: Terry . Mark . Daiichi Sankyo's Hypertension Drug Hits Mark in Diabetic Nephropathy Trial . 3 December 2020 . BioSpace . 8 November 2019.
  39. News: EC nod for Daiichi Sankyo's cholesterol lowerers Nilemdo and Nustendi . 13 May 2021 . The Pharma Letter . 6 April 2020.
  40. News: EC nod for Daiichi Sankyo's cholesterol lowerers Nilemdo and Nustendi . 13 May 2021 . The Pharma Letter . 6 April 2020.
  41. News: New combination therapy for type 2 diabetes approved in Japan . 3 December 2020 . The Pharma Letter . 3 July 2017.
  42. News: Dey . Sushmi . Ranbaxy launches authorised generic of Daiichi's Evoxac in US . 13 May 2021 . Business Standard India . 9 October 2012.
  43. News: Steinberg . Julie . Daiichi Sankyo Still Faces Claims Over Injectable Anemia Drug . 3 December 2020 . Bloomberg Law . 29 July 2020.
  44. News: Daiichi Sankyo Looking to Establish "Base Treatment" Position for Memary . 3 December 2020 . Pharma Japan . 23 April 2012.
  45. News: AZ pockets $100 million in Daiichi Sankyo deal for Nexium . 3 December 2020 . PharmaTimes . 29 October 2010.
  46. News: Daiichi Sankyo files Ranmark to treat giant cell tumor of bone in Japan . 3 December 2020 . The Pharma Letter . 29 August 2013.
  47. News: Daiichi Sankyo debuts bone cancer drug Ranmark in Japan . 3 December 2020 . The Pharma Letter . 17 April 2012.
  48. News: Daiichi Sankyo wins approval to compete with Lyrica in Japan . 3 December 2020 . The Pharma Letter . 9 January 2019.
  49. 10.1007/s13300-018-0416-2 . Safety and Efficacy of Teneligliptin in Patients with Type 2 Diabetes Mellitus and Impaired Renal Function: Interim Report from Post-marketing Surveillance . 2018 . Haneda . Masakazu . Kadowaki . Takashi . Ito . Hiroshi . Sasaki . Kazuyo . Hiraie . Sonoe . Ishii . Manabu . Matsukawa . Miyuki . Ueno . Makoto . Diabetes Therapy . 9 . 3 . 1083–1097 . 29637459 . 5984919.
  50. News: Bulik . Beth Snyder . Daiichi Sankyo partners with Crohn's & Colitis Foundation to draw attention to iron deficiency . 3 December 2020 . Fierce Pharma . 1 April 2018.
  51. News: UCB and Daiichi Sankyo's Vimpat approved in Japan . 3 December 2020 . The Pharma Letter . 4 July 2016.
  52. News: Daiichi Sankyo says FDA OKs Welchol for diabetes treatment . 3 December 2020 . Reuters . 18 January 2008.
  53. Web site: Datopotamab deruxtecan – DS-1062 (TROP2 ADC) . ADC Review . 17 December 2020.
  54. News: Hergert . Jessica . Relapsed/Refractory Metastatic NSCLC Tumors Respond to Datopotamab Deruxtecan in Early Trial . 13 May 2021 . Cancer Network . 31 January 2021.
  55. Web site: Patritumab Deruxtecan – U3-1402 – HER3 ADC . ADC Review . 17 December 2020.
  56. News: Seymour . Caroline . Patritumab Deruxtecan Shows Early Activity in Metastatic EGFR-Mutant NSCLC . 13 May 2021 . Targeted Oncology . 30 January 2021.
  57. News: Daiichi Sankyo sets out plans for dissolution of Japan Vaccine . 3 December 2020 . The Pharma Letter . 26 December 2018.
  58. News: Daiichi Sankyo's Oncolytic Virus Gets Orphan Status . 17 December 2020 . Pharma Japan . 12 July 2017.
  59. News: Daiichi Sankyo submits Enhertu sNDA to Japan to treat patients with HER2 mutant metastatic non-small cell lung cancer . 13 April 2023 . PharmaBiz . 14 December 2022.

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