Daiichi Sankyo

Japanese pharmaceutical company

Daiichi Sankyo Company, Limited

Native name

| 第一三共株式会社

Romanized name

| Daiichi Sankyō kabushiki gaisha
Company type| Public

Traded as

| TYO: 4568
TOPIX Large 70 Component
TOPIX 100 Component
Nikkei 225 Component
Industry| Pharmaceutical
Predecessors|

* Daiichi Pharmaceutical Company
* Sankyo Company
* Zepharma
* Ambit Biosciences

Founded| 2005; 20 years ago (2005), in Tokyo, Japan (by merger)
Headquarters| Daiichi Sankyo Building A/B 3-5-1, Nihonbashi-honcho, Chūō-ku, Tokyo 103–8426, Japan

Key people

* Sunao Manabe (Representative Director and CEO)
* Hiroyuki Okuzawa (Representative Director, President and COO)[1]
* Ken Keller (President and CEO, Daiichi Sankyo, Inc.)[2]

Products|

* Medical equipment
* Pharmaceutical products
* Veterinary medicines

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)[3]

Number of employees

| 17,435 (as of May 2023)[4]
Website| www.daiichisankyo.com
Footnotes / references
[5]

Daiichi Sankyo Company, Limited (Japanese: 第一三共株式会社, Hepburn: Daiichi Sankyō Kabushiki-gaisha) is a global pharmaceutical company and the second-largest pharmaceutical company in Japan. It achieved JPY 1,278 billion in revenue in 2022.[3] 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

[edit]

Daiichi Sankyo was established in 2005 through the merger of Sankyo Company, Limited (三共株式会社, Sankyō Kabushiki Kaisha) and Daiichi Pharmaceutical Company, Limited (第一製薬株式会社, Daiichi Seiyaku Kabushiki Kaisha), which were century-old pharmaceutical companies based in Japan.

Sankyo Co., Ltd. was founded by Jokichi Takamine, who patented the isolation of adrenaline.[6][7] Takamine was president of Sankyo Co., Ltd from March 1913 until July 1922.[8]

In 1990, Sankyo acquired the German Luitpold-Werk Group, a pharmaceutical company based in Munich.[9] In 2019, Luitpold renamed itself after its American Regent brand.[10] American Regent, now based in the United States, is a subsidiary of Daiichi Sankyo.[11][12]

### Acquisitions

[edit]

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.[13][14]

It acquired U3 Pharma in June 2008, contributing a therapeutic anti-HER3 antibody to the company's anticancer portfolio.[15] The company closed U3 Pharma in 2015.[16]

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.[17] The shutdown of Plexxikon was announced in 2022[18] as Daiichi Sankyo pivots to focus on more antibody-drug conjugate therapies.[19]

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.[20] 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.[21]

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.[22] The company acquired ramosetron, nicardipine and barnidipine from Astellas Pharma in October 2019.[23]

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,[24] an antibody-drug conjugate for cancer treatment.[25] Daiichi Sankyo developed Enhertu in cooperation with AstraZeneca,[24] which agreed in March 2019 to pay up to $6.9 billion to Daiichi Sankyo in exchange for a share of Enhertu's sales.[26][27]

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

Daiichi Sankyo

|  |

|  |

|  |

|  |

| Daiichi Sankyo  |

|  |

Sankyo Company, Limited

|

Daiichi Pharmaceutical Company, Limited

Zepharma
(Acq 2006)

|  |

Ranbaxy Laboratories
(Acq 2008)

|

|  |

U3 Pharma
(Acq 2008)

|

|  |

Plexxikon
(Acq 2011)

|

|  |

Ambit Biosciences
(Acq 2014)

|

### Kickbacks, 2015

[edit]

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.[28]

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.[28] 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.[28] 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.[28]

“Schemes such as this are particularly abhorrent,” said Inspector General Daniel R. Levinson for the U.S. Department of Health and Human Services.[28] “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.”[28]

## Products

[edit]

This list is not comprehensive.[29]

Oncology

* Enhertu (trastuzumab deruxtecan, fam-trastuzumab deruxtecan-nxki in the United States only)[30]
* Ezharmia (valemetostat) (available only in Japan)[31]
* Turalio (pexidartinib) (available only in the United States)[32]
* Vanflyta (quizartinib) [33][34]
* Zelboraf (vemurafenib)[35][36]
*   *   *

Cardiovascular

* Effient (prasugrel) (co-marketed with Eli Lilly and Company; also sold as Efient)[37]
* Lixiana/Savaysa (edoxaban)[38][39]
* Minnebro (esaxerenone) (available only in Japan)[40]
* Nilemdo (bempedoic acid, only sold in the EU)[41]
* Nustendi (fixed dose combination of bempedoic acid and ezetimibe) [42]

Other

* Canalia (teneligliptin, canagliflozin) (available only in Japan)[43]
* Evoxac (cevimeline hydrochloride)[44]
* Injectafer (ferric carboxymaltose injection)[45]
* Memary (memantine hydrochloride) (available only in Japan)[46]
* Nexium (esomeprazole) (only in Japan; marketed by AstraZeneca elsewhere)[47]
* Pralia (denosumab)[48] (only available in Japan; also sold there as Ranmark)[49]
* Tarlige (mirogabalin) (only available in Japan)[50]
* Tenelia (teneligliptin hydrobromide hydrate)[51]
* Venofer (iron sucrose)[52]
* Vimpat (lacosamide) (only available in Japan; co-marketed with UCB)[53]
* Welchol (colesevelam HCl)[54]

## Pipeline candidates

[edit]

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

* Datopotamab deruxtecan (Dato-DXd)[55][56]
* Patritumab deruxtecan (HER3-DXd)[57][58]
* VN-0102[59]
* DS-1647[60]
* Ifinatamab deruxtecan (I-DXd; DS-7300)[61]
* Raludotatug deruxtecan (R-DXd; DS-6000) An antibody-drug conjugate (ADC) composed of a humanized immunoglobulin G1 (IgG1) monoclonal antibody against the tumor-associated antigen (TAA) cadherin-6 (CDH6) conjugated to deruxtecan (DXd), a cytotoxic DNA topoisomerase I inhibitor.

## References

[edit]

1. ^ "Our Leadership - Our Mission & Strengths - About Us". Daiichi Sankyo. Retrieved 13 April 2023.
2. ^ "Corporate Management Information". Daiichi Sankyo US. Retrieved 13 April 2023.
3. ^ a b "Consolidated Financial Results for Year Ended March 31, 2023 (Fiscal 2022)" (PDF). Daiichi Sankyo. 27 April 2023. Retrieved 18 May 2023.
4. ^ "About Us". Daiichi Sankyo. Retrieved 15 May 2023.
5. ^ "Value Report 2020" (PDF). Daiichi Sankyo Group. 31 March 2020. p. 45. Retrieved 30 November 2020.
6. ^ Bennett, Joan. "The Time Line: Adrenalin and cherry trees". pubs.acs.org. Retrieved 24 January 2016.
7. ^ Kawakami, K. K. (1928). Jokichi Takamine: A Record of his American Achievements. New York: William Edwin Rudge.
8. ^ "13th Takamine Memorial Daiichi Sankyo Prize Winner Announced - Media & Investors - Daiichi Sankyo". www.daiichisankyo.com. Retrieved 24 January 2016.
9. ^ "Sankyo Buys Drug Maker". The New York Times. 19 January 1990. Retrieved 17 December 2020.
10. ^ "Luitpold Pharmaceuticals Renamed American Regent". American Pharmaceutical Review. 2 January 2019. Retrieved 17 December 2020.
11. ^ "Daiichi Sankyo creates new biz unit for oncology". BioSpectrum Asia. 13 November 2020. Retrieved 17 December 2020.
12. ^ "Leadership Transitions Upcoming at Daiichi Sankyo, American Regent". PharmaLive. 7 December 2020. Retrieved 17 December 2020.
13. ^ "Ranbaxy-Daiichi marriage: Implications for Indian pharma". June 11, 2008. Retrieved April 29, 2014.
14. ^ "Ranbaxy promoters to sell stake to Japan's Daiichi". June 11, 2008. Retrieved April 29, 2014.
15. ^ "Daiichi Sankyo Intends to Purchase U3 Pharma for Roughly $236M". Genetic Engineering & Biotechnology News. Mary Ann Liebert, Inc. May 21, 2008. Retrieved July 6, 2008.
16. ^ White, Victoria (1 December 2015). "Daiichi Sankyo to close research subsidiary U3 Pharma". Drug Target Review. Archived from the original on 2021-05-20. Retrieved 1 December 2020.
17. ^ "Daiichi Sankyo To Acquire Plexxikon". Plexxikon. February 28, 2011. Archived from the original on 2011-03-06. Retrieved April 29, 2014.
18. ^ Wells, Madeline (2022-01-12). "South SF company bought for $800 million is being shut down". SFGATE. Archived from the original on 2022-01-12.
19. ^ Taylor, Nick P. (2022-01-12). "Daiichi axes 60-person Plexxikon R&D facility in California to free up cash for ADC development". Fierce Biotech. Archived from the original on 2022-01-12.
20. ^ "GEN - News Highlights:Daiichi Sankyo to Acquire Ambit Biosciences for Up to $410M". GEN. 2014-09-29.
21. ^ "GEN - News Highlights:Daiichi Sankyo Sells Off Stake in Sun Pharma". GEN. 2015-04-21.
22. ^ "Daiichi Sankyo splits to offload old assets and focus on oncology ambition". The Pharma Letter. 1 August 2018. Retrieved 1 December 2020.
23. ^ "Daiichi Sankyo buys three drugs to boost presence in Asia". The Pharma Letter. 15 October 2019. Retrieved 1 December 2020.
24. ^ a b Takada, Noriyuki; Kawana, Yukihiro; Sakabe, Yoshinaru (28 January 2020). "Daiichi Sankyo harnesses 'old' R&D to strike cancer drug gold". Nikkei Asia. Retrieved 1 December 2020.
25. ^ Matsuyama, Kanoko (16 June 2019). "Drug devised to replace chemotherapy may reshape cancer care". The Japan Times. Retrieved 1 December 2020.
26. ^ Terry, Mark (29 March 2019). "AstraZeneca and Daiichi Sankyo Sign $6.9 Billion Deal for a Single Cancer Drug". BioSpace. Retrieved 1 December 2020.
27. ^ Tatelbaum, Julianna (29 March 2019). "Global pharma giant AstraZeneca strikes $6.9 billion deal to expand cancer portfolio". CNBC. Retrieved 1 December 2020.
28. ^ a b c d e f "Daiichi Sankyo Inc. Agrees to Pay $39 Million to Settle Kickback Allegations Under the False Claims Act". Office of Public Affairs. U.S. Department of Justice. 2015-01-09. Retrieved 2016-04-06. This article incorporates text from this source, which is in the public domain.
29. ^ "Products - Daiichi Sankyo". Daiichi Sankyo. Retrieved June 15, 2021.
30. ^ "AZ, Daiichi Sankyo get early okay for DS-8201, now named Enhertu". PMLive. 23 December 2019. Retrieved 3 December 2020.
31. ^ "Dual EZH1 and EZH2 inhibitor Ezharmia launched in Japan". The Pharma Letter. 20 December 2022. Retrieved 13 April 2023.
32. ^ Taylor, Phil (5 August 2019). "Daiichi Sankyo's pexidartinib is first FDA-approved drug for rare tumour". Pharma Phorum. Retrieved 3 December 2020.
33. ^ Idrus, Amirah Al (21 June 2019). "FDA nixes Daiichi's blood cancer drug quizartinib after Japanese regulators wave it through". Fierce Biotech. Retrieved 3 December 2020.
34. ^ "VANFLYTA (quizartinib), FDA Approved in the U.S. for Newly Diagnosed FLT3-ITD Positive Acute Myeloid Leukemia, Available at Biologics by McKesson | McKesson". www.mckesson.com. Retrieved 2023-08-07.
35. ^ "First-in-class skin cancer drug approved". PMLive. 18 August 2011. Retrieved 13 May 2021.
36. ^ "Products". Daiichi Sankyo. Retrieved 2 December 2020.
37. ^ "Daiichi Sankyo says prasugrel hits goals in thrombotic stroke study". The Pharma Letter. 21 July 2020. Retrieved 3 December 2020.
38. ^ Weinberg, Ido (9 January 2015). "FDA approves edoxaban to reduce stroke risk, treat DVT and PE". Healio. Retrieved 3 December 2020.
39. ^ "FDA approves Daiichi Sankyo bloodthinner Savaysa". PharmaTimes. 9 January 2015. Retrieved 3 December 2020.
40. ^ Terry, Mark (8 November 2019). "Daiichi Sankyo's Hypertension Drug Hits Mark in Diabetic Nephropathy Trial". BioSpace. Retrieved 3 December 2020.
41. ^ "EC nod for Daiichi Sankyo's cholesterol lowerers Nilemdo and Nustendi". The Pharma Letter. 6 April 2020. Retrieved 13 May 2021.
42. ^ "EC nod for Daiichi Sankyo's cholesterol lowerers Nilemdo and Nustendi". The Pharma Letter. 6 April 2020. Retrieved 13 May 2021.
43. ^ "New combination therapy for type 2 diabetes approved in Japan". The Pharma Letter. 3 July 2017. Retrieved 3 December 2020.
44. ^ Dey, Sushmi (9 October 2012). "Ranbaxy launches authorised generic of Daiichi's Evoxac in US". Business Standard India. Retrieved 13 May 2021.
45. ^ Steinberg, Julie (29 July 2020). "Daiichi Sankyo Still Faces Claims Over Injectable Anemia Drug". Bloomberg Law. Retrieved 3 December 2020.
46. ^ "Daiichi Sankyo Looking to Establish "Base Treatment" Position for Memary". Pharma Japan. 23 April 2012. Retrieved 3 December 2020.
47. ^ "AZ pockets $100 million in Daiichi Sankyo deal for Nexium". PharmaTimes. 29 October 2010. Retrieved 3 December 2020.
48. ^ "Daiichi Sankyo files Ranmark to treat giant cell tumor of bone in Japan". The Pharma Letter. 29 August 2013. Retrieved 3 December 2020.
49. ^ "Daiichi Sankyo debuts bone cancer drug Ranmark in Japan". The Pharma Letter. 17 April 2012. Retrieved 3 December 2020.
50. ^ "Daiichi Sankyo wins approval to compete with Lyrica in Japan". The Pharma Letter. 9 January 2019. Retrieved 3 December 2020.
51. ^ Haneda, Masakazu; Kadowaki, Takashi; Ito, Hiroshi; Sasaki, Kazuyo; Hiraie, Sonoe; Ishii, Manabu; Matsukawa, Miyuki; Ueno, Makoto (2018). "Safety and Efficacy of Teneligliptin in Patients with Type 2 Diabetes Mellitus and Impaired Renal Function: Interim Report from Post-marketing Surveillance". Diabetes Therapy. 9 (3): 1083–1097\. doi:10.1007/s13300-018-0416-2. PMC 5984919. PMID 29637459.1083-1097&rft.date=2018&rft_id=https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5984919#id-name=PMC&rft_id=info:pmid/29637459&rft_id=info:doi/10.1007/s13300-018-0416-2&rft.aulast=Haneda&rft.aufirst=Masakazu&rft.au=Kadowaki,+Takashi&rft.au=Ito,+Hiroshi&rft.au=Sasaki,+Kazuyo&rft.au=Hiraie,+Sonoe&rft.au=Ishii,+Manabu&rft.au=Matsukawa,+Miyuki&rft.au=Ueno,+Makoto&rft_id=https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5984919&rfr_id=info:sid/en.wikipedia.org:Daiichi+Sankyo" class="Z3988">
52. ^ Bulik, Beth Snyder (1 April 2018). "Daiichi Sankyo partners with Crohn's & Colitis Foundation to draw attention to iron deficiency". Fierce Pharma. Retrieved 3 December 2020.
53. ^ "UCB and Daiichi Sankyo's Vimpat approved in Japan". The Pharma Letter. 4 July 2016. Retrieved 3 December 2020.
54. ^ "Daiichi Sankyo says FDA OKs Welchol for diabetes treatment". Reuters. 18 January 2008. Retrieved 3 December 2020.
55. ^ "Datopotamab deruxtecan – DS-1062 (TROP2 ADC)". ADC Review. Retrieved 17 December 2020.
56. ^ Hergert, Jessica (31 January 2021). "Relapsed/Refractory Metastatic NSCLC Tumors Respond to Datopotamab Deruxtecan in Early Trial". Cancer Network. Retrieved 13 May 2021.
57. ^ "Patritumab Deruxtecan – U3-1402 – HER3 ADC". ADC Review. Retrieved 17 December 2020.
58. ^ Seymour, Caroline (30 January 2021). "Patritumab Deruxtecan Shows Early Activity in Metastatic EGFR-Mutant NSCLC". Targeted Oncology. Retrieved 13 May 2021.
59. ^ "Daiichi Sankyo sets out plans for dissolution of Japan Vaccine". The Pharma Letter. 26 December 2018. Retrieved 3 December 2020.
60. ^ "Daiichi Sankyo's Oncolytic Virus Gets Orphan Status". Pharma Japan. 12 July 2017. Retrieved 17 December 2020.
61. ^ "Daiichi Sankyo submits Enhertu sNDA to Japan to treat patients with HER2 mutant metastatic non-small cell lung cancer". PharmaBiz. 14 December 2022. Retrieved 13 April 2023.

* Daiichi Sankyo Annual Report 2008

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