Daiichi Sankyo Company, Limited (Japanese:第一三共株式会社,Hepburn:Daiichi SankyōKabushiki-gaisha) is a globalpharmaceutical company and the second-largest pharmaceutical company inJapan. 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 inBasking Ridge,New Jersey.
Daiichi Sankyo Europe, GmbH (DSE), the European subsidiary, is headquartered inMunich,Germany. The organization is responsible for development and manufacturing for 12 European countries.
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-oldpharmaceutical companies based inJapan.
Sankyo Co., Ltd. was founded byJokichi 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 inMunich.[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]
In 2006, Daiichi Sankyo acquired Zepharma, theOTC drugs unit ofAstellas Pharma. On June 10, 2008, the company agreed to take a majority (64%) stake inIndian generic drug makerRanbaxy, with a deal valued at about $4.6 billion.[13][14]
It acquiredU3 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, aBerkeley, 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 acquireAmbit Biosciences for approximately $410 million, the deal enabled Daiichi to gain the cancer compoundquizartinib.[20] On April 20, 2015, the company announced it had sold off the 8.9% stake inSun Pharmaceutical Industries it acquired when acquiringRanbaxy, 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 acquiredramosetron,nicardipine andbarnidipine from Astellas Pharma in October 2019.[23]
In January 2020, the company's market value rose above JPY 5 trillion after theU.S. Food and Drug Administration approval and release ofEnhertu,[24] anantibody-drug conjugate for cancer treatment.[25] Daiichi Sankyo developed Enhertu in cooperation withAstraZeneca,[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):
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 theFalse Claims Act, an anti-kickback statute.[28]
Daiichi Sankyo agreed to pay the United States and stateMedicaid programs $39 million to settle allegations by theUnited 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 their own staff in their 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 GeneralDaniel R. Levinson for theU.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 ourcorporate integrity agreement we will be closely monitoring Daiichi Sankyo."[28]