is a global
pharmaceutical company
The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate sympto ...
and the second-largest pharmaceutical company in
Japan
Japan ( ja, 日本, or , and formally , ''Nihonkoku'') is an island country in East Asia. It is situated in the northwest Pacific Ocean, and is bordered on the west by the Sea of Japan, while extending from the Sea of Okhotsk in the north ...
. It achieved JPY 981.8 billion in revenue in 2019. The company owns the American biotechnology company
Plexxikon
Plexxikon is an American drug discovery company based in South San Francisco, California. It was co-founded in 2001 by Joseph Schlessinger of Yale University, and Sung-Hou Kim of the University of California, Berkeley.
It uses a proprietary struc ...
, American pharmaceutical company American Regent, German biotechnology company U3 Pharma, and recently sold
Ranbaxy Laboratories
Ranbaxy Laboratories Limited was an Indian multinational pharmaceutical company that was incorporated in India in 1961 and remained an entity until 2014. The company went public in 1973. Ownership of Ranbaxy changed twice over the course of its ...
in India. Daiichi Sankyo Co., Ltd. is the producer of
Benicar
Olmesartan, sold under the trade name Benicar among others, is a medication used to treat high blood pressure, heart failure, and diabetic kidney disease. It is a reasonable initial treatment for high blood pressure. It is taken by mouth. Vers ...
(Olmesartan), an
angiotensin II receptor antagonist
Angiotensin II receptor blockers (ARBs), formally angiotensin II receptor type 1 (AT1) antagonists, also known as angiotensin receptor blockers, angiotensin II receptor antagonists, or AT1 receptor antagonists, are a group of pharmaceuticals tha ...
and top selling drug in the U.S. Global sales of Olmesartan in 2013 were 300.2 billion yen.
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
New Jersey is a state in the Mid-Atlantic and Northeastern regions of the United States. It is bordered on the north and east by the state of New York; on the east, southeast, and south by the Atlantic Ocean; on the west by the Delaware ...
.
Daiichi Sankyo Europe, GmbH (DSE), the European subsidiary, is headquartered in
Munich
Munich ( ; german: München ; bar, Minga ) is the capital and most populous city of the States of Germany, German state of Bavaria. With a population of 1,558,395 inhabitants as of 31 July 2020, it is the List of cities in Germany by popu ...
,
Germany
Germany,, officially the Federal Republic of Germany, is a country in Central Europe. It is the second most populous country in Europe after Russia, and the most populous member state of the European Union. Germany is situated betwe ...
. The organization is responsible for development and manufacturing for 12 European countries.
Daiichi Sankyo Company, Limited is a full member of the
(EFPIA) and of the
(IFPMA).
History
Daiichi Sankyo was established in 2005 through the merger of and , which were century-old
pharmaceutical companies
The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate symptoms. ...
based in
Japan
Japan ( ja, 日本, or , and formally , ''Nihonkoku'') is an island country in East Asia. It is situated in the northwest Pacific Ocean, and is bordered on the west by the Sea of Japan, while extending from the Sea of Okhotsk in the north ...
. Sankyo Co., Ltd. was founded by Dr.
Jokichi Takamine, who patented the isolation of adrenalin. Takamine was also the first president of Sankyo Co., Ltd from March 1913 – July 1922. In 1990, Sankyo acquired Luitpold-Werk Group, a pharmaceutical company based in
Munich
Munich ( ; german: München ; bar, Minga ) is the capital and most populous city of the States of Germany, German state of Bavaria. With a population of 1,558,395 inhabitants as of 31 July 2020, it is the List of cities in Germany by popu ...
. In 2019, Luitpold renamed itself after its American Regent brand. American Regent, now based in the United States, is a subsidiary of Daiichi Sankyo.
Kickbacks
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
The False Claims Act (FCA), also called the "Lincoln Law", is an American federal law that imposes liability on persons and companies (typically federal contractors) who defraud governmental programs. It is the federal government's primary litigat ...
, an anti-
kickback statute.
[ ]
Daiichi Sankyo agreed to pay the United States and state
Medicaid
Medicaid in the United States is a federal and state program that helps with healthcare costs for some people with limited income and resources. Medicaid also offers benefits not normally covered by Medicare, including nursing home care and pers ...
programs $39 million to settle allegations by the
United States Department of Justice
The United States Department of Justice (DOJ), also known as the Justice Department, is a federal executive department of the United States government tasked with the enforcement of federal law and administration of justice in the United State ...
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
The United States Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the U.S. federal government created to protect the health of all Americans and providing essential human services. Its motto is " ...
.
“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 A corporate integrity agreement (CIA) is a document outlining the obligations that a company involved in health care in the United States makes with a federal government agency or a state government as part of a civil settlement. On the federal lev ...
we will be closely monitoring Daiichi Sankyo.”
Acquisitions
In 2006, Daiichi Sankyo acquired Zepharma, the
OTC drugs unit of
Astellas Pharma
is a Japanese multinational pharmaceutical company, formed on 1 April 2005 from the merger of and . On February 5, 2020, the company announced management changes effective from April 1, 2020.
Astellas is a member of the Mitsubishi UFJ Finan ...
. On June 10, 2008, the company agreed to take a majority (64%) stake in
India
India, officially the Republic of India (Hindi: ), is a country in South Asia. It is the seventh-largest country by area, the second-most populous country, and the most populous democracy in the world. Bounded by the Indian Ocean on the so ...
n generic drug maker
Ranbaxy
Ranbaxy Laboratories Limited was an Indian multinational pharmaceutical company that was incorporated in India in 1961 and remained an entity until 2014. The company went public in 1973. Ownership of Ranbaxy changed twice over the course of its ...
, with a deal valued at about $4.6 billion.
It acquired
U3 Pharma U3 or U-3 may refer to:
Transportation
* U3, an underground rapid transit line in many major German/Austrian cities:
** U3 (Berlin U-Bahn)
** U3 (Frankfurt U-Bahn)
** U3 (Hamburg U-Bahn)
** U3 (Munich U-Bahn)
** U3 (Nuremberg U-Bahn)
** U3 (S ...
in June 2008, contributing a therapeutic anti-
HER3 antibody to the company's anticancer portfolio. The company closed U3 Pharma in 2015.
The acquisition of Plexxikon, a
Berkeley, California
Berkeley ( ) is a city on the eastern shore of San Francisco Bay in northern Alameda County, California, United States. It is named after the 18th-century Irish bishop and philosopher George Berkeley. It borders the cities of Oakland and Emer ...
-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.
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. The transaction is set to close in December 2014, pending shareholder, court and regulatory approvals and other customary conditions. On September 29, 2014, Daiichi Sankyo agreed to acquire
Ambit Biosciences Ambit was an American pharmaceutical company focused on development of kinase inhibitor therapeutics to treat a variety of human diseases.The SEC 10K submission for 2013 indicates that the company is a "biopharmaceutical" company, which implies tha ...
for approximately $410 million, the deal enabled Daiichi to gain the Phase III cancer compound
quizartinib
Quizartinib (AC220) is a small molecule receptor tyrosine kinase inhibitor, originally from Ambit Biosciences and later acquired by Daiichi Sankyo, that is currently under development for the treatment of acute myeloid leukaemia. Quizartinib is so ...
. On April 20, 2015, the company announced it had sold off the 8.9% stake in
Sun Pharmaceutical Industries
Sun Pharmaceutical Industries Limited (d/b/a Sun Pharma) is an Indian multinational pharmaceutical company headquartered in Mumbai, that manufactures and sells pharmaceutical formulations and active pharmaceutical ingredients (APIs) in more th ...
it acquired when acquiring
Ranbaxy
Ranbaxy Laboratories Limited was an Indian multinational pharmaceutical company that was incorporated in India in 1961 and remained an entity until 2014. The company went public in 1973. Ownership of Ranbaxy changed twice over the course of its ...
, raising $3.2 billion.
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. The company acquired
ramosetron
Ramosetron (INN) is a serotonin 5-HT3 receptor antagonist for the treatment of nausea and vomiting. Ramosetron is also indicated for a treatment of "diarrhea-predominant irritable bowel syndrome in male and women". In India it is marketed under ...
,
nicardipine
Nicardipine (Cardene) is a medication used to treat high blood pressure and angina. It belongs to the dihydropyridine class of calcium channel blockers (CCBs). It is also used for Raynaud's phenomenon. It is available in by mouth and intravenous ...
and
barnidipine
Barnidipine (INN
Inns are generally establishments or buildings where travelers can seek lodging, and usually, food and drink. Inns are typically located in the country or along a highway; before the advent of motorized transportation they al ...
from Astellas Pharma in October 2019.
In January 2020, the company's market value rose above JPY 5 trillion after the
U.S. Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...
approval and release of
Enhertu,
an
antibody-drug conjugate
Antibody-drug conjugates or ADCs are a class of biopharmaceutical drugs designed as a targeted therapy for treating cancer. Unlike chemotherapy, ADCs are intended to target and kill tumor cells while sparing healthy cells. As of 2019, some 56 phar ...
for cancer treatment. Daiichi Sankyo developed Enhertu in cooperation with
AstraZeneca
AstraZeneca plc () is a British-Swedish multinational pharmaceutical and biotechnology company with its headquarters at the Cambridge Biomedical Campus in Cambridge, England. It has a portfolio of products for major diseases in areas includin ...
,
which agreed in March 2019 to pay up to $6.9 billion to Daiichi Sankyo in exchange for a share of Enhertu's sales. The shutdown of Plexxikon was announced in 2022 as Daiichi Sankyo pivots to focus on more antibody-drug conjugate therapies.
The following is an illustration of the company's major mergers and acquisitions and historical predecessors (this is not a comprehensive list):
Products
This list is not comprehensive.
;Oncology
* Enhertu (
trastuzumab deruxtecan
Trastuzumab deruxtecan, sold under the brand name Enhertu, is an antibody-drug conjugate consisting of the humanized monoclonal antibody trastuzumab (Herceptin) covalently linked to the topoisomerase I inhibitor deruxtecan (a derivative of ...
, fam-trastuzumab deruxtecan-nxki in the United States only)
* Turalio (
pexidartinib
Pexidartinib, sold under the brand name Turalio, is a kinase inhibitor drug for the treatment of adults with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improve ...
)
* Vanflyta (
quizartinib
Quizartinib (AC220) is a small molecule receptor tyrosine kinase inhibitor, originally from Ambit Biosciences and later acquired by Daiichi Sankyo, that is currently under development for the treatment of acute myeloid leukaemia. Quizartinib is so ...
) (available only in Japan)
* Zelboraf (
vemurafenib
Vemurafenib (INN, marketed as Zelboraf) is an inhibitor of the B-Raf enzyme developed by Plexxikon (now part of Daiichi-Sankyo) and Genentech for the treatment of late-stage melanoma.; The name "vemurafenib" comes from V600E mutated BRAF in ...
)
*
*
*
;Cardiovascular
* Benicar (
olmesartan medoxomil
Olmesartan, sold under the trade name Benicar among others, is a medication used to treat high blood pressure, heart failure, and diabetic kidney disease. It is a reasonable initial treatment for high blood pressure. It is taken by mouth. Versio ...
) (also sold as Benicar HCT, Azor, Olmetec, Rezaltas, Sevikar, and Tribenzor)
* Effient (
prasugrel
Prasugrel, sold under the brand name Effient in the US, Australia and India, and Efient in the EU) is a medication used to prevent formation of blood clots. It is a platelet inhibitor and an irreversible antagonist of P2Y12 ADP receptors and is ...
) (co-marketed with
Eli Lilly and Company
Eli Lilly and Company is an American pharmaceutical company headquartered in Indianapolis, Indiana, with offices in 18 countries. Its products are sold in approximately 125 countries. The company was founded in 1876 by, and named after, Colonel ...
; also sold as Efient)
* Lixiana/Savaysa (
edoxaban
Edoxaban, sold under the brand name Lixiana among others, is an anticoagulant medication and a direct factor Xa inhibitor. It is taken Oral administration, by mouth.
Compared with warfarin it has fewer drug interactions.
It was developed by ...
)
* Minnebro (
esaxerenone
Esaxerenone () (brand name Minnebro; developmental code names CS-3150, XL-550) is a nonsteroidal antimineralocorticoid which was discovered by Exelixis and developed by Daiichi Sankyo Company and is approved in Japan for the treatment of hyperte ...
) (available only in Japan)
* Nilemdo (
bempedoic acid
Bempedoic acid, sold under the brand name Nexletol among others, is a medication for the treatment of hypercholesterolemia (high blood cholesterol levels). Text was copied from this source which is © European Medicines Agency. Reproduction is a ...
, only sold in the EU) (also sold as Nustendi)
;Other
* Canalia (
teneligliptin
Teneligliptin (INN; trade name Tenelia) is a pharmaceutical drug for the treatment of type 2 diabetes mellitus. It belongs to the class of anti-diabetic drugs known as dipeptidyl peptidase-4 inhibitors or "gliptins".
Creation
It was created by M ...
,
canagliflozin
Canagliflozin, sold under the brand name Invokana among others, is a medication used to treat type 2 diabetes. It is a third-line medication to be tried after metformin, a first-line medication for type 2 diabetes. It is used together with exe ...
) (available only in Japan)
* Evoxac (
cevimeline
Cevimeline (trade name Evoxac) is a synthetic analog of the natural alkaloid muscarine with a particular agonistic effect on M1 and M3 receptors. It is used in the treatment of dry mouth and Sjögren's syndrome.
Medical uses
Cevimeline is us ...
hydrochloride)
* Injectafer (
ferric carboxymaltose injection)
* Memary (
memantine hydrochloride
Memantine is a medication used to slow the progression of moderate-to-severe Alzheimer's disease. It is taken by mouth.
Common side effects include headache, constipation, sleepiness, and dizziness. Severe side effects may include blood clots ...
) (available only in Japan)
* Nexium (
esomeprazole
Esomeprazole, sold under the brand name Nexium among others, is a medication which reduces stomach acid. It is used to treat gastroesophageal reflux disease, peptic ulcer disease, and Zollinger–Ellison syndrome. Effectiveness is similar to o ...
) (only in Japan; marketed by AstraZeneca elsewhere)
* Pralia (
denosumab
Denosumab (trade names Prolia and Xgeva) is a human monoclonal antibody for the treatment of osteoporosis, treatment-induced bone loss, metastases to bone, and giant cell tumor of bone.
Denosumab is contraindicated in people with low blood calci ...
) (only available in Japan; also sold there as Ranmark)
* Tarlige (
mirogabalin
Mirogabalin (brand name Tarlige; developmental code name DS-5565) is a medication developed by Daiichi Sankyo, a gabapentinoid. Gabapentin and pregabalin are also members of this class. As a gabapentinoid, mirogabalin binds to the α2δ subu ...
) (only available in Japan)
* Tenelia (
teneligliptin
Teneligliptin (INN; trade name Tenelia) is a pharmaceutical drug for the treatment of type 2 diabetes mellitus. It belongs to the class of anti-diabetic drugs known as dipeptidyl peptidase-4 inhibitors or "gliptins".
Creation
It was created by M ...
hydrobromide In chemistry, a hydrobromide is an acid salt resulting, or regarded as resulting, from the reaction of hydrobromic acid with an organic base (e.g. an amine). The compounds are similar to hydrochlorides.
Some drugs are formulated as hydrobromides, ...
hydrate)
* Venofer (
iron sucrose
Intravenous iron sucrose is a commonly used treatment for iron deficiency anemia. Iron sucrose replaces iron in the blood to foster red blood cell production in patients with chronic kidney disease. Iron sucrose has the trade name Venofer.
Chem ...
)
* Vimpat (
lacosamide
Lacosamide, sold under the brand name Vimpat among others, is a medication used for the treatment of partial-onset seizures and primary generalized tonic-clonic seizures. It is used by mouth or intravenously.
It is available as a generic medic ...
) (only available in Japan; co-marketed with
UCB)
* Welchol (
colesevelam
Colesevelam is a bile acid sequestrant administered orally. It was developed by GelTex Pharmaceuticals and later acquired by Genzyme. It is marketed in the U.S. by Daiichi Sankyo under the brand name Welchol and elsewhere by Genzyme as Cholestage ...
HCl)
Pipeline candidates
Select mid-stage and late-stage investigational candidates in Daiichi-Sankyo's pipeline include:
*
Datopotamab deruxtecan (Dato-DXd)
*
Patritumab deruxtecan (HER3-DXd)
* VN-0102
*
Valemetostat
* DS-1647
References
Daiichi Sankyo Annual Report 2008
External links
Daiichi Sankyo
* Wiki collection of bibliographic works on Daiichi Sankyo
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