About Daiichi Sankyo
Daiichi Sankyo Company, Limited is the second largest pharmaceutical company in Japan. It is a global holding company which sells products and services in over 20 countries, including the U.S. and has 16,000 employees worldwide. In 2021, Daiichi Sankyo annual revenues were estimated at $10 billion.
Daiichi Sankyo Co, Ltd is headquartered in Tokyo and was formed in 2005 from the merger of two separate companies, Sankyo Co. and Daiichi Pharmaceutical Co. whose histories reach back to 1899. Daiichi Sankyo was responsible for the original discovery and production of “Adrenalin”, a pharmaceutical form of the naturally occurring neurotransmitter, epinephrine and has been a pioneer in the cardiovascular, gastrointestinal and immunology markets.
The company has additional subsidiaries and business units including:
- Daiichi Sankyo Healthcare Co., Ltd. – non-prescription medications based in Japan
- ASCA Company – strategic development company for regions outside of Japan, US, and EU
- Daiichi Sankyo Pharmaceutical Co., Ltd.
- Daiichi Sankyo, Inc. (DSI) – U.S. subsidiary, headquartered in New Jersey
- Daiichi Sankyo Europe, GmbH (DSE) – headquartered in Munich, Germany
- American Regent – drugs and medical devices for healthcare professionals, clinics and hospitals across the United States and Canada
- U3 – a German biotech research company
- Daiichi Sankyo Development Ltd. – prescription drug development headquartered in UK
- Daiichi Sankyo Holdings Co., Ltd. – headquartered in China
- Ranbaxy Laboratories, Ltd. – an India-based pharmaceutical company which is one of the largest worldwide generic manufacturers
- Daichi Sankyo Pharma Development – headquartered in New Jersey
- Daiichi Sankyo Espha Co., Ltd.
- Plexxikon – an American biotech research company
- Luitpold Pharmaceuticals, Inc. – Drug and device development and marketing for institutions in US and Canada
- Kitasato Daiichi Sankyo Vaccine Co., Ltd. – research, strategy and vaccines based in Japan
- Japan Vaccine Co., Ltd. Joint Venture with GlaxoSmithKline K.K.
Daiichi manufacturers the anti-hypertensive medication Benicar (olmesartan medoxomil) which was the second highest selling brand name anti-hypertensive in the US in 2013 and accounted for $3.1 billion in worldwide revenue for the company.
In 2013, the Food and Drug Administration issued a warning related to Benicar, stating that the medication could lead to serious side effects such as chronic diarrhea with substantial weight loss. Benicar is the only medication of the ARB class of anti-hypertensives that has been shown to cause this serious problem and has been the subject of numerous drug injury lawsuits.
More recently, the company has faced lawsuits over accusations of drug injury due to hypophosphatemia caused by Injectafer (ferric carboxymaltose) injection, used to treat iron deficiency anemia.
History of Daiichi Sankyo
Daiichi Sankyo Company, Limited is a pharmaceutical and health products company which was founded in 2005 through the merger of two separate companies in Japan: Daiichi and Sankyo. The company is based in Tokyo with U.S. Headquarters located in New Jersey.
Japanese company, Sankyo Shoten was formed in 1899 and was the original producer of “Adrenalin”, the pharmaceutical form of the naturally occurring neurotransmitter epinephrine and still in use today for medical emergencies. The name of the company was changed to Sankyo Co. Ltd. In 1913. Sankyo went public on the Tokyo Stock Exchange in 1949 and continued to produce cold medications, antibiotics, analgesics, vitamins, anti-cholesterol medications, anti-hypertensive medications, and anti-diabetics along with agricultural products. Sankyo launched angiotensin II receptor blocker (ARB) Benicar (olmesartan), for high blood pressure in the US in 2002.
A separate Japanese pharmaceutical company, Arsemin Shokai was founded in 1915 with the launch of “Arsemin”, a medication for syphilis. In 1918, the company name was changed to Daiichi Pharmaceutical co., Ltd. The company produced Bosmin for asthma and Therapol, a sulfa-type antibiotic before going public in 1949 and continued to produce digestive products, antibiotics, immunology products, pain medications, blood clotting agents and vitamin products until merger.
Daiichi Pharmaceutical and Sankyo Co. merged in 2005 under the name Daiichi Sankyo Company, Limited with headquarters in Tokyo, Japan. The company has since continued to launch medications for dysuria, anti-clotting, anti-hypertensives, antivirals, CNS medications, anti-cancer agents, and GI medications including the blockbuster “Nexium” for esophageal reflux and peptic ulcers.
In 2006, Daiichi Sankyo, Inc. (DSI) was established as the U.S. subsidiary of Daiichi Sankyo and is headquartered in Basking Ridge, New Jersey. Currently, Daiichi Sankyo is focused on cardiovascular medicine, immunology, oncology, and hemodynamics along with other areas.
Since its merger, Daiichi Sankyo has acquired a number of biotech and pharma companies, launched a joint vaccine venture with Glaxo-Smith Kline, and in 2008, Daiichi Sankyo paid $4.6 billion to acquire a substantial stake in the Indian generics manufacturer, Ranbaxy which was later sold as part of divestment package.
Major acquisitions include:
- U3 Pharma (2008)
- Ranbaxy (2008) – divested in 2014
- Zepharma, OTC unit of Astellas (2006)
- Plexxicon (2011)
- Ambit Biosciences (2014)
- IM Co., Ltd. (2015)
Daiichi Sankyo Products
Current research and development at Daiichi Sankyo is focused on cardiovascular medicine, immunology, oncology and specialty medicines.
Currently manufactured and marketed medications include:
- Lixiana/Savaysa (edoxaban)
- Minnebro (esaxerenone)
- Olmetec/Sevikar (olmesartan)
- Sevikar HCT (olmesartan, hydrochlorothiazide)
- Rezaltas (olmesartan, azelnidipine)
- Nilemdo (bempedoic acid)
- Nustenzi (bempedoic acid, ezetimibe)
- Enhertu (fam-trastuzumab deruxetan-nxki)
- Turalio (pexidartinib)
- Injectafer (ferric carboxymaltose)
- Venofer (iron sucrose)
- Vanflyta (quizartinib)
- Canalia (tenigliptin, canagliflozin)
- Emgality (galcanezumab-gnlm)
- Pralia/Ranmark (denosumab)
- Tarlige (mirogabalin)
- Tenelia (teneligliptin hydrobromide hydrate)
- Vimpat (lacosamide)
- Influenza HA Vaccine
- H5N1 Vaccine
- Measles/Rubella Vaccine
- Mumps Vaccine
Legacy products which are no longer manufactured by Daiichi Sankyo but may still be available by other manufacturers include:
A number of other pharmaceutical products are exclusively available in Japan.
Daiichi Sankyo and Ranbaxy
Daiichi Sankyo acquired a substantial stake in Indian generics manufacturer, Ranbaxy in 2008. The Ranbaxy acquisition was intended to ensure Daiichi Sankyo’s place in the big-pharma arena but many of the products have been deemed unsafe by the FDA.
Some of Ranbaxy’s FDA interactions included:
- FDA warnings, alerts and bans regarding imports which may not meet US specifications
- FDA drug applications blocked after falsified data was discovered
- Criminal charges and fines of over $500 million
- Recalls of nearly 500 thousand bottles of atorvastatin (generic Lipitor)
In April of 2014 after $ billions were lost over Ranbaxy difficulties; the majority share of Ranbaxy was sold to Sun Pharmaceuticals for $3.2 billion. Daiichi Sankyo later completed divestment of the remaining 9% in a stock exchange deal.
Other Daiichi Sankyo Product Liabilities
Though Ranbaxy products produced a number of problems and losses in revenue for Daiichi Sankyo, other products have caused significant issues as well, including Rezulin, Benicar and more recently, Injectafer.
Daiichi Sankyo and Rezulin
Daiichi Sankyo developed Rezulin (troglitazone), the first “glitazone” anti-diabetic. This class of anti-diabetic medications is also known as thiazolidinediones (TZD) which are used to treat Type 2 diabetes. Other TZDs include Actos (pioglitazone) and Avandia (rosiglitazone).
Rezulin (troglitazone) was developed by Daiichi Sankyo and approved for the US market in 1997, to be manufactured and marketed by the US pharmaceutical company, Parke Davis. That same year, it was withdrawn from the UK market due to liver toxicity. It was removed from the US market in 2000, only 3 years after its introduction and from Japan, shortly afterwards. Pharma giant Pfizer acquired Rezulin’s manufacturer, Parke Davis and has faced numerous drug injury lawsuits for serious side effects caused by Rezulin, most of which were settled by 2009.
Avandia and Actos remain on the market today, but both have been restricted due to severe risks such as heart attack, congestive heart failure and bladder cancer. A number of other TZDs were never approved and no additional drugs have been developed in this category.
Daiichi Sankyo and Benicar
Benicar (olmesartan medoxomil) is an angiotensin II receptor antagonist or ARB. It is used to treat high blood pressure and was originally developed by Sankyo in 1995, to be introduced to the US market in 2002. Benicar has been shown to cause severe intestinal problems such as “sprue-like enteropathy” which has symptoms of severe and chronic diarrhea with substantial weight loss.
The ARB class of anti-hypertensives includes 6 different “sartans” but Benicar is the only member which has been reported to cause GI disturbances. In addition, the ARB class of medications has been investigated for an increased risk of myocardial infarction (heart attack) and for an increased risk of cancer, but studies have shown conflicting results and no direct link has been established.
Daiichi Sankyo has faced thousands of lawsuits filed by those who were seriously injured by Benicar use. Olmesartan is one ingredient in several combination anti-hypertensive products including Azor, Tribenzor, Benicar HCT, Sevikar HCT, and Rezaltas which will have the same health risks.
Daiichi Sankyo lost patent protection for Benicar in 2013 and sold the brand and sister-medications to other manufacturers. The company still makes olmesartan products including a number of authorized generics and combination products.
Daiichi Sankyo was also charged under the False Claims Act by the Department of Justice and was required to pay $39 million in fines for Benicar, due to misleading and aggressive marketing and kickbacks which were provided to healthcare professionals.
Daiichi Sankyo in the Future
Daiichi Sankyo has partnered with other companies both in and outside of the U.S. for promotion, manufacturing and co-marketing and has recently reorganized its subsidiaries into fewer business units. The company has focused its concentration into three major areas: cardiovascular, oncology and immunology but maintains other medication production.
Much of Daiichi Sankyo’s product development is in the monoclonal antibody (mab) area of new medications which are used in a number of disease treatment areas. The oncology treatment division has four drugs which have been submitted for approval for the treatment of breast cancer, gastric cancer, and lung cancers, along with dozens of drugs in clinical testing trials and has multiple products in immunology and other areas in development.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.