Daiichi Sankyo Company, Limited is the second largest pharmaceutical company in Japan and the 17th largest in the world. It is a global holding company which sells products and services in over 50 countries, including the US.
Daiichi Sankyo Company, Limited is headquartered in Tokyo with a history of two separate companies, now merged, reaching back to 1899. It is headquartered in Japan and 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
- Kitasato Daiichi Sankyo Vaccine Co., Ltd. – research, strategy and vaccines based in Japan
- ASCA Company – strategic development company for regions outside of Japan, US and EU
- Daiichi Sankyo Europe, GmbH (DSE) – headquartered in Munich, Germany
- 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 larges worldwide generic manufacturers
- Daiichi Sankyo, Inc. (DSI) – headquartered in New Jersey
- Daichi Sankyo Pharma Development – headquartered in New Jersey
- Plexxikon – an American biotech research company
- Luitpold Pharmaceuticals, Inc. – Drug and device development and marketing for institutions in US and Canada
In 2013, Daiichi revenues were reported at over $11 billion. Daiichi manufacturers the anti-hypertensive medication Benicar (olmesartan medoxomil) which, 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.
History of Daiichi Sankyo
Daiichi Sankyo Company, Limited is a pharmaceutical and health products holding company. A holding company is the corporate shell which serves as the management for a number of separate corporations. Daiichi Sankyo was founded in 2005 through the merger of two separate companies in Japan; Daiichi and Sankyo.
Sankyo Shoten was formed in 1899 and was the original producer of “Adrenalin”, the pharmaceutical form of the naturally occurring neurotransmitter epinephrine, still in use today for medical emergencies. The name of the company was changed to Sankyo Co. Ltd. In 1913. The company 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 Benicar (olmesartan) in the US in 2002.
Arsemin Shokai was founded in 1915 with the launch of “Arsemin”, a medication for syphilis. In 1918, the company nake 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.
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.
Since its merger, Daiichi Sankyo has acquired U3 and Plexxikon, both biotech research and development companies; launched a joint vaccine venture with Glaxo-Smith Kline; and has operations in over 50 countries worldwide. In 2008, Daiichi Sankyo paid $4.6 billion to acquired a substantial stake in the Indian generics manufacturer, Ranbaxy.
Daiichi Sankyo and Ranbaxy
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 include:
- 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 lost over Ranbaxy difficulties, the majority share of Ranbaxy was sold to Sun Pharmaceuticals for $3.2 billion. Daiichi Sankyo still maintains a 9 percent interest in Ranbaxy.
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.
Daiichi Sankyo developed the first “glitazone”, a particular class of anti-diabetic medication which is used for Type 2 diabetes, also known as Adult-onset Diabetes (AOD) or Non-insulin Dependent Diabetes Mellitus (NIDDM). The glitazone class of anti-diabetics is also known as thiazolidinediones and includes medications such as pioglitazone (Actos) and rosiglitazone (Avandia) which are still on the market.
The first glitazone troglitazone (Rezulin) 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.
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. 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.
Benicar is the only member of the ARB class of anti-hypertensives which has been reported to cause GI disturbances. 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 is facing a number of lawsuits filed in relation to those who were seriously injured by Benicar use. Olmesartan is included in a two additional combination anti-hypertensive products including Azor and Benicar HCT, both of which will have the same health risks.
Daiichi Sankyo in the Future
Daiichi Sankyo has partnered with another Japanese company, Mitsubishi Tanabe Pharma Corporation for promotion of two anti-diabetics, teneligliptin and canagliflozin and plans to reorganize some of its subsidiaries in 2015. It filed for approval of edoxaban, an anticoagulant medication in January of 2014. The medication will compete with Pradaxa, and Eliquis, other anti-platelet medications which have already been shown to cause significant risk.
Daiichi Sankyo launched the TaNeDs Global Programme (Take a New Challenge for Drug Discovery) in Japan in 2011 to encourage drug discovery in universities and research institutes and has expanded the program to include all EU member countries plus Norway and Switzerland. The focus of research is cancer, cardiovascular and metabolic and biologic therapies.