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Daiichi Sankyo

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Daiichi Sankyo is a global pharmaceutical holding company and the second largest drug company in Japan. It faces lawsuits over its blood pressure drug Benicar, which can cause serious gastrointestinal side effects.

Daiichi Sankyo (Die-EE-chee SANK-yo) Company, Limited, makes pharmaceuticals for use by humans and animals and manufactures medical tools and equipment. It also produces food, food additives, livestock feeds and agrochemicals and researches and promotes products through related companies throughout the world.

Its top-selling hypertensive drug, Benicar (olmesartan medoxomil), brought in $3.1 billion in worldwide sales in the 2013 fiscal year and $2.4 billion in the 2014 fiscal year. The lucrative patent expires in 2016, but the drug has been causing legal headaches for the company.

The U.S. Food and Drug Administration (FDA) in 2013 warned Benicar can lead to serious health issues like chronic diarrhea and substantial weight loss. Injured patients began filing lawsuits against Daiichi Sankyo soon after the warning.Daiichi Sankyo Company, Limited

The company has a global reach, providing products and services in more than 50 countries. The company includes four functional units – R&D (research and development), Pharmaceutical Technology, Supply Chain and Quality & Safety.

It has seven business units, including U.S. subsidiary Daiichi Sankyo Inc., located in Parsippany, New Jersey. The U.S. company markets a range of treatments for hypertension, heart disease, diabetes and hyperlipidemia/atherosclerosis. The other units are:

  • Japan Company (maximizes business performance in Japan)
  • Vaccine Business Intelligence Division (enhances investment strategies for vaccine research, production, and business tie-up and development for Kitasato Daiichi Sankyo Vaccine Co., Ltd.)
  • Daiichi Sankyo Healthcare Co., Ltd. (develops, manufactures and sells non-prescription products and medications in Japan)
  • Luitpold Pharmaceuticals, Inc. (develops and markets drugs and medical devices for health care professionals, clinics and hospitals in U.S. and Canada)
  • Daiichi Sankyo Europe GmbH (subsidiary does business in 12 European countries)
  • ASCA Company (develops strategies for regions outside Japan, U.S. and Europe)
  • Ranbaxy Laboratories Ltd. (one of the world’s top generic manufacturers)
Fast Facts about Daiichi Sankyo
Established: 2005
President and CEO: Joji Nakayama
Headquarters: Tokyo
Size: 30,000 employees worldwide
2014 Revenue: $7 billion

History

Daiichi Sankyo is a holding company that was established in 2005 through a merger of Sankyo and Daiichi Pharmaceutical, but its roots go back more than a century.

Sankyo Shoten was founded in 1899 through a joint investment by businessmen Matasaku Shiobara, Shotaro Nishimura and Genjiro Fukui.

In 1910, Dr. Umetaro Suzuki, a future Sankyo scientific adviser, made the world’s first discovery of vitamin B1 in rice bran and established a foundation for the theory of vitamins. Five years later, Arsemin Shokai was founded by Dr. Katsuzaemon Keimatsu and five others. The named changed to Daiichi Pharmaceutical in 1918.

Sankyo manufactured Japan’s first insecticide in 1921, while Daiichi focused on syphilis treatments, asthma medicine and sulfa drugs. Both companies were listed on the Tokyo Stock Exchange in 1949.

During the 1950s, ’60s and ’70s, Sankyo manufactured the first antibiotic produced in Japan, a vitamin B compound and an anti-cancer drug (Krestin). Daiichi launched Iscotin, a medicine for tuberculosis, an antiplasmin medication and a treatment for ulcers.

As the turn of the century approached, the two companies worked on blood pressure medicines, antibiotics, and diabetes drugs. Sankyo launched the popular antacid Zantac in 1984 and the first statin drug in 1989 (Mevalotin). It also established business units around the globe.

Sankyo launched Benicar in the U.S. in 2002 and in Japan two years later. In 2005, the two companies established a joint holding company, and operations as Daiichi Sankyo Co., Ltd. began in April 2007.

Together, they launched an antiplatelet agent (Effient), a flu vaccine (Inavir), a treatment of Alzheimer’s disease (Memary), and Nexium, a popular acid reflux drug (with AstraZeneca).

In 2008, Daiichi Sankyo paid $4.6 billion for a majority share in Ranbaxy Laboratories, India’s largest pharmaceutical company and one of the world’s top generic manufacturers. The purchase was intended to catapult the company into the industry’s big leagues. Instead, it lost billions on a business with many products that were blocked as unsafe by U.S. officials.

FDA actions against Ranbaxy included:

  • Warnings, import alerts and bans on imports
  • Drug applications frozen after company falsified data
  • Criminal charges and $500 million in civil and criminal fines
  • 480,000 bottles of generic Lipitor recalled

In April 2014, Sun Pharmaceutical bought Ranbaxy for $3.2 billion, leaving Daiichi Sankyo with a nine percent share of the company.

Problematic Products

On its website, Daiichi Sankyo boasts of developing “the first glitazone, which revolutionized long-term control of Type 2 diabetes.” These drugs, also known as thiazolidinediones, lower blood sugar by helping the body to use insulin better. As it turns out, there’s not much to boast about.

The company removed one of its drugs, Rezulin (troglitazone), from the U.S. market in 2000 because of its toxic effects on the liver. A different company’s glitazone, Avandia, was restricted by the FDA over its heart attack risk, and yet another company’s glitazone, Actos, is linked to both congestive heart failure and bladder cancer.

Daiichi Sankyo also deals with criticism because of the severe gastrointestinal side effects of Benicar. Introduced in 2002, Daiichi Sankyo spent close to $1 billion promoting it in the years that followed.

The company claims the drug is superior to other drugs in the angiotensin receptor blocker (ARB) class. However, according to medical studies and the FDA, no other drugs in the class causes severe intestinal issues known as sprue-like enteropathy. Symptoms include severe, chronic diarrhea and substantial weight loss.

Patients who suffered from severe side effects began filing lawsuits in 2014, claiming they were not warned about the risk. Courts consolidated more than 30 cases to multidistrict litigation in the U.S. District Court for the District of New Jersey in April 2015.

Future

In 2012, the company partnered with Mitsubishi Tanabe Pharma Corporation to conduct joint sales activities for two diabetes drugs: teneligliptin and canagliflozin. It also reorganized its three Japanese supply chain subsidiaries – Daiichi Sankyo Propharma, Daiichi Sankyo Chemical Pharma and Daiichi Sankyo Logistics – into two operating units in 2015.

The company is also readying its manufacturing network for a Western market launch of Savaysa (edoxaban), an anticoagulant approved in 2015. Savaysa is in the same class as Xarelto, and will also compete with Pradaxa and Eliquis.

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