Executive Summary
Eisai Co., Ltd. is a pharmaceutical company founded on December 6, 1941, and is headquartered in 4-6-10 Koishikawa, Bunkyo-ku, Tokyo 112-8088, Japan. The company’s United States headquarters are in 100 Tice Boulevard Woodcliff Lake, NJ.
Eisai is engaged in the research and development, manufacture, sale and import and export of pharmaceuticals. The Company’s business segments include pharmaceutical segment and other segment. The pharmaceutical segment is engaged in the research, develop, manufacture and sale of pharmaceuticals for medical use, generic drugs, general medicines, among others. The other segment consists of pharmaceutical raw materials, logistics services and business services businesses.
History of Eisai
Nihon Eisai Co. Ltd. was established in 1941. In 1944, a merger with Sakuragaoka Research Laboratory resulted in creation of Eisai Co. Ltd. The American subsidiary of the company, Eisai Inc., was established in 1995.
In 1996, Eisai received approval from the United States Food and Drug Administration (USFDA) for Aricept (donepezil), a drug discovered in the company’s labs and co-marketed with Pfizer. Three years later in 1999, the company received USFDA approval for Aciphex (rabeprazole), a drug co-marketed with Johnson & Johnson.
In September 2006, the company acquired four oncology products from Ligand Pharmaceuticals.
In April 2007, Eisai acquired Exton, Pennsylvania-based Morphotek, a company developing therapeutic monoclonal antibodies for the treatment of cancer, rheumatoid arthritis, and infectious diseases.
In December 2007, Eisai acquired MGI Pharma, a company specializing in oncology, for $3.9 billion USD. This event brought Dacogen (decitabine), Aloxi (palonosetron), Hexalen (altretamine) for ovarian cancer, and the Gliadel Wafer (carmustine) for brain tumors into the Eisai product portfolio.
Very recently, in 2018, Eisai agreed upon a strategic collaboration for the drug Lenvima with Merck & Co. The company also opened a new Suzhou plant in China. Lenvima is also launched in China.
In 2019, Eisai, Co., Ltd. established the Epochal Precision Anti-Cancer Therapeutics (EPAT) in Exton, PA. EPAT focuses on oncology drug development utilizing Eisai’s unique Antibody-Drug Conjugate (ADC) technology and proprietary payloads. Utilizing the insights gained from the AiM Institute, the Center will harness the power of human genetics to develop next-generation medicines for Alzheimer’s disease (AD) and other dementias.
Subsidiaries of Eisai
Eisai Co., Ltd. has a number of subsidiaries, including but not limited to:
- Elmed Eisai Co., Ltd.
- KAN Research Institute, Inc.
- Eisai Distribution Co. Ltd.
- Sunplanet Co., Ltd.
- Morphotek, Inc.
- H3 Biomedicine Inc.
- Bracco-Eisai Co., Ltd.
Popular Products of Eisai
Eisai positions “neurology” and “oncology” as two strategically important areas.
Eisai’s most popular products are the following:
- Actonel (risedronic acid) – Osteoporosis (Japan)
- Aloxi (palonosetron) – Chemotherapy-induced nausea and vomiting
- Aricept (donepezil) – Mild to moderate dementia for Alzheimer’s Disease patients. This product accounted for 40% of the company’s revenue, as of March 2010.
- Banzel/Inovelon (rufinamide) – Seizures related to Lennox-Gastaut Syndrome
- Fragmin (dalteparin) – Deep vein thrombosis and pulmonary embolism
- Fycompa (perampanel) – Partial-onset seizures
- Halaven (eribulin) – Metastatic breast cancer
- Iomeron (iomeprol) – Non-ionic contrast medium
- Methylcobal (methylcobalamin) – Peripheral neuropathy
- Myonal (eperisone) – Muscle relaxant
- Selbex (teprenone) – Gastric ulcers and gastritis
- Zonegran (zonisamide) – Partial-onset seizures
- Gliadel Wafer (carmustine) – Treatment for Brain Tumors
Eisai’s top drugs in the United States are:
- Lenvima (lenvatinib) – Thyroid Cancer or Kidney Cancer
- Banzel/Inovelon (rufinamide) – Seizures related to Lennox-Gastaut Syndrome
- Halaven (eribulin) – Metastatic breast cancer
- Fycompa (perampanel) – Partial-onset seizures
- Aciphex/Pariet (rabeprazole) – Gastroesophageal reflux disease
- Belviq (lorcaserin) – Obesity
Product Recalls and Lawsuits
- In 2011, Eisai recalled their Chocola BB Sparkling (Vitamin Drink) due to mislabeling of nutritional information. Specifically, Carbohydrates 14g has been mislabeled as Carbohydrates 14mg. As the product label does not comply with labeling standards required under the Health Promotion Act and other related laws of Japan, Eisai decided to recall the product in order to correct the error.
- In 2016, Eisai voluntary recalled and discontinued the sales of egg white lysozyme preparation Neuzym. This came after a committee found that the medical usefulness of the product had decreased.
Litigation Settlements
- In 2015, Eisai entered into a settlement with Glenmark Pharmaceuticals to resolve a patent dispute related to Eisai’s Banzel (rufinamide) in the United States.
- In 2010, Eisai paid USD11 million to Elan to resolve civil liability for off-label marketing of Elan’s drug Zonegran.
Sources:
https://www.eisai.com/ir/library/report/pdf/e105_02.pdf
https://www.eisai.com/company/profile/index.html
https://en.wikipedia.org/wiki/Eisai_(company)
https://www.marketwatch.com/investing/stock/esaly
Tracy Everhart
Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.