Otsuka America Pharmaceuticals Inc.

Executive Summary

This company was established in 1989 as a subsidiary of Otsuka Pharmaceuticals, a parent company that is based in Japan. Its headquarters is in San Francisco, California United States. It is a holding company having many other subsidiaries and it offers very innovative products in the consumer, pharmaceutical and nutraceutical markets. These different markets work entirely to make Otsuka America great and offer products as follows;

1. Consumer Market;

This business market under the Otsuka is mainly dedicated to give out the best and most pure water as well as the most flavored wines to the market.

1. Pharmaceutical Market;

This sector deals with developing and marketing the company’s products for treatment of diseases in the areas of oncology, the central nervous system, cardiovascular system and ophthalmology.

1. Nutraceutical Market;

This market is highly associated in the improvement of human health through giving out quality minerals, vitamins and other supplements in order to ensure that nutrition is complete.

Collaborations and Agreements:

-ABILIFY MYCITE

In August 2018, Otsuka America Pharmaceutical Inc made its first collaboration agreement to facilitate Abilify Mycite system to the selected regional networks which were contracted by Magellan Health.

The Abilify Mycite system is the provision of an opportunity for a well connected care approach to treatment for the intended patients which is done through a sensor which is embedded to Aripiprazole tablet, the mycite app which is obviously a Smartphone app and the mycite dashboard. 

This system was to understand how it normally fits with the patients with serious mental illness and their caregivers and how they will benefit from the information that is given or received from this system. It was also intended to help doctors focus on the future improvement on the treatment of the same.

Lawsuits Currently Involved in:

Abilify Lawsuits:

In 2005 and 2016, the FDA warned the public of the dangers of Abilify when using it. This included mortality among the elderly, suicidal thoughts among the children, compulsive behaviors like sexual activities, excessive eating and gambling which were associated with the use of Abilify. All these behaviors stopped immediately when those affected stopped using the drug Abilify or reduced its dosage drastically.

Many of the affected patients sued the company Otsuka America Pharmaceutical which is the manufacture of this drug and Bristol-Myers Squibb which is the sole marketer of this drug. 

They claimed that the companies knew of the risk which was associated with this drug of the additive behavior from using the drug and totally failed intentionally to warn the public of the risk involved or the consequences.

Currently there are more than 2,300 cases still pending in courts which has not been settled or concluded concerning the use of this drug Abilify.

History of Otsuka America Pharmaceuticals

The history of Otsuka America Pharmaceuticals began in 1921 when Busaburo Otsuka established his company called Otsuka Seiyaku Kogyo – bu factory in Tokushima Japan. In 1964, Otsuka Pharmaceuticals Ltd was established and started its core business in pharmaceuticals and nutraceuticals globally. The company first established it branches to Europe and in 1989, it opened the subsidiary in the United states called Otsuka America Pharmaceuticals inc which has really developed with time and opened other branches all over the great US and other areas. This is the major subsidiary company in the United States of the larger Otsuka group of companies.

Subsidiaries of Otsuka America Pharmaceuticals  

1. Astex Pharmaceuticals

Astex was formerly formed through the merger of two companies, Astex therapeutics based in UK and SuperGen based in US in the year 2011. The company then was acquired in 2013 by Otsuka America Pharmaceuticals at a cost of $886 million. Astex Pharmaceuticals mainly focuses on cancer drugs and this would boost the cancer department very much. Astex Pharmaceuticals then became one of the Otsuka America Pharmaceuticals’ subsidiaries joining the Otsuka family at large. This acquisition saw Otsuka expand in the lager United States base and broaden its services to the US citizens in reaching them near and near.

1. Avanir Pharmaceuticals 

Avanir Pharmaceuticals is another great subsidiary of Otsuka Pharmaceuticals which was founded in 1988. The company was acquired by Otsuka America Pharmaceuticals in December 2014 at a cost of $3.5 billion. This is a biopharmaceutical company which whose focus is to bring medicine to patients with nervous system disorders and treat them to completion. 

Through the pipeline, Avanir through regular innovations continuously develops solutions for patients who are suffering from very much complicated and difficult brain disorders.

1. Visterra Inc.

This is a subsidiary of Otsuka America Pharmaceuticals which was acquired in July 2018 at a cost of $430 million all of which was cash in the agreement. Visterra was established in 2007 and it is much involved in the area of designing and engineering of antibody based therapies. Visterra was fully owned by Otsuka America and it became part of the whole family of Otsuka Pharmaceuticals Ltd. It is based in Waltham, Massachusetts United States.

1. Neurovance Inc.

Neurovance is a company that was established in 2011. In April 2017, Otsuka America Pharmaceutical acquired Neurovance Inc at a cost of $250 million as acquisition fee. Neurovance then became a wholly subsidiary of Otsuka America Pharmaceutical. It is a neuroscience company which actually focuses mostly on the development of therapies for both adult and children with hyperactivity disorders. It is based and headquartered in Cambridge, Massachusetts United States.

Popular Products

There are a number of products produced by Otsuka America Pharmaceutical Inc which are mostly used in the United States. They include the following;

1. Abilify (Aripiprazole)

This is the drug which is made by Otsuka America Pharmaceutical which is known by its generic name Aripiprazole. Its generic availability is tabs, orally disintegrating tabs and soln. It is used by both adults and children but children are given lower dosage and from the age of 10 to 17 years.

In Psychosis its indications are schizophrenia which is tourette’s disorder. It is also used to treat acute manic or mixed episodes in bipolar disorder monotherapy

1. Ability Mycite

In psychosis its indications are schizophrenia which is used by adults only and no children. It is swallowed as whole tab.

Its adverse reactions are anxiety, constipation, vomiting, nausea, dizziness and fatigue.

1. Rexulti

This is a drug manufactured and marketed by Otsuka America Pharmaceutical Inc which is used under psychiatric disorders. Its generic name is Brexpiprazole and has the following formulations; 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg, tabs.

It is not given to children and its adverse reactions are weight gain, headache, tremor, restlessness and anxiety.

1. Busulfex

This is a popular drug manufactured by Otsuka America Pharmaceutical which is used to treat lymphomas, leukemia and other hematologic cancers. Its generic name is Busulfan and in the following formulations; 6mg, soln for infusion after being diluted.

It is prescribed to both adults and children but under strict full labeling and following the formulations carefully. Its adverse reactions are vomiting, nausea, diarrhea, fever, headache and abdominal pain.

1. Jynarque

This is a very popular drug which is manufactured by the Otsuka America Company and is being used for urological disorders whose generic name is Tolvaptan and has the following formulations; 15mg, 30mg, 45mg, 60mg, 90mg, tabs. 

It is used to treat and prevent miscellaneous urogenital disorders. It is prescribed for only adults and not for children. This is because it can cause fatal liver injuries and should be carefully administered.

Its adverse reactions include the following; hepatic injury, dehydration, thirst and nocturia.

1. Samsca

This is a drug for cardiovascular diseases. Its generic name is Tolvaptan and its generic formulations are; 15mg, 30mg and tabs.

It is used and indicated for electrolyte disturbances and administered to adults only and it not yet established for the children.

Its adverse reactions include the following; dry mouth, thirst, constipation, hyperglycemia, liver injuries and hyperkalemia.

Product Recalls and Lawsuits

• Class 2 Device UBiTIR300 Infrared Spectrophotometer Recall

Otsuka America Pharmaceutical Inc recalled back from the market Class 2 device UBiTIR300 infrared Spectrophotometer in January 2008.

This recall was subject due to the reason that the device’s power supply has a fault and may very much overheat and produce much smoke from the device. This recall affected both the devices given out to the nationwide distributors and Mexico.

From this recall, there was no harm that was reported and no lawsuit was filed against the company for any damage or lose caused by this device due to this fault.

Litigation Settlements

1. $4 million Settlement of Abilify Off-label Marketing

In March 2008, Otsuka America Pharmaceutical agreed to pay $4 million to settle and resolve completely a case which it was involved in the off label marketing. The government alleged that Otsuka America Pharmaceutical promoted highly the sale and use of Abilify in directing this sales force urging all prescriptions for pediatric patients to be prescribed for Abilify. 

The amount was paid as $2.3 million as federal recovery and $1.7 to Medicaid programs.

Sources:

http://www.otsuka-america.com/story/

https://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=3428649

https://www.baumhedlundlaw.com/bristol-myers-abilify-settlement-19-billion/

https://www.mlg.law/defective-drugs/abilify-lawsuit/

https://www.empr.com/manufacture/otsuka-america-pharmaceutical-inc/

https://medtruth.com/abilify-settlement-illegal-marketing/

https://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapid=182413794

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69717

https://www.justice.gov/archive/opa/pr/2008/March/08_civ_244.html