Ross Laboratories

Abbott Laboratories is an American multinational medical devices and health care company with headquarters in Abbott Park, Illinois, United States. The company was founded by Chicago physician Wallace Calvin Abbott in 1888 to formulate known drugs; today, it sells medical devices, diagnostics, branded generic medicines and nutritional products. It split off its research-based pharmaceuticals business into AbbVie in 2013. The firm has also been present in India for over 100 years through its subsidiary Abbott India Limited, and it is currently India's largest healthcare products company.

Among its well-known products across the medical devices, diagnostics, and nutrition product divisions are Pedialyte, Similac, BinaxNOW, Ensure, Glucerna, ZonePerfect, FreeStyle Libre, i-STAT and MitraClip.

History

Foundation and early history

In 1888 at the age of 30, Wallace Abbott (1857–1921), an 1885 graduate of the University of Michigan, founded the Abbott Alkaloidal Company in Ravenswood, Chicago. At the time, he was a practicing physician and owned a drug store. His innovation was the use of the active part of a medicinal plant, generally an alkaloid (e.g., morphine, quinine, strychnine and codeine), which he formed into tiny "dosimetric granules". This approach was successful since it produced more consistent and effective dosages for patients. In 1922, the company moved from Ravenswood to North Chicago, Illinois.

International expansion

Abbott's first international affiliate was in London in 1907; the company later added an affiliate in Montreal, Canada. Abbott India Ltd was originally incorporated on August 22, 1944, as Boots Pure Drug Company (India) Ltd. The company name was changed to The Boots Company (India) Ltd on November 1, 1971, and to Boots Pharmaceuticals Ltd on January 1, 1991. On October 31, 1995, the name was changed to Knoll Pharmaceuticals Ltd and on July 1, 2002, to their present name Abbott India Ltd.I Abbott started operations in Pakistan as a marketing affiliate in 1948; the company has steadily expanded to comprise a work force of over 1500 employees. Currently, two manufacturing facilities located at Landhi and Korangi in Karachi continue to produce pharmaceutical products. In 1962 Abbott entered into a joint venture with Dainippon Pharmaceutical Co., Ltd., of Osaka, Japan, to manufacture radio-pharmaceuticals. In 1964, it merged with Ross Laboratories, making Ross a wholly owned subsidiary of Abbott, and Richard Ross gained a seat on Abbott's board of directors until his retirement in 1983. The acquisition of Ross brought Similac under the Abbott umbrella. In the years following the acquisition, Pedialyte and Ensure were introduced as nutritional products by Ross Laboratories while under Abbott's leadership.

In 1965, Abbott's expansion in Europe continued with offices in Italy and France.

According to Harvard professor Lester Grinspoon and Peter Hedblom, "In 1966 Abbott Laboratories sold the equivalent of two million doses of methamphetamine in powder form to a Long Island criminal dealer".

21st century

In 2001, the company acquired Knoll, the pharmaceutical division of BASF. In 2002, it divested the Selsun Blue brand to Chattem. Later in 2002, it sold Clear Eyes and Murine to Prestige Brands. In 2004, it acquired TheraSense, a diabetes-care company, which it merged with its MediSense division to become Abbott Diabetes Care. In 2006, Abbott assisted Boston Scientific in its purchase of Guidant Corporation purchasing the vascular device division of Guidant.

In 2007, Abbott acquired Kos Pharmaceuticals for $3.7 billion in cash. At the time of acquisition, Kos marketed Niaspan, which raises levels of "good", or HDL, cholesterol and Advicor, a Niaspan combination drug for patients with multiple lipid disorders.

In January 2007, the company agreed to sell its ''in vitro'' diagnostics and Point-of-Care diagnostics divisions to General Electric for more than $8 billion, to be integrated into the GE Healthcare business unit. The transaction was approved by the boards of directors of Abbott and GE and was targeted to close in the first half of 2007. However, on 11 July 2007, Abbott announced that it had terminated its agreement with GE because the parties could not agree on the terms of the deal.

On 8 September 2007, the company completed the sale of the UK manufacturing plant at Queenborough to Aesica Pharmaceuticals, a private equity-owned UK manufacturer.

In November 2007, Abbott announced that Ross Products would be renamed Abbott Nutrition.

On 26 February 2009, the company completed its acquisition of Advanced Medical Optics based in Santa Ana, California. It sold this business to Johnson & Johnson in February 2017. In 2009, Abbott opened a satellite research and development facility at Research Park, University of Illinois at Urbana-Champaign.

In February 2010, Abbott completed its $6.2 billion (EUR 4.5 billion) acquisition of the pharmaceuticals unit of Solvay S.A. This provided Abbott with a large complementary portfolio of pharmaceutical products and also expanded its presence in key emerging markets.

On 22 March 2010, the company completed its acquisition of a Hollywood, Florida-based laboratory information management system company STARLIMS. Under the terms of the deal, Abbott acquired the company for $14 per share in an all-cash transaction valued at $123 million. On 21 May 2010, Abbott said it would buy Piramal Healthcare Ltd.'s Healthcare Solutions unit for $2.2 billion, thus becoming the biggest drug company in India.

Spin-offs

In 2004, Abbott spun off its hospital products division into a new 14,000 employee company, Hospira. Hospira was later acquired by Pfizer in 2015.

In October 2011, Abbott planned to separate into two companies, one for research-based pharmaceuticals and the other for medical devices, generic drugs sold internationally, and diagnostics, with the latter retaining the Abbott name. Abbott Nutrition, whose products include Similac, Pedialyte, Glucerna, and Ensure, also retained the Abbott name. In March 2012, the company announced that the spun-off research-based pharmaceuticals company would be named AbbVie. In preparation for the reorganization, Abbott made severe budget cuts and took a $478 million charge in Q3-2012 to pay for the restructuring. The separation was effective as of 1 January 2013 and AbbVie was officially listed in the New York Stock Exchange on 2 January 2013.

Further developments

On 16 May 2014, it was announced that Abbott would acquire the holding company Kalo Pharma Internacional S.L. for $2.9 billion in order to secure the 73% it held of Chilean pharmaceutical company, CFR Pharmaceuticals, which the company said would more than double its branded generic drug portfolio.

In December 2014, the company acquired Russian pharmaceutical manufacturer Veropharm ( Voronezh) in a deal worth $410 million, which included three manufacturing facilities. Abbott, which already employed 1,400 people in Russia, said it planned to set up a manufacturing presence in the country when the deal closed.

In September 2015, the company announced it had completed its acquisition of Tendyne Holdings, Inc., a private medical device company focused on developing minimally invasive mitral valve replacement therapies. Tendyne was acquired for a total transaction value of $250 million. In January 2020, the Tendyne Mitral Valve became the world's first commercially available solution for Mitral Valve Replacement Technology. Abbott obtained CE Mark for the device which now makes it possible to implant it in Europe outside of a clinical setting. The US clinical study for federal approval is still ongoing.

In February 2016, the company announced it would acquire Alere for $5.8 billion. In January 2017, Abbott announced it would acquire St. Jude Medical for $25 billion (each share receiving $46.75 in cash & 0.8708 shares of Abbott common stock, equating to an approximate value of $85). On 3 October 2017, the company closed the Alere acquisition making the surviving entity the market leader player in the $7 billion point-of-care diagnostic space within the broader $50 billion in-vitro diagnostics market with this takeover. With the acquisition of Alere, the company also obtained the subsidiary Arriva Medical, which is the largest mail-order diabetic supplier. Arriva Medical announced business closure after Abbott acquisition effective 31 December 2017.

In 2017, the FDA approved Abbott's FreeStyle Libre glucose monitoring system, which reads glucose levels through a self-applied sensor without finger pricks.

In August 2018, Reuters reported that Abbott Laboratories was among the top five companies for branded generic drugs in Russia.

In November 2018, Abbott received United States FDA clearance for FreeStyle LibreLink, a glucose reader smartphone app.

In January 2019 purchased Cephea Valve Technologies, Inc. which is developing a less-invasive replacement heart valve for people with mitral valve disease.

In March 2020, Abbott received emergency use authorization (EUA) from the US FDA for a SARS-CoV-2 test during the COVID-19 pandemic. The tester is small (comparable to a small toaster), and produces results within 13 minutes. Detroit received these tests on April 1, 2020. Also in March, the firm received EUA for a molecular COVID-19 test that runs on its m2000 RealTime lab-based platform. In April 2020, itt received EUA from the FDA for its third COVID-19 test, an antibody test that helps detect the IgG antibody to SARS-CoV-2 using the company's ARCHITECT laboratory instruments. In May 2020, it received EUA from the FDA for another lab-based COVID-19 antibody test that helps detect the IgG antibody to SARS-CoV-2 using the company's Alinity i system. Also in May, it received EUA from the FDA for a molecular COVID-19 test for use on the company's Alinity molecular laboratory instrument.

In August 2020, Abbott received EUA from the FDA for its credit-card-sized $5, 15-minute, portable COVID-19 antigen test, BinaxNOW, compatible with the NAVICA mobile app.

In October 2020, Abbott received EUA from the FDA for its lab-based COVID-19 IgM antibody blood test.
In December 2020, its rapid (20') antigen BinaxNOW COVID-19 test received EUA from the FDA for home use.
''Forbes'' reported in January 2021 that the firm had delivered more than 400 million COVID-19 tests, 300 million in the fourth quarter of 2020.

Today, Abbott operates in over 160 countries.

In September 2021 Abbott acquired Walk Vascular, LLC.

Acquisition history

*Abbott Laboratories (Est. 1885, Abbott Alkaloidal Company)
**Ross Laboratories (Acq 1964)
**SmithKline Beecham (Acq 1982, later sold)
** Knoll (Acq 2001)
**Selsun Blue (Sold to Chattem 2002)
**Murine (Sold to Prestige Brands2002)
**Clear Eyes (Sold to Prestige Brands2002)
**i-STAT (Acq 2004)
**TheraSense (Acq 2004)
** Guidant (vascular device division) (Acq 2006)
***IntraLase Corp (Acq 2007)
**Advanced Medical Optics (Acq 2009)
**Solvay Pharmaceuticals (Acq 2010)
**STARLIMS (Acq 2010)
***Lab Data Management Ltd (Acq 2008)
**IDEV Technologies (Acq 2013)
**OptiMedica Corporation (Acq 2013)
**Veropharm (Acq 2014)
**Topera, Inc (Acq 2014)
**Kalo Pharma Internacional S.L. (Acq 2014)
***CFR Pharmaceuticals
** Tendyne Holdings Inc. (Acq 2015)
** Alere (Acq 2016)
***Epocal, Inc. (Acq 2013)
***Arriva Medical (Acq 2012)
**St. Jude Medical (Est 1976, Acq 2016)
***Pacesetter, Inc. (Acq 1994)
***Daig Corporation (Acq 1996)
***Heart Valve Company (Acq 1996)
***Biocor Industria (Acq 1996)
***Ventritex (Acq 1997)
*** Tyco International (Angio-Seal division) (Acq 1999)
***Endocardial Solutions (Acq 2005)
***Advanced Neuromodulation Systems (Acq 2005)
***MediGuide (Acq 2008)
***AGA Medical (Acq 2010)
***LightLab Imaging (Acq 2010)
***Nanostim Inc (Acq 2013)
***Endosense (Acq 2013)
***CardioMEMS Inc. (Acq 2014)
***Spinal Modulation (Acq 2015)
*** Thoratec Corporation (Acq 2015)
****Apica Cardiovascular Limited (Acq 2014)
****Levitronix (Medical division) (Acq 2011)
**** Getinge Group (Heat pump technology division) (Acq 2014)
****Thermo Cardiosystems (Acq 2010)
**Cephea Valve Technologies, Inc. (Acq 2019)
**Walk Vascular, LLC (Acq 2021)

Finances

Accounts

For the fiscal year 2021, Abbott Laboratories reported earnings of US$7.071 billion, with an annual revenue of US$43.075 billion, which grew 24.5% on an organic basis versus the year prior. Abbott's year-end 2021 stock price was $140.74.

Taxation

On 19 March 2019, it was reported that Abbott was a long-term user of the Double Irish tax structure, a legal but controversial Irish taxation tool used by U.S. multinationals to reduce U.S. corporate taxes on non-U.S profits. Abbott's Irish holding company, the Bermuda-resident Abbott Laboratories Vascular Enterprises (ALVE), employed no staff in 2017, but was responsible for distributing Abbot's products and licensing its technology worldwide. Newly filed accounts showed that ALVE was incorporated in 2003 and had a pre-tax profit of €2 billion in 2016 and 2017 on revenues of €5.2 billion; no taxation was paid on these profits. ALVE had never filed accounts in Ireland since 2003 as it was structured as an unlimited liability company (ULC); however, new EU accounts directives required ALVE to file Irish accounts in 2018. These accounts listed ALVE's registered office as the address of Ireland's largest tax-law firm, Matheson, who have been identified with Double Irish tax structures for Microsoft and Google.

In September 2021, the '' Irish Times'' reported that Abbott was using the Single Malt tax tool to shield profits on its COVID-19 testing kits.

Operations

Organization

Abbott's core businesses focus on diagnostics, medical devices, branded generic medicines and nutritional products, which have been supplemented through acquisitions.

, the firm's divisions are:

* Nutrition: Pediatric nutrition (e.g., Similac, Isomil, and Gain), Adult Nutrition (e.g., Ensure and ZonePerfect) and special dietary needs (e.g., Glucerna and Juven)
* Diagnostics: core lab, molecular, point of care, rapid diagnostics and Informatics
* Medical devices: rhythm management, electrophysiology, heart failure, structural heart, neuromodulation, diabetes care
* Established Pharmaceuticals: branded generic drugs sold exclusively in developing markets

Management

Miles D. White is the executive chairman of Abbott. He joined the firm in 1984, serving in management positions including senior vice president of diagnostic operations, executive vice president, and long-time CEO. He was elected to the board of directors in April 1998, to chief executive officer in 1998, and to chairman of the board in April 1999.

In November 2019, White announced that he was stepping down as CEO after 21 years. At the end of March 2020, Robert B. Ford, a long-time Abbott executive, took over as president and chief executive officer. Ford joined Abbott in 1996, serving in various management positions including executive vice president of the company's medical device business. White remains the company's executive chairman.

Recognition

Abbott was ranked 89th on the Fortune 500 list of largest US-based corporations in 2021. ''Fortune'' also named Abbott as one of its Top 50 World's Most Admired Companies in 2021, among its Blue Ribbon companies again in 2021, to its Change the World list in 2020, and among its Best Big Companies to Work For in 2021.

The company has been listed on ''Working Mother'' magazine's "100 Best Companies" list for 20 years in a row, named a top company by the National Association for Female Executives for 12 consecutive years, and included on “Science” magazine's Top 20 Employees list 17 times, most recently in 2020. The company has also been recognized as a top company by ''DiversityInc'' for diversity within the company for 18 consecutive years (2004-2021) and has been included on the Dow Jones Sustainability Index for eight consecutive years.

Products

Nutrition

Pediatric nutrition products manufactured by Abbott Laboratories include:

* Similac
* Pedialyte
* PediaSure

Adult nutrition products manufactured by Abbott Laboratories include:

* Ensure
* Glucerna (Ensure Diabetes Care in India)
* Juven
* ZonePerfect

Diagnostics

Diagnostics products manufactured by Abbott include:
* i-STAT (While intended for a human audience, the point of care analyzers also demonstrate utility for the veterinary profession and are marketed by Abaxis.)
* Alinity
* Architect
* BinaxNOW

Medical devices

* FreeStyle Libre

Cardiovascular devices manufactured by Abbott Laboratories include:

* MitraClip
* Confirm Rx
* Amplatzer Piccolo Occluder
* Heartmate
* Xience
* CARDIOMEMS
* Gallant ICD
* CentriMag

Neuromodulation devices manufactured by Abbott Laboratories include:

* BurstDR Technology
* Proclaim DRG Neurostimulation System
* Infinity Deep Brain Stimulation System

Litigation and Controversies

Humira

In March 2003, British company Cambridge Antibody Technology (CAT) stated its wish to "initiate discussions regarding the applicability of the royalty offset provisions for Humira" ( Adalimumab) with Abbott Laboratories in the High Court of London. In December 2004, the judgment ruled for CAT.

Abbott was required to pay CAT US$255 million, some of which was to be passed to its partners in development. Of this sum, the Medical Research Council (MRC) of the United Kingdom received US$191 million, and in addition, Abbott was asked to pay the MRC a further $7.5 million over five years from 2006 providing that Humira remains on the market.

Depakote

On 2 October 2012, the company was charged with a $500 million fine and $198.5 million forfeiture for illegal marketing of Depakote for uses not approved by the FDA. The court also ordered Abbott to a five-year term of probation and court supervision.Abbott Labs to Pay $1.5 Billion to Resolve Criminal & Civil Investigations of Off-label Promotion of Depakote
Press Release, United States Department of Justice Office of Public Affairs, 7 May 2012. Retrieved 17 August 2014. Shareholders then brought derivative suits against the company directors for breach of fiduciary duty. Following Abbott's spinoff of its research-based pharmaceuticals business, it no longer owns the commercial rights and associated responsibilities for Humira and Depakote.

Glucose Monitors

In 2021, two of Abbott Laboratories' subsidiaries, Arriva Medical LLC and Alere Inc, had to pay $160M to resolve claims that they had fraudulently billed Medicare for glucose monitors. Supposedly, Arriva used free glucose monitors to entice patients into placing more orders, then took kickbacks on the increased sales. The company was also accused of charging Medicare for glucose monitors given to ineligible patients, including patients who were dead.

Leuprorelin

In October 2001, the US Department of Justice, states attorneys general, and TAP Pharmaceutical Products, a subsidiary of Abbott Laboratories, settled criminal and civil charges against TAP related to federal and state medicare fraud and illegal marketing of the drug leuprorelin. TAP paid a total of $875 million, which was a record high at the time. The $875 million settlement broke down to $290 million for violating the Prescription Drug Marketing Act, $559.5 million to settle federal fraud charges for overcharging Medicare, and $25.5 million reimbursement to 50 states and Washington, D.C., for filing false claims with the states' Medicaid programs. The case arose under the False Claims Act with claims filed by Douglas Durand, a former TAP vice president of sales, and Joseph Gerstein, a doctor at Tufts University's HMO practice. Durand, Gerstein, and Tufts shared $95 million of the settlement.

There have since been various suits concerning leuprorelin use, none successful. They either concern the oversubscription of the drug or undue warning about the side effects. Between 2010 and 2013, the FDA updated the Lupron drug label to include new safety information on the risk of thromboembolism, loss of bone density and convulsions. The FDA then asserted that the benefits of leuprorelin outweigh its risks when used according to its approved labeling. Since 2017, the FDA has been evaluating leuprorelin's connection to pain and discomfort in musculoskeletal and connective tissue.

Operation Headwaters

In October 2003, Abbott Laboratories and two of its units agreed to pay a total of $600 million in the first combined civil settlement and criminal conviction for offering kickbacks to agents of "Operations Headwaters", an undercover investigation by the FBI.

Plant Shutdown

In February 2022, Abbott recalled baby formulas from the market and shutdown their Michigan plant. This is after complaints of infants being sick with serious bacterial infections while consuming formula product made at the Sturgis plant. The recall caused a nationwide shortage of formula milk with at least 73% of baby products out of stock according to data firm Datasembly. In a recent development and with Abbotts' meeting the initial requirement of the U.S. Food & Drug Administration, the facility could start operation and begin production of other special and metabolic formulas in 2–3 weeks time.

Sponsorship

Since 2015, Abbott has been the title sponsor of the World Marathon Majors.

See also

* List of Illinois companies
* List of largest biomedical companies by market capitalization
* List of pharmaceutical companies
* Clara Abbott
* 2022 United States infant formula shortage

Notes and references

External links

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1888 establishments in Illinois
1920s initial public offerings

Biotechnology companies of the United States
Companies based in Lake County, Illinois
Pharmaceutical companies established in 1888
American companies established in 1888
Companies listed on the New York Stock Exchange
Multinational companies headquartered in the United States
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Pharmaceutical companies of the United States
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