AbbVie Inc
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AbbVie is an American publicly traded
biopharmaceutical A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, t ...
company founded in 2013. It originated as a spin-off of Abbott Laboratories.


History

On October 19, 2011, Abbott Laboratories announced its plan to separate into two publicly traded companies. The new Abbott Laboratories would specialize in diversified products including medical devices, diagnostic equipment and nutrition products, while AbbVie would operate as a research-based pharmaceutical manufacturer. The separation was effective January 1, 2013, and AbbVie was officially listed on the
New York Stock Exchange The New York Stock Exchange (NYSE, nicknamed "The Big Board") is an American stock exchange in the Financial District of Lower Manhattan in New York City. It is by far the world's largest stock exchange by market capitalization of its listed ...
(ABBV) on January 2, 2013. According to Miles White, CEO at the time, the purpose of the split was to allow markets to value the two businesses separately. Some investors were concerned that the split was done to protect the value of the device business from the loss of value facing the drug division due to the imminent expiration of patents on
Humira Adalimumab, sold under the brand name Humira, among others, is a monoclonal antibody used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativ ...
, which accounted for about half of the drug division's revenue. As of December 2015, the company employed in excess of 28,000 globally, and provided products to individuals in more than 170 countries. As of October 2022, the company now employs over 50,000 globally and provides products in over 175 countries. In March 2020, as the
COVID-19 pandemic The COVID-19 pandemic, also known as the coronavirus pandemic, is an ongoing global pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The novel virus was first identi ...
developed into an international crisis, the Israeli government announced that it would force AbbVie to license its patents for
Kaletra Lopinavir/ritonavir (LPV/r), sold under the brand name Kaletra among others, is a fixed-dose combination antiretroviral medication for the treatment and prevention of HIV/AIDS. It combines lopinavir with a low dose of ritonavir. It is generall ...
, the brand name of
lopinavir/ritonavir Lopinavir/ritonavir (LPV/r), sold under the brand name Kaletra among others, is a fixed-dose combination antiretroviral medication for the treatment and prevention of HIV/AIDS. It combines lopinavir with a low dose of ritonavir. It is generall ...
, a fixed dose combination medication for the treatment and prevention of HIV/AIDS which was also thought to have some applicability to fighting
COVID-19 Coronavirus disease 2019 (COVID-19) is a contagious disease caused by a virus, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first known case was identified in Wuhan, China, in December 2019. The disease quickly ...
. In response, AbbVie announced that it would cease enforcing its patents on the drug entirely. In June 2021, the
US Senate Finance Committee The United States Senate Committee on Finance (or, less formally, Senate Finance Committee) is a standing committee of the United States Senate. The Committee concerns itself with matters relating to taxation and other revenue measures generall ...
, under Chair Ron Wyden (D-OR), began an investigation to determine if the company used the
Tax Cuts and Jobs Act of 2017 The Act to provide for reconciliation pursuant to titles II and V of the concurrent resolution on the budget for fiscal year 2018, , is a congressional revenue act of the United States originally introduced in Congress as the Tax Cuts and Jobs A ...
to buy back its own stock using income saved by the tax law. In a letter to AbbVie CEO Richard Gonzalez, Wyden noted the company suffered a 2020 pretax loss in the US of $4.5 billion and an overseas pretax profit of $7.9 billion the same year. Wyden accused the company of shifting revenue to avoid US taxes.


Acquisitions

In January 2014, the company acquired ImmuVen for an undisclosed sum. On September 3, 2014, AbbVie and Infinity Pharmaceuticals announced that they had entered into a global collaboration to develop and commercialize
duvelisib Duvelisib, sold under the brand name Copiktra, is a medication used to treat chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and follicular lymphoma after other treatments have failed. It is taken by mouth. It is a PI3 kin ...
, Infinity's
PI3K inhibitor Phosphoinositide 3-kinase inhibitors (PI3K inhibitors) are a class of medical drugs that are mainly used to treat advanced cancers. They function by inhibiting one or more of the phosphoinositide 3-kinase (PI3K) enzymes, which are part of the PI3 ...
for the treatment of patients with cancer. On the same day, AbbVie and
Calico Calico (; in British usage since 1505) is a heavy plain-woven textile made from unbleached, and often not fully processed, cotton. It may also contain unseparated husk parts. The fabric is far coarser than muslin, but less coarse and thick than ...
announced that they had entered into a R&D collaboration intended to discover, develop and bring to market new therapies for patients with diseases of aging including neurodegeneration and cancer. California Life Company, operating as Calico, is an
Alphabet Inc. Alphabet Inc. is an American multinational technology conglomerate holding company headquartered in Mountain View, California. It was created through a restructuring of Google on October 2, 2015, and became the parent company of Google and sev ...
subsidiary focused on aging and age-related diseases, and led by former Genentech chairman and CEO of Arthur D. Levinson and former Genentech EVP and chief medical officer
Hal V. Barron Hal V. Barron (born 1962) is an American clinician-scientist and drug developer who served as president of research and development at GlaxoSmithKline from March 2018 until 2022, when he resigned in order to join the cellular reprogramming ventu ...
(who subsequently left the company). In October 2014, after a long negotiation, AbbVie stopped its efforts to acquire Shire, which would have been one of the largest M&A deals of that year and one of the largest tax inversions in history, due to changes in the US tax code by the US Treasury; AbbVie had to pay a $1.6 billion breakup fee. On March 4, 2015, AbbVie announced its agreement to acquire the
oncology Oncology is a branch of medicine that deals with the study, treatment, diagnosis and prevention of cancer. A medical professional who practices oncology is an ''oncologist''. The name's etymological origin is the Greek word ὄγκος (''à ...
firm Pharmacyclics and its treatment for blood cancers,
ibrutinib Ibrutinib, sold under the brand name Imbruvica among others, is a small molecule drug that inhibits B-cell proliferation and survival by irreversibly binding the protein Bruton's tyrosine kinase (BTK). Blocking BTK inhibits the B-cell receptor ...
;
AstraZeneca AstraZeneca plc () is a British-Swedish multinational pharmaceutical and biotechnology company with its headquarters at the Cambridge Biomedical Campus in Cambridge, England. It has a portfolio of products for major diseases in areas includi ...
had also been bidding to acquire Pharmacyclics. Under the terms of the transaction, AbbVie agreed to pay $261.25 per share as a mix of cash and AbbVie equity. The acquisition valued at approximately $21 billion was completed on May 26, 2015. The Pharmacyclics name was retained, and it operates as a subsidiary of AbbVie from its previous Sunnyvale, California, headquarters. On June 3, 2015, AbbVie and Halozyme Therapeutics announced that they had entered into a global collaboration and licensing agreement to develop and commercialize products that combine AbbVie's treatments and Halozyme's ENHANZE drug-delivery technology, this was terminated in November 2016. On 28 April 2016, the company announced it would acquire Stemcentrx for up to $9.8 billion. A day later, the company announced an expansion of a two and a half-year-old cystic fibrosis deal with Galapagos, potentially doubling milestone payments to $600 million. On 25 June 2019, AbbVie announced it would acquire Irish-based
Allergan plc Allergan plc is an American, Irish-domiciled pharmaceutical company that acquires, develops, manufactures and markets brand name drugs and medical devices in the areas of medical aesthetics, eye care, central nervous system, and gastroenterology. ...
for about $63 billion; however the transaction would not be structured as a tax inversion, and that post the transaction, AbbVie (and the group) would remain legally domiciled in the U.S. for tax purposes; AbbVie acquisition of Allergan plc violated antitrust ruled by the Federal Trade Commission on September 4, 2020, leading to the group divesting certain assets to enable the merger to proceed. In July, the company announced it would acquire Mavupharma, boosting its cancer drug pipeline. In May 2021, Allergan Aesthetics announced it would acquire Soliton. In June, Abbvie announced it would acquire TeneoOne and its lead compound TNB-383B. The compound is a BCMA-targeting immunotherapeutic for relapsed or refractory multiple myeloma. In March 2022, Abbvie announced it would acquire Belgian-based Syndesi Therapeutics for up to $1 billion and its portfolio of novel modulators of the
synaptic vesicle protein 2A Synaptic vesicle glycoprotein 2A is a ubiquitous synaptic vesicle protein that in humans is encoded by the ''SV2A'' gene. The protein is targeted by the anti-epileptic drugs (anticonvulsants) levetiracetam and brivaracetam Brivaracetam, sold u ...
and lead compound SDI-118. In October, AbbVie announced they would acquire U.K.-based biotechnology business DJS Antibodies for $225 milion, in a deal that gives it access to an experimental drug for an aggressive lung disease as well as technology to develop certain kinds of antibody medicines.


Acquisition history

*Abbvie (Spin off from Abbott Laboratories) ** Pharmacyclics (Acq 2015) ** Stemcentrx (Acq 2016) **Venice Subsidiary LLC ***
Allergan, plc Allergan plc is an American, Irish-domiciled pharmaceutical company that acquires, develops, manufactures and markets brand name drugs and medical devices in the areas of medical aesthetics, eye care, central nervous system, and gastroenterology. ...
(Acq 2019) ****
Allergan, inc Allergan, Inc. was an American global pharmaceutical company focused on eye care, neurosciences, medical dermatology, medical aesthetics, breast enhancement, obesity intervention and urologics. Allergan, Inc. was formed in 1948, incorporated in ...
*****MAP Pharmaceuticals Inc (Acq 2013) *****Kythera Biopharmaceuticals (Acq 2015) ****
Actavis plc Actavis Generics (formerly known as Watson Pharmaceuticals and Actavis plc, prior to the acquisition of Irish-based Allergan Inc) is a global pharmaceutical company focused on acquiring, developing, manufacturing and marketing branded pharmaceuti ...
*****Eden Biodesign *****Watson Pharmaceuticals *****Warner Chilcott Plc (Acq 2000) *****Andrx Corporation (Acq 2006) *****Procter & Gamble (Prescription drug div, Acq 2009) *****Arrow Group (Acq 2009) *****Specifar Pharmaceuticals S.A. (Acq 2011) *****Ascent Pharmahealth Ltd (Acq 2012) *****Actavis Group (Acq 2012) *****Galen (Acq 2013) *****Uteron Pharma, S.A. (Acq 2013) *****Durata Therapeutics (Acq 2014) *****Silom Medical Company (Acq 2014) *****
Forest Laboratories Forest Laboratories was a company in the pharmaceutical industry incorporated in Delaware, with its principal office in New York City. It was known for licensing European pharmaceuticals for sale in the United States. On July 1, 2014, the compan ...
(Acq 2014) ******Aptalis Pharma *******Axcan Pharma *******Eurand Pharmaceuticals ******Furiex Pharmaceuticals Inc (Acq 2014) *****Auden Mckenzie Holdings Limited (Acq 2015) ****Oculeve, Inc (Acq 2015) ****Naurex Inc (Acq 2015) ****AqueSys (Acq 2015) ****Northwood Medical Innovation Ltd (Acq 2015) ****Topokine Therapeutics (Acq 2016) ****Vitae Pharmaceuticals, Inc (Acq 2016) ****Tobira Therapeutics (Acq 2016) ****ForSight VISION5 (Acq 2016) ****RetroSense Therapeutics (Acq 2016) ****Akarna Therapeutics (Acq 2016) ****Motus Therapeutics (Acq 2016) ****Chase Pharmaceuticals (Acq 2016) ****LifeCell (Acq 2016) ****Zeltiq Aesthetics Inc. (Acq 2017) ****Keller Medical, Inc (Acq 2017) ****
Repros Therapeutics Repros Therapeutics Inc. (), was a US-based development stage biopharmaceutical company headquartered in The Woodlands, Texas. Founded in 1987 as Zonagen, it focused on the development of oral small molecule drugs to address major unmet medical n ...
(Acq 2017) ****Envy Medical, Inc. (Acq 2019) ****Mavupharma (Acq 2019) ****Soliton (Acq 2021) **TeneoOne (Acq 2021) **Syndesi Therapeutics (Acq 2022) **DJS Antibodies (Acq 2022)


Collaboration

On February 10, 2016, AbbVie and
Cambridge, Massachusetts Cambridge ( ) is a city in Middlesex County, Massachusetts, United States. As part of the Boston metropolitan area, the cities population of the 2020 U.S. census was 118,403, making it the fourth most populous city in the state, behind Boston ...
-based Synlogic announced a multi-year R&D collaboration. Synlogic is a
synthetic biology Synthetic biology (SynBio) is a multidisciplinary area of research that seeks to create new biological parts, devices, and systems, or to redesign systems that are already found in nature. It is a branch of science that encompasses a broad ran ...
company built on research from the labs of James Collins and Tim Lu at
MIT The Massachusetts Institute of Technology (MIT) is a private land-grant research university in Cambridge, Massachusetts. Established in 1861, MIT has played a key role in the development of modern technology and science, and is one of the m ...
. As part of the collaboration, AbbVie is getting worldwide rights to Synlogic's
probiotic Probiotics are live microorganisms promoted with claims that they provide health benefits when consumed, generally by improving or restoring the gut microbiota. Probiotics are considered generally safe to consume, but may cause bacteria- host ...
-based technology for treating inflammatory bowel disease, and the research teams will focus on Crohn's disease and
ulcerative colitis Ulcerative colitis (UC) is a long-term condition that results in inflammation and ulcers of the colon and rectum. The primary symptoms of active disease are abdominal pain and diarrhea mixed with blood (hematochezia). Weight loss, fever, and ...
. In April 2016, the company partnered with the
University of Chicago The University of Chicago (UChicago, Chicago, U of C, or UChi) is a private university, private research university in Chicago, Illinois. Its main campus is located in Chicago's Hyde Park, Chicago, Hyde Park neighborhood. The University of Chic ...
to investigate a number of areas of oncology: breast, lung, prostate, colorectal and hematological cancers. In the same month the company announced it would co-commercialize Argenx's preclinical immunotherapy, ARGX-115. ARGX-115 is a first-in-class immunotherapy targeting GARP (glycoprotein A repetitions predominant), a membrane protein believed to enhance the immunosuppressive effects of
T cells A T cell is a type of lymphocyte. T cells are one of the important white blood cells of the immune system and play a central role in the adaptive immune response. T cells can be distinguished from other lymphocytes by the presence of a T-cell re ...
. The company also announced a deal to co-develop/commercialize at least one of CytomX Probody's conjugates against
CD71 Transferrin receptor protein 1 (TfR1), also known as Cluster of Differentiation 71 (CD71), is a protein that in humans is encoded by the ''TFRC'' gene. TfR1 is required for iron import from transferrin into cells by endocytosis. Structure and func ...
(transferrin receptor 1). In March 2020, AbbVie announced plans to evaluate the Kaletra/Aluvia HIV medicine as possible COVID-19 treatment. The company entered into various partnerships with health authorities in different countries to investigate the efficacy of the medication. However, the first non-blinded, randomized trial found the drug not useful to treat severe COVID-19.


Products

According to the ''Wall Street Journal'' as of January 2016
ibrutinib Ibrutinib, sold under the brand name Imbruvica among others, is a small molecule drug that inhibits B-cell proliferation and survival by irreversibly binding the protein Bruton's tyrosine kinase (BTK). Blocking BTK inhibits the B-cell receptor ...
, a
specialty drug Specialty drugs or specialty pharmaceuticals are a recent designation of pharmaceuticals that are classified as high-cost, high complexity and/or high touch. Specialty drugs are often biologics—"drugs derived from living cells" that are injectab ...
, cost US$116,600 to $155,400 a year wholesale in the United States. In spite of discounts and medical insurance, the prohibitive price causes some patients to not fill their prescriptions. AbbVie estimates global sales of the drug at $1 billion in 2016 and $5 billion in 2020. In 2018, it started litigation against NHS England in the
Technology and Construction Court The King's Bench Division (or Queen's Bench Division when the monarch is female) of the High Court of Justice deals with a wide range of common law cases and has supervisory responsibility over certain lower courts. It hears appeals on point ...
claiming that they breached procurement rules and had not treated the company fairly during what was described as "the single largest medicines procurement ever done by the NHS" when seeking suppliers for hepatitis C treatments. In 2019, a UK court dismissed AbbVie's case against the NHS. As of 2019, the company remained committed to product development in the cystic fibrosis disease area, despite major success by their main competitor in the area,
Vertex Vertex, vertices or vertexes may refer to: Science and technology Mathematics and computer science *Vertex (geometry), a point where two or more curves, lines, or edges meet * Vertex (computer graphics), a data structure that describes the positio ...
.


Controversies


Drug price hikes

Humira is a drug used to treat
rheumatoid arthritis Rheumatoid arthritis (RA) is a long-term autoimmune disorder that primarily affects joints. It typically results in warm, swollen, and painful joints. Pain and stiffness often worsen following rest. Most commonly, the wrist and hands are invol ...
, Crohn's, and other autoimmune diseases. First released in 2003, AbbVie has since raised the drug's price by more than 470 percent, culminating in an annual supply now costing about $77,000. It has increased the price of Imbruvica, a drug used to treat
mantle cell lymphoma Mantle cell lymphoma (MCL) is a type of non-Hodgkin's lymphoma (NHL), comprising about 6% of NHL cases. There are only about 15,000 patients presently in the United States with mantle cell lymphoma. It is named for the mantle zone of the lymph n ...
and other cancers, by 82 percent since it launched in 2013. In 2022, it’s priced at $181,529. For patients taking four pills each day, it costs $242,039.


Anti-competitive practices

AbbVie has been accused of using anti-competitive patent thickets to prevent potentially cheaper
biosimilars A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company. Biosimilars are officially approved v ...
from entering the market. It is currently caught up in a legislative battle against Icelandic Alvotech, which is trying to bring a Humira biosimilar to market.
Forest Laboratories Forest Laboratories was a company in the pharmaceutical industry incorporated in Delaware, with its principal office in New York City. It was known for licensing European pharmaceuticals for sale in the United States. On July 1, 2014, the compan ...
, a subsidiary of AbbVie, has been accused of using unlawful deals to prevent generic versions of its
Alzheimer’s disease Alzheimer's disease (AD) is a neurodegenerative disease that usually starts slowly and progressively worsens. It is the cause of 60–70% of cases of dementia. The most common early symptom is difficulty in remembering recent events. As t ...
drug, Namenda, from entering the market. In 2018, AbbVie agreed to pay $25 million to resolve allegations that it made use of kickback schemes to promote its cholesterol drug
Tricor Fenofibrate (sold under the brand names ''Tricor'', ''Fenobrat'' etc.), is an oral medication of the fibrate class used to treat abnormal blood lipid levels. It is less commonly used compared than statins because it treats a different type of ...
. In 2020, AbbVie agreed to pay $24M to resolve allegations that it made use of kickback schemes to promote its
rheumatoid arthritis Rheumatoid arthritis (RA) is a long-term autoimmune disorder that primarily affects joints. It typically results in warm, swollen, and painful joints. Pain and stiffness often worsen following rest. Most commonly, the wrist and hands are invol ...
drug Humira using "nurse ambassadors".


Marketing of Opioid painkillers

In July 2022 the company agreed to pay up to $2.37 billion to settle U.S. lawsuits against its
Allergan Allergan plc is an American, Irish-domiciled pharmaceutical company that acquires, develops, manufactures and markets brand name drugs and medical devices in the areas of medical aesthetics, eye care, central nervous system, and gastroenterology. ...
unit over the marketing of
opioid Opioids are substances that act on opioid receptors to produce morphine-like effects. Medically they are primarily used for pain relief, including anesthesia. Other medical uses include suppression of diarrhea, replacement therapy for opioid use ...
painkillers An analgesic drug, also called simply an analgesic (American English), analgaesic (British English), pain reliever, or painkiller, is any member of the group of drugs used to achieve relief from pain (that is, analgesia or pain management). It i ...
. As part of the settlement, AbbVie, denied any wrongdoing. The company's stock fell 6 percent following an earnings report that included a $2.2 billion charge related to the opioid deal.


Carbon footprint

AbbVie reported Total CO2e emissions (Direct + Indirect) for the twelve months ending 31 December 2020 at 508 Kt (-57 /-10.1% y-o-y).Alt URL
/ref> and plans to reduce emissions 25% by 2025 from a 2015 base year.Alt URL
/ref>


References


External links

* * {{Authority control 2013 establishments in Illinois Biotechnology companies of the United States Biopharmaceutical companies Companies based in Lake County, Illinois Biotechnology companies established in 2013 Pharmaceutical companies established in 2013 American companies established in 2013 Companies listed on the New York Stock Exchange Orphan drug companies Pharmaceutical companies of the United States Health care companies based in Illinois Corporate spin-offs Abbott Laboratories 2013 initial public offerings