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AbbVie
AbbVie Inc.
TypePublic company
IndustryBiopharmaceutical
Founded2013; 9 years ago (2013)
HeadquartersNorth Chicago, Illinois, U.S.
Area served
Worldwide
(170+ countries)
Key people
Richard A. Gonzalez
(Chairman and CEO)
Michael Severino
(Vice Chairman and President)
ProductsPharmaceutical drugs
RevenueIncrease US$56.20 billion (2021)[1]
Decrease US$17.92 billion (2021)[1]
Decrease US$11.54 billion (2021)[1]
Total assetsDecrease US$146.53 billion (2021)[1]
Total equityIncrease US$15.44 billion (2021)[1]
Number of employees
Increase 50,000 (Jan 2022)[1]
Websiteabbvie.com

AbbVie is an American publicly traded biopharmaceutical 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.[2] The separation was effective January 1, 2013, and AbbVie was officially listed on the New York Stock Exchange (ABBV) on January 2, 2013.[3]

According to Miles White, CEO at the time, the purpose of the split was to allow markets to value the two businesses separately.[4] 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, which accounted for about half of the drug division's revenue.[4]

As of December 2015, the company employed in excess of 28,000 globally, and provided products to individuals in more than 170 countries.[5]

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 developed into an international crisis, the Israeli government announced that it would force AbbVie to license its patents for Kaletra, the brand name of lopinavir/ritonavir, 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. In response, AbbVie announced that it would cease enforcing its patents on the drug entirely.[6]

In June 2021, the US Senate Finance Committee, under Chair Ron Wyden (D-OR), began an investigation to determine if the company used the Tax Cuts and Jobs Act of 2017 to buy back its own stock using income saved by the tax law.[7] 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.[8]

Acquisitions

In January 2014, the company acquired ImmuVen for an undisclosed sum.[citation needed] On September 3, 2014, AbbVie and Infinity Pharmaceuticals announced that they had entered into a global collaboration to develop and commercialize duvelisib, Infinity's PI3K inhibitor for the treatment of patients with cancer. On the same day, AbbVie and Calico 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. 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 (who subsequently left the company).[9]

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.[10]

On March 4, 2015, AbbVie announced its agreement to acquire the oncology firm Pharmacyclics and its treatment for blood cancers, ibrutinib; AstraZeneca had also been bidding to acquire Pharmacyclics.[11][12] 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.[13] The Pharmacyclics name was retained, and it operates as a subsidiary of AbbVie from its previous Sunnyvale, California, headquarters.[14] 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.[15]

On 28 April 2016, the company announced it would acquire Stemcentrx for up to $9.8 billion.[16] 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.[17]

On 25 June 2019, AbbVie announced it would acquire Irish-based Allergan plc 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;[18][19] 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.[20][21] In July, the company announced it would acquire Mavupharma, boosting its cancer drug pipeline.[22][23]

In May 2021, Allergan Aesthetics announced it would acquire Soliton.[24] 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.[25]

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 and lead compound SDI-118.[26][27] 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.[28]


Acquisition history

The following is an illustration of the company's major mergers and acquisitions and historical predecessors (this is not a comprehensive list):
  • Abbvie (Spin off from Abbott Laboratories)
    • Pharmacyclics (Acq 2015)
    • Stemcentrx (Acq 2016)
    • Venice Subsidiary LLC[29]
      • Allergan, plc (Acq 2019)
        • Allergan, inc
          • MAP Pharmaceuticals Inc (Acq 2013)
          • Kythera Biopharmaceuticals (Acq 2015)
        • Actavis plc
          • 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 (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 (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-based Synlogic announced a multi-year R&D collaboration. Synlogic is a synthetic biology company built on research from the labs of James Collins and Tim Lu at MIT. As part of the collaboration, AbbVie is getting worldwide rights to Synlogic's probiotic-based technology for treating inflammatory bowel disease, and the research teams will focus on Crohn's disease and ulcerative colitis.[30] In April 2016, the company partnered with the University of Chicago to investigate a number of areas of oncology: breast, lung, prostate, colorectal and hematological cancers.[31] 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.[32] The company also announced a deal to co-develop/commercialize at least one of CytomX Probody's conjugates against CD71 (transferrin receptor 1).[33]

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.[34] However, the first non-blinded, randomized trial found the drug not useful to treat severe COVID-19.[35]

Products

According to the Wall Street Journal as of January 2016 ibrutinib, a specialty drug, 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.[36] AbbVie estimates global sales of the drug at $1 billion in 2016 and $5 billion in 2020.[36]

In 2018, it started litigation against NHS England in the Technology and Construction Court 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.[37] In 2019, a UK court dismissed AbbVie's case against the NHS.[38]

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.[39]

Controversies

Drug price hikes

Humira is a drug used to treat rheumatoid arthritis, 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 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.[40]

Anti-competitive practices

AbbVie has been accused of using anti-competitive patent thickets to prevent potentially cheaper biosimilars 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.[41][42] Forest Laboratories, a subsidiary of AbbVie, has been accused of using unlawful deals to prevent generic versions of its Alzheimer’s disease drug, Namenda, from entering the market.[43][44]

In 2018, AbbVie agreed to pay $25 million to resolve allegations that it made use of kickback schemes to promote its cholesterol drug Tricor.[45] In 2020, AbbVie agreed to pay $24M to resolve allegations that it made use of kickback schemes to promote its rheumatoid arthritis drug Humira using "nurse ambassadors".[46][47]

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 unit over the marketing of opioid painkillers. 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.[48]

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).[49] and plans to reduce emissions 25% by 2025 from a 2015 base year.[50]

AbbVie's annual Total CO2e Emissions - Market-Based Scope 1 + Scope 2 (in kilotonnes)
Dec 2014 Dec 2015 Dec 2016 Dec 2017 Dec 2018 Dec 2019 Dec 2020
679[51] 654[52] 610[53] 583[54] 585[55] 565[56] 508[49]

References

  1. ^ a b c d e f "AbbVie Inc. 2021 Annual Report (Form 10-K)". U.S. Securities and Exchange Commission. 18 February 2022.
  2. ^ "Abbott Labs to Split Into 2 Companies". The New York Times. October 19, 2011. Retrieved October 19, 2011.
  3. ^ "Abbott Completes Separation of Research-Based Pharmaceuticals Business". AbbVie Inc. January 2, 2013. Archived from the original on January 14, 2013. Retrieved January 2, 2013.
  4. ^ a b "More than splitting pills: Health care giant Abbott Laboratories ready to spin off AbbVie". Chicago Tribune. December 30, 2012. Retrieved October 25, 2016.
  5. ^ "AbbVie - About Us". abbvie.com. Retrieved 1 January 2016.
  6. ^ Bonadio, Enrico; Baldini, Andrea (April 1, 2020). "Drug companies should drop their patents and collaborate to fight coronavirus". The Conversation.
  7. ^ Kovaleski, Dave (2021-06-04). "Senate Finance Committee launches investigation into Abbvie tax practices". Financial Regulation News. Washington DC: Macallan Communications.
  8. ^ Owusu, Tony (2 June 2021). "AbbVie Faces U.S. Senate Pressure Over Tax Payments". TheStreet. New York NY.
  9. ^ "Google-Backed Calico Joins AbbVie in Up to $1.5B Collaboration". Genetic Engineering & Biotechnology News. September 3, 2014. Retrieved June 4, 2015.
  10. ^ Gelles, David (2014). "After Tax Inversion Rules Change, AbbVie and Shire Agree to Terminate Their Deal". The New York Times (online, October 20 ed.).
  11. ^ Nisen, Max (2015). "AstraZeneca Chases AbbVie, Cheaply". Chicago Business (online, December 17 ed.). Crain's. Retrieved 31 December 2015.
  12. ^ Staff (1 April 2015). "AbVie Acquires Oncology Drug Firm Pharmacyclics for $21B". News: Industry Watch. Genetic Engineering & Biotechnology News (Paper). 35 (5): 10.
  13. ^ Rockoff, Jonathan D.; Loftus, Peter (5 March 2015). "AbbVie to Buy Pharmacyclics in $21 Billion Deal". The Wall Street Journal. Retrieved 4 June 2015.(subscription required)
  14. ^ "AbbVie (ABBV) Announces Completion of Pharmacyclics Acquisition". StreetInsider.com. May 26, 2015. Retrieved June 5, 2015.
  15. ^ "Abbvie Terminates Development Deal with Halozyme - GEN". GEN. 21 November 2016.
  16. ^ "AbbVie to Acquire Stemcentrx for Up to $9.8B". GEN. 28 April 2016.
  17. ^ "Galapagos, AbbVie Expand CF Collaboration to Up-to-$600M". GEN. 29 April 2016.
  18. ^ Julia Kollewe (25 June 2019). "Botox maker Allergan bought by US drug giant for $63bn". The Guardian. Retrieved 25 June 2019.
  19. ^ Rebecca Spalding; Riley Griffin (25 June 2019). "AbbVie Strikes $63 Billion Deal for Botox Maker Allergan". Bloomberg News. Retrieved 25 June 2019. The deal will return Allergan to the U.S., at least for tax purposes.
  20. ^ "FTC Approves Final Order Imposing Conditions on AbbVie Inc.'s Acquisition of Allergan plc". Federal Trade Commission. 2020-09-04. Retrieved 2020-09-05.
  21. ^ Blankenship, Kyle (5 May 2020). "AbbVie, Allergan score FTC approval for $63B merger with one final hurdle left to go". Fierce Pharma.
  22. ^ "AbbVie Dives into STING and Boehringer Ingelheim Snaps Up Swiss-based AMAL". BioSpace. July 15, 2019.
  23. ^ "AbbVie Enhances Early Stage Oncology Pipeline with Acquisition of Mavupharma". BioSpace. July 15, 2019.
  24. ^ "Allergan Aesthetics to Acquire Soliton, Expanding Body Contouring Portfolio".
  25. ^ "With Myeloma Drug Proving Merit in Phase I, AbbVie Scoops up TeneoOne".
  26. ^ "AbbVie Bolsters Neuro Platform with $1B Syndesi Buy".
  27. ^ "AbbVie Acquires Syndesi Therapeutics, Strengthening Neuroscience Portfolio".
  28. ^ "AbbVie Gains Access to Pulmonary Fibrosis Antibody with $225M DJS Buy".
  29. ^ "AbbVie Announces Commencement of Exchange Offers and Consent Solicitations for Allergan Notes". BioSpace.
  30. ^ "AbbVie, Maker of World's No. 1 Drug, Bets Synthetic Biology Startup Can Raise the Bar". Forbes. February 10, 2016. Retrieved February 10, 2016.
  31. ^ "AbbVie, University of Chicago Launch Cancer Research Alliance". GEN. 20 April 2016.
  32. ^ "AbbVie to Co-Develop argenx's Cancer Immunotherapy ARGX-115 - GEN News Highlights - GEN". GEN.
  33. ^ "AbbVie to Co-Commercialize CytomX's Probody Drug Conjugates". GEN.
  34. ^ "Covid-19 treatment tested through HIV medicine by AbbVie". 11 March 2020. Retrieved 2020-03-11.
  35. ^ Cao B, Wang Y, Wen D, Liu W, Wang J, Fan G, et al. (March 2020). "A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19". New England Journal of Medicine. 382 (19): 1787–1799. doi:10.1056/NEJMoa2001282. PMC 7121492. PMID 32187464. This randomized trial found that lopinavir–ritonavir treatment added to standard supportive care was not associated with clinical improvement or mortality in seriously ill patients with Covid-19 different from that associated with standard care alone.
  36. ^ a b Walker, Joseph (1 January 2016). "Patients Struggle With High Drug Prices". Wall Street Journal. Retrieved 1 January 2016.
  37. ^ "NHS England taken to court over 'largest ever medicines procurement'". Health Service Journal. 6 November 2018. Retrieved 8 December 2018.
  38. '^ Burki, Talha (2019). "UK court dismisses Abb Vies legal challenge against the NHS". The Lancet. 393 (10169): 307–308. doi:10.1016/S0140-6736(19)30156-4. S2CID 72332746.
  39. ^ Carroll, John (October 25, 2019). "AbbVie doubles down on cystic fibrosis R&D, adding a new drug to the pipeline as Vertex seals its domination of the field with Trikafta OK". EndpointNews.
  40. ^ "Pharmaceutical company AbbVie inflated prices for two major drugs, House Oversight report says". NBC News. Retrieved 2022-02-06.
  41. ^ "Alvotech Files Suit to Invalidate Humira Patents". The Center For Biosimilars. Retrieved 2022-02-06.
  42. ^ "Alvotech Beats Back AbbVie's Trade Secrets Lawsuit". www.businesswire.com. 2021-10-07. Retrieved 2022-02-06.
  43. ^ "AbbVie subsidiary Forest faces more antitrust litigation over Alzheimer's drug as judge rejects its bid to toss case". FiercePharma. 14 June 2021. Retrieved 2022-02-06.
  44. ^ Pierson, Brendan (2021-06-11). "AbbVie must face health plans' lawsuit over Alzheimer's drug". Reuters. Retrieved 2022-02-06.
  45. ^ "Abbott Laboratories and AbbVie Inc. to Pay $25 Million to Resolve False Claims Act Allegations of Kickbacks and Off-Label Marketing of the Drug TriCor®". www.justice.gov. 2018-10-26. Retrieved 2022-02-06.
  46. ^ "AbbVie accused of 'far-reaching' kickback scheme for Humira". BioPharma Dive. Retrieved 2022-02-06.
  47. ^ "In kickbacks case, California insurance chief says AbbVie used nurse 'ambassadors' to protect Humira sales". FiercePharma. 18 September 2018. Retrieved 2022-02-06.
  48. ^ Mishra, Manas; Pierson, Brendan (2022-07-29). "AbbVie to pay up to $2.37 billion to settle U.S. opioid claims". Reuters. Retrieved 2022-08-01.
  49. ^ a b "AbbVie's Sustainability Report for 2020Q4" (PDF). Archived from the original (PDF) on September 17, 2021. Alt URL
  50. ^ "AbbVie's Sustainability Report for 2020Q4" (PDF). Archived from the original (PDF) on July 11, 2021. Alt URL
  51. ^ "AbbVie's Sustainability Report for 2018Q4" (PDF). Archived from the original (PDF) on October 1, 2021. Alt URL
  52. ^ "AbbVie's Sustainability Report for 2019Q4" (PDF). Archived from the original (PDF) on September 25, 2020. Alt URL
  53. ^ "AbbVie's Sustainability Report for 2020Q4" (PDF). Archived from the original (PDF) on September 17, 2021. Alt URL
  54. ^ "AbbVie's Sustainability Report for 2020Q4" (PDF). Archived from the original (PDF) on September 17, 2021. Alt URL
  55. ^ "AbbVie's Sustainability Report for 2020Q4" (PDF). Archived from the original (PDF) on September 17, 2021. Alt URL
  56. ^ "AbbVie's Sustainability Report for 2020Q4" (PDF). Archived from the original (PDF) on September 17, 2021. Alt URL

External links

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