Mallinckrodt

Mallinckrodt PLC
Public
Traded as
Headquarters United Kingdom
Revenue US$3.222 billion (2017)[1]
US$1.609 billion (2017)[1]
Number of employees
 3,600 (March 2018)
Website mallinckrodt.com

Mallinckrodt Pharmaceuticals, based in Staines-upon-Thames, England, with its U.S. headquarters in St. Louis, Missouri, produces specialty pharmaceutical products, including generic drugs and imaging agents.[2]

Mallinckrodt manufactures and distributes products used in diagnostic procedures and in the treatment of pain and related conditions. This includes the development, manufacture and distribution of specialty pharmaceuticals, active pharmaceutical ingredients, contrast products and radiopharmaceuticals. The company employs 5,500 at 47 locations around the world. Net sales were $2 billion in 2011[3] and were $3.35 billion in 2016.[4]

History

Early history

In 1867, the Mallinckrodt brothers, Gustav, Otto and Edward, founded G. Mallinckrodt & Co. in St. Louis, Missouri.[5] The Mallinckrodt family had immigrated from Germany, and Otto and Edward both returned to Germany, the leader in chemistry at the time, for advanced training.[6] Mallinckrodt Chemical Works was incorporated 15 years later. By 1898, the company had established itself as a pharmaceuticals supplier and in 1913 became the first to introduce barium sulfate as a contrast medium for x-rays.[5]

In part due to early success in production of radiology agents, and at the behest of surgeon Evarts Graham, Edward Mallinckrodt Sr. assigned one of the company's top chemists to collaborate in developing the first radiographic agent for gallbladder and bile duct imaging.[7] A posthumous endowment by Edward Mallinckrodt Jr. on behalf of his father to the Washington University medical school radiology department resulted in the creation of the Mallinckrodt Institute of Radiology.[8]

Nuclear waste in St. Louis, Missouri

Henry Farr and John Ruhoff, technical managers for Mallinckrodt, Inc. were directed by Edward Mallinckrodt Jr. to develop a chemical process for purifying large quantities of uranium.[9] Uranium purified by Mallinckrodt was used at the University of Chicago Chicago Pile-1, the first nuclear chain reaction. Mallinckrodt also contributed uranium to the Manhattan Project, producing fissionable materials used in the atomic weapons detonated over Hiroshima and Nagasaki. From 1942 to 1957 Mallinckrodt purified 50,000 short tons (45,000,000 kg) of uranium products at various locations in and around the city of St. Louis.[10] The waste was secretly dumped on Cold Water Creek and in various St. Louis suburbs, including Berkeley, Hazelwood, Bridgeton, and Weldon Spring with the approval of the federal government.

Cleanup efforts are currently underway by the Army Corps of Engineers.[11] Cleanup sites include the St. Louis Downtown Site (SLDS), where uranium was refined; the St. Louis Airport Site (SLAPS), where waste produced at SLDS was stored; the Hazelwood Interim Storage Site (HISS), where waste from SLAPS was relocated; and the St. Louis Airport Site Vicinity Properties (SLAPS VPs), areas where contamination was caused by relocation of waste. Additional nuclear waste was also deposited at the West Lake Landfill, which has now been designated a Superfund site. Various buildings have been decontaminated and demolished and nuclear material has been excavated and shipped out of St. Louis(to where?) by covered rail as part of the cleanup process, yet more nuclear waste remains in and around St. Louis.

Recent history

  • 1981 – Mallinckrodt was listed among Fortune 500 companies[12]
  • 1982 – Avon Products, Inc. acquired Mallinckrodt
  • 1986 – International Minerals and Chemical Corporation (IMCERA Group Inc.) acquired Mallinckrodt from Avon
  • 1988 - Malinckrodt was mentioned in The New York Times as the only company to receive an exception from the DEA for cocaine possession and processing[13]
  • 1995 – Mallinckrodt established generic pharmaceuticals business
  • 1996 – Mallinckrodt acquired maker of urology imaging systems and injectors, Liebel-Flarsheim Co.[14]
  • 2000 – Tyco International acquired Mallinckrodt[15]
  • 2007 – Tyco Healthcare spun off as Covidien, an independent company.[16] The healthcare business units were spun off under the name Covidien.[17]
  • 2011 – Covidien announced plans to spin off Mallinckrodt Pharmaceuticals as a standalone public company[18][19] Mallinckrodt Plc was officially separated as of June 28, 2013. Trading of regular shares of the company’s stock on the New York Stock Exchange began on July 1, 2013, under the ticker symbol MNK.[2]
  • 2012 – Mallinckrodt announced acquisition of CNS Therapeutics for $100 million[20]
  • 2013 – Mallinckrodt spun off from Covidien and began trading under ticker symbol MNK[2]
  • 2014 – Mallinckrodt acquired Cadence Pharmaceuticals[21] and Questcor Pharmaceuticals;[22] joins S&P 500[23]
  • 2015 – Mallinckrodt acquired Ikaria Inc. for $2.3 billion[24]
  • 2015 – Mallinckrodt acquired Therakos for $1.325 billion[25]
  • 2015 - Mallinckrodt sold the Contrast Media and Deliver Systems portion of its portfolio to Guerbet for $270M cash with a loan financed by BNP Paribas [26]
  • 2016 – Mallinckrodt acquired regeneratitive medicine company Stratatech[27]
  • 2017 – In November the company announced its intention to acquire Ocera Therapeutics for up to $117 million.[28] In late December the company announced it would acquire Sucampo Pharmaceuticals Inc for around $840 million, gaining control of constipation drug - Amitiza and a number of experimental rare disease treatments.[29]

Products

Mallinckrodt has two main product lines.[30]

  • Specialty Pharmaceuticals products include branded drugs as well as specialty generics and active pharmaceutical ingredients (APIs). Products include biologics, medicinal opioids, synthetic controlled substances, and acetominophen.
  • Medical Imaging products include contrast media and radiopharmaceuticals for medical imaging applications.

In the fourth quarter of 2014, Specialty Pharmaceuticals accounted for 74% of net sales. Key specialty pharmaceutical products include[30]

  • Acthar gel, an injectable biopharmaceutical used for the treatment of infantile spasms, acute exacerbations of multiple sclerosis, and certain orphan diseases. Mallinckrodt acquired this product via its acquisition of Questcor Pharmaceuticals in 2014.[31] When Questcor acquired the drug in 2001 it sold for $40 a vial; within a year of the acquisition Questcor raised the price of the drug to $1,500 per vial and to $28,000 by 2013.[32] In 2013, Questcor acquired the US rights to a competing product, Synacthen Depot, from Novartis.[32] In 2014 Mallinckrodt raised the price of Acthar further to $34,000.[33] The Federal Trade Commission and attorneys general from five states sued Mallinckrodt for anti-competitive behavior with regard to the acquisition of Synacthen Depot and the monopolistic pricing of Acthar, and in January 2017 the company settled, agreeing to pay $100 million and to license Synacthen Depot to a competitor.[31]
  • Offirmev is a proprietary IV formulation of acetominophen used in conjunction with opioid painkillers in the post surgical setting.
  • Xartemis XR is a controlled release oral combination of acetominophen and oxycodone for the treatment of acute pain.
  • Exalgo is a once-daily, long-acting form of hydromorphone, another pain drug.

Key generic specialty products include:[30]

Medical Imaging products include Optiray (ioversol injection), an iodide based contrast medium for CT scans, and Optimark (gadoversetamide injection) a Gadolinium-Based Contrast Agent used in magnetic resonance imaging of the brain or liver.

As of 1988, Mallinckrodt was the only company in the US that is allowed to receive cocaine, which it has used to make cocaine hydrochloride, a prescription drug used in hospitals as a local anesthetic by eye and ear, nose and throat doctors.[13]

References

  1. 1 2 "News & Media - Mallinckrodt Pharmaceuticals".
  2. 1 2 3 "Mallinckrodt". Wall Street Journal. 1 July 2013. Retrieved 18 July 2013.
  3. ↑ "Form 10-K". Retrieved 6 November 2012.
  4. ↑ "News & Media - Mallinckrodt Pharmaceuticals". www.mallinckrodt.com. Retrieved 6 June 2018.
  5. 1 2 "SHSMO-St. Louis s0452 Mallinckrodt, Edward Jr. (1878–1967)" (PDF). State Historical Society of Missouri. Retrieved 5 February 2015.
  6. ↑ Mercelis, Joris. "Edward Mallinckrodt Sr." In Immigrant Entrepreneurship: German-American Business Biographies, 1720 to the Present, vol. 3, edited by Giles R. Hoyt. German Historical Institute. Last modified March 10, 2015.
  7. ↑ Evens, Ronald G. (2009-01-07). "Roentgenologic Examination of the Gallbladder (Cholecystography)". JAMA. 301 (1): 100–101. doi:10.1001/jama.2008.893. ISSN 0098-7484.
  8. ↑ "S0452 Mallinckrodt, Edward Jr. (1878–1967) Papers, 1798–1981" (PDF). State Historical Society of Missouri: Manuscripts. State Historical Society of Missouri. p. 2. Retrieved 23 April 2017.
  9. ↑ "Tribute to Mallinckrodt Uranium Workers" (PDF). Department of Energy. Retrieved 5 February 2015.
  10. ↑ Schneider, Keith. "Mountain of Nuclear Waste Splits St. Louis and Suburbs". New York Times. The New York Times. Retrieved 5 January 2015.
  11. ↑ "US Army Corps of Engineers FUSRAP". US Army Corps of Engineers - St. Louis Region. Retrieved 5 January 2015.
  12. ↑ "Mallinckrodt: a timeline : Business". Retrieved 6 November 2012.
  13. 1 2 May, Clifford D. (1988-07-01). "How Coca-Cola Obtains Its Coca". The New York Times. ISSN 0362-4331. Retrieved 2016-04-18.
  14. ↑ "TIMELINE: Mallinckrodt over the years - St. Louis Business Journal". Retrieved 6 November 2012.
  15. ↑ "Tyco to Buy Mallinckrodt for $3.2 Billion - Los Angeles Times". Retrieved 18 March 2013.
  16. ↑ "Tyco Healthcare completes spin-off as Covidien - St. Louis Business Journal". Retrieved 6 November 2012.
  17. ↑ https://www.reuters.com/article/reutersEdge/idUSN0237854220070702%7C Reuters press release Mon Jul 2, 2007 4:29pm EDT
  18. ↑ "Covidien Spinning Off Drugs Unit to Focus on Pain Management - Bloomberg". Retrieved 6 November 2012.
  19. ↑ "Covidien to Spin Off Drug Unit". Wall Street Journal. Retrieved 6 November 2012.
  20. ↑ "Covidien completes $100M CNS Therapeutics deal - Businessweek". Retrieved 6 November 2012.
  21. ↑ "Mallinckrodt plc Completes $1.4 Billion Acquisition of Cadence Pharmaceuticals, Inc". Yahoo Finance. 19 March 2014. Retrieved 10 January 2015.
  22. ↑ Armstrong, Drew; Serafino, Phil (7 April 2014). "Mallinckrodt Agrees to Buy Questcor for $5.6 Billion". Bloomberg. Retrieved 10 January 2015.
  23. ↑ "Mallinckrodt Set to Join the S&P 500; Rowan to Join S&P MidCap 400; GulfMark Offshore to Join S&P SmallCap 600". Yahoo Finance. 14 August 2014. Retrieved 10 January 2015.
  24. ↑ McLaughlin, Kim. "Mallinckrodt Buys Ikaria for $2.3 Billion for Neonatal Care". Bloomberg.com. Retrieved 2016-08-12.
  25. ↑ "Mallinckrodt to Acquire Therakos for $1.325B - GEN News Highlights - GEN".
  26. ↑ "Guerbet completes acquisition of Mallinckrodt's Contrast Media and Delivery Systems business (CMDS)". www.guerbet.com. Retrieved 2016-03-21.
  27. ↑ "Mallinckrodt Plans to Purchase Skin Substitute Developer Stratatech - GEN News Highlights - GEN".
  28. ↑ "Mallinckrodt to Acquire Ocera Therapeutics for Up to $117M - GEN". GEN. Retrieved 6 June 2018.
  29. ↑ Mathias, Tamara. "Mallinckrodt to buy Sucampo for about $840 million". Retrieved 6 June 2018.
  30. 1 2 3 "www.sec.gov".
  31. 1 2 Johnson, Carolyn Y. (January 18, 2017). "Maker of $34,000-a-vial drug to pay $100 million for allegedly preventing competition". Washington Post.
  32. 1 2 Staton, Tracy (June 18, 2015). "Questcor's Acthar maneuvers land Mallinckrodt in hot water with FTC, state AGs". FiercePharma.
  33. ↑ Galeon, Dom (21 January 2017). "Company Raises the Price of a Drug That Fights Infant Epilepsy by 85,000%". Futurism.
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