Mallinckrodt

Mallinckrodt PLC

Type	Public
Traded as	NYSE: MNK S&P 400 component
Headquarters	United Kingdom
Revenue	US$3.347 billion (2015)[1]
Net income	US$308.2 million (2015)[1]
Number of employees	5,500 (June 2015)
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]

History

Early history

In 1867, the Mallinckrodt brothers, Gustav, Otto and Edward, founded G. Mallinckrodt & Co. in St. Louis, Missouri.^[4] 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.^[5] 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.^[4]

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.^[6] 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.^[7]

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.^[8] 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.^[9] The waste was secretly dumped on Coldwater Creek and in various St. Louis suburbs, including Berkeley, Hazelwood, Bridgeton, and Weldon Spring with the approval of the federal government, which is now taking financial responsibility for the cleanup.^[10] The dumping substantially contaminated Coldwater Creek.

Cleanup efforts are now 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 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]

Market

Mallinckrodt markets its products to major wholesalers and retail drug store chains. Imaging products are marketed primarily to physicians, technologists and hospitals, imaging centers, cardiology clinics and radiopharmacies.^[3]

Products

Mallinckrodt has two main product lines.^[28]

• 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^[28]

• 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.^[29] 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.^[30] In 2013, Questcor acquired the US rights to a competing product, Synacthen Depot, from Novartis.^[30] In 2014 Mallinckrodt raised the price of Acthar further to $34,000.^[31] 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.^[29]
• 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:^[28]

• Hydrocodone API and tablets
• Oxycodone API and tablets
• Methylphenidate hydrochloride extended release tablets
• Dextroamphetamine sulfate controlled release tablets
• Other controlled substances, including acetominophen-containing products

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

External links

• Official site

• • Business data for Mallinckrodt: Google Finance
  • Yahoo! Finance
  • Reuters
  • SEC filings