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Mylan
Mylan N.V.
FormerlyMilan
Company typePublic (under Dutch law)
Nasdaq: MYL
TASE: MYL
NASDAQ Biotechnology Component
NASDAQ-100 Component
S&P 500 Component
ISINUS6285301072
IndustryPharmaceuticals
Founded1961; 63 years ago (1961) in White Sulphur Springs, West Virginia, United States
FoundersMilan Puskar
Don Panoz
Headquarters
Canonsburg, Pennsylvania
,
United States of America
Area served
Worldwide
Key people
Heather Bresch, CEO
ProductsGeneric and specialty pharmaceuticals and active pharmaceutical ingredients
RevenueIncrease US$9.42 billion[1] (2015)
Decrease US$830.1 million (2015)
Increase US$4.216 billion (2015)
Total assetsIncrease US$ 22.267 billion (2015)
Total equityIncrease US$9.765 billion (2015)
Number of employees
~35,000[1] (2015)
Divisionssee Operations
SubsidiariesMeda
Famy Care
Websitewww.mylan.com

Mylan N.V. is an American global generic and specialty pharmaceuticals company registered in the Netherlands, with principal executive offices in Hatfield, Hertfordshire, UK and global headquarters in Canonsburg, Pennsylvania, US.[2] In 2007, Mylan acquired a controlling interest in India-based Matrix Laboratories Limited, a top producer of active pharmaceutical ingredients (APIs) for generic drugs,[3] and the generics business of Germany-based Merck KGaA.[4] Through these acquisitions, Mylan grew from the third-largest generic and pharmaceuticals company in the United States to the second-largest generic and specialty pharmaceuticals company in the world.[5]

In 2016, Mylan's pricing of the EpiPen, an epinephrine autoinjector, became controversial and was widely referred to as "price gouging". As a result, investigations were opened into whether Mylan had misclassified the EpiPen under the Medicaid Drug Rebate Program, a common form of pharmaceutical fraud. In October 2016, Mylan settled these investigations with the U.S. Department of Justice, agreeing to pay $465 million and enter into a corporate integrity agreement concerning the rebate program. In a report published on June 12, 2017 the Institutional Shareholder Services criticized Mylan for the "outsized compensation" of Mylan's directors. Former CEO Robert Coury received a "$98 million" 2016 "pay package" in spite of the "harm to the company inflicted by the EpiPen controversies" and "steep shareholder losses." The report urged Mylan's shareholders to "oust all of Mylan's existing directors".[6]

Operations

Mylan Inc. operates several divisions and subsidiaries:

In North America and South America, Mylan operates:

  • Mylan Pharmaceuticals, based in Morgantown, West Virginia
  • Mylan Pharmaceuticals ULC (Mylan Canada)
  • Mylan Technologies Inc. (MTI) - transdermal drug delivery systems (TDDS) and related technologies[7]
  • UDL Laboratories Inc.
  • Somerset Pharmaceuticals Inc. a research and development company in Tampa, Florida, owned by Mylan. Somerset develops Emsam, manufactured by Mylan Technologies and marketed in the United States by Dey, another Mylan company[8][9]
  • Mylan Laboratories Limited, Campos dos Goytacazes, Brazil

In Oceania and Central, East, South, and Southeast Asia, Mylan operates:[10]

In Europe, Africa, and West Asia, Mylan operates:[10]

  • Operates under the Mylan name in Austria, Belgium, the Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, the Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, the United Kingdom. Also operates in South Africa.
  • Arcana Arzneimittel GmbH - Germany[12]
  • Generics Pharma Hellas - Greece[13]
  • Gerard Laboratories - Ireland[14]
  • Qualimed - trademark in France, but will stop being marketed under the brand name[15]
  • Docpharma - generic pharmaceutical distribution company in Belgium, the Netherlands and Luxembourg

Location

Founded in 1961, the company was first located in White Sulphur Springs, West Virginia.[16] The company moved to Morgantown, West Virginia, in 1965, and in 1976 it relocated its corporate headquarters to the Pittsburgh suburb Canonsburg, Pennsylvania. Finally in 2004 it moved to a new office center in nearby Southpointe, a suburban business park located in Cecil Township, where it is still located.[17]

Stock

On February 23, 1973, Mylan had its initial public offering (IPO),[18] becoming a publicly traded company on the OTC market under the ticker symbol MYLN. In 1976 the stock moved to NASDAQ. Their final stock move was in 1986, when their stock became available for trade on the New York Stock Exchange under the ticker symbol MYL. Currently, the stock is traded on the NASDAQ.

History

Mylan Pharmaceuticals was founded as a drug distributor in 1961 by Milan Puskar and Don Panoz.[16] In 1966 Mylan began manufacturing penicillin G tablets as well as vitamins and other dietary supplements.[16][19]

Panoz left Mylan in 1969 and Puskar quit the company in 1973, as it grew and experienced financial difficulties; the board hired Roy McKnight as board chairman, who convinced Puskar to return in 1976.[19]

Mylan discontinued operating as a contract manufacturing organization in 1980 and instead chose to market their products under their own "Mylan-labeled" brand.[citation needed]

With the passage of the Hatch-Waxman Act in 1984, Mylan and other small generic companies gained value; in the eighteen months following passage of the law Mylan's earnings grew 166% to $12.5 million and its stock value rose 800%.[20]

In the 1980s one of the most prescribed drugs in the US was Dyazide, a diuretic that was a combination drug containing triamterene and hydrochlorothiazide; it had been on the market since 1965 and its patents had expired in 1980.[21] Complications arose with the introductions of generics versions, because the formulation of Dyazide resulted in variable batches that made it impossible for generic manufacturers to show that their versions were bioequivalent.[22][23]

Some generic companies committed fraud trying to bring a generic version of Dyazide. Bolar Pharmaceutical had the first generic version approved in 1987,[21] but it turned out that Bolar had fraudulently substituted Dyazide for its own version to conduct studies that were submitted to the FDA by 1989 the FDA rescinded its approval based on its suspicions and filed criminal charges against Bolar, to which Bolar eventually pled guilty in 1991.[24][25][26]

Mylan chose to develop a new version of a triamterene/hydrochlorothiazide combination drug instead of going the generic route; it developed a different, more stable formulation[23] and used different dosages of each active ingredient (50 mg hydrochlorothiazide and 75 mg triamterene, compared with Dyazide's 25 mg hydrochlorothiazide and 50 mg triamterene).[27] This drug had to get approval as a new drug, as opposed to a generic; their product was called Maxzide and was approved in 1984.[27][28] The higher dose allowed once per day dosing, which Mylan and its marketing partner, Lederle, believed would help it compete against Dyazide, which had $210M in sales in 1983.[27] However, Mylan's patents on the drug were declared invalid in court, and its marketing exclusivity expired in 1987, prompting a rush of generic competition[29]

Mylan had concerns about the practices of its competitors and the FDA in general, and also with regard to companies seeking to bring generic versions of Maxzide. Mylan hired private investigators to examine its competitors' practices, and when it found evidence of corruption, it submitted it to the House Oversight and Investigations Committee, which investigated and found fraud and corruption within the Food and Drug Administration's generic drugs division and at other generic companies.[19] Two of the companies that had gotten approval to market generic versions of Maxzide, Vitarine Pharmaceutical and Par Pharmaceutical, were targets of Mylan's initial investigation and were found to have used Mylan's Maxzide to obtain their bioequivalence data, leading both companies to withdraw its generic competitor to Mylan's product.[19][30]

The corruption in the nascent generics industry and at the office in the FDA regulating it was widely covered in the media, and led to widespread concern among doctors and the public in the late 1980s and early 1990s that generic drugs were not really the same as the branded drugs they were meant to replace.[24][31][22]

In 1987 Mylan agreed to enter into a joint venture with Bolar to buy Somerset Pharmaceuticals; Mylan wanted access to Somersets' drug discovery capabilities as well as its new drug for Parkinson's, selegiline; the deal was completed in 1988 but its consummation was dependent on FDA approval of selegiline, which came in 1989.[19][32][33]

Mylan acquired Bertek Inc. in 1993 for its transdermal patch technologies, and kept as a subsidiary; in 1999 Mylan renamed the company Mylan Technologies Inc. (MTI).[34] MTI eventually came to be the contract manufacturer for the selegiline transdermal patch and was the first company to market generic nitroglycerin, estradiol, clonidine, and fentanyl transdermal patches.[34] Mylan acquired UDL Laboratories, a supplier of unit dose generic medications to institutional and long-term care facilities in 1996.[35]

In 1998 when it was the world's second largest generics company, Mylan came under investigation from the Federal Trade Commission after it raised the prices of its products, tripling them in the case of lorazepam; Mylan had entered into an exclusive agreement with Profarmica, an Italian company that supplied drug ingredients, after which Mylan's competitors had higher prices and a diminished supply of raw ingredients for lorazepam and other drugs.[36] Before the round of price increases the price of generic drugs had been 5 - 10% of the price of branded drugs and afterwards it was around 50%.[36] The FTC filed suit at the end of 1998 and 32 states filed parallel actions; the case was settled in 2000, with Mylan paying a total of $147M -- $100M in disgorged profits into a fund to reimburse consumers and state agencies that had overpaid, $8 million in attorney's fees to the State Attorneys General, $35 million, plus $4 million in attorney's fees, to settle certain class actions with insurers and managed care organizations -- and Mylan and three ingredient suppliers (Cambrex Corporation, Profarmaco S.R.L., and Gyma Laboratories) also agreed to an injunction barring them from entering into similar anticompetitive agreements in the future.[37][38]

In 2004 Mylan and King Pharmaceuticals began discussing a deal in which Mylan would acquire King for about $4B; Mylan wanted to expand its presence in branded pharmaceuticals and to acquire King's sales force.[39] The deal became one of the business soap operas of the year, and included an SEC investigation into King's accounting and Carl Icahn obtaining a 9.8% interest in Mylan and becoming its largest stakeholder in order to kill the deal; the parties called off the deal in February 2005.[39] Icahn offered to buy Mylan for $5.4B[40] and ran a slate of board members to change the direction of Mylan; he won three seats in May 2005.[41] In June Mylan bought back 25% of its shares in order to fend off Icahn;[42] and in July Icahn gave up his bid and sold his shares.[43]

In August 2006 Mylan announced that it had reached agreement to buy a controlling interest in Matrix Laboratories, an Indian supplier of active pharmaceutical ingredients; the deal gave Mylan access to markets in India and China and was completed in January the next year.[44][45]

In May 2007 Mylan and Merck KGaA agreed that Mylan would acquire Merck's generics arm for $6.6B; the deal was completed that October and tripled the size of Mylan.[46][47] Mylan acquired the rights to market the EpiPen in the transaction; at that time annual sales were around $200 million[48] and the EpiPen had about 90% of the market.[49]

In 2009, the company filed two lawsuits against the Pittsburgh Post-Gazette after the newspaper ran an article that was critical of the quality control procedures used at the company's Morgantown plant.[50][51] The company had earlier quality control issues involving the FDA.[52] The lawsuits were dropped in 2012 without any damages paid by the Post-Gazette, which stated "The Post-Gazette did not find and did not intend to report that Mylan had manufactured or distributed any defective drugs. The Post-Gazette regrets if any reader of the article thought otherwise."[53]

Also in 2009, Mylan and its subsidiary UDL agreed to pay a $118M to settle a suit filed under the False Claims Act in which Mylan/UDL and two other companies were accused of underpaying states under the Medicaid Drug Rebate Program. The program requires drug companies to give rebates to states under Medicaid and the rebates are higher for new drugs than for generics; the suit said that the companies sold new drugs but paid rebates as if they were generics.[54]

In 2011, Mylan entered into an agreement with Pfizer for the exclusive worldwide rights to develop, manufacture and commercialize Pfizer's generic equivalent to GlaxoSmithKline's Advair (US)/Seretide (UK) Diskus incorporating Pfizer's proprietary dry powder inhaler delivery platform;[55] Mylan launched the product in the UK in 2015[56] and in February 2016 the FDA accepted its ANDA, putting it in line behind Hikma and Sandoz to launch a generic version in the US.[57]

In 2012, Mylan launched a program called EpiPen4Schools to sell EpiPens in bulk and with discounts to schools; to participate in the program schools had to agree not to buy epinephrine autoinjectors from any other company for a year.[58]

In December 2012, the National Association of State Boards of Education launched a policy initiative designed to "help state boards of education as they develop student health policies regarding anaphylaxis and epinephrine auto-injector access and use," and advocated for state laws protecting school from legal liability for stocking and using epinephrine autoinjectors. Gayle Manchin, the mother of Mylan's CEO, Heather Bresch, had become president of the association in 2010, and shortly after had discussed donations from her "daughter's company" to the association. Manchin had been appointed to the West Virginia state school board by her husband, then-governor of the state Joe Manchin, in 2007.[59]

In 2013 Mylan acquired an Indian generic injectable drugs company, Agila Specialties Private, for $1.6 billion in cash.[60] In 2015 three plants acquired in that deal were issued warning letters by the FDA.[61]

After successful lobbying from Mylan,[48] in 2013, the "School Access to Emergency Epinephrine Act" became law after passing Congress with broad and bipartisan support; it protected anyone from liability if they administered epinephrine to a child in a school (previously, only trained professionals or the affected person were allowed to administer the drug, and were open to liability), and it provided some financial incentives for schools that didn’t already stock epinephrine autoinjector to start stocking them.[62] Joe Manchin, the father of Mylan's CEO, was a senator at that time.[59]

In July 2014, Mylan and Abbott Laboratories announced an agreement under which Mylan would buy Abbott's generic drugs business in developed markets for stock valued at about $5.3 billion.[63] Mylan acquired Mumbai-based Famy Care and expand its presence in the market for women's contraceptives at about $750 million.[64]

Starting in 2014, according to a 2017 report in the New York Times, mid-level executives began questioning the rate at which the company had increased and was planning to continue to increase the price of the Epi-Pen, and raising concerns that the price increases were unethical; the Times reported that when these concerns were brought to Robert Coury, the chairman of the board, Coury "replied that he was untroubled. He raised both his middle fingers and explained, using colorful language, that anyone criticizing Mylan, including its employees, ought to go copulate with themselves. Critics in Congress and on Wall Street, he said, should do the same. And regulators at the Food and Drug Administration? They, too, deserved a round of anatomically challenging self-fulfillment."  The Times reported that Bresch provided similarly dismissive responses.[65]

In April 2015, Mylan tried negotiate with the management of Irish pharmaceutical firm Perrigo to acquire the company, and when those negotiations failed Mylan attempted a hostile takeover, offering to buy $26B in shares directly from shareholders; too few shareholders agreed to sell their stock by the deadline set in November 2015 and the effort failed.[66]

Two weeks after Mylan made its first offer for Perrigo, Teva Pharmaceutical offered to buy Mylan for $40B; the combined companies would have been the world's largest generic company and the 9th biggest drug company in the world.[67] In July, Teva dropped its bid for Mylan and instead acquired Allergan's generic drug business for about the same price.[68][69]

In June 2015, Mylan agreed to work with Pulmatrix, a company with a proprietary inhaled drug delivery platform, to co-develop a product to treat for chronic obstructive pulmonary disease; the product was PUR0200, a generic drug in a Pulmatrix device.[70]

In February 2016, the company announced it would acquire Meda for $9.9 billion.[71] In May of the same year the company announced it would acquire Renaissance Acquisition Holdings dermatology division for up to $1 billion.[72]

In 2015 Mylan had about $1.5B in sales of EpiPens and those sales accounted for 40% of Mylan's profit.[48] Mylan had maintained about a 90% market share since it had acquired the product, and had continually raised the price of EpiPens starting in 2009: in 2009, the wholesale price of two EpiPens was about $100; by July 2013, the price was about $265; in May 2015, it was around $461; and in May 2016, the price rose again to around $609,[73] around a 500% jump from the price in 2009.[74] In the summer of 2016, as parents prepared to send their children back to school and went to pharmacies to get new EpiPens, people began to express outrage at the cost of the EpiPen and Mylan was widely and harshly criticized.[75][76] The price hikes led to investigations by Congress and states attorneys general; in October 2016 Mylan agreed to pay a $465M fine related to incorrect rebates it paid under the Medicaid Drug Rebate Program.[77]

In December 2016, the attorneys general of 20 states filed a civil complaint accusing Mylan of a coordinated scheme to artificially maintain high prices for a generic antibiotic and diabetes drug. The complaint alleged price collusion schemes between six pharmaceutical firms including informal gatherings, telephone calls, and text messages.[78]

According to the Department of Health and Human Services' Office of Inspector General analysis, the U.S. government may have overpaid "as much as $1.27 billion between 2006 and 2016" to drugmaker Mylan N.V. for the EpiPen emergency allergy treatment. This represents three times the proposed settlement of $465 million announced by Mylan in October 2016. Republican Senator Chuck Grassley, chair of the Senate Judiciary Committee that launched the "probe of EpiPen pricing probe in 2016, released the analysis on May 30, 2017.[79] On the same day, a group of Mylan "investment funds urged shareholders to vote against the re-election of the company's directors after it paid Chairman Robert Coury over $97 million last year."[79]


Acquisition history

The following is an illustration of the company's major mergers and acquisitions and historical predecessors:

Mylan
 

Renaissance Acquisition Holdings
(Dermatology div, Acq 2016)

 

Meda
(Acq 2016)

 

Famy Care
(Acq 2014)

 

Abbott Laboratories
(Generics div, Acq 2014)

 

Merck KGaA
(Generics div, Acq 2007, renamed Mylan Laboratories Inc)

 

UDL Laboratories
(Acq 1996)

 

Bertek Inc
(Acq 1993, renamed Mylan Technologies Inc)

Milan Pharmaceuticals
(Founded 1961)

Criticism

EpiPen pricing

See also: Epinephrine autoinjector § Cost
See also: Heather Bresch § Business executive

Mylan acquired the right to market and distribute the EpiPen line of epinephrine autoinjector devices from Merck KGaA as part of their 2007 deal;[73] that right had formerly been held by Dey LP, a wholly owned subsidiary of Merck.[80] The devices deliver about $1 worth of drug.[48] At that time annual sales were around $200M.[48] Bresch, the company's CEO, saw an opportunity to increase sales through marketing and advocacy, and the company launched a marketing campaign to increase awareness of the dangers of anaphylaxis for people with severe allergies that made the brand "EpiPen" as identified with its product as "Kleenex" is with facial tissue; the company also successfully lobbied the FDA to broaden the label to include risk of anaphylaxis and in parallel, successfully lobbied Congress to generate legislation making EpiPens available in schools and in public places like defibrillators are, and hired the same people that Medtronic had worked with on defibrillator legislation to do so.[48] Mylan's efforts to gain market dominance were aided when Sanofi's competing product was recalled in November 2015 and further when Teva's generic competitor was rejected by the FDA in March 2016.[81]

By the first half of 2015, Mylan had an 85% market share of such devices in the US[48] and in that year sales reached around $1.5B and accounted for 40% of Mylan's profit.[82] Those profits were also due in part to Mylan's continually raising the price of EpiPens starting in 2009; in 2007 the wholesale price of two EpiPens was about $100, the price was about the same in 2009, by July 2013 the price about $265, in May 2015 it was around $461, and in May 2016 the price rose again to around $609.[73] The last price increase sparked widespread outrage, including criticism from Martin Shkreli, "poster boy for grasping pharma greed," letters from two Senators and initiation of Congressional investigations,[82][83] and Mylan's pricing of the EpiPen was widely referred to as price gouging.[84][85][86] The last price increase coincided with a new line of TV commercials that were described as "shocking" and "no holds barred", depicting an anaphylactic reaction from the point of view of the young woman having it at a party, and ending with the young woman seeing her swollen and hive-covered face in the mirror before she collapses.[87] In response to criticism, Mylan increased financial assistance available for some patients to purchase EpiPens,[88] a gesture that was called a "classic public relations move" by Harvard Medical School professor Aaron Kesselheim.[89] The up to $300 saving cards can only be used by a small number of people who need the drug, and no one on Medicaid. They do nothing about the high price which is still being paid by insurers, who ultimately pass the cost onto consumers.[89]

In September 2016, the New York State Attorney General began an investigation into Mylan's EpiPen4Schools program in New York to determine if the program's contracts violated antitrust law[90] and the West Virginia State Attorney General opened an investigation into whether Mylan had given the state the correct discount under the Medicaid Drug Rebate Program and subpoenaed the company when it refused to provide the documentation the state requested.[91]

In October 2016 the CEO of Mylan testified to Congress that Pfizer/King charged Mylan about $34.50 for one device.[92] In September 2016, a Silicon Valley engineering consultancy performed a teardown analysis of the EpiPen and estimated the manufacturing and packaging costs at about $10 for a two-pack.[93]

In October 2016, Mylan announced a settlement with the US Department of Justice over rebates paid by Mylan to states under the Medicaid Drug Rebate Program.[77] Questions had been raised by Congress and others about why EpiPen had been classified as a generic rather a proprietary product in the program since 1997; generic drugs have lower rebates (13%) than proprietary drugs (23%), and price hikes for generic drugs cannot be passed onto states, and a common form of pharmaceutical fraud involves misclassifying proprietary drugs as generic under the program.[94] Under the agreement Mylan agreed to pay a $465 million payment and to a sign a corporate integrity agreement requiring it to perform better in the future;[77] the settlement also resolved cases brought by states related to the rebates.[95] Simultaneously with the settlement Mylan also announced it was being investigated by the Securities and Exchange Commission related to the drug rebate program.[96]

In June 2017 the New York Times published an article reporting on internal Mylan discussions about price increases on the EpiPen between 2014 and 2016, in which the company chairman expressed disdain for people and agencies who might criticize the company; the reporter wrote: "Those top leaders’ responses are a far cry from the message on Mylan’s website, which says that 'we challenge every member of every team to challenge the status quo,' and that 'we put people and patients first, trusting that profits will follow.'", and also noted that "The firm is a case study in the limits of what consumer and employee activism, as well as government oversight, can achieve." [65][97][98][99]

Execution drugs

Mylan manufactures rocuronium bromide, which is approved by the state of Alabama for use in executions by lethal injection. European manufacturers refuse to sell drugs which can be used for executions to the United States, except to distributors or users who sign legally binding agreements that the drug will not be used for executions down the delivery chain.[100]

In September 2014, the London-based human rights organization Reprieve told Mylan that they were the only FDA-approved manufacturer of rocuronium bromide without legal controls in place to prevent its use in executions, and there was "a very real risk that Mylan may soon become the go-to provider of execution drugs for states across the country". The German asset manager DJE Kapital [de] divested itself of $70 million in Mylan shares for that reason. Mylan said that their distribution was "legally compliant".[100]

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