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Mylan
Mylan N.V.
FormerlyMilan
Company typePublic (under Dutch law)
Nasdaq: MYL TASE: MYL
NASDAQ-100 Component
NASDAQ Biotechnology Index 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, principal executive offices in Hatfield (UK) and global headquarters Canonsburg, Pennsylvania.[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 has grown 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] Mylan has approximately 35,000 employees,[1] more than 1,400 separate products,[6] and serves customers in more than 150 countries and territories.[6] Mylan has a global manufacturing output of more than 45 billion doses.[6]

In 2016, Mylan's pricing of the EpiPen became controversial and was widely referred to as "price gouging".

Operations

Mylan Inc. operates several divisions and subsidiaries:

In North America, Mylan operates:

In the Asia Pacific region, Mylan operates:[10]

In Europe, the Middle East, and Africa, 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
  • Mylan Laboratories Limited, Campos dos Goytacazes,Brasil.

History

Location

Mylan Pharmaceuticals was founded in 1961 as Milan Pharmaceuticals by Milan Puskar and Don Panoz in White Sulphur Springs, West Virginia. The company moved to Morgantown, West Virginia, in 1965, and in 1976 it relocated its corporate headquarters to the Pittsburgh suburb Canonsburg, Pennsylvania, and 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.[16] The company began as a distributor, but in 1966, Mylan received approval to begin manufacturing penicillin G tablets.

Stock

On February 23, 1973, Mylan had its initial public offering (IPO) [17] 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.

Acquisitions

Mylan acquired Bertek Inc. in 1993, and in 1999 renamed the company Mylan Technologies Inc. Mylan acquired UDL Laboratories, a supplier of generic medications to institutional and long-term care facilities in 1996. In October 2007 Mylan bought the generics arm of Merck KGaA, and renamed the entire corporation from Mylan Laboratories Inc. to Mylan Inc. 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 Diskus and Seretide Diskus incorporating Pfizer's proprietary dry powder inhaler delivery platform.[18]

In 2013 Mylan acquired an Indian generic injectable drugs company, Agila Specialties Private, for $1.6 billion in cash.[19] In 2015 three plants acquired in that deal were issued warning letters by the FDA.[20]

On July 14, 2014, Mylan announced that it would be purchasing Abbott Laboratories' generic-drugs business in developed markets for stock valued at about $5.3 billion.[21] Mylan acquired Mumbai-based Famy Care and expand its presence in the market for women's contraceptives at about $750 million.[22]

In April 2015, Mylan offered to buy Irish pharmaceutical firm Perrigo for a fee of $29 billion,[23] this offer was rejected. Subsequently, Mylan increased its offer to, $75 in cash and 2.3 shares, $32 billion total.[24] Mylan stated in June 2015 that Teva's disclosure that it had a 1.35 percent stake in Mylan violated US anti-trust rules.[25] In July, Allergan agreed to sell off its generic drug business to Teva Pharmaceutical Industries for $40.5 billion[26][27][28] ($33.75 billion in cash and $6.75 billion worth of shares).[29] As a result, Teva dropped its pursuit of Mylan.

In February 2016, the company announced it would acquire Meda for $9.9 billion.[30] In May of the same year the company announced it would acquire Renaissance Acquisition Holdings dermatology division for up to $1 billion.[31]

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)

Pharmaceuticals

Mylan discontinued private-label manufacturing in 1980 and instead chose to market their products under their own "Mylan-labeled" brand. Their first Mylan-invented product, Maxzide, received approval for treating hypertension in 1984, and was the first new drug to be patented by a manufacturer of generic drugs. By 1995, Mylan had become the most dispensed line of pharmaceuticals in America, according to the December 2004 IMS National Prescription Audit. Sales of Mylan's generic drugs exceeded $1 billion in 2002, and in 2004 Mylan was added to the S&P 500.

In 2011, the company launched a generic version of famciclovir.[32]

In June 2015, the company agreed to co-develop Pulmatrixs clinical drug candidate, PUR0200, for treatment of chronic obstructive pulmonary disease.[33]

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;[34] that right had formerly been held by Dey LP, a wholly owned subsidiary of Merck.[35] The devices deliver about $1 worth of drug.[36] At that time annual sales were around $200M.[36] 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.[36] 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.[37] By the first half of 2015, Mylan had an 85% market share of such devices in the US[36] and in that year sales reached around $1.5B and accounted for 40% of Mylan's profit.[38] 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.[34] 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,[38][39] and Mylan's pricing of the EpiPen was widely referred to as price gouging.[40][41][42] 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.[43] In response to criticism, Mylan increased financial assistance available for some patients to purchase EpiPens,[44] a gesture that was called a "classic public relations move" by Harvard Medical School professor Aaron Kesselheim.[45] 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.[45]

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.[46]

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 de [DJE Kapital] divested itself of $70 million in Mylan shares for that reason. Mylan said that their distribution was "legally compliant".[46]

In 1989, CEO Roy McKnight testified before the House Oversight and Investigations Committee, exposing fraud and corruption within the Food and Drug Administration's generic drugs division. The corruption came to light after Mylan had hired private detectives in 1987—"out of desperation"—to "snoop around the Food and Drug Administration, which it suspected had been stalling its applications to make new generic drugs". It also sued four competitors that had bribed the FDA under federal antitrust laws and the Racketeer Influenced and Corrupt Organizations Act.[47]

In 2000, the company agreed to pay $147 million to settle accusations by the FTC that they had raised the price of generic lorazepam by 2,600% and generic clorazepate by 3,200%. Mylan obtained exclusive licensing agreements in 1998 for certain ingredients. The company did not admit to any wrongdoing.[48]

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.[49][50] The company had earlier quality control issues involving the FDA.[51]

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."[52]

References

  1. ^ a b c "Public Filings -- Form 10-K". Mylan Investor's Relations. Retrieved 26 August 2016.
  2. ^ Mylan NV 10-K for the Fiscal Year Ended December 31, 2015
  3. ^ "Mylan buys part of drug maker". Pittsburgh Business Times. December 30, 2013.
  4. ^ "Mylan Laboratories To Acquire Generics Business Of Merck KGaA For 4.9 Billion Euros". Medical News Today. May 26, 2007.
  5. ^ "Pharmaceutical giants tracking Mylan's prosperity". The Pittsburgh Tribune-Review. August 13, 2008.
  6. ^ a b c "Mylan Inc. Corporate Profile".
  7. ^ "Transdermal Patches - Mylan". mylantech.com.
  8. ^ "Brand Name Medicines - Mylan". dey.com.
  9. ^ "About Us". mylan.com.
  10. ^ a b "About Us". mylan.com.
  11. ^ "matrixlabsindia.com". matrixlabsindia.com.
  12. ^ "What's new - ARCANA Arzneimittel-Herstellung". arcana.de.
  13. ^ http://www.manta.com/coms2/dnbcompany_wsklv1
  14. ^ http://www.idaireland.com/search-companies.xml?ss_id=3837
  15. ^ http://www.bioportfolio.com/news/pdf/454777/Us-Mylan-To-Withdraw-Qualimed-Brand-From-French-Market-Report.pdf
  16. ^ "Mylan 50 years young and still making history". Mylan. Retrieved April 18, 2012.
  17. ^ "MYL Stock History - Mylan". Retrieved 25 August 2016.
  18. ^ "Mylan acquires rights to Pfizer's inhaler technology". drugstorenews.com. Retrieved May 1, 2012.
  19. ^ Thomas, Katie (Feb 27, 2013). "Mylan Buys Drug Maker of Generic Injectables". New York Times.
  20. ^ Palmer, Eric (Aug 18, 2015). "UPDATED: FDA castigates three Mylan sterile drug plants in warning letter". FiercePharma.
  21. ^ ABC News. "Business News, Personal Finance and Money News - ABC News". ABC News. Retrieved July 14, 2014.
  22. ^ "US drugmaker Mylan to acquire Famy Care for $750 Million". timesofindia-economictimes. 3 February 2015.
  23. ^ "Generic drugmaker Mylan offers $29 billion for Perrigo" (Press release). Reuters. 8 April 2015.
  24. ^ Crayton Harrison (29 April 2015). "Mylan Raises Offer to Acquire Perrigo to $32.7 Billion". Bloomberg.com.
  25. ^ Anjali Rao Koppala (1 June 2015). "Mylan says Teva's stake buy violates U.S. anti-trust rules". Reuters. Retrieved 2 June 2015.
  26. ^ "Teva to Buy Allergan's Generic Drug Unit". Bloomberg.com. 27 July 2015.
  27. ^ Cynthia Koons (27 July 2015). "Teva CEO: $40.5 Billion Allergan Deal is Just the Beginning - Bloomberg Business". Bloomberg.com.
  28. ^ "Teva Purchasing Allergan's Generics Unit in $40.5B Deal". Bloomberg.com. 27 July 2015.
  29. ^ Chitra Somayaji (27 July 2015). "Teva Snaps Up Allergan's Generics Arm, Dumping Mylan". Bloomberg.com.
  30. ^ "Mylan to Acquire Meda for $9.9B - GEN News Highlights - GEN". Retrieved 25 August 2016.
  31. ^ "Mylan snaps up dermatology biz from investors in $1B deal - FiercePharma". Retrieved 25 August 2016.
  32. ^ "Mylan Launches Generic Version of Famvir® Tablets" (Press release). Mylan. 20 April 2011. Retrieved 21 April 2011.
  33. ^ "Mylan to Co-Develop Pulmatrix' COPD Candidate". GEN.
  34. ^ a b Tara Parker-Pope and Rachel Rabkin Peachman for the New York Times. Aug 22, 2016 EpiPen Price Rise Sparks Concern for Allergy Sufferers
  35. ^ King Pharmaceuticals Oct 21, 2002. Press Release: King Pharmaceuticals to Acquire Meridian Medical Technologies
  36. ^ a b c d Cynthia Koons and Robert Langreth for Bloomberg Businessweek. September 23, 2015 How Marketing Turned the EpiPen Into a Billion-Dollar Business
  37. ^ Carly Helfand for FiercePharma Mar 1, 2016 FDA swats down Teva's EpiPen copy, putting Mylan in cruise control
  38. ^ a b Emily Willingham for Forbes. Aug 21, 2016 Why Did Mylan Hike EpiPen Prices 400%? Because They Could
  39. ^ Emma Court for MarketWatch. Aug 18, 2016 Mylan’s EpiPen price increases are Valeant-like in size, Shkreli-like in approach
  40. ^ Brad Tuttle for Time Aug. 22, 2016 5 Signs That EpiPen Prices Are Completely Out of Control
  41. ^ Michael Hiltzik for the Los Angeles Times. Aug 23, 2016 Another reason to hate Mylan, which jacked up the price of life-saving EpiPens: It's a tax dodger
  42. ^ Matt Novak for Gizmodo. Aug 23, 2016 How Congress, the FDA, and Sarah Jessica Parker Helped EpiPen Become a $1 Billion Business
  43. ^ Beth Snyder Bulik for FiercePharma. May 1, 2016 No holds barred in Mylan’s ultra-realistic peanut allergy campaign
  44. ^ "Mylan to provide EpiPen cost assistance as CEO is asked to testify on price hike | Business | The Guardian".
  45. ^ a b Carolyn Y. Johnson (August 25, 2016). "Why Mylan's 'savings card' won't make EpiPen cheaper for all patients". Washington Post. Washington Post.
  46. ^ a b Owen Dyer (24 October 2014). "Drug company is targeted for refusing to adopt ban on distribution of execution drug". BMJ. 2014 (349): g6452. doi:10.1136/bmj.g6452. {{cite journal}}: Cite has empty unknown parameter: |authors= (help)
  47. ^ Freudenheim, Milt (10 September 1989). "Exposing the F.D.A." New York Times.
  48. ^ Labaton, Stephen (July 13, 2000). "Generic-Drug Maker Agrees to Settlement In Price-Fixing Case". The New York Times. Retrieved April 18, 2012.
  49. ^ Adams, Russell (October 30, 2009). "Mylan Again Sues Pittsburgh Post-Gazette". Wall Street Journal. Retrieved August 26, 2016.
  50. ^ Sabatini, Patricia; Boselovic, Len (July 26, 2009). "Mylan workers overrode drug quality controls Internal report detailed 'pervasive' practice of ignoring safety procedures". Pittsburgh Post-Gazette. Retrieved August 26, 2016.
  51. ^ Edwards, Jim (July 28, 2009). "It's Not Mylan's First Quality Control Beef With FDA". Money Watch. CBS News. Retrieved August 26, 2016.
  52. ^ "Mylan, Pittsburgh Post-Gazette settle lawsuits". CBS News. Associated Press. February 17, 2012. Retrieved August 26, 2016.

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