Mylan

Mylan N.V.

Type	Naamloze vennootschap
Traded as	NASDAQ: MYL NASDAQ-100 Component NASDAQ Biotechnology Index Component S&P 500 Component
Industry	Pharmaceuticals
Founded	White Sulphur Springs, West Virginia, United States (1961 (1961))
Founder	Milan Puskar Don Panoz
Headquarters	Amsterdam, The Netherlands
Key people	Heather Bresch (CEO)
Products	Generic and specialty pharmaceuticals and active pharmaceutical ingredients
Revenue	US$ 7.72 billion (2014)
Operating income	US$ 1.01 billion (2011)
Net income	US$ 640.9 million (2012)
Total assets	US$ 11.598 billion (2011)
Total equity	US$ 3.504 billion (2011)
Number of employees	approximately 30,000 (2015)
Website	www.mylan.com

Mylan N.V. is a global generic and specialty pharmaceuticals company registered in the Netherlands and with operational headquarters in Hatfield, Hertfordshire in the United Kingdom. In 2007, Mylan acquired a controlling interest in India-based Matrix Laboratories Limited, a top producer of active pharmaceutical ingredients (APIs) for generic drugs, and the generics business of Germany-based Merck KGaA. 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. Mylan now has approximately 30,000 employees, more than 1,000 separate products, and serves customers in more than 150 countries and territories. Mylan has a global manufacturing output of more than 45 billion doses.

Operations

Mylan Inc. operates several divisions and subsidiaries:

In North 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
• 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

In the Asia Pacific region, Mylan operates:

• Mylan New Zealand Limited - New Zealand
• Mylan Laboratories Limited - headquartered in Hyderabad, India; operates nine Active pharmaceutical ingredient (API) and intermediate manufacturing facilities located in India and China
• Mylan Seiyaku Ltd. - Japan
• Alphapharm - Australia
• Agila Specialties Pvt. Ltd. - India
• OncoTherapies Ltd. - India

In Europe, the Middle East, and Africa, Mylan operates:

• 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
• Generics Pharma Hellas - Greece
• Gerard Laboratories - Ireland
• Qualimed - trademark in France, but will stop being marketed under the brand name
• Docpharma - generic pharmaceutical distribution company in Belgium, the Netherlands and Luxembourg

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 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. 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) becoming a publicly traded company on the OTC market under the ticker symbol MYLN. In 1976 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.

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. Mylan acquired Mumbai-based Famy Care and expand its presence in the market for women's contraceptives at about $750 million.

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

Acquisition history

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

	Mylan   Famy Care (Acq 2014)   Abbott Laboratories (Acq 2014, Generics division)   Merck KGaA (Acq 2007, Generics division, 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.

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

Mylan also manufactures and distributes the EpiPen line of Epinephrine autoinjector devices, although in Canada, it had licensed the brand to Pfizer Canada. In the first half of 2015, Mylan already had an 85% market share of such devices in the US. The company is expected to benefit from the recall of the competing Sanofi brand's auto-injectors, called Auvi-Q in the US and Allerject in Canada, according to a report published in the Fierce Pharma newsletter of November 2, 2015: ".... it is very hard to see Auvi-Q returning to the market, as it will need to be redesigned and face uphill battle to recapture patient trust after the recall," Bernstein analyst Ronny Gal wrote in a note to clients on Monday. Gal also believes that Mylan will be to capture about 95% of the Epinephrine auto-injector market, according to another Fierce Pharma report on November 3, 2015.

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.

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 divested itself of $70 million in Mylan shares for that reason. Mylan said that their distribution was “legally compliant”.

Legal issues

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.

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.

External link

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