Mylan N.V. was a global generic and specialty pharmaceuticals company. In November 2020, Mylan merged with Upjohn, Pfizer's off-patent medicine division, to form Viatris. Previously, the company was domiciled in the Netherlands, with principal executive offices in Hatfield, Hertfordshire, UK and a "Global Center" in Canonsburg, Pennsylvania, US.
In 2007, the company 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, the company grew from the third-largest generic and specialty pharmaceuticals company in the United States to the second-largest generic and specialty pharmaceuticals company in the world.
Mylan went public on the OTC market in February 1973. It was listed on the NASDAQ, and its shares were a component of the NASDAQ Biotechnology and the S&P 500 indices.
The company was founded in 1961 and developed and produced medicines for a wide range of medical disciplines, including oncology, anaphylaxis, antiretrovirals, cardiovascular, respiratory, dermatology, immunology, anesthesia and pain management, infectious disease, gastroenterology, diabetology/endocrinology, and women's healthcare.
Corporate headquarters Founded in 1961, the company was located in an abandoned skating rink in White Sulphur Springs, West Virginia. The facility was moved to Pennsauken, New Jersey in 1962, to Princeton, West Virginia in 1963, and then 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 the Pittsburgh suburb of Cecil Township.
Stock
On February 23, 1973, Mylan had its initial public offering (IPO), when it became a publicly traded company on the OTC market under the ticker symbol MYLN. In 1976 the stock moved to the National Association of Securities Dealers Automated Quotations (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. Prior to the Viatris combination, the stock was traded on the NASDAQ.
History Founding to 1980 Mylan Pharmaceuticals was founded as a drug distributor in 1961 by Milan Puskar and Don Panoz. In 1966, the company began manufacturing penicillin G tablets as well as vitamins and other dietary supplements.
Panoz left the company 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.
The company discontinued operating as a contract manufacturing organization in 1980 and instead chose to market their products under their own "Mylan-labeled" brand.
1980s With the passage of the Hatch-Waxman Act in 1984, the company and other small generic companies gained value; in the eighteen months following passage of the law the company's earnings grew 166% to $12.5 million and its stock value rose 800%.
Dyazide & Maxzide 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. 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.John Seaman and John T. Landry. Mylan 50 Years of Unconventional Success. Mylan, in association with University Press of New England, 2011. . Page 50
Some generic companies committed fraud trying to bring a generic version of Dyazide. Bolar Pharmaceutical had the first generic version approved in 1987, 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.
The company 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 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). 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.Pink Sheet October 22, 1984 Mylan's Maxzide is "Approvable" at FDA: Lederle To Market Brand Competition to Smithkline's No. 3-Ranked Dyazide; Final Approval Anticipated "Imminently"FDA Approval History NDA 019129: Maxzide Page accessed September 8, 2016 The higher dose allowed once per day dosing, which the company and its marketing partner, Lederle, believed would help it compete against Dyazide, which had $210M in sales in 1983. However, the company's patents on the drug were declared invalid in court, and its marketing exclusivity expired in 1987, prompting a rush of generic competition.
The company 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. The company 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. Two of the companies that had gotten approval to market generic versions of Maxzide, Vitarine Pharmaceutical and Par Pharmaceutical, were targets of the company's initial investigation and were found to have used Maxzide to obtain their bioequivalence data, leading both companies to withdraw its generic competitor to Mylan's product.
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.
Acquisitions begin In 1987, the company entered 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.
1990s The company acquired Bertek Inc. in 1993 for its transdermal patch technologies, and kept it as a subsidiary. In 1999, the company renamed Bertek as Mylan Technologies Inc. (MTI). 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.
In 1996, the company acquired UDL Laboratories, a supplier of unit dose generic medications to institutional and long-term care facilities.
In 1998 when it was the world's second largest generics company, the company came under investigation from the Federal Trade Commission after it raised the prices of its products, tripling them in the case of lorazepam. The company had entered into an exclusive agreement with Profarmica, an Italian company that supplied drug ingredients, after which the company's competitors had higher prices and a diminished supply of raw ingredients for lorazepam and other drugs. 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%. The FTC filed suit at the end of 1998 and 32 states filed parallel actions. The case was settled in 2000, with the company 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.
2000s Attempted King Pharmaceuticals acquisition In 2004, the company and King Pharmaceuticals began discussing a deal in which Mylan would acquire King for $4 billion; Mylan wanted to expand its presence in branded pharmaceuticals and to acquire King's sales force. The deal was complicated by a number of factors, 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. Afterwards, Icahn offered to buy Mylan for $5.4 billion and nominated a slate of board members to change the direction of Mylan; he won three seats in May 2005. In June, the company bought back 25% of its shares in order to fend off Icahn. In July, Icahn gave up his bid and sold his shares.
Matrix acquisition In January 2007, the company acquired a controlling interest in Matrix Laboratories, an Indian supplier of active pharmaceutical ingredients, for approximately $736 million, with the takeover including all of Matrix's subsidiary firms, for example Docpharma. It was at the time the largest-ever takeover in the Indian pharma industry and also gave access to markets in China, India, and Africa.
EpiPen acquisition In October 2007, the company acquired the generics division of Merck KGaA for $6.6 billion. The company acquired the rights to market the EpiPen in the transaction. At that time annual sales were around $200 million and the EpiPen had about 90% of the market.
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. The company had earlier quality control issues involving the FDA. 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."
Also in 2009, the company and its subsidiary UDL agreed to pay $118 million 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.
2010s Generic Advair agreement In 2011, the company 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. The company launched the product in the UK in 2015 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.
EpiPen4Schools launch