Mylan N.V. is a US registered global registered generic and drug company in the Netherlands, with major executive offices in Hatfield, Hertfordshire, England and global headquarters in Canonsburg, Pennsylvania, USA. In 2007, Mylan acquired a controlling stake in India-based Matrix Laboratories Limited, a major producer of active pharmaceutical ingredients (API) for generic drugs, and German-based generic Merck KGaA business. Through this acquisition, Mylan grew from the third largest generic and pharmaceutical drug company in the United States to the world's second largest generic and special drug company.
Mylan went public in the OTC market in February 1973. It is listed on NASDAQ, and its shares have become a component of NASDAQ Biotechnology, NASDAQ 100, and the S & amp; P 500.
By 2016, the price of Mylan for EpiPen, an epinephrine autoinjector, becomes controversial and is widely referred to as "price gouging". As a result, an investigation was opened about whether Mylan had misinterpreted EpiPen under the Medicaid Medicines Rebate Program, a common form of pharmaceutical fraud. In October 2016, Mylan completed this investigation with the US Department of Justice, agreeing to pay $ 465 million and enter the company's integrity agreement regarding the rebate program. In a report issued on June 12, 2017, the Institutional Shareholder Service criticized Mylan for the "overwhelming compensation" of Mylan directors. Former CEO Robert Coury received a "$ 98 million" 2016 "payment package regardless of" the loss to the company caused by the EpiPen controversy "and" lost steep shareholders. "The report urges Mylan shareholders to" get rid of all directors in Mylan ".
Video Mylan
Operation
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, based in Etobicoke, Ontario
- Mylan Technologies Inc. (MTI) - transdermal drug delivery system (TDDS) and related technology based in St. Albans, Vermont
- UDL Laboratories Inc. based in Rockford, Illinois
- Somerset Pharmaceuticals Inc. is a research and development company based in Tampa, Florida, owned by Mylan. Somerset developed Emsam, manufactured by Mylan Technologies and marketed in the United States by Dey, later renamed Mylan Specialty
- Mylan Laboratories Limited, based in Campos dos Goytacazes, Brazil
In Oceania and Central, East, South, and Southeast Asia, Mylan operates:
- Mylan New Zealand Limited, based in Auckland, New Zealand
- Mylan Laboratories Limited - headquartered in Hyderabad, India and operates about a dozen manufacturing facilities located in India and China
- Mylan Seiyaku Ltd. based in Tokyo, Japan
- Alphapharm is based in Australia
- Agila Specialties Pvt. Ltd. based in Bengaluru, India
- OncoTherapies Ltd. based in Bangalore, India
In Europe, Africa and West Asia, Mylan operates:
- Divisions under the name Mylan in Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, & amp; United Kingdom.
- Arcana Arzneimittel GmbH based in Germany
- Generics Pharma Hellas based in Greece
- Gerard Laboratories based in Ireland
- Docpharma - a generic pharmaceutical distribution company based in Belgium, the Netherlands and Luxembourg
Maps Mylan
Locations
Founded in 1961, the company was first in White Sulfur Springs, West Virginia. The company moved to Morgantown, West Virginia, in 1965, and in 1976 he moved his corporate headquarters to the suburb of Pittsburgh, Canonsburg, Pennsylvania. Finally in 2004 moved to a new office center near Southpointe, a suburban business park located in Cecil Township, where the location is still.
Stock
On February 23, 1973, Mylan had an initial public offering (IPO), becoming a public company in the OTC market with a ticker symbol MYLN. In 1976, shares were transferred to NASDAQ. Their final stock move was in 1986, when their stock became available for trading on the New York Stock Exchange under the ticker MYL symbol. Currently, the shares are trading on NASDAQ.
History
Founded in 1980
Mylan Pharmaceuticals was founded as a drug distributor in 1961 by Milan Puskar and Don Panoz. In 1966 Mylan began producing penicillin G tablets as well as vitamins and other dietary supplements.
Panoz left Mylan in 1969 and Puskar left the company in 1973, when he grew up and was having financial difficulties. The Council hired Roy McKnight as chairman of the board, who convinced Puskar to return in 1976.
Mylan ceased to operate as a contract manufacturing organization in 1980 and chose to market their products under their own "Mylan-labeled" brand.
1980s
With the passing of the Hatch-Waxman Act in 1984, Mylan and other small generic companies scored; within eighteen months after the passing of the law, Mylan's income grew 166% to $ 12.5 million and its share value rose 800%.
In the 1980s one of the most prescribed drugs in the US was Dyazide, a diuretic which was a combination drug containing triamterene and hydrochlorothiazide; has been on the market since 1965 and its patent has ended in 1980. Complications arise with the introduction of a generic version, because the Dyazide formulation produces a set of variables that make it impossible for the generic manufacturer to show that the version is bioequivalent.
Some generic companies commit fraud trying to bring a generic version of Dyazide. Bolar Pharmaceutical has the first generic version approved in 1987, but it turns out Bolar has been fraudulently replacing Dyazide for its own version to conduct research submitted to the FDA. In 1989, the FDA canceled its approval on suspicion and filed criminal charges against Bolar, which Bolar finally pleaded guilty in 1991.
Mylan chose to develop a new version of the triamterene/hydrochlorothiazide drug combination instead of using a generic route; this developed a different, more stable formulation and used different doses of each active ingredient (50 mg of hydrochlorothiazide and 75 mg triamterene, compared with 25 mg of Dyazide hydrochlorothiazide and 50 mg triamterene). This drug should be approved as a new drug, compared to generic drugs. Their product was called Maxzide and was approved in 1984. A higher dose is allowed once per day, which Mylan and his marketing partner, Lederle, believe will help him compete with Dyazide, which had $ 210 million in sales in 1983. However, the drug was declared invalid in court, and its marketing exclusivity ended in 1987, pushing the rushing of general competition
Mylan worries about the practice of its competitors and FDA in general, and also deals with companies that want to bring a generic version of Maxzide. Mylan hired a private investigator to examine the practices of his rivals, and when he found evidence of corruption, he submitted it to the House Watch and Investigation Committee, which investigated and found fraud and corruption in the generic drug division of Drugs and other generics. company. Two companies that have received approval to market a generic version of Maxzide, Vitarine Pharmaceutical and Par Pharmaceutical, are Mylan's initial investigation targets and were found to have used Mylan's Maxzide to obtain their bioequivalence data, which caused both companies to attract their generic competitors to Mylan Products.
Corruption in the newborn generic industry and in the FDA's governing offices was widely covered in the media, and caused widespread concern among physicians and society in the late 1980s and early 1990s that generic drugs were not exactly the same as drugs branded medications that they should replace.
In 1987, Mylan agreed to join a joint venture with Bolar to buy Somerset Pharmaceuticals; Mylan wants access to Somersets' drug discovery capabilities as well as his new drug for Parkinson's, selegiline; The deal was completed in 1988 but its refinement depends on FDA selegiline approval, which came in 1989.
1990s
Mylan acquired Bertek Inc. in 1993 for transdermal patch technology, and kept it as a subsidiary. In 1999 Mylan renamed its company Mylan Technologies Inc. (MTI). MTI eventually became a contract manufacturer for transdermal selegiline patches and was the first company to market generic nitroglycerin, estradiol, clonidine, and transdermal fentanyl patches. Mylan acquired UDL Laboratories, a generic drug supplier dose unit for institutional and long-term care facilities in 1996.
In 1998 when the world's second-largest generic drug company, Mylan was under investigation from the Federal Trade Commission after raising its product price, threefold in the case of lorazepam. Mylan has signed an exclusive agreement with Profarmica, an Italian company supplying ingredients of drugs, after which Mylan's competitors have higher prices and the supply of raw materials of lorazepam and other drugs is reduced. Before the price round increases, the price of generic drugs is 5 - 10% of the price of branded drugs and after that about 50%. The FTC filed suit at the end of 1998 and 32 countries filed parallel actions. The case was resolved in 2000, with Mylan paying a total of $ 147M - $ 100M in profit violated to a fund to replace consumers and state agencies that pay more, $ 8 million in attorney fees to the State Attorney General, $ 35 million, plus $ 4 million in attorney fees, to complete certain classroom actions with insurance companies and managed care organizations - and Mylan and three material suppliers (Cambrex Corporation, Profarmaco SRL, and Gyma Laboratories) also approved an order prohibiting them from entering into similar anti-competitive agreements in the future.
2000s
In 2004, Mylan and King Pharmaceuticals began discussing the deal in which Mylan would acquire a King of about $ 4B; Mylan wants to expand her presence in branded drugs and get King's sales force. The deal became one of the business soap operas this year, and includes SEC's investigation into accounting King and Carl Icahn earned 9.8% interest in Mylan and became the biggest stakeholder to kill the deal. The parties canceled the agreement in February 2005. Icahn offered to buy Mylan for $ 5.4B and manage a list of board members to change Mylan's direction; he won three seats in May 2005. In June Mylan bought back 25% of his stake to fend off Icahn. In July Icahn submitted his offer and sold his shares.
In August 2006 Mylan announced that it had reached an agreement to purchase a controlling stake in Matrix Laboratories, India's leading supplier of pharmaceutical ingredients. The deal gave Mylan access to markets in India and China and finished in January next year.
In May 2007 Mylan and Merck KGaA agreed that Mylan would get a generic arm of Merck for $ 6.6B. The deal was settled in October and tripled the size of Mylan. Mylan acquired the right to market EpiPen in a transaction. At that time annual sales were around $ 200 million and EpiPen had about 90% of the market.
In 2009, the company filed two lawsuits against the Pittsburgh Post-Gazette after the newspaper published an article criticizing the quality control procedures used at the Morgantown plant. The company has previous quality control issues involving the FDA. The lawsuit was 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 produced or distributed the damaged drug.The Post-Gazette deplores if there is an article reader it thinks otherwise. "
Also in 2009, Mylan and its subsidiaries UDL agreed to pay $ 118M to settle the lawsuit filed under the False Claim Act where Mylan/UDL and two other companies were accused of underpaid countries under the Medicaid Medicines Rebate Program. The program requires drug companies to give rebates to states under Medicaid and higher rebates for new drugs than generics; The lawsuit says that the company sells new drugs but pays rebates as if they are generic drugs.
2010s
In 2011, Mylan signed an agreement with Pfizer for worldwide exclusive rights to develop, manufacture and commercialize a generic Pfizer equivalent to GlaxoSmithKline Advair (AS)/Seretide (UK) Discus that incorporates Pfizer's dry powder inhaler delivery platform. Mylan launched its products in the UK in 2015 and in February 2016, the FDA received the Certificate, placed it behind Hikma and Sandoz to launch a generic version in the US.
In 2012, Mylan launched a program called EpiPen4Schools to sell EpiPens in bulk and with discounts to schools. To participate in the school the program must agree not to buy an epinephrine autoinjector from another company for a year.
In December 2012, the National Association of State Education Councils launched a policy initiative designed to "assist state education councils as they develop student health policies regarding anaphylaxis and access and use of auto-injector epinephrine," and advocate state legislation that protects schools from liability answer the law for storing and using epinephrine autoinjector. Gayle Manchin, mother of Mylan's CEO, Heather Bresch, has been president of the association in 2010, and shortly after discussing donations from her "daughter company" to the association. Manchin has been appointed to the West Virginia state school board by her husband, then-country governor Joe Manchin, in 2007.
After the successful lobby of Mylan, in 2013, "School Access to the Emergency Epinephrine Act" became law after passing Congress with broad and bipartisan support; it protects anyone from responsibility if they deliver epinephrine to a child in school (previously, only trained professionals or exposed persons were allowed to administer the drug, and open to obligations), and it provided some financial incentives for schools that did not already stock autoinjector epinephrine to start spreading them. Joe Manchin, father of Mylan's CEO, was a senator at the time.
In 2013 Mylan acquired India's generic generic injection drug company, Agila Specialties Private, for $ 1.6 billion in cash. By 2015 three factories obtained in the deal were issued warning letters by the FDA.
In July 2014, Mylan and Abbott Laboratories announced an agreement under which Mylan would buy Abbott's generic drug business in developed markets for shares worth approximately $ 5.3 billion. Mylan acquired Mumbai-based Famy Care and expanded its presence in the market for female contraception by approximately $ 750 million.
Beginning in 2014, according to a 2017 report on the New York Times , middle-level executives began to question the degree to which the company has improved and plans to continue raising Epi-Pen prices, and raised fears that price increases are unethical; The Times reported that when these concerns were brought to Robert Coury, the chairman of the council, Coury "replied that he was not bothered.He raised his middle fingers and explained, using colorful language, that anyone who criticizes Mylan, including their employees, have to copulate with themselves. Criticism in Congress and Wall Street, he says, should do the same. And regulators at the Food and Drug Administration - they also deserve a round of self-anatomy challenging fulfillment. The Times reported that Bresch gave the same disparaging response.
In April 2015, Mylan tried to negotiate with the Irish pharmaceutical company Perrigo's management to acquire the company, and when the negotiations failed, Mylan attempted an unfriendly takeover, offering to buy a $ 26b share directly from shareholders. Too few shareholders agreed to sell their shares at the deadline set in November 2015 and the attempt failed.
Two weeks after Mylan made his first offer for Perrigo, Teva Pharmaceutical offered to buy Mylan for $ 40B; the combined company will be the world's largest generic company and the 9th largest drug company in the world. In July, Teva lowered her bid for Mylan and instead acquired Allergan's generic drug business for the same price.
In June 2015, Mylan agreed to work with Pulmatrix, a company with an inhaled drug delivery platform, to jointly develop products to treat chronic obstructive pulmonary disease; the product is PUR0200, a generic drug in Pulmatrix device.
In February 2016, the company announced it would acquire Meda for $ 9.9 billion. In May of the same year, the company announced it would acquire the dermatology division of Renaissance Acquisition Holdings up to $ 1 billion.
In 2015 Mylan has about $ 1.5 billion in EpiPens sales and the sale accounts for 40% of Mylan's profits. Mylan has retained about 90% market share for having acquired the product, and has been constantly raising EpiPens prices starting in 2009: in 2009, the wholesale price of two EpiPens was around $ 100; in July 2013, it cost about $ 265; in May 2015, it was about $ 461; and in May 2016, prices rose again to about $ 609, about a 500% jump from prices in 2009. In summer 2016, when parents prepare to send their children back to school and go to a pharmacy to get new EpiPens , people began to express anger at the cost of EpiPen and Mylan were widely and rudely criticized. The price increase led to an investigation by Congress and declared the attorney general; in October 2016 Mylan agreed to pay a $ 465 million fine in connection with the wrong rebates paid under the Medicaid Medicines Rebate Program.
In December 2016, public prosecutors from 20 states filed a civil suit accusing Mylan of a coordinated scheme to artificially maintain a high price for generic antibiotic and diabetes drugs. Complaints of alleged price collusion schemes among six pharmaceutical companies include informal meetings, phone calls, and text messages.
According to the Department of Analysis of the Inspector General of the Department of Health and Human Services, the US government may have paid too much "as much as $ 1.27 billion between 2006 and 2016" to drugmaker Mylan N.V. for emergency allergy treatment EpiPen. This represents the proposed three-time settlement of $ 465 million announced by Mylan in October 2016. Republican Sen. Chuck Grassley, chairman of the Senate Judiciary Committee that launched the "EpiPen price inquiry probe by 2016, released the analysis on May 30, 2017. On the same day , a group of "investment funds" Mylan urged shareholders to vote against the re-election of the company's directors after paying Chairman Robert Coury over $ 97 million last year. "
In May 2018, Mylan announced a collaboration with West Virginia University to expose children throughout West Virginia to the STEM education initiative.
Acquisition history
The following is an illustration of major mergers and acquisitions of corporations and historical predecessors:
Criticism
EpiPen Price
Mylan acquired the right to market and distribute EpiPen EpinPer's line of epinephrine autoinjector devices from Merck KGaA as part of their 2007 agreement; the right was previously held by Dey LP, a wholly owned subsidiary of Merck. The device sends $ 1 worth of medicine. At that time the annual sale is about $ 200 million. Bresch, the company's CEO, sees opportunities to increase sales through marketing and advocacy, and the company launches a marketing campaign to raise awareness of the dangers of anaphylaxis for people with severe allergies who make the "EpiPen" brand as identified by its product as "Kleenex" face. The company also successfully lobbied the FDA to expand the label to include the risk of anaphylaxis and in parallel, successfully lobbying Congress to produce legislation that makes EpiPens available in schools and in public places such as defibrillators, and hiring the same people who have worked with Medtronic in law - invite the defibrillator to do it. Mylan's efforts to gain market dominance are aided when Sanofi's competing products were recalled in November 2015 and subsequently when the Teva generic competitors were rejected by the FDA in March 2016.
In the first half of 2015, Mylan had 85% of the device's market share in the US and that year sales totaled about $ 1.5 billion and accounted for 40% of Mylan's profits. That profit is also partly because Mylan continues to raise EpiPens prices starting in 2009; in 2007 the wholesale price of two EpiPens was about $ 100, the price was almost the same in 2009, in July 2013 the price was about $ 265, in May 2015 about $ 461, and in May 2016 the price rose again to about $ 609. the latest price sparked widespread anger, including criticism from Martin Shkreli, "the poster boy for grasping pharmaceutical greed," letters from two Senators and Congressional Initiation initiatives, and Mylan's pricing for EpiPen is widely referred to as gawking prices. The latest price increase coincides with a new line of TV commercials depicted as "shocking" and "no holds barred", which depicts an anaphylactic reaction from the point of view of the young woman who has it at the party, and ends with a young woman looking at her swollen face and mustache in the mirror before he collapsed. In response to criticism, Mylan increased the financial assistance available to some patients to buy EpiPens, a movement called "classic public relations steps" by Harvard Medical School professor Aaron Kesselheim. Frugal cards of up to $ 300 can only be used by a small number of people who need drugs, and no one in Medicaid. They do not do anything about the high prices that are still paid by the insurance company, which ultimately provide cost to the consumer.
In September 2016, New York State Attorney General began an investigation of Mylan's EpiPen4Schools program in New York to determine whether the program contract violated antitrust laws and the Attorney General of the State of West Virginia opened an investigation into whether Mylan had granted the state the correct discounts under the Medicaid Medicines Rebate Program and calling the company when it refuses to provide the documentation that the country requests.
In October 2016, Mylan CEO testified to Congress that Pfizer/King accused Mylan of around $ 34.50 for one device. In September 2016, Silicon Valley engineering consultants conducted a teardown analysis from EpiPen and estimated the cost of manufacturing and packing about $ 10 for package two.
In October 2016, Mylan announced a settlement with the US Department of Justice on a discounted price paid by Mylan to the state under the Medicaid Medicines Rebate Program. Questions have been raised by Congress and others on why EpiPen has been classified as a generic product and not belonging in this program since 1997; Generic drugs have lower rebates (13%) than exclusive drugs (23%), and the price increase of generic drugs can not be passed on to states, and the general form of pharmaceutical fraud involves misclassification of exclusive drugs as generic under the program. Under the agreement, Mylan agreed to pay $ 465 million in payments and sign a company integrity agreement requiring it to perform better in the future; the settlement also resolves cases brought by countries related to the discounted price. Along with the settlement Mylan also announced it is being investigated by the Securities and Exchange Commission related to drug rebate programs.
In June 2017, the New York Times published an article reporting Mylan's internal discussion of the price increase on EpiPen between 2014 and 2016, in which the chairman of the company expressed defamation of persons and institutions that might criticize the company; The reporter wrote: "The top leader's response was far from a message on Mylan's website, saying that 'we challenge every member of each team to challenge the status quo,' and that 'we put people and patients first, trusting the profits will follow.' ", and also notes that" This company is a case study on the boundaries of consumer and employee activity, as well as government oversight, is achievable. "
Drug execution
Mylan produces rocuronium bromide, which is approved by the state of Alabama for use in execution by lethal injection. European producers refuse to sell drugs that can be used for execution to the United States, except for distributors or users who enter into legally binding agreements that the drug will not be used for execution on the delivery chain.
In September 2014, the London-based human rights organization REPrieve told Mylan that they were the only FDA approved Focalonium bromide manufacturer without legal control in place to prevent its use in execution, and there was "a very real risk that would soon be Mylan became a provider of execution drugs for countries across the country ". German asset manager DJE Kapital escaped $ 70 million of Mylan's shares for that reason. Mylan says that their distribution is "legally appropriate".
References
External links
Media related to Mylan in Wikimedia Commons
Source of the article : Wikipedia
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