Merck & Co.

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Not to be confused with Merck KGaA, the original parent company, whose American assets were seized during WWI creating this company.
Merck & Co., Inc.
(Merck Sharp & Dohme (MSD) outside the United States and Canada)
Type Public
Traded as NYSE: MRK
Dow Jones Industrial Average Component
S&P 500 Component
Industry Pharmaceuticals
Founded 1891 as a subsidiary of Merck KGaA
1917 as an independent company
Headquarters Whitehouse Station, New Jersey, United States
Key people Kenneth Frazier
(Chairman, President and CEO)
Products

Gardasil
Singulair
Propecia/Proscar
Zocor Vioxx Fosamax

See more complete products listing.
Revenue increase US$ 45.987 billion (2010)[1]
Operating income decrease US$ 1.653 billion (2010)[1]
Net income decrease US$ 861 million (2010)[1]
Total assets decrease US$ 105.781 billion (2010)[1]
Total equity decrease US$ 56.805 billion (2010)[1]
Employees 94,000 (2010)[1]
Website Merck.com

Merck & Co., Inc. (NYSE: MRK), dba Merck Sharp & Dohme, MSD outside the United States and Canada, is one of the largest pharmaceutical companies in the world. Merck headquarters is located in Whitehouse Station, New Jersey. The company was established in 1891 as the United States subsidiary of the German company now known as Merck KGaA. Merck & Co. was confiscated by the US government during World War I and subsequently established as an independent American company. It is currently one of the World's seven largest pharmaceutical companies by market capitalization and revenue.

The company describes itself as "a global research-driven pharmaceutical company" that "discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health, directly and through its joint ventures".

Merck also publishes The Merck Manuals, a series of medical reference books for physicians, nurses, and technicians. These include the Merck Manual of Diagnosis and Therapy, the world's best-selling medical textbook, and the Merck Index, a compendium of chemical compounds.

In 2011 the company received the "Facility of the Year"-Award for the integration of its global clinical supplies manufacturing, packing, and warehouse building in Summit, New Jersey, USA.

Contents

[edit] History

Merck & Co. traces its origins to Friedrich Jacob Merck, who purchased a drug store in Darmstadt, Germany, in 1668, and also to Emanuel Merck, who took over the store several generations later in 1816. Emanuel and his successors gradually built up a chemical-pharmaceutical factory that produced raw materials for pharmaceutical and other preparations.

In 1891, George Merck emigrated to the United States and set up Merck & Co. in New York as the US arm of the family partnership, E. Merck (named for Emanuel Merck), which is now Merck KGaA. In keeping with a national wartime policy, Merck & Co. was confiscated in 1917 and re-established as an independent American company. Until the end of World War II, the company was led by George W. Merck, who oversaw America's germ-warfare research at Fort Detrick. Today, the US company has about 51,000 (S&P NetAdvantage) employees in 120 countries with 31 factories worldwide. It is one of the world's seven largest pharmaceutical companies, exceeding the size of its German ancestor, which currently employs 41,000 people in 67 countries.

In 1965 Merck acquired Charles E. Frosst Ltd. of Montreal (founded 1899) and created Merck-Frosst Canada, Inc., as its Canadian subsidiary and pharmaceutical research facility. Merck closed this facility in July 2010,[2] and the company was renamed Merck Canada in 2011.

In 2005, CEO Raymond Gilmartin retired following Merck's voluntary worldwide withdrawal of Vioxx. Former president of manufacturing Richard Clark was named CEO and company president. Clark retired in October 2011 and Kenneth Frazier became CEO.

In November 2009, Merck announced that it would merge with competitor Schering-Plough in a US$41 billion deal.[3][4][5][6] The purchase was a "reverse merger" in which Schering-Plough would be renamed Merck and continue as the surviving public corporation. The new company would be operated under the trade name Merck in the United States and Canada and as MSD elsewhere.

The Merck Company Foundation has distributed more than $480 million to educational and non-profit organizations since it was founded in 1957.[7]

[edit] Products[8]

[edit] Products from Schering-Plough

[edit] Products under development

[edit] Patient assistance programs

Merck & Co. was one of the first American pharmaceutical companies to offer assistance to those unable to afford its medications, beginning a program in the 1950s.[10] Currently, Merck & Co. offers 7 patient assistance programs, each with specific eligibility requirements.[11][12]

[edit] Available programs

[edit] Recent Case Histories

[edit] Vioxx

In 1999, the U.S. Food and Drug Administration (FDA) approved Vioxx (known generically as rofecoxib), a Merck product for treating arthritis. Vioxx was stronger than existing medications, while easier on the stomach than established anti-inflammatory drugs such as naproxen. Vioxx became one of the most prescribed drugs in history. According to internal e-mail traffic released at a later lawsuit, Merck had a list of doctors critical of Vioxx to be "neutralised" or "discredited." "We may need to seek them out and destroy them where they live," wrote an employee. Also alleged were intimidation of researchers and impingement upon academic freedom.[13]

Thereafter, studies by Merck and by others found an increased risk of heart attack associated with Vioxx use when compared with naproxen. There was no indication of this risk in the original placebo-controlled safety trials, and it was possible that the effect was more related to naproxen decreasing the risk of heart attacks than one of Vioxx increasing the risk. Merck adjusted the labeling of Vioxx to reflect possible cardiovascular risks in 2002.

On September 23, 2004, Merck received information about results from a clinical trial it was conducting that included findings of increased risk of heart attacks among Vioxx users who had been using the medication for over eighteen months.[14] On September 28, 2004, Merck notified the FDA that it was voluntarily withdrawing Vioxx from the market, and it publicly announced the withdrawal on September 30. The FDA has since recommended that Vioxx be put back on the market, but with a more prominent warning regarding cardiovascular risks on its label.[citation needed]

On November 5, 2004 the medical journal The Lancet published the results of its analysis of the available studies. It concluded that "the unacceptable cardiovascular risks of Vioxx (rofecoxib) were evident as early as 2000..."[15] The journal's editors criticized Merck for having kept the drug on the market as long as it did before withdrawing it, and also criticized the FDA for its failure of regulatory oversight.

About 50,000 people have sued Merck claiming that they or their family members have suffered medical problems such as heart attacks or strokes after taking Vioxx.[16] In 2005, Merck was found liable in the first case that went to trial and the plaintiff was awarded $253.4 million in damages; however, the judgement was subsequently reduced to $20 million and then, upon appeal, the verdict was reversed in 2008.[16] In November 2007, Merck proposed to pay $4.85 billion to settle most of the pending Vioxx lawsuits.[17][18] The settlement will require that claimants provide medical proof of having suffered a heart attack or a stroke and show they received at least 30 Vioxx pills. This proposed settlement is generally viewed by industry analysts and investors as a victory for Merck, considering that original estimates of Merck's liability reached as high as $50 billion. As of mid-2008, plaintiffs have prevailed in only three of the twenty cases that have reached juries, all with relatively small awards.[16]

On May 20, 2008, Merck was found liable for using deceptive marketing tactics to promote Vioxx and 30 states will split the $58 million settlement. The amount is the largest multi-state settlement against a pharmaceutical company.[19] All its new television pain-advertisements must be vetted by the Food and Drug Administration and changed or delayed upon request until 2018.[20]

[edit] Mectizan

In 1987, Merck & Co. began a program with UNICEF to donate its new drug Mectizan to "all that need it for as long as needed"[21] in an effort to combat Onchocerciasis, also known as river blindness, primarily in Africa. Up to that point, the World Health Organization had fought the disease through the use of insecticides to lower the population of its primary vector, the Black Fly.[22] However, when studies in the 1980s showed how effective the drug was at treating and preventing the disease, the WHO agreed to use it instead of its previous strategies. Merck's involvement is considered a key factor in the success against the disease all over the world,[23] and the decision to donate the entirety of the drug to all those in need of it is used[by whom?] as a case study in corporate ethics today.

[edit] Cordaptive

On September 4, 2007, Merck & Co. introduced the experimental drug Cordaptive, which can both raise HDL and lower LDL (combining an extended-release form of the B vitamin niacin with laropiprant, a novel compound intended to inhibit flushing or redness of the face). Cordaptive caused 18% drop in levels of LDL-C00, a 26% drop in triglycerides, and a 20% increase in HDL-C. Merck's cholesterol statin drug Zocor has seen sales plunge since its patent expired in 2006. In addition, Merck and partner Schering-Plough Corp. jointly market two other cholesterol drugs, Zetia and Vytorin.[24]

On April 24, 2008, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of the combination, to be marketed in Europe as Tredaptive.[25]

On April 28, 2008, the FDA issued a "not approvable" letter for Cordaptive. In the FDA's letter, the agency rejected the proposed trade name CORDAPTIVE for MK-0524A.[26][27]

The drug was later approved by the EMA on July 3, 2008.[28][29]

[edit] Phony medical journal

From 2002 through 2005 the Australian affiliate of Merck sponsored the eight issues of a medical journal, the Australasian Journal of Bone and Joint Medicine, published by Elsevier. Although it gave the appearance of being an independent peer-reviewed journal, without any indication that Merck had paid for it, the journal actually reprinted articles that originally appeared in other publications and that were favorable to Merck. The misleading publication came to light in 2009 during a personal injury lawsuit filed over Vioxx; 9 of 29 articles in the journal's second issue referred positively to Vioxx.[30] In 2009, the CEO of Elsevier's Health Sciences Division, Michael Hansen, admitted that the practice was "unacceptable".[31]

[edit] Medicaid overbilling

A US Justice Department fraud investigation began in 2000 when allegations were brought in two separate lawsuits filed by whistleblowers under the False Claims Act.[32] They alleged that Merck failed to pay proper rebates to Medicaid and other health care programs and paid illegal remuneration to health care providers.[33] On February 7, 2008 Merck agreed to pay more than $650 million to settle charges that it routinely overbilled Medicaid for its most popular medicines. The federal government received more than $360 million, and 49 states and Washington, DC, over $290 million. One whistleblower received a $68 million reward.[32][34] Merck made the settlement without an admission of liability or wrongdoing.[35]

[edit] Environmental record

Merck & Co. once used methylene chloride, an animal carcinogen on the United States Environmental Protection Agency's list of pollutants, as an ingredient in some of its pharmaceuticals. Merck chemists and engineers subsequently replaced the compound with others having fewer negative environmental effects. Merck has also modified its equipment to protect the environment, installing a distributed control system that coordinates chemical reactions more efficiently and expedites manufacturing by 50 percent, eliminating the need for the disposal and storage of harmful waste. Biological oxygen demand has also been reduced.[36]

In 1991, Merck's Kelco subsidiary was responsible for 1/3 of the volatile organic compound (VOC) emission pollution in the San Diego area. Ground level ozone was causing lung tissue damage by exposure to harmful bacteria.[37]

In 1996 Merck paid $1.8 million for polluting the air. New machines were installed to reduce smog emissions by 680,000 lb (310,000 kg) a year.[38]

[edit] Isentress

Raltegravir (Isentress), Merck's HIV integrase inhibitor was unanimously recommended for accelerated approval by the FDA's Advisory Committee on September 5, 2007. Isentress works by acting on a specific enzyme in HIV, integrase, that allows the RNA from HIV to become part of human DNA in the replication process.[39] Isentress was approved by the FDA on October 12, 2007.[40]

[edit] Singulair

The FDA is looking into a link between Merck's Singulair and suicide and is considering further studies of the drug. Singulair blocks the leukotriene pathway in asthma and allergic rhinitis.[41]

[edit] Facebook fan page controversy

Merck KGaA of Germany said it negotiated exclusive rights to the webpage entitled "www.facebook.com/merck" in March, 2010, and began legal action against Facebook for allowing USA's Merck & Co. to assume control of the page.[42]

[edit] See also

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[edit] References

  1. ^ a b c d e f "2010 Form 10-K, Merck & Co., Inc.". United States Securities and Exchange Commission. http://www.sec.gov/Archives/edgar/data/310158/000095012311019286/y87773e10vk.htm. 
  2. ^ "Montreal plant among 17 closed by drugmaker Merck". The Star (Toronto). July 8, 2010. http://www.thestar.com/business/article/833712--montreal-plant-among-17-closed-by-drugmaker-merck. 
  3. ^ Singer, Natasha (March 10, 2009). "Merck to Buy Schering-Plough for $41.1 Billion". The New York Times. http://www.nytimes.com/2009/03/10/business/10drug.html. Retrieved 2009-11-14. 
  4. ^ "Merck and Schering-Plough to Complete Merger Today" (Press release). Merck & Co.. November 3, 2009. http://www.merck.com/newsroom/news-release-archive/corporate/2009_1103.html. Retrieved 2009-11-13. 
  5. ^ "New Merck Begins Operations" (Press release). Merck & Co.. November 4, 2009. http://www.merck.com/newsroom/news-release-archive/corporate/2009_1104.html. Retrieved 2009-11-13. 
  6. ^ "Notice of Reorganization Event". November 12, 2009. http:///phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9MjA0NDh8Q2hpbGRJRD0tMXxUeXBlPTM=&t=1. Retrieved 2009-11-13. 
  7. ^ Princeton University and The Merck Company Foundation Announce Creation Of New Global Health Scholars Program and Lecture Series
  8. ^ http://www.merck.com
  9. ^ Freepatentsonline.com, Merck's patent for "a pharmaceutical composition and method of counteracting HMG-CoA reductase inhibitor-associated elevated transaminase levels"
  10. ^ "Merck to Create New Patient Assistance Program for Vaccines" Retrieved on May 20, 2008.
  11. ^ "Patient Assistance - Available Prescription Assistance Programs From Merck & Co." Retrieved on May 20, 2008.
  12. ^ Merck Patient Assistance Programs
  13. ^ Rout, Milanda (2009-04-01). "Vioxx maker Merck and Co drew up doctor hit list". The Australian. http://www.theaustralian.news.com.au/story/0,25197,25272600-2702,00.html. Retrieved 2009-04-26. [dead link]
  14. ^ Finance.senate.gov
  15. ^ Elsevier
  16. ^ a b c Courts Reject Two Major Vioxx Verdicts, The New York Times, May 30, 2008
  17. ^ Merck proposes $4.85B Vioxx settlement, USA Today, November 12, 2007
  18. ^ "Merck's outlook revised to developing from negative on Vioxx agreement - Moody's". forbes.com. Thomson Financial. 2007-11-12. http://www.forbes.com/feeds/afx/2007/11/12/afx4326773.html. Retrieved 2009-05-04. 
  19. ^ Arizona gets $2.3 Million from Vioxx Settlement 92.3 KTAR Retrieved on May 19, 2008
  20. ^ Merck Agrees to Settlement Over Vioxx Ads, The New York Times, May 20, 2008]
  21. ^ Merck supports the worldwide fight against river blindness, UNICEF
  22. ^ Ivermectin History, Stanford, 2005
  23. ^ Onchocerciasis: Africa's victory over river blindness., Africa Recovery, Vol.17 #1 (May 2003), page 6
  24. ^ Yahoo.com, Merck niacin drug controls cholesterol
  25. ^ Merck & Co., Inc. press release - Two Merck Medicines Recommended for Approval in the European Union Retrieved on April 30, 2008.
  26. ^ Merck & Co., Inc. press release - Merck Receives Not Approvable Letter from FDA for MK-0524A (ER niacin/laropiprant) Retrieved on April 30, 2008.
  27. ^ Carey, John (April 29, 2008). "FDA Rejects Merck's Cordaptive". BusinessWeek. http://www.businessweek.com/bwdaily/dnflash/content/apr2008/db20080429_182260.htm. Retrieved 2009-11-13. 
  28. ^ Merck & Co., Inc. press release - TREDAPTIVE (nicotinic acid /laropiprant) Approved in the European Union: New Lipid-Modifying Therapy to Treat LDL-C, HDL-C and Triglycerides Retrieved on July 26, 2008.
  29. ^ "Tredaptive European Public Assessment Report". European Medicines Agency. http://www.emea.europa.eu/humandocs/Humans/EPAR/tredaptive/tredaptive.htm. Retrieved November 13, 2009. 
  30. ^ Singer N (2009-05-13). "Merck paid for medical 'journal' without disclosure". The New York Times. http://www.nytimes.com/2009/05/14/business/14vioxxside.html. Retrieved 2009-06-17. 
  31. ^ "Statement From Michael Hansen, CEO Of Elsevier's Health Sciences Division, Regarding Australia Based Sponsored Journal Practices Between 2000 And 2005" (Press release). Elsevier. May 7, 2009. http://www.elsevier.com/wps/find/authored_newsitem.cws_home/companynews05_01203. Retrieved Nov 20, 2009. "It has recently come to my attention that from 2000 to 2005, our Australia office published a series of sponsored article compilation publications, on behalf of pharmaceutical clients, that were made to look like journals and lacked the proper disclosures. This was an unacceptable practice, and we regret that it took place." 
  32. ^ a b Johnson, Carrie (February 8, 2008). "Merck to Pay $650 Million In Medicaid Settlement". The Washington Post. http://www.washingtonpost.com/wp-dyn/content/article/2008/02/07/AR2008020701336.html. Retrieved 8 February 2010. 
  33. ^ USDOJ.GOV, Merck to Pay More than $650 Million to Resolve Claims of Fraudulent Price Reporting and Kickbacks. February 7, 2008
  34. ^ Pharmalot.com: Ed Silverman, Merck To Pay $670 Million Over Medicaid Fraud.
  35. ^ "Merck Resolves Federal and State Investigations Related to Certain Past Pricing And Certain Past Sales and Marketing Activities". Merck. February 7, 2008. http://www.merck.com/newsroom/news-release-archive/corporate/2008_0207.html. Retrieved 8 February 2010. [dead link]
  36. ^ P2pays.org
  37. ^ ET 10/96: Repairing a legacy of pollution by Kelco
  38. ^ U.S. settles $1.8 million pollution case with Merck and Monsanto | Newsroom | US EPA
  39. ^ Merck.com FDA Advisory Committee Unanimously Recommends Accelerated Approval of ISENTRESS (raltegravir), Merck's Investigational Oral Integrase Inhibitor, for Treatment of HIV
  40. ^ "FDA approval of Isentress (raltegravir)". U.S. Food and Drug Administration (FDA). June 25, 2009. http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm124040.htm. Retrieved 2009-11-15. 
  41. ^ "FDA looks into Singulair, risks of suicidal thoughts", USA Today
  42. ^ "Drugmaker Merck challenges Facebook after 'losing' page". bbc.co.uk/news. 25 November 2011. http://www.bbc.co.uk/news/technology-15888843. 

[edit] External links

Merck & Co., Inc.
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Annual Revenue: $22.9 billion USD (increase2% FY 2004) · Employees: 63,000 · Stock Symbol: NYSE: MRK · Website: merck.com
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