Merck & Co.
|Traded as||NYSE: MRK
Dow Jones Industrial Average Component
S&P 500 Component
|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)
Zocor Vioxx Fosamax
|Revenue||US$ 48.047 billion (2011)|
|Operating income||US$ 7.334 billion (2011)|
|Net income||US$ 6.272 billion (2011)|
|Total assets||US$ 105.128 billion (2011)|
|Total equity||US$ 56.943 billion (2011)|
|Employees||76,000 (Dec 2013)|
Merck & Co., Inc. (NYSE: MRK), d.b.a. Merck Sharp & Dohme, MSD outside the United States and Canada, is an American pharmaceutical company and one of the largest pharmaceutical companies in the world. Merck headquarters is located in Whitehouse Station, New Jersey, though in 2013 the company announced it would be relocating to Kenilworth, New Jersey by 2015. 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 the world's seventh largest pharmaceutical company by market capitalization and revenue.
Merck 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.
- 1 History
- 2 Corporate governance
- 3 Products
- 4 Society and Culture
- 5 See also
- 6 Notes and references
- 7 External links
Merck & Co. traces its origins to Jacob Friedrich 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. Merck & Co. hold the rights to the name in North America, while its former parent company retains the rights in the rest of the world.
In 1929, H.K. Mulford Co merged with Sharpe and Dohme, Inc. This company brought to the future Merck & Co, Inc vaccine technology, including immunization of calvary horses in World War I and delivery of a diphtheria antitoxin in 1925.
In 1953, Merck merged with Philadelphia-based Sharp & Dohme, Inc., founded by Alpheus Phineas Sharp and Carl Friedrich Louis Dohme in 1845, becoming the largest US drugmaker. The merger combined Merck's strength in scientific research and chemical manufacturing with Sharp & Dohme's sales and distribution system and its marketing expertise. The combined company kept the trade name Merck in the United States and Canada, and as Merck Sharp & Dohme (MSD) outside North America.
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, and the company was renamed Merck Canada in 2011.
In November 1993, Merck completed a $6 billion purchase of Medco Containment Services Inc., one of the largest mail-order pharmacy and managed-care drug companies.
In November 2009, Merck announced that it would merge with competitor Schering-Plough in a US$41 billion deal. Although Merck was in reality acquiring Schering-Plough, the purchase was structured on paper as a "reverse merger", in which "Old" Merck was renamed Merck Sharpe & Dohme, and Schering-Plough renamed as "Merck & Co., Inc." so that it could, technically, continue as the surviving public corporation. The maneuver was an attempt to preserve Schering-Plough's rights to market Remicade, which was ultimately decided by arbitration. The merger was completed on 2009-11-04.
As of December 2013, the US company had approximately 76,000 employees in 120 countries with 31 factories worldwide. It is one of the world's seven largest pharmaceutical companies.
The Merck Company Foundation has distributed more than $480 million to educational and non-profit organizations since it was founded in 1957 (and $740 million in overall charitable distributions). On December 7, 2012, the foundation announced that it was ending its donations to the Boy Scouts of America because of "its policy that excludes members on the basis of sexual orientation", which "directly conflicts with the Merck Foundation's giving guidelines."
In October 2013, Merck has announced it will cut 8,500 jobs in an attempt to cut $2.5bn (£1.5bn) from its costs by 2015. The company's shares rose 2.35% to $48.73 in New York trading after it announced the cuts. The new losses, combined with 7,500 job cuts announced in 2011 and 2012, amount in total to 20% of its workforce.
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.
As of August 2014, Merck's research and development effort has led to the approval of more new drugs than that of any other company. Research performed at Merck has led to U.S. FDA approval of 63 New Molecular Entities. In 2014, Merck's major products included
- Januvia (sitagliptin), a dipeptidyl peptidase IV inhibitor for the treatment of type 2 diabetes. In 2013, Januvia was the second largest selling diabetes drug worldwide, with $4.0 billion in worldwide sales. Januvia is commonly paired with the generic anti-diabetes drug metformin. It has been popular due in part because unlike many other diabetes drugs, it causes little or no weight gain and is not associated with hypoglycemic episodes. Merck also sells a single pill combination drug containing both Januvia and metformin under the trade name Janumet. There has been some concern that treatment with Januvia and other DPP-IV inhibitors may be associated with a modestly increased risk of pancreatitis.
- Zetia(ezetimibe) is a drug for hypercholesterolemia that acts by inhibiting the absorption of dietary cholesterol. Sales in 2013 amounted to $2.7 billion. Zetia has been controversial as it was approved based on its impact on serum cholesterol levels without proof that it actually impacts the incidence of cardiovascular disease. Clinical trial results obtained post-approval suggest little or no impact.
- Remicade (infliximab) is a monoclonal antibody directed toward the cytokine TNF-alpha and used for the treatment of a wide range of autoimmune disorders, including rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, plaque psoriasis, and others. Remicade and other TNF-alpha inhibitors exhibit additive therapeutic effects with methotrexate and improve quality of life. Adverse effects include increased risk of infection and certain cancers.
- Gardasil (recombinant human papilloma virus vaccine) is a vaccine against multiple serotypes of human papilloma virus (HPV), which is responsible for most cases of cervical cancer worldwide.
- Isentress (raltegravir) is a human immunodeficiency virus integrase inhibitor for the treatment of HIV infection. It is the first anti-HIV compound having this mechanism of action. Sales in 2013 were $1.8 billion. It is part of one of several first line treatment regimens recommended by the United States Department of Health and Human Services.
- Keytruda (pembrolzumab) is an immune modulator for the treatment of cancer. On September 4, 2014, the US Food and Drug Administration (FDA) approved Pembrolizumab (MK-3475) as a breakthrough therapy for melanoma treatment. In clinical trials, pembrolzumab provided partial tumor regression in about one quarter of patients, many of whom have not seen further progression of their disease in over 6 months of follow-up.
Medically important developed at Merck include the first mumps vaccine, and the first rubella vaccine, each of which was developed by Merck scientist Maurice Hilleman. The incidence of rubella-associated birth defects fell from up to 10,000 per year in the U.S. to zero in the aftermath of the rubella vaccine's development.
In 1985 Merck received approval for the imipenem, the first member of the carbapenem class of antibiotics. Antibiotics of the carbapenem class play an important role in treatment guidelines for certain hospital-acquired and multi-drug resistant infections.
In 1999, the U.S. Food and Drug Administration (FDA) approved Vioxx (known generically as rofecoxib), a Merck product for treating arthritis. Vioxx was designed as a selective inhibitor of the enzyme cyclooxygenase-2. Such compounds were expected to cause less gastrointestinal bleeding than older anti-inflammatory drugs such as naproxen, which were associated with 20,000 hospitalizations and 2000 deaths each year. Vioxx became one of the most prescribed drugs in history.
Thereafter, studies by Merck and by others found an increased risk of heart attack associated with Vioxx use when compared with naproxen. 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. 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. An analysis based on U.S. Medical Expenditure Survey data estimated that Vioxx was ultimately responsible for approximately 50,000 excess heart attacks and 25,000 deaths.
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. In November 2007, Merck proposed to pay $4.85 billion to settle most of the pending Vioxx lawsuits. 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.
According to internal e-mail traffic released at a later lawsuit, Merck had a list of doctors critical of Vioxx to be "neutralized" 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 infringement upon academic freedom.
On May 20, 2008, Merck settled for $58 million with 30 states alleging that Merck engaged in deceptive marketing tactics to promote Vioxx. All its new television pain-advertisements must be vetted by the Food and Drug Administration and changed or delayed upon request until 2018.
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" 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. 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, and the decision to donate the entirety of the drug to all those in need of it is used as part of the Mectizan Donation Program that covers countries such as Yemen and in African countries.
More than 700 million people have been treated since the inception of the program with 80 million people still undergoing treatment in Africa, Latin America, and Yemen. Blindness caused by onchocerciasis is decreasing and there are regions of Latin America and Africa that have been shown to have completely eliminated the disease altogether.
Fosamax (alendronate) is a bisphosphonate used for the treatment of post-menopausal osteoporosis and for the prevention of skeletal problems in certain cancers. The American College of Clinical Endocrinology, the American College of Obstetricians and Gynecologists, the North American Menopause Society and the UK National Osteoporosis Guideline Group recommend alendronate and certain other bisphosphonates as first line treatments for post-menopausal osteopotosis. Long-term treatment with bisphosponates produces anti-fracture and bone mineral density effects that persist for 3-5 years after an initial 3-5 years of treatment. Alendronate reduces the risk of hip, vertebral, and wrist fractures by 35-39%.
In December 2013, Merck agreed to pay a total of $27.7 million to 1,200 plaintiffs in a class action lawsuit alleging that the company's osteoporosis drug had caused them to develop osteonecrosis of the jaw. Prior to the settlement, Merck had prevailed in 3 of 5 so-called "bellweather" trials. Approximately 4000 cases still await adjudiction or settlement as of August 2014.
Society and Culture
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. Merck & Co. offers seven patient assistance programs, each with specific eligibility requirements.
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. In 2009, the CEO of Elsevier's Health Sciences Division, Michael Hansen, admitted that the practice was "unacceptable".
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. They alleged that Merck failed to pay proper rebates to Medicaid and other health care programs and paid illegal remuneration to health care providers. 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 settlement was one of the largest pharmaceutical settlements in history. The federal government received more than $360 million, plus 49 states and Washington, DC, received over $290 million. One whistleblower received a $68 million reward. Merck made the settlement without an admission of liability or wrongdoing.
Merck & Co. once used methylene chloride, an animal carcinogen on the United States Environmental Protection Agency's list of pollutants, as a solvent in some of its manufacturing processes. 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.
In 1991, Merck's Kelco subsidiary was responsible for volatile organic compound (VOC) emission pollution in the San Diego area. Ground level ozone was causing lung tissue damage by exposure to harmful bacteria.
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.
Notes and references
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- Time Magazine: Merck's Merger, March 16, 1953. Retrieved 2012-09-03.
- The New York Times: Key Facts About Merck, November 3, 2005. Retrieved 2012-09-03.
- "Montreal plant among 17 closed by drugmaker Merck". The Star (Toronto). July 8, 2010.
- "Merck & Co. completes Medco purchase". November 19, 1993. Retrieved January 14, 2014.
- Singer, Natasha (March 10, 2009). "Merck to Buy Schering-Plough for $41.1 Billion". The New York Times. Retrieved 2009-11-14.
- "Merck and Schering-Plough to Complete Merger Today" (Press release). Merck & Co. November 3, 2009. Retrieved 2009-11-13.[dead link]
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- Edwards, Jim (November 10, 2009). "Merck Legally Changed Its Name 3 Times to Achieve Reverse Merger With Schering". CBS News. Retrieved 2012-09-02.
- Merck's News Release: Merck and Johnson & Johnson Reach Agreement on Distribution Rights for Remicade and Simponi, April 15, 2011. Retrieved 2012-09-03.
- "Princeton University and The Merck Company Foundation Announce Creation Of New Global Health Scholars Program and Lecture Series" (PDF). Retrieved 2012-06-05.
- Scouts for Equality: Merck pauses Boy Scout Funding, accessed December 10, 2012
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- Deacon CF, Mannucci E, Ahrén B (August 2012). "Glycaemic efficacy of glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors as add-on therapy to metformin in subjects with type 2 diabetes-a review and meta analysis". Diabetes Obes Metab 14 (8): 762–7. doi:10.1111/j.1463-1326.2012.01603.x. PMID 22471248.
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- Courts Reject Two Major Vioxx Verdicts, The New York Times, May 30, 2008
- "Merck proposes $4.85B Vioxx settlement". News.idsk.com. August 28, 2003. Retrieved 2012-06-05.
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- Rout, Milanda (April 1, 2009). "Vioxx maker Merck and Co drew up doctor hit list". The Australian. Retrieved 2009-04-26.
- Arizona gets $2.3 Million from Vioxx Settlement 92.3 KTAR Retrieved May 19, 2008
- Merck Agrees to Settlement Over Vioxx Ads, The New York Times, May 20, 2008]
- Merck supports the worldwide fight against river blindness, UNICEF
- "Ivermectin History". Stanford.edu. February 24, 1981. Retrieved 2012-06-05.
- Onchocerciasis: Africa's victory over river blindness., Africa Recovery, Vol.17 No. 1 (May 2003), page 6
- Mectizan Donation Program
- "Management of osteoporosis in postmenopausal women: 2010 position statement of The North American Menopause Society". Menopause 17 (1): 25–54; quiz 55–6. 2010. doi:10.1097/gme.0b013e3181c617e6. PMID 20061894.
- Hauk L (August 2013). "ACOG releases practice bulletin on osteoporosis". Am Fam Physician 88 (4): 269–75. PMID 23944732.
- Compston J, Bowring C, Cooper A, et al. (August 2013). "Diagnosis and management of osteoporosis in postmenopausal women and older men in the UK: National Osteoporosis Guideline Group (NOGG) update 2013". Maturitas 75 (4): 392–6. doi:10.1016/j.maturitas.2013.05.013. PMID 23810490.
- Eriksen EF, Díez-Pérez A, Boonen S (January 2014). "Update on long-term treatment with bisphosphonates for postmenopausal osteoporosis: a systematic review". Bone 58: 126–35. doi:10.1016/j.bone.2013.09.023. PMID 24120384.
- Serrano AJ, Begoña L, Anitua E, Cobos R, Orive G (December 2013). "Systematic review and meta-analysis of the efficacy and safety of alendronate and zoledronate for the treatment of postmenopausal osteoporosis". Gynecol. Endocrinol. 29 (12): 1005–14. doi:10.3109/09513590.2013.813468. PMID 24063695.
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- Merck Patient Assistance Programs[dead link]
- Singer N (May 13, 2009). "Merck paid for medical 'journal' without disclosure". The New York Times. Retrieved 2009-06-17.
- "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. Retrieved November 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."
- Johnson, Carrie (February 8, 2008). "Merck to Pay $650 Million In Medicaid Settlement". The Washington Post. Retrieved February 8, 2010.
- "Merck to Pay More than $650 Million to Resolve Claims of Fraudulent Price Reporting and Kickbacks". US Department of Justice. February 7, 2008. Retrieved 2012-06-05.
- Silverman, Ed (February 7, 2008). "Merck To Pay $670 Million Over Medicaid Fraud". Pharmalot.com. Retrieved 2012-06-05.
- "Merck Resolves Federal and State Investigations Related to Certain Past Pricing And Certain Past Sales and Marketing Activities". Merck. February 7, 2008. Retrieved February 8, 2010.
- "ET 10/96: Repairing a legacy of pollution by Kelco". Sdearthtimes.com. Retrieved 2012-06-05.
- "U.S. settles $1.8 million pollution case with Merck and Monsanto | US EPA". Yosemite.epa.gov. Retrieved 2012-06-05.