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.
In 2012 the company received the "Facility of the Year"-Category Winner for Facility Integration Award for the Vaccine Bulk Manufacturing Facility (VBF) Program of Projects in Durham, North Carolina, USA.
- 1 Products
- 2 History
- 3 Corporate governance
- 4 Patient assistance programs
- 5 Case histories
- 6 See also
- 7 Notes and references
- 8 External links
In 2013, Merck's major products included
- Januvia, 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 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 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 is a vaccine against multiple serotypes of human papilloma virus, which is responsible for most cases of cervical cancer worldwide.
- Isentress 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.
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 vaccine's development.
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 June 2014 Merck announced its acquisition of Idenix Pharmaceuticals for approximately $3.85 billion. On September 4 2014, the US Food and Drug Administration (FDA) approved Pembrolizumab (MK-3475) as a breakthrough therapy for melanoma treatment. On September 17 2014, it was announced that Merck had licenced its Phase III chronic plaque psoriasis drug candidate, Tildrakizumab (MK-3222), to Sun Pharmaceutical, potentially making the company more than $80 million.
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.
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.
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 "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.
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. 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.
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..." 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. The New York pension fund also sought lead plaintiff status in this case on behalf of all investors that had lost money. 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. 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.
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.
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.
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.
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.
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. Isentress was approved by the FDA on October 12, 2007.
Merck is being sued over allegations that it failed to warn patients of alleged persistent sexual dysfunction, loss of libido, impotence, severe depression, cognitive impairment, Peyronie’s disease, penile shrinkage and gynecomastia from Propecia.
In December 2013, Merck agreed to pay a total of $27.7 million dollars to 1,200 plantiffs 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.
Notes and references
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- 2012 Facility of the Year Awards Category Winners  Accessed 2012-12-20.
- "The top 10 best-selling diabetes drugs of 2013 - FiercePharma".
- Zhan M, Xu T, Wu F, Tang Y (August 2012). "Sitagliptin in the treatment of type 2 diabetes: a meta-analysis". J Evid Based Med 5 (3): 154–65. doi:10.1111/j.1756-5391.2012.01189.x. PMID 23672222.
- 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.
- Li L, Shen J, Bala MM, et al. (2014). "Incretin treatment and risk of pancreatitis in patients with type 2 diabetes mellitus: systematic review and meta-analysis of randomised and non-randomised studies". BMJ 348: g2366. PMC 3987051. PMID 24736555.
- Lu L, Krumholz HM, Tu JV, Ross JS, Ko DT, Jackevicius CA (May 2014). "Impact of the ENHANCE trial on the use of ezetimibe in the United States and Canada". Am. Heart J. 167 (5): 683–9. doi:10.1016/j.ahj.2014.01.014. PMID 24766978.
- Aaltonen KJ, Virkki LM, Malmivaara A, Konttinen YT, Nordström DC, Blom M (2012). "Systematic review and meta-analysis of the efficacy and safety of existing TNF blocking agents in treatment of rheumatoid arthritis". PLoS ONE 7 (1): e30275. doi:10.1371/journal.pone.0030275. PMC 3260264. PMID 22272322.
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- Mectizan Donation Program
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- Merck & Co., Inc. press release – Two Merck Medicines Recommended for Approval in the European Union Retrieved April 30, 2008.
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- 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[dead link] Retrieved July 26, 2008.
- "Tredaptive European Public Assessment Report". European Medicines Agency. Retrieved November 13, 2009.
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- "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.
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