Merck & Co.

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Merck & Co Inc.
(Merck Sharp & Dohme (MSD) outside the United States and Canada)
Type Public (NYSE: MRK)
Founded 1891 as a subsidiary of Merck KGaA
1917 as an independent company
Headquarters Whitehouse Station, New Jersey, United States Flag of the United States
Key people Richard T. Clark, President & CEO
Industry Pharmaceuticals
Products Gardasil
Singulair
Propecia/Proscar
Zocor
See more complete products listing.
Revenue ▲$22.012 billion USD (2005)
Operating income ▲$5.536 billion USD (2005)
Net income ▲$4.631 billion USD (2005)
Employees 61,500 (2005)
Website www.merck.com

Merck & Co., Inc. (NYSE: MRK), also known as Merck Sharp & Dohme or MSD outside the USA and Canada, is one of the largest pharmaceutical companies in the world. The headquarters of the company is located in Whitehouse Station, NJ. It was established in 1891 as the United States subsidiary of the German company now known as Merck KGaA. In common with many other German assets in the United States, Merck & Co. was confiscated in 1917 during World War I and set up as an independent company. It is currently one of the seven largest pharmaceutical companies in the world both by capital and revenue.

Merck & Co. or MSD describes itself as a "a global research-driven pharmaceutical company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health, directly and through its joint ventures." The Merck Company Foundation has distributed over $480 million to educational and non-profit organizations since it was founded in 1957.[1]

Merck publishes the Merck Manual of Diagnosis and Therapy, the world's best-selling medical textbook, and the Merck Index, a collection of information about chemical compounds.

Contents

[edit] History

Merck & Co. traces its origins to Friedrich Jacob Merck who purchased a drug store in Darmstadt in 1668; and 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 — in addition to raw materials for pharmaceutical preparations — a multitude of other chemicals.

In 1891, George Merck established his roots in 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. Merck & Co. was confiscated in 1917 during World War I and set up as an independent company in the United States. Between the wars and during 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 61,500 employees in 120 countries and 31 factories worldwide. It is one of the top 7 pharmaceutical companies worldwide, much larger than its German ancestor, which currently employs around 28,600 people in 54 countries.

In 2005, CEO Raymond Gilmartin retired at the age of 64 following Merck's voluntary worldwide withdrawal of Vioxx. Former president of manufacturing Richard Clark was named CEO and President of the company.

[edit] Corporate governance

Current members of the board of directors of Merck & Co. are: Richard Clark, Johnnetta Cole, William Harrison, William Kelley Rochelle Lazarus, Thomas Shenk, Anne Tatlock, Samuel Thier, Wendell Weeks, and Peter Wendell.[2]

[edit] Products

[edit] Products on the market

[edit] Products under development

[edit] Patient Assistance Programs

In the early 1950s, Merck & Co. was one of the first pharmaceutical companies to provide patient assistance programs in the U.S. to those unable to afford their medications. [3] Currently, Merck & Co. offers 7 patient assistance programs, each with specific eligibility requirements. [4]

[edit] Available programs

[edit] Vioxx

In 1999, the United States Food and Drug Administration ("FDA") approved Vioxx (known generically as rofecoxib), a Merck product that became widely used 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.

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. Nonetheless, in 2002 Merck adjusted the labeling of Vioxx to reflect possible cardiovascular risks.

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.[5] 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..." [6] 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.[7] 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.[7] In November 2007, Merck proposed to pay $4.85 billion to settle most of the pending Vioxx lawsuits.[8] 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.[9] As of mid-2008, plaintiffs have prevailed in only three of the twenty cases that have reached juries, all with relatively small awards.[7]

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.[10] All its new television pain-killer advertisements must be vetted by the Food and Drug Adminstration and changed or delayed upon request until 2018.[11]

[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.[12]

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.[13]

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.[14]

[edit] Environmental record

Merck & Co used methylene chloride which was an animal carcinogen and according to the Federal Environmental Protection Agency was on the lists of pollutants. To get rid of this problem Merck chemists and engineers discovered a new way to manufacture chemistry without using methylene chloride. The new way of creating chemicals seemed to have fewer environmental effects. Merck has also changed its equipment to help better the environment. Merck installed a computerized distributed control system that helped with the process of operations by 50 percent and it ran chemical reaction steps more effectively. With the new machines they eliminated the disposal and storage of harmful waste. The biological oxygen demand was reduce by 75% with the new process to help with water waste and polluted waste.[15] In 1991, Kelco, owned by Merck was responsible for 1/3 of the VOC emission pollution in the San Diego area. The ground level ozone cause health problems such as damaging lung tissue and making the lungs easily vulnerable to other harmful bacterias.[16] In 1996 Merck paid 1.8 million dollars in a settlement that accused them of polluting the air. Along with the money settlement new machines were installed to cut the air pollution the companies facilities were giving off. The new machines will reduce the smog level emissions by 680,000 lbs a year.[17]

[edit] Isentress

Raltegravir, 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 DNA from HIV to become part of human DNA in the replication process. [18]

[edit] Singulair

The FDA is beginning to look into a link between the Merck drug Singulair, suicide and other psychological side effects, and is conducting research to see if Singulair should be reviewed further. Singulair works on blocking the Leukotriene pathway in both Asthma and Allergic Rhinitis. [19]

[edit] Awards

Merck & Co. was named one of the 100 Best Companies for Working Mothers in 2004 by Working Mothers magazine.[citation needed]

[edit] See also

[edit] References

  1. ^ Princeton University and The Merck Company Foundation Announce Creation Of New Global Health Scholars Program and Lecture Series
  2. ^ Merck Board of Directors. Retrieved on 2007-09-15.
  3. ^ "Merck to Create New Patient Assistance Program for Vaccines" Retrieved on May 20, 2008.
  4. ^ "Patient Assistance - Available Prescription Assistance Programs From Merck & Co." Retrieved on May 20, 2008.
  5. ^ http://finance.senate.gov/press/Gpress/2004/prg101504.pdf
  6. ^ Elsevier
  7. ^ a b c Courts Reject Two Major Vioxx Verdicts, New York Times, May 30, 2008
  8. ^ Merck proposes $4.85B Vioxx settlement, USA Today, November 12, 2007
  9. ^ "Merck's outlook revised to developing from negative on Vioxx agreement", Forbes, November 11, 2007
  10. ^ Arizona gets $2.3 Million from Vioxx Settlement 92.3 KTAR Retrieved on May 19, 2008
  11. ^ Merck Agrees to Settlement Over Vioxx Ads, New York Times, May 20, 2008]
  12. ^ Yahoo.com, Merck niacin drug controls cholesterol
  13. ^ Merck & Co., Inc. press release - Two Merck Medicines Recommended for Approval in the European Union Retrieved on April 30, 2008.
  14. ^ Merck & Co., Inc. press release - Merck Receives Not Approvable Letter from FDA for MK-0524A (ER niacin/laropiprant) Retrieved on April 30, 2008.
  15. ^ http://www.p2pays.org/ref%5C01/00155.pdf
  16. ^ ET 10/96: Repairing a legacy of pollution by Kelco
  17. ^ U.S. SETTLES $1.8 MILLION POLLUTION CASE WITH MERCK AND MONSANTO | Newsroom | US EPA
  18. ^ Merck.com FDA Advisory Committee Unanimously Recommends Accelerated Approval of ISENTRESS (raltegravir), Merck's Investigational Oral Integrase Inhibitor, for Treatment of HIV
  19. ^ "FDA looks into Singulair, risks of suicidal thoughts", USA Today

[edit] External links

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Merck & Co., Inc.
Corporate Directors:
Richard Clark · Johnnetta Cole · William Harrison · William Kelley · Rochelle Lazarus · Thomas Shenk · Anne Tatlock · Samuel Thier · Wendell Weeks · Peter Wendell
Products:
Publications:
Annual Revenue: $22.9 billion USD (▲2% FY 2004) · Employees: 63,000 · Stock Symbol: NYSE: MRK · Website: www.merck.com
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