Merck & Co.

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 top 7 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.

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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.

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]

Products

• Arcoxia (etoricoxib) - for the symptomatic treatment of osteoarthritis (not approved in the US, but approved and sold in Europe, Latin America, the Asia-Pacific region and Middle East/Northern Africa)
• Cosopt (dorzolamide and timolol) - reduces intraocular pressure in people with glaucoma or ocular hypertension.
• Cozaar/Hyzaar (losartan)- used to treat hypertension and to reduce the risk of strokes.
• Crixivan (indinavir) – a protease inhibitor HIV medication.
• Emend (aprepitant) – treats vomiting and nausea brought about by chemotherapy.
• Fosamax (alendronate) – osteroporosis medication.
• Fosamax Plus D (alendronate/vitamin D) – osteroporosis medication.
• Gardasil (HPV vaccine) - a vaccine against human papillomavirus, a sexually transmitted disease that is the most common cause of cervical cancer.
• Invanz - an injectable antibiotic (carbapenem) used for those with diabetic foot infections.
• Isentress (raltegravir) - HIV integrase inhibitor.
• Januvia (sitagliptin) - a dipeptidyl peptidase-4 inhibitor for the treatment of diabetes
• Maxalt (rizatriptan) one of many triptans used to treat migraines.
• Mectizan/Stromectol (ivermectin) - used to treat river blindness.
• Primaxin (imipenem with cilastatin) – a broad spectrum carbapenem antibiotic.
• Propecia/Proscar (finasteride) – used for alopecia (male pattern baldness) and prostatic conditions.
• ProQuad (MMRV vaccine) - a vaccine for simultaneous vaccination against measles, mumps, rubella, and varicella in children.
• Rotateq - a vaccine to prevent rotavirus gastroenteritis, a leading cause of severe diarrhea in infants and young children.
• Singulair (montelukast) – an asthma medication that blocks leukotrienes.
• Vytorin (ezetimibe/simvastatin) – a combination cholesterol-lowering preparation marketed in collaboration with Schering-Plough.
• Zetia (ezetimibe) - cholesterol absorption inhibitor which lowers LDL
• Zocor (simvastatin) – a cholesterol-lowering statin.
• Zolinza (vorinostat) - a histone deacetylase inhibitor for the treatment of cutaneous T cell lymphoma.
• Zostavax - a vaccine for prevention of shingles in adults older than 60 years of age.

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.^[3] On September 28, 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...” ^[4] The Lancet condemned Merck for having kept the drug on the market, despite its knowledge of the risks, and also criticized the FDA for its failure of regulatory oversight.

On August 19, 2005, Merck was found liable in the death of a man who took Vioxx. The plaintiff was awarded $253.4 million in damages, which were subsequently reduced to $20 million, the maximum allowed by Texas statute. In a followup case in New Jersey, Merck was found not liable. A third case is pending in Louisiana. Merck's stock fell $2.35 to $28.06/share (7.73%) in the minutes after the verdict was announced. At the time of the verdict, there were over 4,000 other lawsuits pending against Merck regarding Vioxx, and several thousand against Pfizer, the maker of a similar, and also withdrawn (USA), anti-inflammatory drug Bextra, which, in some cases, caused an adverse skin reaction.

Subsequently, Merck tried unsuccessfully to get a successor drug to Vioxx, called etoricoxib (Arcoxia), which is approved in 60 countries worldwide, approved in the USA. Two other drug companies, Pfizer and Novartis, are trying to get alternatives to Vioxx approved. Their drugs are called parecoxib (Dynastat) and lumiracoxib (Prexige), respectively.

In November 2007, Merck proposed to pay $4.85 billion to settle most of the nearly 27,000 pending Vioxx lawsuits.^[5] 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.^[6]

Cordaptive

On September 4. 2007, Merck & Co. introduced the experimental drug Cordaptive, which can both raise good cholesterol and lower bad cholesterol (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.^[7]

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. ^[8]

Awards

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

See also

• Merck family

References