|Type||Public limited company|
|Traded as||LSE: GSK
|Predecessor(s)||Glaxo Wellcome plc
SmithKline Beecham plc
|Key people||Chris Gent (Chairman)
Andrew Witty (chief executive)
|Products||Pharmaceuticals, vaccines, oral healthcare products, nutritional products, over-the-counter medicines|
|Revenue||£25.602 billion (2013)|
|Operating income||£7.771 billion (2013)|
|Net income||£5.237 billion (2013)|
|Employees||Over 99,000 (2013)|
GlaxoSmithKline plc (GSK) is a British multinational pharmaceutical, biologics, vaccines and consumer healthcare company headquartered in Brentford, London. It is the world's fourth-largest pharmaceutical company after Pfizer, Novartis and Sanofi, measured by 2009 prescription drug sales. The company was established in 2000 by the merger of Glaxo Wellcome plc (formed from the acquisition of Wellcome plc by Glaxo plc) and SmithKline Beecham plc (formed from the merger of Beecham plc and SmithKline Beckman Corporation, which in turn was formed by combining the Smith Kline French and Beckman companies).
GSK has a portfolio of products for major disease areas such as asthma, cancer, virus control, infections, mental health, diabetes and digestive conditions. It also has a large consumer healthcare division that produces oral healthcare and nutritional products, drinks and over-the-counter medicines, including Sensodyne, Boost and Horlicks. Andrew Witty has been the chief executive officer since May 2008.
The company has a primary listing on the London Stock Exchange and is a constituent of the FTSE 100 Index. As of 6 July 2012 it had a market capitalisation of £74.8 billion, the fifth-largest of any company listed on the London Stock Exchange. It has a secondary listing on the New York Stock Exchange.
In July 2012 GSK pleaded guilty to criminal charges in the United States, and agreed to pay $3 billion in fines, including a criminal fine of $1 billion, in what was the largest health-care fraud case to date in that country and the largest settlement by a drug company. The charges were related to the company's promotion of its anti-depressants paroxetine (marketed in the United States as Paxil) and bupropion (Wellbutrin) for unapproved uses, and its failure to report safety data about rosiglitazone (Avandia), a diabetes drug. Part of the rest of the settlement was related to the company's sales and marketing of an asthma drug, fluticasone/salmeterol (Advair).
On December 17, 2013, GSK announced that it would cease compensating doctors for prescribing the company’s products, would stop paying professionals for speaking at medical conferences, and that it would remove prescription-related sales targets for its reps. However, according to Reuters, the drugmaker would “still pay fees to doctors carrying out company-sponsored clinical research, advisory activities and market research.”
- 1 History
- 2 Overview
- 3 Controversies
- 4 See also
- 5 References
- 6 External links
Burroughs Wellcome & Company was founded in 1880 in London by the American pharmacists Henry Wellcome and Silas Burroughs. The Wellcome Tropical Research Laboratories opened in 1902. In 1959 the Wellcome Company bought Cooper, McDougall & Robertson Inc. to become more active in animal health. The Wellcome Company production centre was moved from New York to North Carolina in 1970, and the following year another research centre was built.
Glaxo was founded in Bunnythorpe, New Zealand, in 1904. It was originally a baby food manufacturer processing milk into a baby food of the same name: the product was sold under the slogan "Glaxo builds bonny babies" from 1908. Still visible on the main street of Bunnythorpe is a dairy factory (factory for drying and processing cows' milk into powder) with the original Glaxo logo clearly visible; it is now a car repair shop.
Glaxo became Glaxo Laboratories and opened new units in London in 1935. Glaxo Laboratories bought two companies, Joseph Nathan and Allen & Hanburys in 1947 and 1958 respectively. After the company bought Meyer Laboratories in 1978, it started to play an important role in the US market. In 1983 the American arm, Glaxo Inc., moved to Research Triangle Park (US headquarters/research) and Zebulon (US manufacturing) in North Carolina. Burroughs Wellcome and Glaxo merged in 1995 to form Glaxo Wellcome, which opened its Medicine Research Centre that year in Stevenage, England. Three years later Glaxo Wellcome bought Polfa Poznan Company in Poland.
In 1843 Thomas Beecham launched his Beecham's Pills laxative in England giving birth to the Beecham Group. Beecham opened its first factory in St Helens, Lancashire, England, for rapid production of medicines in 1859. The original factory was closed in 1994 and passed to the local college for re-development. By the 1960s Beecham was extensively involved in pharmaceuticals.
In 1830 John K. Smith opened its first pharmacy in Philadelphia. In 1865 Mahlon Kline joined the business, which 10 years later became Smith, Kline & Co. In 1891 it merged with French, Richard and Company. It changed its name to Smith Kline & French Laboratories in 1929 as it focused more on research. Years later Smith Kline & French Laboratories opened a new laboratory in Philadelphia; it then bought Norden Laboratories, a business doing research into animal health. Smith Kline & French Laboratories bought Recherche et Industrie Thérapeutiques (Belgium) in 1963 to focus on vaccines. The company started to expand globally, buying seven laboratories in Canada and the US in 1969. In 1982 it bought Allergan , a manufacturer of eye and skincare products. The company merged with Beckman Inc. later that year and changed its name to SmithKline Beckman.
In 1988 SmithKline Beckman bought its biggest competitor, International Clinical Laboratories, and in 1989 merged with Beecham to form SmithKline Beecham plc. The headquarters of the company was moved to England. To expand research and development in the US, SmithKline Beecham bought a new research center in 1995. Another new research centre at New Frontiers Science Park in Harlow, England, was opened in 1997.
Glaxo Wellcome and SmithKline Beecham announced their intention to merge on 17 January 2000. The merger was completed in December that year, forming GlaxoSmithKline (GSK).
GSK House, the world headquarters of GlaxoSmithKline in Brentford, London
GSK produces and sells a wide range of prescription-only and over-the-counter products, including drinks and toothpastes (see sidebar, right). According to its website, it manufactures and distributes over four billion packets of products to over 150 countries every year, and nearly 900 million doses of its vaccines were distributed to 170 countries in 2012. Its top-selling prescription drugs include the anti-depressant Paxil, which by 2012 had attracted $11.6 billion in sales, the diabetes drug Avandia at $10.4 billion, the anti-depressant Wellbutrin at $5.9 billion, the asthma drugs Advair, Flovent and Ventolin, and an H2 antagonist, Zantac.
The company's over-the-counter health-care products include Abreva to treat cold sores; Aquafresh, Maclean's and Sensodyne toothpastes; Night Nurse, a cold remedy; Breathe Right nasal strips; and Nicoderm and Nicorette nicotine replacements. It also sells several drinks, including Horlicks, a malted milk drink and Boost, a chocolate-flavoured drink, and formerly sold Lucozade, marketed as an energy drink, and Ribena, a fruit drink.
As of 2013 GSK has offices in over 115 countries. Its global headquarters are in the UK at GSK House in Brentford, a suburb of west London, and its US headquarters are in Research Triangle Park, North Carolina. The company employs over 99,000 people, 12,500 of whom work in research and development. The company's single largest market is the United States. Its consumer-products division is based in the Pittsburgh suburb of Moon Township, Allegheny County, Pennsylvania. The research-and-development division has major facilities in south-east England, Philadelphia and North Carolina. Company facilities include:
- R&D sites in Stockley Park,Stevenage and Ware, England; Zagreb, Croatia; Évreux and Les Ulis, France; Research Triangle Park, North Carolina, and Collegeville, Pennsylvania, US; Laval, Quebec, Canada; Shanghai, China; and Thane and Nashik, Maharashtra, India.
- Centres for biopharmaceutical products in Wavre and Rixensart, Belgium; Dresden, Germany; Gödöllő, Hungary; Quebec City, Canada; Marietta, Pennsylvania and Hamilton, Montana, US.
- Manufacturing sites for prescription products in Irvine and Montrose, Scotland; Ware, Barnard Castle, Worthing and Ulverston, England; Cork, Ireland; Évreux, France; Poznań, Poland; Parma, Italy; Brașov, Romania; Brussels, Belgium; Bristol, Tennessee, King of Prussia, Pennsylvania and Zebulon, North Carolina, US; Cidra, Puerto Rico; Jurong, Singapore; Boronia, Australia.
- Manufacturing sites for consumer products in Maidenhead, England; Dungarvan, Ireland; Mississauga, Ontario, Canada; Aiken, South Carolina, Oak Hill, New York and St. Louis, Missouri, US; and Kenya.
Operations and acquisitions
In 2001 GSK completed the acquisition of New Jersey-based Block Drug for US$1.24 billion. In July 2002 GSK House, located in Brentford, London, was officially opened as GSK's new world headquarters by then-Prime Minister Tony Blair. The building was erected at a cost of £300 million and is home to around 3,000 staff. In October 2006 GSK acquired the US-based consumer healthcare company CNS Inc., whose products included Breathe Right nasal strips and FiberChoice dietary fibre supplements, for US$566 million in cash. GSK opened its first R&D centre in China in May 2007, located in Shanghai, and initially focused on neurodegenerative diseases.
Since 2008 GSK has been running clinical trials of a new malaria vaccine. Known as RTS,S, the vaccine has been in development for more than 25 years, at first for the American military, then with major support from the Bill and Melinda Gates Foundation. The clinical trial is scheduled to continue through 2014 and will include tests on more than 15,000 children, starting at infancy.
In February 2009 GSK head Andrew Witty announced that the company would cut drug prices by 25 percent in 50 of the poorest nations, release intellectual property rights for substances and processes relevant to neglected disease into a patent pool to encourage new drug development, and would invest 20 percent of profits from the least developed countries in medical infrastructure for those countries. The decision received mixed reactions from medical charities. Médecins Sans Frontières welcomed the decision, encouraging other companies to follow suit, but criticized GSK for failing to include HIV patents in their patent pool, and for not including middle-income countries in the initiative.
In April 2009 GSK agreed to acquire the US-based dermatological pharmaceuticals company Stiefel Laboratories for US$3.6 billion (£2.5 billion). On 16 November that year the US Food and Drug Administration (FDA) announced that a vaccine for 2009 H1N1 influenza protection (manufactured by GSK's ID Biomedical Corp. subsidiary) would join the four vaccines approved on 15 September. Also in November 2009 GSK formed a joint venture with Pfizer to create ViiV Healthcare. Viiv Healthcare received all of Pfizer and GSK's HIV assets. ViiV Healthcare is 85 percent owned by GSK and 15 percent by Pfizer.
In June 2010 the company acquired Laboratorios Phoenix, an Argentine pharmaceutical company focused on the development, marketing and sale of branded generic products, for a cash consideration of approximately $253m. In December that year GSK announced its acquisition of the UK-based sports nutrition company Maxinutrition for £162 million (US$256 million). In February 2011 GSK announced plans to sell some of its "non-core" brands. In December that year the company agreed to a $660 million deal with Prestige Brands Holdings, taking over 17 brands with sales of $210 million, including BC Powder, Beano, Ecotrin, Fiber Choice, Goody's Powder, Sominex and Tagamet.
In March 2012 the company announced that it planned to invest around £500 million in manufacturing facilities in Ulverston, northern England, designating it as the site for a previously announced biotech plant. GSK made a US$2.6 billion (£1.6 billion) offer for the United States-based biopharmaceutical company Human Genome Sciences in April 2012. In 2013 the company said it would seek marketing approval for the world's first malaria vaccine in 2014, after trial data showed the vaccine had significant effects in cutting cases of the disease in African children.
On March 27, 2014, GlaxoSmithKline announced that Alli, a popular over-the-counter weight loss drug, was being recalled in the United States and Puerto Rico because of possible tampering following customer complaints in seven states. "A range of tablets and capsules of various shapes and colors were reported to be found inside bottles," the company said. "Additionally, some bottles inside the outer carton were missing labels and had tamper-evident seals that were not authentic."
GSK has been active, with the World Health Organization (WHO), in the Global Alliance to Eliminate Lymphatic Filariasis (GAELF). Around 120 million people globally are believed to be infected with lymphatic filariasis. The company endorsed the London Declaration on Neglected Tropical Diseases, a collaborative disease eradication programme launched on 30 January 2012 in London. Under this agreement GSK will donate 400 million albendazole tablets to the WHO each year to fight soil-transmitted helminthiasis. It will continue to provide 600 million albendazole tablets every year for lymphatic filariasis until the disease is eradicated.
The company received a perfect score of 100 percent from the Human Rights Campaign, an LGBT-rights advocacy group, in its 2008 Corporate Equality Index, an annual report card of corporate America's treatment of lesbian, gay, bisexual and transgender employees, customers and investors.
2012 fraud settlement
On 2 July 2012 GSK pleaded guilty to criminal charges and agreed to a $3 billion settlement of the largest health-care fraud case in the United States and the largest payment by a drug company. The settlement was related to the company's illegal promotion of prescription drugs, its failure to report safety data, bribing doctors and promoting medicines for uses for which they were not licensed. The drugs involved were Paxil (which reached sales of $11.6 billion during the period covered by the settlement)), Wellbutrin ($5.9 billion), Avandia ($10.4 billion), Advair, Lamictal and Zofran for off-label, non-covered uses. Those drugs, as well as Imitrex, Lotronex, Flovent and Valtrex, were involved in a kickback scheme. The government investigation was launched largely on the basis of information provided by four whistleblowers who filed two qui tam (whistleblower) lawsuits against the company under the False Claims Act. GSK settled the whistleblowers' lawsuits for $1.017 billion out of the $3 billion settlement, the largest civil False Claims Act settlement to date.
On 14 June 2007 a meta-analysis by Steve Nissen, Chair of the Division of Cardiovascular Medicine at the Cleveland Clinic, published in the New England Journal of Medicine, showed an increased odds ratio of myocardial infarction in patients taking rosiglitazone, marketed as Avandia. The New York Times published an article detailing Nissen's conversation with pharmaceutical executives; the conversations were recorded, unbeknownst to the GSK executives. A Congressional investigation was subsequently initiated to determine what information was known at the time of the drug's approval, as well as post approval, and whether GSK had wilfully suppressed such information. In February 2010 GSK tried to suppress publication of a critical article concerning rosiglitazone. In July a US Finance Committee Letter asserted GSK had "to publish studies in a timely manner that found problems with Avandia." In November 2007 a United States congressional committee released a report describing intimidation of Dr. John Buse (University of North Carolina at Chapel Hill) by GSK over his concerns about the cardiovascular risks associated with rosiglitazone.
Paroxetine (Paxil, Seroxat)
Paroxetine is an SSRI anti-depressant released by GSK in 1992 and sold as Paxil, Seroxat, Aropax, Brisdelle, Pexeva and Sereupin. The company's promotion of the drug for children was one of the grounds for the 2012 fraud case in the United States. For 10 years the drug was marketed as "not habit forming," which numerous experts and at least one court found to be incorrect. Approximately 5,000 US citizens have sued GSK after using paroxetine; lawsuits have also been filed in the UK. The lawsuits allege that the drug has serious side effects, which GSK downplayed in patient information.
In early 2004 GSK agreed to settle charges of consumer fraud for $2.5 million; the drug had $2.7 billion in yearly sales at that time. The legal discovery process also uncovered evidence of deliberate, systematic suppression of unfavorable Paxil research results. One of GSK's internal documents said, "It would be commercially unacceptable to include a statement that efficacy [in children] had not been demonstrated, as this would undermine the profile of paroxetine." In June 2004 FDA published a violation letter to GSK in response to a "false or misleading" television commercial for Paxil CR, writing: "This ad is concerning from a public health perspective because it broadens the use of Paxil CR [beyond the conditions it was approved for] while also minimizing the serious risks associated with the drug." GSK said that the commercial had been reviewed by the FDA, and that it would not run again.
In March 2008 the Medicines and Healthcare Products Regulatory Agency concluded that GSK should have warned of the possible ill effects of taking paroxetine a lot sooner. GSK could not be prosecuted under the old legislation. As of 2008 GSK's prescribing information acknowledges that "serious discontinuation symptoms" may occur. Court documents released in October 2008 indicated that GSK "and/or researchers may have suppressed or obscured suicide risk data during clinical trials" of paroxetine. The suppression of the unfavorable research findings and the legal discovery process that uncovered it is the subject of Side Effects (2008), a book by Alison Bass.
GSK pleaded guilty in March 2007 in an Auckland District Court to 15 charges relating to misleading conduct brought under the Fair Trading Act by New Zealand's Commerce Commission. The charges related to Ribena, the blackcurrant fruit drink, which the company had led consumers to believe contained high levels of vitamin C. As part of a school science project, Anna Devathasan and Jenny Suo, 14-year-old schoolgirls from Pakuranga College in Auckland, discovered that it contained very little vitamin C. Approaches to the company did not resolve the issue, and after the matter was publicised on a consumer affairs show it came to the attention of the Commerce Commission. The commission's testing found that ready-to-drink Ribena contained no detectable vitamin C and the company was fined $217,000. GSK maintains that it did not intend to mislead consumers and that the advertising claims were based on test procedures that have since been changed.
SB Pharmco Puerto Rico
In October 2010 the US Department of Justice announced that GSK would pay $150 million in criminal charges, at that time the largest such payment ever by a manufacturer of adulterated drugs, and $600 million in civil penalties. GSK agreed to pay the settlement in response to criminal and civil complaints stemming from production of improperly made and adulterated drugs at its subsidiary, SB Pharmco Puerto Rico Inc., in Puerto Rico, which at the time produced $5.5 billion of products each year. According to the report the case began in 2002 when GSK sent a team of quality experts to fix problems cited by an FDA warning letter a month earlier. The quality control at the plant was found to be "a mess: the water system was contaminated; the air system allowed for cross-contamination between products; the warehouse was so overcrowded that rented vans were used for storage; the plant could not ensure the sterility of intravenous drugs for cancer; and pills of differing strengths were sometimes mixed in the same bottles." The lead inspector complained to senior managers and recommended recalls of defective products, but they were not authorised, and she was made redundant in 2003. She eventually notified the FDA and sued. In 2005 federal marshals seized $2 billion worth of products, the largest such seizure in history. Unable to fix the plant, GSK closed it in 2009.
- In 2003 GSK signed a corporate integrity agreement and paid $88 million in a civil fine for overcharging Medicaid for the anti-depressant Paxil, and nasal-allergy spray Flonase. Also in 2003 it was reported that GSK owed the Internal Revenue Service (IRS) $7.8 billion in backdated taxes and interest, the highest in IRS history.
- In 2004 Italian police asked to proceed with charges for bribery against almost 5000 people, including 273 GSK employees. The Guardia di Finanza said GSK and its predecessor had spent £152m on "sweeteners," such as cameras, computers, holidays and cash, for physicians, pharmacists and others. Prescribing drugs in exchange for gifts or money is called comparaggio in Italy and is illegal. An identical controversy erupted in Germany in 2002.
- In March 2006 California Attorney General Bill Lockyer announced that GSK would pay $14 million to "resolve allegations that state-government programs paid inflated prices for the firm's anti-depressant drug Paxil because GSK engaged in patent fraud, anti-trust violations and frivolous litigation to maintain a monopoly and block generic versions from entering the market."
- On 12 September 2006 GSK settled the largest tax dispute in IRS history, agreeing to pay $3.1 billion. At issue in the case were Zantac and the other Glaxo Group heritage products sold in 1989–2005. The case was about an area of taxation dealing with intracompany "transfer pricing"—determining the share of profit attributable to the US subsidiaries of GSK and subject to tax by the IRS. Taxes for large multi-divisional companies are paid to revenue authorities based on the profits reported in particular tax jurisdictions, so how profits were allocated among various legacy Glaxo divisions based on the functions they performed was central to the dispute in this case.
- In July 2013 Chinese authorities announced that since 2007 more than 700 travel agencies and consulting firms had been used by GSK to funnel nearly three billion yuan (HK$3.8 billion) in kickbacks to GSK managers, doctors, hospitals and others who prescribed their drugs. GSK issued a statement expressing concern and disappointment, and said it would co-operate with the investigation. In July the company admitted that some of its senior Chinese executives broke the law; Chinese authorities arrested four executives as part of a four-month investigation into claims that doctors were bribed with cash and sexual favours in return for prescribing GSK's drugs.
- According to The Guardian, GSK is a major donor to the State Policy Network, an American network of free-market-oriented think tanks.
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- Official website
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