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GlaxoSmithKline plc
Company typePublic limited company
LSEGSK
NYSEGSK
IndustryPharmaceutical, biotechnology
PredecessorGlaxo Wellcome
SmithKline Beecham
Founded2000 (London)
HeadquartersLondon, United Kingdom
Key people
Chris Gent (Chairman)
Andrew Witty (Chief Executive)
ProductsPharmaceuticals, vaccines, oral healthcare products, nutritional products, over-the-counter medicines
Revenue£27.387 billion (2011)[1]
£8.397 billion (2011)[1]
£5.458 billion (2011)[1]
Number of employees
96,500 (2010)[2]
Websitewww.gsk.com

GlaxoSmithKline plc (GSK) (LSEGSK, NYSEGSK) is a British multinational pharmaceutical, biologics, vaccines, and consumer healthcare company headquartered in London, United Kingdom. It is the world's fourth-largest pharmaceutical company measured by 2009 prescription drug sales (after Pfizer, Novartis and Sanofi).[3]

GSK has a portfolio of products for major disease areas including asthma, cancer, virus control, infections, mental health, diabetes, and digestive conditions.[4] It also has a large consumer healthcare division which produces and markets oral healthcare and nutritional products and over-the-counter medicines including Sensodyne, Boost, Horlicks, and Gaviscon.[4][5]

GSK has a primary listing on the London Stock Exchange and is a constituent of the FTSE 100 Index. In December 2011 it had a market capitalisation of £73.8 billion, the fifth-largest company listed on the London Stock Exchange.[6] It has a secondary listing on the New York Stock Exchange.

History

GSK was formed in 2000 by the merger of GlaxoWellcome 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).

GlaxoWellcome

In 1880, Burroughs Wellcome & Company was founded in London by the American pharmacists Henry Wellcome and Silas Burroughs.[7] The Wellcome Tropical Research Laboratories opened in 1902.[7] In 1959 the Wellcome Company bought Cooper, McDougall & Robertson Inc. to become more active in animal health.[7] 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.[7] Originally Glaxo was 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 derelict dairy factory (factory for drying and processing cows' milk into powder) with the original Glaxo logo clearly visible, but nothing to indicate that this was the start of a major multinational company.

Glaxo became Glaxo Laboratories, and opened new units in London in 1935.[7] Glaxo Laboratories bought two companies, Joseph Nathan and Allen & Hanburys, in 1947 and 1958 respectively.[7] After the company bought Meyer Laboratories in 1978,[7] 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 GlaxoWellcome.[7] In the same year, GlaxoWellcome opened its Medicine Research Centre in Stevenage.[7] Three years later GlaxoWellcome bought Polfa Poznan Company in Poland.[7]

SmithKline Beecham

Beecham's Clock Tower, constructed in 1877 as part of the Beecham factory in St Helens

In 1843, Thomas Beecham launched his Beecham's Pills laxative in England giving birth to the Beecham Group.[7]
Beechams 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.[7] In 1865 Mahlon Kline joined the business which 10 years later became Smith, Kline & Co.[7] Subsequently, in 1891, it merged with French, Richard and Company.[7] It changed its name to Smith Kline & French Laboratories as it focused more on research in 1929. 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 in order to focus on vaccines.[7] 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.[7] The company merged with Beckman Inc. later that year and changed its name to SmithKline Beckman.[7]

In 1988, SmithKline Beckman bought its biggest competitor, International Clinical Laboratories,[7] and in 1989 merged with Beecham to form SmithKline Beecham plc.[7] The headquarters of the company was moved to England. To expand research & development in the US, SmithKline Beecham bought a new research center in 1995. Another new research centre at New Frontiers Science Park in Harlow was opened in 1997.[7]

2000 to present

The current world headquarters of GlaxoSmithKline in Brentford, London

In 2000, Glaxo Wellcome and SmithKline Beecham merged to form GlaxoSmithKline.[8]

In 2001 GSK completed the acquisition of New Jersey-based Block Drug for US$1.24 billion.[9]

In February 2009, GSK head Andrew Witty announced that the company would cut drug prices by 25% 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 invest 20% of profits from the least developed countries in medical infrastructure for those countries.[10] The decision has received mixed reactions from medical charities.[11][12] Médecins Sans Frontières welcomed the decision, encouraging other companies to follow suit, but criticised GSK for failing to include HIV patents in their patent pool, and for not including middle-income countries in the initiative.[13]

On 16 November 2009, 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.[14] 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.[15] In December 2010, GSK announced its acquisition of the sports nutrition company Maxinutrition.[16]

Since 2008, GSK has been running clinical trails of a new malaria vaccine. The vaccine, which is known as RTS,S, has been in development for more than 25 years, at first for the American military and 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.[17]

In November 2009, GlaxoSmithKline formed a joint venture with Pfizer to create ViiV Healthcare. Viiv Healthcare received all of Pfizer and GlaxoSmithKline's HIV assets.[18] ViiV Healthcare is 85% owned by GlaxoSmithKline and 15% owned by Pfizer.

In February 2011, GSK announced plans to sell some "non-core" brands. In December 2011, the company agreed to a $660 million deal with Prestige Brands Holdings, which will take over 17 brands with sales of $210 million, including BC Powder, Beano, Ecotrin, Fiber Choice, Goody's Powder, Sominex, and Tagamet.[19] In March 2012 GSK announced plans to invest around £500 million in manufacturing facilities in Ulverston, northern England, designating it as the site for a previously announced biotech plant.[20]

Operations

The GlaxoSmithKline Biologicals facility in Dresden, Germany

GSK employs 97,000 people worldwide[21] of whom about 12,500 work in research and development. Its global headquarters are GSK House in Brentford, United Kingdom, with its United States headquarters based in Research Triangle Park (RTP) in North Carolina[22] and its consumer products division based in the Pittsburgh suburb of Moon Township, Pennsylvania. The research and development division has major facilities in South East England, Philadelphia and Research Triangle Park (RTP) in North Carolina. GSK has a presence in 99 cities across 39 countries.

GSK's single largest market is in the United States, which generates approximately 45% of its revenues, although the company sells its products in around 70 countries.

Major facilities

The headquarters of GlaxoSmithKline Japan in Tokyo

Major GSK facilities include:

Products

GSK's current products include:

Corporate affairs

Stockmarket listings

GSK's stock is listed on the London stock exchange and ADRs are listed on the NYSE.

Senior management

Andrew Witty, who has been the Chief Executive Officer of GlaxoSmithKline since May 2008.

The current members of GSK's board of directors are:

  • Sir Christopher Gent (Non-Executive Chairman);
  • Sir Andrew Witty (Chief Executive Officer, Executive Director);
  • Dr Stephanie Burns (Non-Executive Director);
  • Lawrence Culp (Non-Executive Director);
  • Sir Crispin Davis (Non-Executive Director);
  • Julian Spenser Heslop (Chief Financial Officer, Executive Director);
  • Sir Deryck Maughan (Non-Executive Director);
  • Sir Ian Prosser (Senior Independent Non-Executive Director);
  • Dr Ronaldo Schmitz (Non-Executive Director);
  • Moncef Slaoui (Chairman, Executive Director, Research & Development);
  • Robert Wilson (Non-Executive Director);
  • Dr Daniel Podolsky (Non-Executive Director);
  • Tom De Swaan (Independent Non-Executive Director);
  • Marc Dunoyer (President, Pharmaceuticals Asia Pacific/Japan);
  • David Pulman PhD (President – Global Manufacturing and Supply);
  • John Clarke (President – Consumer Healthcare);
  • Emma Walmsley (President – Consumer Healthcare Europe);
  • Eddie Gray (President, Pharmaceuticals Europe);
  • Abbas Hussain (President – Emerging Markets);
  • Roberto C. Taboada (President and Managing Director of Philippine); and
  • Deirdre P. Connelly (President, North American Pharmaceuticals).

Corporate social responsibility

Disease eradication

GSK has been active in a global alliance to eliminate lymphatic filariasis.[23] Jean-Pierre (JP) Garnier, former CEO of GlaxoSmithKline has said, “The Egyptian data shows that we can now eliminate a disease that has plagued the world for centuries. We remain committed to donating as much albendazole as required to eliminate this disabling disease, but ultimate success will depend on continued long-term commitments by all partners across the globe.”

In addition GlaxoSmithKline has been short-listed for awards such as the Worldaware Business Award for its work to eliminate malaria in Kenya.[24]

GlaxoSmithKline recently donated money to the British flood appeal, and was ranked first on the 2006 UK Corporate Citizenship Index for donations.[25]

Diversity

GSK was named one of the 100 Best Companies for Working Mothers in 2007 by Working Mother magazine[26] and was recognised by the International Charter for its efforts. GSK also received a perfect score of 100 percent from the Human Rights Campaign Foundation's 2008 Corporate Equality Index, an annual report card of corporate America's treatment of gay, lesbian, bisexual, and transgender (GLBT) employees, customers and investors. GSK also supports employee diversity networks for groups such as ECN, PTPN, GLBT, AAA, etc.

Controversies

Avandia

On 14 June 2007, an article was published by Steve Nissen, Chair of the Division of Cardiovascular Medicine at the Cleveland Clinic in the New England Journal of Medicine. This meta-analysis showed an increased odds ratio of myocardial infarction in patients taking rosiglitazone marketed as Avandia. More recently, the New York Times published an article detailing Nissen's conversation with pharmaceutical executives. These conversations were recorded unbeknownst to the GSK executives but are legal in the State of Ohio as long as one participating party is aware. Currently, a Congressional investigation has been initiated to determine what information was known at the time of the approval of rosiglitazone as well as post approval and whether or not GSK wilfully suppressed such information. On February 2010, GlaxoSmithKline tried to suppress publishing of a critical article[27] concerning rosiglitazone.[28] In July, a US Finance Committee Letter asserted GSK had "to publish studies in a timely manner that found problems with Avandia".[29]

In November 2007, a United States congressional committee released a report[30] describing intimidation of Dr John Buse (University of North Carolina at Chapel Hill)[31][32] by GlaxoSmithKline over his concerns about the cardiovascular risks associated with the company's anti-diabetes drug rosiglitazone (Avandia).[33]

Paroxetine

Paroxetine (Seroxat, Paxil) is an SSRI anti-depressant released in 1992 by GlaxoSmithKline. In March 2004 the FDA ordered a black box warning placed on SSRI and other anti-depressants, warning of the risk for potential suicidal thinking in children and adolescents. Since the FDA approved paroxetine in 1992, approximately 5,000 U.S. citizens have sued GSK. On 29 January 2007, the BBC in the UK broadcast a fourth documentary in its 'Panorama' series about Seroxat.[34] There is as yet no proven link between SSRI's and actual suicide, and the addition of blackbox warning labels was said to be controversial[35][36][37]

For the first 10 years of paroxetine's availability, GlaxoSmithKline's marketing of the drug stated falsely that it was "not habit forming".[38] In 2001, the BBC reported the World Health Organization had found paroxetine to have the hardest withdrawal problems of any anti-depressant.[39] In 2002, the U.S. Food and Drug Administration published a new product warning about the drug, and the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) declared GSK guilty of misleading the public about paroxetine on US television.[40] The British Medical Journal quoted Charles Medawar, head of Social Audit:

This drug has been promoted for years as safe and easy to discontinue.... The fact that it can cause intolerable withdrawal symptoms of the kind that could lead to dependence is enormously important to patients, doctors, investors, and the company. GlaxoSmithKline has evaded the issue since it was granted a licence for paroxetine over 10 years ago, and the drug has become a blockbuster for them, generating about a tenth of their entire revenue. The company has been promoting paroxetine directly to consumers as 'non-habit forming' for a long time.[40]

On 22 December 2006, a US court decided in Hoorman, et al. v. SmithKline Beecham Corp that individuals who purchased Paxil or Paxil CR (paroxetine) for a minor child may be eligible for benefits under a $63.8 million Proposed Settlement.[41]

According to the Paxil Protest website,[42] hundreds more lawsuits have been filed against GSK. The original Paxil Protest website was removed from the internet in 2006. It is understood that the action to take down the site was undertaken as part of a confidentiality agreement or 'gagging order' which the owner of the site entered into as part of a settlement of his action against GlaxoSmithKline. (However, in March 2007, the website Seroxat Secrets[43] discovered that an archive of Paxil Protest site[44] was still available on the internet via Archive.org)

In January 2007, according to the Seroxat Secrets website,[45] the national group litigation in the United Kingdom, on behalf of several hundred people who allege withdrawal reactions through their use of the drug Seroxat, against GlaxoSmithKline plc, moved a step closer to the High Court in London, with the confirmation that Public Funding had been reinstated following a decision by the Public Interest Appeal Panel. The issue at the heart of this particular action claims Seroxat has a propensity to cause a withdrawal reaction. Hugh James Solicitors have confirmed this news.[46]

In March 2008 the Medicines and Healthcare Products Regulatory Agency concluded that GSK should have warned of the possible ill effects of taking Seroxat a lot sooner.[47] GSK could not be prosecuted under the old legislation.

As of 2008, GlaxoSmithKline's prescribing information acknowledges that "serious discontinuation symptoms" may occur.[48]

Ribena

On 27 March 2007, GSK pleaded guilty 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 the popular blackcurrant fruit drink Ribena, 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 ready-to-drink juice sold in 100ml containers contained very little vitamin C. Approaches by the two teens to the company did not resolve the issue, and after the matter was publicised on national consumer affairs television show Fair Go it came to the attention of the Commerce Commission. The commission's testing found that ready-to-drink Ribena contained no detectable vitamin C.

The company was fined $217,000 for the 15 charges. The number of charges was reduced from 88 and covered the period from March 2002 to March 2006. GSK maintains that it did not intend to mislead consumers and that the advertising claims were based on testing procedures that have since been changed. It was ordered to run an advertising campaign to provide the facts after it admitted misleading the public about the vitamin C component in its Ribena drink. Through its lawyer, Adam Ross, the company accepted Commerce Commission allegations that claims that ready-to-drink Ribena contained 7 mg of vitamin C per 100ml, or 44% of the recommended daily intake, were incorrect. The company also agreed television advertising claiming the blackcurrants in Ribena had four times the vitamin C of oranges, while literally true, were likely to mislead consumers about the relative levels of vitamin C in Ribena.[49]

Criminal charges of July 2012

On 2 July 2012, GSK pleaded guilty to criminal charges and agreed to a $3 billion settlement of the largest health-care fraud settlement in the U.S. and the largest payment by a drug company. The settlement is related to the company's illegal promotion of prescription drugs, its failure to report safety data,[50] bribing doctors, and promoting medicines for uses for which they were not licensed. The drugs involved were Paxil, Wellbutrin, Advair, Lamictal and Zofran for off-label, non-covered uses. Those and the drugs Imitrex, Lotronex, Flovent and Valtrex were involved in the kickback scheme.[51][52][53][further explanation needed]

Other

  • In March 2006, California Attorney General Bill Lockyer announced that "GlaxoSmithKline (GSK) will 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."[54]
  • At the AGM on 19 May 2003, GSK shareholders rejected a motion regarding a £22 million pay and benefits package for CEO, JP Garnier. This was the first time such a rebellion by shareholders against a major British company has occurred, but was regarded as a possible turning point against other so-called "fat cat" deals within executive pay structure.
  • The company and its shareholders have been targeted by animal rights activists because it is a customer of the controversial animal-testing company, Huntingdon Life Sciences (HLS).[55] On 7 September 2005, the ALF detonated a bomb containing two litres of fuel and four pounds of explosives on the doorstop of the Buckinghamshire home of Paul Blackburn, GSK's corporate controller, causing minor damage.
  • In November 2005, AIDS Healthcare Foundation accused the company of boosting its short-term monopoly profit by not increasing production of the anti-AIDS drug AZT despite a surge in demand, hence creating a shortage that affected many AIDS patients in Africa. GSK announced that it had halted clinical trials of the CCR5 entry inhibitor, aplaviroc (GW873140), in HIV-infected, treatment-naive patients because of concerns about severe hepatotoxicity.[56] In June 2006 GSK said it was further cutting, by about 30%, the not-for-profit prices it charges for some of these medicines in the world's poorest countries.[57]
  • In December 2003, Allen Roses, the then worldwide vice-president of genetics at GSK, noted that most prescription medicines do not work on most people who take them. "The vast majority of drugs – more than 90 per cent – only work in 30 or 50 per cent of the people," Dr Roses said. "I wouldn't say that most drugs don't work. I would say that most drugs work in 30 to 50 per cent of people."[58] Roses therefore advocates the use of pharmacogenomics to target just those patients who can benefit most from each medication.[58]
  • The U.S. Department of Justice announced in October 2010 that GSK would pay $150 million in criminal fines and $600 million in civil penalties. GSK agreed to pay the settlement in response to criminal and civil complaints against the company stemming from production of improperly made and adulterated drugs at their subsidiary SB Pharmco Puerto Rico Inc in Cidra, Puerto Rico.[59]
  • 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. Later that year GSK also ran afoul of the Internal Revenue Service (IRS) and was facing a demand for $7.8 billion in backdated taxes and interest, the highest in IRS history.
  • On 26 August 2004, New York State Attorney General Eliot Spitzer's office announced it had settled legal action against GSK. The settlement required GSK to post a registry which would include much more information about pretrial and clinical drug study results than what the U.S. Food and Drug Administration (FDA) and other pharmaceutical companies had thus far been willing to make public. Attorney General Spitzer hailed the settlement as "transformational in that it will provide doctors and patients access to the clinical testing data necessary to make informed judgments." This part of the settlement was the main objective of the New York AG and Rose Firestein, who worked in the office of the AG and initially argued the case should be undertaken. As for the monetary compensation, both sides finally agreed to $2.5 million. On 3 August 2004, shortly before the settlement, Senator Charles Grassley, a Republican senator from Iowa, sent a letter to GSK, stating that he was concerned that "some drug companies" may not have provided the FDA with all the information at their disposal. His letter was spurred by statements earlier in 2008 by Dr. Andrew Mosholder, an FDA official, who had told senators at a 2 February 2004 hearing that "GlaxoSmithKline, in his opinion, was attempting to 'sugar-coat' the adverse effects of Paxil on children by 'miscoding' suicidal ideations and/or suicidal behaviour." GSK officials never commented on whether there was any connection between Senator Grassley's letter and their decision to pursue a settlement with the New York State attorney general's lawsuit.[60]
  • On 12 September 2006 GSK settled the largest tax dispute in IRS history, agreeing to pay $3.1 billion. At issue in the case were Zantac and the other Glaxo Group heritage products sold in 1989–2005. The case was about an area of taxation dealing with intracompany "transfer pricing"—determining the share of profit attributable to the US subsidiaries of GSK and subject to tax by the IRS. Taxes for large multi-divisional companies are paid to revenue authorities based on the profits reported in particular tax jurisdictions, so how profits were allocated among various legacy Glaxo divisions based on the functions they performed was central to the dispute in this case.[61]
  • In February 2007, the Serious Fraud Office in the UK launched an investigation into allegations of GSK being involved in the discredited oil-for-food sanctions regime in Iraq. They are accused of paying bribes to Saddam Hussein's regime.[62]
  • On 3 January 2012, Argentina fined GSK 400,000 AR$ (US$92,000 at current exchange rates) for irregularities in documentation of a clinical trial for the Synflorix vaccine.[63]

See also

References

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  24. ^ The Shell Technology for Development Award Worldware Business Award
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  30. ^ "Committee staff report to the chairman and ranking member. Committee on Finance United States Senate. The intimidation of Dr John Buse and the diabetes drug Avandia. November 2007" (PDF). United States Congressional committee. Archived from the original (PDF) on 28 December 2007. Retrieved 22 January 2008.
  31. ^ "Speakers at Carolina". Retrieved 22 January 2008.
  32. ^ "About the American Diabetes Association". American Diabetes Association.
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  55. ^ BBC"Glaxo 'won't be driven out of UK'". 17 May 2006
  56. ^ Trials of Aplaviroc Halted in Treatment-Naive Patients Journal Watch 15 September 2005
  57. ^ Glaxo Will Cut AIDS Drug Prices For Poor Nations Chemical & Engineering News. 1 June 2006
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  61. ^ GSK settles largest tax dispute in history for $3.1bn. The Times (UK). 12 September 2006
  62. ^ David Leigh and Rob Evans (14 February 2007). "Firms accused of bribing Saddam to be investigated by fraud office". The Guardian. UK. Retrieved 18 April 2011.
  63. ^ "Argentina fines drug company over vaccine trial". CNN. 3 January 2012.