GlaxoSmithKline

GlaxoSmithKline

Type	Public (LSE: GSK NYSE: GSK)
Industry	Pharmaceutical
Founded	2000, by merger of Glaxo Wellcome and SmithKline Beecham
Headquarters	London, United Kingdom
Key people	Chris Gent, Chairman Andrew Witty, Chief Executive Julian Heslop, Chief Financial Officer Dr. Moncef Slaoui, Chairman of Research and Development
Products	Pharmaceuticals
Revenue	£28.36 billion(2009)[1]
Operating income	£9.25 billion (2009)[1]
Net income	£5.66 billion (2009)[1]
Employees	99,000 (2009)[2]
Website	www.gsk.com

GlaxoSmithKline plc (GSK) (LSE: GSK NYSE: GSK) is a global pharmaceutical, biologics, vaccines and consumer healthcare company headquartered in London, United Kingdom. It is the world's third largest pharmaceutical company measured by revenues (after Johnson & Johnson and Pfizer).^[3] It 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 products, nutritional drinks and over-the-counter medicines, including Sensodyne, Horlicks and Gaviscon.^[4]

Its primary listing is on the London Stock Exchange and it is a constituent of the FTSE 100 Index. It has a secondary listing on the New York Stock Exchange.

History

Former GlaxoSmithKline building in Hamburg, Germany

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 (from the merger of Beecham plc, and SmithKlineBeckman Corporation).

GlaxoWellcome

In 1880, Burroughs Wellcome & Company was founded in London by American pharmacists Henry Wellcome and Silas Burroughs.^[5] The Wellcome Tropical Research Laboratories opened in 1902.^[5] In 1959 the Wellcome Company bought Cooper, McDougall & Robertson Inc. to become more active in animal health.^[5] 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.^[5] Originally Glaxo was a baby food manufacturer processing local milk into a baby food by the same name: the product was sold in the 1930s under the slogan "Glaxo builds bonny babies". 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.^[5] Glaxo Laboratories bought two companies called Joseph Nathan and Allen & Hanburys in 1947 and 1958 respectively.^[5] After the Company bought Meyer Laboratories in 1978,^[5] 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.^[5] In the same year, GlaxoWellcome opened its Medicine Research Centre in Stevenage.^[5] Three years later GlaxoWellcome bought Polfa Poznan Company in Poland.^[5]

SmithKline Beecham

In 1843, Thomas Beecham launched his Beecham's Pills laxative in England giving birth to the Beecham Group.^[5]
Beechams opened its first factory in St Helens, Lancashire, England for rapid production of medicines in 1859. By the 1960s it was extensively involved in pharmaceuticals.

The GSK Headquarters in Brentford

In 1830, John K. Smith opened its first pharmacy in Philadelphia.^[5] In 1865 Mahlon Kline joined the business which, 10 years later, became Smith, Kline & Co.^[5] Subsequently, in 1891, it merged with French, Richard and Company.^[5] 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 to order to focus on vaccines.^[5] 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.^[5] The Company merged with Beckman Inc. later that year and then changed its name to SmithKline Beckman.^[5]

In 1988, SmithKline Beckman bought its biggest competitor, International Clinical Laboratories,^[5] and in 1989 merged with Beecham to form SmithKline Beecham plc.^[5] The headquarters of the Company were then 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.^[5]

In 2000, Glaxo Wellcome and SmithKline Beecham merged to form GlaxoSmithKline.^[6]

Recent developments

In 2001 it completed its purchase of New Jersey-based Block Drug.^[7]

On November 16, 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 September 15.^[8]

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. ^[9]

Operations

As the second largest pharmaceutical company in the world, based on net income, the company had sales of £22.7 billion and made a profit of £7.8 billion in 2007.^[10] It employs over 90,000 people worldwide, according to their website(2009)^[11], including over 40,000 in sales and marketing. Its global headquarters are GSK House in Brentford, London, United Kingdom, with its United States headquarters based in Research Triangle Park (RTP) in North Carolina^[12] and its consumer products division based in the Pittsburgh suburb of Moon Township, Pennsylvania. The research and development division has major headquarters in South East England, Philadelphia and Research Triangle Park (RTP) in North Carolina.

The company's stock is listed on the London stock exchange and ADRs are listed on the NYSE. The single largest market is in the United States (approximately 45% of revenue), although the company has a presence in almost 70 countries.

Products

The company's products include:

Initiatives to eradicate disease

Glaxo SmithKline has been active in a global alliance to eliminate lymphatic filariasis.^[13] 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 Glaxo has been short-listed for awards such as the Worldaware Business Award for its work to eliminate malaria in Kenya.^[14]

GlaxoSmithKline recently donated money to the British flood appeal, and was ranked first on the 2006 UK Corporate Citizenship Index for donations.^[15]

Global locations

Factory in Ulverston

An entrance to the Ulverston plant

• Global Pharmaceutical Operations headquarters in Brentford, United Kingdom with US operations based in Research Triangle Park, North Carolina.
• Consumer Products headquarters in Moon Township, Pennsylvania suburb of Pittsburgh
• Major R&D sites in Greenford, Stevenage, Harlow, Ware and Beckenham in the United Kingdom; Verona, Italy; Zagreb, Croatia; Evreux and Les Ulis in France; Research Triangle Park, North Carolina; Laval, Quebec and Upper Merion and Collegeville, Pennsylvania
• Major centre for biopharmaceutical products in Belgium (Wavre and Rixensart), Germany (Dresden), Canada (Quebec, QC) and USA (Marietta PA & Hamilton)
• New R&D centres in Thane, India and Nashik, India
• R&D centres in Shanghai, China and Boston, USA
• Major manufacturing sites for prescription products in Irvine, Ware, Montrose, Barnard Castle, Crawley, Worthing and Ulverston in the United Kingdom; Evreux, France; Bristol, King of Prussia and Zebulon in the United States; Cidra, Puerto Rico; Jurong, Singapore; Cork, Ireland; Poznań, Poland; Parma, Italy; Brasov, Romania; Boronia, Australia.
• Major manufacturing sites for consumer products in Maidenhead, United Kingdom; Dungarvan, Ireland; Mississauga, Ontario; Aiken, South Carolina; Clifton, New Jersey; and St. Louis, Missouri, and Kenya
• GSK has a presence in 99 cities across 39 countries

Corporate governance

Current members of the board of directors of GlaxoSmithKline are:

• Sir Christopher Gent (Non-Executive Chairman);
• 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 Ph.D. (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);
• Deirdre P. Connelly (President, North American Pharmaceuticals);
• James Murdoch (Non-Executive Director).

On October 8, 2007 it was announced that Dr Garnier would be succeeded as Chief Executive by Mr Andrew Witty. Mr Witty, 44, has taken up the position in May 2008 and joined the Board. Although job losses have been widespread in the company, Mr Witty himself has seen his pay increase by 76% over the last year.

Diversity

GlaxoSmithKline was named one of the 100 Best Companies for Working Mothers in 2007 by Working Mother magazine^[16] 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.

Controversy

• Paroxetine (Seroxat, Paxil) is an SSRI antidepressant released in 1992 by GlaxoSmithKline. In March 2004 the FDA ordered a black box warning placed on SSRI and other antidepressants, 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 January 29, 2007, the BBC in the UK broadcast a fourth documentary in its 'Panorama' series about Seroxat.^[17] 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 ^[18][19][20] But many recent analyses prove the link, even with older patients^[21]

• In November 2007, a United States Congressional committee released a report^[22] describing intimidation of Dr John Buse (University of North Carolina at Chapel Hill^[23][24]) by GlaxoSmithKline over his concerns about the cardiovascular risks associated with the company's antidiabetes drug Rosiglitazone (Avandia).^[25]

• 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, antitrust violations and frivolous litigation to maintain a monopoly and block generic versions from entering the market."^[26]

• 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).^[27] HLS has been the subject since 1999 of an international campaign by Stop Huntingdon Animal Cruelty (SHAC) and the Animal Liberation Front (ALF), ever since footage shot covertly by People for the Ethical Treatment of Animals (PETA), which was shown on British television, showed staff punching, kicking, screaming and laughing at the animals in their care. 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.^[28] 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.^[29]

• In December 2003, Allen Roses, the then worldwide vice-president of genetics at GlaxoSmithKline, admitted 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." ^[30]

Legal

In 2003 GSK signed a corporate integrity agreement and paid $88 million in a civil fine for overcharging Medicaid for the antidepressant 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 August 26, 2004, New York State Attorney General Eliot Spitzer's office announced it had settled legal action against GlaxoSmithKline. 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 August 3, 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 February 2, 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 behavior." Glaxo 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.^[31]

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 from 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.^[32]

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.^[33]

Paroxetine

For the first 10 years of paroxetine's availability, GlaxoSmithKline's marketing of the drug stated falsely that it was "not habit forming".^[34] In 2001, the BBC reported the World Health Organization had found paroxetine to have the hardest withdrawal problems of any antidepressant.^[35] 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.^[36] 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 far too long."^[36]

On 22 December 2006, a US court decided in Hoorman, et al. v. SmithKline Beecham Corp that individuals who purchased Paxil(R) or Paxil CR(TM) (paroxetine) for a minor child may be eligible for benefits under a $63.8 million Proposed Settlement.^[37] The lawsuit stemmed from a consumer advocate protest against Paroxetine manufacturer GSK. Since the FDA approved paroxetine in 1992, approximately 5,000 U.S. citizens – and thousands more worldwide – have sued GSK. Most of these people feel they were not sufficiently warned in advance of the drug's side effects and addictive properties.

According to the Paxil Protest website,^[38] 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^[39] discovered that an archive of Paxil Protest site^[40] was still available on the internet via Archive.org)

In January 2007, according to the Seroxat Secrets website,^[41] 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.^[42]

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.^[43] GSK could not be prosecuted under the old legislation.

As of 2008, GlaxoSmithKline's prescribing information acknowledges that "serious discontinuation symptoms" may occur.^[44]

Ribena

On March 27, 2007, GSK pleaded guilty in an Auckland District Court to 15 charges relating to misleading conduct brought against them under the Fair Trading Act by New Zealand's Commerce Commission. The charges related to a 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, two 14-year-old school girls (Anna Devathasan and Jenny Suo) from Pakuranga College in Auckland (New Zealand) discovered that ready-to-drink juice sold in 100ml containers contained very little vitamin C. Approaches by the two teens to the company didn't resolve the issue but after the matter was publicised on a national consumer affairs television show (Fair Go) the matter came to the attention of the Commerce Commission (a government funded 'consumer watch-dog'). 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 a 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 per cent 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.^[45]

Avandia

On June 14, 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 demonstrated 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 willfully suppressed such information. On February 2010 GlaxoSmithKline tried to suppress publishing of a critical article^[46] concerning rosiglitazone.^[47] In July a US Finance Committee Letter accessed GSK of failing "to publish studies in a timely manner that found problems with Avandia".^[48]

Announced policy change

In February 2009, GSK head Andrew Witty announced that the company will 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.^[49]. The decision has received mixed reactions from medical charities^[50][51]. 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^[52].

See also

• Recherche et Industrie Thérapeutiques (R.I.T.)
• Quest Diagnostics
• Pfizer
• Wyeth

References

External links

• Official website
• Financial Times Quote, profile & news
• London Stock Exchange Quote, regulatory filings & news
• New York Stock Exchange Quote, profile, regulatory filings & news
• GlaxoSmithKline will overtake Pfizer to become world's largest pharmaceutical company by 2012 URCH Publishing (Press Release)

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