glaxosmithkline - freevax · pdf file · 2017-07-09brentford, london. established...

GSK's head office, Brentford, London TW8

Type Public limited company

Traded as LSE: GSK(http://www.londonstockexchange.com/exchange/searchengine/search.html?q=GSK)NYSE: GSK (https://www.nyse.com/quote/XNYS:GSK)FTSE 100 Component

Industry PharmaceuticalBiotechnologyConsumer goods

Predecessor Glaxo plcWellcome plcBeecham Group plcKline & FrenchBeckman CompaniesSmith plc

Founded December 2000

Headquarters Brentford, London, England, U.K.

Area served Worldwide

Key people Sir Philip Hampton(Chairman)Emma Walmsley(CEO)

Products Pharmaceuticals, vaccines, oralhealthcare, nutritional products, over-the-counter medicines

Revenue £27.889 billion (2016)[1]

Operatingincome

£2.598 billion (2016)[1]

Net income £1.062 billion (2016)[1]

Number ofemployees

99,300 (2016)[2]

Subsidiaries Stiefel Laboratories

Website www.gsk.com (http://www.gsk.com/)

GlaxoSmithKline

GlaxoSmithKlineFrom Wikipedia, the free encyclopedia

GlaxoSmithKline plc (GSK) is a British pharmaceutical company headquartered inBrentford, London. Established in 2000 by a merger of Glaxo Wellcome andSmithKline Beecham, GSK was the world's sixth largest pharmaceutical company as of2015, after Pfizer, Novartis, Merck, Hoffmann-La Roche and Sanofi.[n 1][3] EmmaWalmsley became CEO on 31 March 2017 and is the first female CEO of the company.

The company has a primary listing on the London Stock Exchange and is a constituentof the FTSE 100 Index. As of August 2016 it had a market capitalisation of £81 billion(around $107 billion), the fourth largest on the London Stock Exchange.[4] It has asecondary listing on the New York Stock Exchange.

GSK's drugs and vaccines earned £21.3 billion in 2013.[5] Its top-selling products thatyear were Advair, Avodart, Flovent, Augmentin, Lovaza and Lamictal. GSK's consumerproducts, which earned £5.2 billion in 2013, include Sensodyne and Aquafreshtoothpaste, the malted-milk drink Horlicks, Abreva for cold sores, Breathe Right nasalstrips, Nicoderm and Nicorette nicotine replacements, and Night Nurse, a coldremedy.[6] The company developed the first malaria vaccine, RTS,S, which it said in2014 it would make available for five percent above cost.[7] Legacy products developedat GSK include several listed in the World Health Organization Model List of EssentialMedicines, such as amoxicillin, mercaptopurine, pyrimethamine and zidovudine.

In 2012, GSK pleaded guilty to promotion of drugs for unapproved uses, failure toreport safety data, and kickbacks to physicians in the United States and agreed to pay a$3 billion (£1.9bn) settlement, the largest settlement in the country by a drugcompany.[8]

Contents1 History

1.1 Glaxo Wellcome1.2 SmithKline Beecham1.3 GlaxoSmithKline1.4 Venture arms

2 Research, products2.1 Pharmaceuticals2.2 Malaria vaccine2.3 Consumer healthcare2.4 Facilities2.5 Scientific recognition

3 Operations and acquisitions since 20013.1 2001–20103.2 2011–present

4 Philanthropy and social responsibility5 2012 criminal and civil settlement

5.1 Overview5.2 Rosiglitazone (Avandia)5.3 Paroxetine (Paxil/Seroxat)5.4 Bupropion (Wellbutrin)

6 Other controversies6.1 Antitrust case over griseofulvin6.2 Ribena6.3 SB Pharmco Puerto Rico6.4 China6.5 Market manipulation in the UK6.6 Miscellaneous

7 Diagram of acquisition history8 See also9 Notes10 References11 External links

History

GlaxoSmithKline - Wikipedia https://en.wikipedia.org/wiki/GlaxoSmithKline

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The historic Glaxo factory in Bunnythorpe, NewZealand, with the Glaxo Laboratories sign stillvisible

Beecham's Clock Tower, constructed 1877, part ofthe Beecham's factory, St Helens

Glaxo Wellcome

Glaxo was founded in the 1850s as a general trading company in Bunnythorpe, NewZealand, by a Londoner, Joseph Edward Nathan.[9] In 1904 it began producing dried-milkbaby food, first known as Defiance, then as Glaxo (from lacto), under the slogan "Glaxobuilds bonny babies."[10][11]:306[12] The Glaxo Laboratories sign is still visible (right) onwhat is now a car repair shop on the main street of Bunnythorpe. The company's firstpharmaceutical product, produced in 1920, was vitamin D.[11]:306

Glaxo Laboratories opened new units in London in 1935. The company bought twocompanies, Joseph Nathan and Allen & Hanburys in 1947 and 1958 respectively. TheScottish pharmacologist David Jack was working for Allen & Hanbury's when Glaxo tookit over; he went on to lead the company's R&D until 1987.[11]:306 After the companybought Meyer Laboratories in 1978, it began to play an important role in the US market.In 1983 the American arm, Glaxo Inc., moved to Research Triangle Park (USheadquarters/research) and Zebulon (US manufacturing) in North Carolina.[12]

Burroughs Wellcome & Company was founded in 1880 in London by the Americanpharmacists Henry Wellcome and Silas Burroughs. The Wellcome Tropical ResearchLaboratories opened in 1902. In the 1920s Burroughs Wellcome established research and manufacturing facilities in Tuckahoe, NewYork,[13]:18[14][15] which served as the US headquarters until the company moved to Research Triangle Park in North Carolina in 1971.[16]

The Nobel Prize winning scientists Gertrude B. Elion and George H. Hitchings worked there and invented drugs still used many years later,such as mercaptopurine.[17] In 1959 the Wellcome Company bought Cooper, McDougall & Robertson Inc to become more active in animalhealth.[12] Glaxo and Burroughs Wellcome merged in 1995 to form Glaxo Wellcome.[18][11]:309 Glaxo restructured its R&D operation thatyear, cutting 10,000 jobs worldwide, closing its R&D facility in Beckenham, Kent, and opening a Medicines Research Centre in Stevenage,Hertfordshire.[19][20][21] Also that year, Glaxo Wellcome acquired the California-based Affymax, a leader in the field of combinatorialchemistry.[22]

By 1999 Glaxo Wellcome had become the world's third-largest pharmaceutical company by revenues (behind Novartis and Merck), with aglobal market share of around 4 per cent.[23] Its products included Imigran (for the treatment of migraine), salbutamol (Ventolin) (for thetreatment of asthma), Zovirax (for the treatment of coldsores), and Retrovir and Epivir (for the treatment of AIDS). In 1999 the company wasthe world's largest manufacturer of drugs for the treatment of asthma and HIV/AIDS.[24] It employed 59,000 people, including 13,400 in theUK, had 76 operating companies and 50 manufacturing facilities worldwide, and seven of its products were among the world's top 50 best-selling pharmaceuticals. The company had R&D facilities in Hertfordshire, Kent and London, and manufacturing plants in Scotland and thenorth of England. It had R&D centres in the US and Japan, and production facilities in the US, Europe and the Far East.[25]

SmithKline Beecham

In 1843 Thomas Beecham launched his Beecham's Pills laxative in England, giving birthto the Beecham Group. In 1859 Beecham opened its first factory in St Helens, Lancashire.By the 1960s Beecham was extensively involved in pharmaceuticals.[12]

John K. Smith opened his first pharmacy in Philadelphia in 1830. In 1865 Mahlon Klinejoined the business, which 10 years later became Smith, Kline & Co. In 1891 it mergedwith French, Richard and Company, and in 1929 changed its name to Smith Kline &French Laboratories as it focused more on research. Years later it bought NordenLaboratories, a business doing research into animal health, and Recherche et IndustrieThérapeutiques in Belgium in 1963 to focus on vaccines. The company began to expandglobally, buying seven laboratories in Canada and the United States in 1969. In 1982 itbought Allergan, a manufacturer of eye and skincare products.[12]

SmithKline & French merged with Beckman Inc. in 1982 and changed its name toSmithKline Beckman. In 1988 it bought its biggest competitor, International ClinicalLaboratories, and in 1989 merged with Beecham to form SmithKline Beecham Plc. Theheadquarters moved from the United States to England. To expand R&D in the UnitedStates, the company bought a new research center in 1995; another opened in 1997 inEngland at New Frontiers Science Park, Harlow.[12]

GlaxoSmithKline

Glaxo Wellcome and SmithKline Beecham announced their intention to merge in January 2000. The merger was completed in December thatyear, forming GlaxoSmithKline (GSK).[26][27] The company's global headquarters are at GSK House, Brentford, London, officially opened in2002 by then-Prime Minister Tony Blair. The building was erected at a cost of £300 million and as of 2002 was home to 3,000 administrativestaff.[28]

Venture arms

SR One was established in 1985 by SmithKline Beecham to invest in new biotechnology companies and continued operating after GSK wasformed; by 2003 GSK had formed another subsidiary, GSK Ventures, to out-license or start new companies around drug candidates that it did


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not intend to develop further.[29] As of 2003, SR One tended to invest only if the company aligned with GSK's business.[29]

SR One was led by:

1985 to 1999: Peter Sears[30]

1999 to 2001: Brenda Gavin[31]

2001 to 2003: Barbara Dalton[31]

2004 to ? Maxine Gowen[32]

? to ?: Joyce Lonergan[33]

? to ?: Tamar Howson[33]

2008 to 2010: Russell Greig[34]

2010 to 2011: Christoph Westphal[35][33]

2011: Jens Eckstein[36]

Research, productsPharmaceuticals

GSK manufactures products for major disease areas such as asthma, cancer, infections, diabetes and mental health. Its biggest-selling in 2013were Advair, Avodart, Flovent, Augmentin, Lovaza, and Lamictal; its drugs and vaccines earned £21.3 billion that year. Other top-sellingproducts include its asthma/COPD inhalers Advair, Ventolin, and Flovent; its diphtheria/tetanus/pertussis vaccine Infanrix and its hepatitis Bvaccine; the epilepsy drug Lamictal, and the antibacterial Augmentin.[5]:220

Medicines historically discovered or developed at GSK and its legacy companies and now sold as generics include amoxicillin[37] andamoxicillin-clavulanate,[38] ticarcillin-clavulanate,[39] mupirocin,[40] and ceftazidime[41] for bacterial infections, zidovudine for HIVinfection, valacyclovir for herpes virus infections, albendazole for parasitic infections, sumatriptan for migraine, lamotrigine for epilepsy,bupropion and paroxetine for major depressive disorder, cimetidine and ranitidine for gastroesophageal reflux disorder, mercaptopurine[42]

and thioguanine[43] for the treatment of leukemia, allopurinol for gout,[44] pyrimethamine for malaria,[45] and the antibacterialtrimethoprim.[43]

Among these, albendazole, amoxicillin, amoxicillin-clavulanate, allopurinol, mercaptopurine, mupriocin, pyrimethamine, ranitidine,thioguanine, trimethoprim and zidovudine are listed on the World Health Organization's list of essential medications.[46]

Malaria vaccine

In 2014 GSK applied for regulatory approval for the first malaria vaccine.[47] Malaria is responsible for over 650,000 deaths annually, mainlyin Africa.[48] Known as RTS,S, the vaccine was developed as a joint project with the PATH vaccines initiative and the Bill and Melinda GatesFoundation. The company has committed to making the vaccine available in developing countries for five percent above the cost ofproduction.[7]

As of 2013 RTS,S, which uses GSK's proprietary AS01 adjuvant, was being examined in a Phase 3 trial in eight African countries. PATHreported that "[i]n the 12-month period following vaccination, RTS,S conferred approximately 50% protection from clinical Plasmodiumfalciparum disease in children aged 5-17 months, and approximately 30% protection in children aged 6-12 weeks when administered inconjunction with Expanded Program for Immunization (EPI) vaccines."[49] In 2014 Glaxo said it had spent more than $350 million andexpected to spend an additional $260 million before seeking regulatory approval.[50][51] A second generation malaria vaccine is beingevaluated in Phase 2 clinical trials.[52]

Consumer healthcare

GSK's consumer healthcare division, which earned £5.2 billion in 2013, sells oral healthcare, including Aquafresh, Maclean's and Sensodynetoothpastes; and drinks such as Horlicks, Boost, a chocolate-flavoured malt drink sold in India, and formerly Lucozade and Ribena, sold in2013 to Suntory for £1.35bn.[53] Other products include Abreva to treat cold sores; Night Nurse, a cold remedy; Breathe Right nasal strips;and Nicoderm and Nicorette nicotine replacements.[54] In March 2014 it recalled Alli, an over-the-counter weight-loss drug, in the UnitedStates and Puerto Rico because of possible tampering, following customer complaints.[55]

Facilities

As of 2013 GSK had offices in over 115 countries and employed over 99,000 people, 12,500 in R&D. The company's single largest market isthe United States. Its US headquarters are in The Navy Yard, Philadelphia, and Research Triangle Park, North Carolina; its consumer-products division is in Moon Township, Pennsylvania.[5]:7[56] Company facilities include:

R&D sites: England (Stevenage, Stockley Park, Ware), the US (Research Triangle Park, North Carolina, and Collegeville,Pennsylvania), Canada, China, Croatia, France and India. GSK is also planning to open a R&D centre in partnership with McLarenTechnology Group at the McLaren Technology Campus.Centres for biopharmaceutical products: the US (Marietta, Pennsylvania, and Hamilton, Montana), Belgium, Canada, Germany andHungary.Manufacturing sites for prescription products: (Scotland (Irvine and Montrose), England (Ware, Barnard Castle, Worthing and


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Andrew Witty, GSK's CEO since May 2008

Ulverston), Ireland (Cork), the US (Bristol, Tennessee; King of Prussia, Pennsylvania; Zebulon, North Carolina), as well as Australia,Belgium, France, Italy, Malaysia, Poland, Puerto Rico, Romania and Singapore.Manufacturing sites for consumer products: England (Maidenhead), Ireland (Dungarvan), the US (Aiken, South Carolina; Oak Hill,New York; St. Louis, Missouri), Brazil, Canada and Kenya.

Scientific recognition

Four GlaxoSmithKline scientists have been recognized by the Nobel Committee for their contributions to basic medical science and/ortherapeutics development.

Henry Dale, a former student of Paul Ehrlich, received the 1936 Nobel Prize in Medicine for his work on the chemical transmission ofneural impulses. Dale served as a pharmacologist and then as Director of the Wellcome Physiological Research Laboratories from 1904to 1914, and later served as Trustee and Chairman of the Board of the Wellcome Trust.[57]

John Vane of Wellcome Research Laboratories shared the 1982 Nobel Prize for Medicine for his work on prostaglandin biology and thediscovery of prostacyclin. Vane served as Group Research and Development Director for The Wellcome Foundation from 1973 to1985.[58]

Gertrude B. Elion and George Hitchings, both of the Wellcome Research Laboratories, shared the 1988 Nobel Prize in Medicine withSir James W. Black ""for their discoveries of important principles for drug treatment"." Elliot and Hitchings were responsible for thediscovery of a plethora of important drugs, including mercaptopurine[42] and thioguanine[43] for the treatment of leukemia, theimmunosuppressant azothioprine,[59] allopurinol for gout,[44] pyrimethamine for malaria,[45] the antibacterial trimethoprim,[43]

acyclovir for herpes virus infection,[60] and nelarabine for cancer treatment.[61]

Operations and acquisitions since 20012001–2010

GSK completed the acquisition of New Jersey-based Block Drug in 2001 for US$1.24billion.[62] In 2006 GSK acquired the US-based consumer healthcare company CNS Inc.,whose products included Breathe Right nasal strips and FiberChoice dietary supplements,for US$566 million in cash.[63]

Chris Gent, previously CEO of Vodafone, was appointed chairman of the board in2005.[64]

GSK opened its first R&D centre in China in 2007, in Shanghai, initially focused onneurodegenerative diseases.[65]

[Andrew Witty]] became the chief executive officer in 2008.[66] Witty joined Glaxo in1985 and had been president of GSK's Pharmaceuticals Europe since 2003.[67]

In 2009 GSK acquired Stiefel Laboratories, then the world's largest independent dermatology drug company, for US$3.6bn.[68] In Novemberthe FDA approved GSK's vaccine for 2009 H1N1 influenza protection, manufactured by the company's ID Biomedical Corp in Canada.[69]

Also in November 2009 GSK formed a joint venture with Pfizer to create ViiV Healthcare, which specializes in HIV research.[70] In 2010 thecompany acquired Laboratorios Phoenix, an Argentine pharmaceutical company, for US$253m,[71] and the UK-based sports nutritioncompany Maxinutrition for £162 million (US$256 million).[72]

2011–present

In 2011, in a $660-million deal, Prestige Brands Holdings took over 17 GSK brands with sales of $210 million, including BC Powder, Beano,Ecotrin, Fiber Choice, Goody's Powder, Sominex and Tagamet.[73] In 2012 the company announced that it would invest £500 million inmanufacturing facilities in Ulverston, northern England, designating it as the site for a previously announced biotech plant.[74] In May thatyear it acquired CellZome, a German biotech company, for US$98 million,[75] and in June worldwide rights to alitretinoin (Toctino), aneczema drug, for $302 million.[76] In 2013 GSK acquired Human Genome Sciences (HGS) for $3 billion; the companies had collaborated ondeveloping the lupus drug Belimumab (Benlysta), albiglutide for type 2 diabetes, and darapladib for atherosclerosis.[77]

In March 2014 GSK paid $1 billion to raise its stake in its Indian pharmaceutical unit, GlaxoSmithKline Pharmaceuticals, to 75 percent aspart of a move to focus on emerging markets.[78] In April 2014 Novartis and Glaxo agreed on more than $20 billion in deals, with Novartisselling its vaccine business to GSK and buying GSK's cancer business.[79][80] In February 2015 GSK announced that it would acquireGlycoVaxyn, a Swiss pharmaceutical company, for $190 million,[81] and in June that year that it would sell two meningitis drugs to Pfizer,Nimenrix and Mencevax for around $130 million.[82]

Philip Hampton, at that time chair of the Royal Bank of Scotland, became GSK chairman in September 2015.[83]

In September 2016 the company announced that Witty would be succeeded as CEO by Emma Walmsley in March 2017; Walmsley was amanagement professional originally from Lancashire with a background in marketing.[84]

Philanthropy and social responsibility


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GlaxoSmithKline, Center City, Philadelphia

Rosiglitazone

Since 2010 GlaxoSmithKline has several times ranked first among pharmaceuticalcompanies on the Global Access to Medicines Index, which is funded by the Bill andMelinda Gates Foundation.[85] In 2014 the Human Rights Campaign, an LGBT-rightsadvocacy group gave GSK a score of 100 percent in its Corporate Equality Index.[86]

GSK has been active, with the World Health Organization (WHO), in the Global Allianceto Eliminate Lymphatic Filariasis (GAELF). Around 120 million people globally arebelieved to be infected with lymphatic filariasis.[87] In 2012 the company endorsed theLondon Declaration on Neglected Tropical Diseases; it agreed to donate 400 millionalbendazole tablets to the WHO each year to fight soil-transmitted helminthiasis and toprovide 600 million albendazole tablets every year for lymphatic filariasis until thedisease is eradicated.[88] As of 2014 over 5 billion treatments had been delivered, and 18of 73 countries in which the disease is considered endemic had progressed to thesurveillance stage.[89]

In 2009 the company said it would cut drug prices by 25 percent in 50 of the poorest nations, release intellectual property rights forsubstances and processes relevant to neglected disease into a patent pool to encourage new drug development, and invest 20 percent of profitsfrom the least-developed countries in medical infrastructure for those countries.[90][91] Médecins Sans Frontières welcomed the decision, butcriticized GSK for failing to include HIV patents in its patent pool and for not including middle-income countries in the initiative.[92]

In 2013 GSK licensed its HIV portfolio to the Medicines Patent Pool for use in children, and agreed to negotiate a license for dolutegravir, anintegrase inhibitor then in clinical development.[93] In 2014 this license was extended to include dolutegravir and adults with HIV. Thelicenses include countries in which 93 percent of adults and 99 percent of children with HIV live.[94] Also in 2013 GSK joined AllTrials, aBritish campaign to ensure that all clinical trials are registered and the results reported. The company said it would make its past clinical-trialreports available and future ones within a year of the studies' end.[95]

2012 criminal and civil settlementOverview

In July 2012 GSK pleaded guilty in the United States to criminal charges, and agreed to pay $3 billion, in what was the largest settlement untilthen between the Justice Department and a drug company. The $3 billion included a criminal fine of $956,814,400 and forfeiture of$43,185,600. The remaining $2 billion covered a civil settlement with the government under the False Claims Act. The investigation waslaunched largely on the basis of information from four whistleblowers who filed qui tam (whistleblower) lawsuits against the company underthe False Claims Act.[8]

The charges stemmed from GSK's promotion of the anti-depressants Paxil (paroxetine) and Wellbutrin (bupropion) for unapproved uses from1998–2003, specifically as suitable for patients under the age of 18, and from its failure to report safety data about Avandia (rosiglitazone),both in violation of the Federal Food, Drug, and Cosmetic Act. Other drugs promoted for unapproved uses were two inhalers, Advair(fluticasone/salmeterol) and Flovent (fluticasone propionate), as well as Zofran (ondansetron), Imitrex (sumatriptan), Lotronex (alosetron) andValtrex (valaciclovir).[8]

The settlement also covered reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program, andkickbacks to physicians to prescribe GSK's drugs. There were all-expenses-paid spa treatments and hunting trips for doctors and theirspouses, speakers' fees at conferences, and payment for articles ghostwritten by the company and placed by physicians in medical journals.[8]

The company set up a ghostwriting programme called CASPPER, initially to produce articles about Paxil but which was extended to coverAvandia.[96]

As part of the settlement GSK signed a five-year Corporate Integrity Agreement with the Department of Health and Human Services, whichobliged the company to make major changes in the way it did business, including changing its compensation programmes for its sales forceand executives, and to implement and maintain transparency in its research practices and publication policies.[8] It announced in 2013 that itwould no longer pay doctors to promote its drugs or attend medical conferences, and that its sales staff would no longer have prescriptiontargets.[97]

Rosiglitazone (Avandia)

The 2012 settlement included a criminal fine of $242,612,800 for failing to report safety data to theFDA about Avandia (rosiglitazone), a diabetes drug approved in 1999, and a civil settlement of $657million for making false claims about it. The Justice Department said GSK had promoted rosiglitazoneto physicians with misleading information, including that it conferred cardiovascular benefits despitean FDA-mandated label warning of cardiovascular risks.[8]

In 1999 John Buse, a diabetes specialist, told medical conferences that rosiglitazone might carry anincreased risk of cardiovascular problems. GSK threatened to sue him, called his university head ofdepartment, and persuaded him to sign a retraction.[98] GSK raised questions internally about thedrug's safety in 2000, and in 2002 the company ghostwrote an article in Circulation describing a GSK-funded clinical trial that suggested rosiglitazone might have a beneficial effect on cardiovascularrisk.[99] From 2001 reports began to link the thiazolidinediones (the class of drugs to whichrosiglitazone belongs) to heart failure.[100] In April that year GSK began a six-year, open-label, randomized trial, known as RECORD, to


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Paroxetine, known as Paxil andSeroxat

examine rosiglitazone and cardiovascular events.[101] Two GSK meta-analyses in 2005 and 2006 showed an increased risk of cardiovascularproblems with rosiglitazone; the information was passed to the FDA and posted on the company website, but not otherwise published. ByDecember 2006 rosiglitazone had become the top-selling diabetes drug, with annual sales of US$3.3 billion.[100]

In June 2007 the New England Journal of Medicine published a meta-analysis that associated the drug with an increased risk of heartattack.[102] GSK had reportedly tried to persuade one of the authors, Steven Nissen, not to publish it, after receiving an advance copy fromone of the journal's peer reviewers, a GSK consultant.[103] In July 2007 FDA scientists suggested that rosiglitazone had caused 83,000 excessheart attacks between 1999 and 2007.[104]:4[105] The FDA placed restrictions on the drug, including adding a boxed warning, but did notwithdraw it.[106] (In 2013 the FDA rejected that the drug had caused excess heart attacks.)[107] A Senate Finance Committee inquiryconcluded in 2010 that GSK had sought to intimidate scientists who had concerns about rosiglitazone.[104] In February that year the companytried to halt publication of an editorial about the controversy by Nissen in the European Heart Journal.[108]

The results of GSK's RECORD trial were published in June 2009. It confirmed an association between rosiglitazone and an increased risk ofheart failure and fractures, but not of heart attack, and concluded that it "does not increase the risk of overall cardiovascular morbidity ormortality compared with standard glucose-lowering drugs."[101] Steven Nissan and Kathy Wolkski argued that the study's low event ratesreduced its statistical power.[109] In September 2009 rosiglitazone was suspended in Europe.[110] The results of the RECORD study wereconfirmed in 2013 by the Duke Clinical Research Institute, in an independent review required by the FDA.[111] In November that year theFDA lifted the restrictions it had placed on the drug.[112] The boxed warning about heart attack was removed; the warning about heart failureremained in place.[107]

Paroxetine (Paxil/Seroxat)

GSK was fined for promoting Paxil/Seroxat (paroxetine) for treating depression in the under-18s,although the drug had not been approved for pediatric use.[8] Paxil had $4.97 billion worldwide salesin 2003.[113] The company conducted nine clinical trials between 1994 and 2002, none of whichshowed that Paxil helped children with depression.[114] From 1998 to 2003 it promoted the drug forthe under-18s, paying physicians to go on all-expenses paid trips, five-star hotels and spas.[8] From2004 Paxil's label, along with those of similar drugs, included an FDA-mandated boxed warning that itmight increase the risk of suicidal ideation and behaviour in patients under 18.[8]

An internal SmithKline Beecham document said in 1998, about withheld data from two GSK studies:"It would be commercially unacceptable to include a statement that [pediatric] efficacy had not beendemonstrated, as this would undermine the profile of paroxetine."[113][115] The company ghostwrotean article, published in 2001 in the Journal of the American Academy of Child and AdolescentPsychiatry, that misreported the results of one of its clinical trials, Study 329.[8][116] The articleconcluded that Paxil was "generally well tolerated and effective for major depression in adolescents."[117] The suppression of the researchfindings is the subject of Side Effects (2008) by Alison Bass.[118]

For 10 years GSK marketed Paxil as non-habit forming. In 2001 35 patients filed a class-action suit alleging they had suffered withdrawalsymptoms, and in 2002, a Los Angeles court issued an injunction preventing GSK from advertising that the drug was not habit forming.[119]

The court withdrew the injunction after the FDA objected that the court had no jurisdiction over drug marketing that the FDA hadapproved.[120] In 2003, a World Health Organization committee reported that Paxil was among the top 30 drugs, and top threeantidepressants, for which dependence had been reported.[121][n 2]

Bupropion (Wellbutrin)

The company was also fined for promoting Wellbutrin (bupropion) – approved at the time for major depressive disorder and also sold as asmoking-cessation aid, Zyban – for weight loss and the treatment of attention deficit hyperactivity disorder, sexual dysfunction and substanceaddiction. GSK paid doctors to promote these off-label uses, and set up supposedly independent advisory boards and Continuing MedicalEducation programmes.[8]

Other controversiesAntitrust case over griseofulvin

In the 1960s Glaxo Group Ltd. (Glaxo) and Imperial Chemical Industries (ICI) each owned patents covering various aspects of the antifungaldrug griseofulvin.[122]:54, nn. 1–2[123] They created a patent pool by cross-licensing their patents, subject to express licensing restrictions thatthe chemical from which the "finished" form of the drug (tablets and capsules) was made must not be resold in bulk form, and they licensedother drug companies to sell the drug in finished form and subject to similar restrictions.[122]:54–55[123] The effect and intent of the bulk-salerestriction was to keep the drug chemical out of the hands of small companies that might act as price-cutters, and the effect was to maintainstable, uniform prices.[124][125][126]

The United States brought an antitrust suit against the two companies—United States v. Glaxo Group Ltd.—charging them with violation ofthe Sherman Act and also seeking to have the patents declared invalid.[122]:55[123] The trial court found that the defendants had engaged inseveral unlawful conspiracies, but dismissed the part of the suit seeking invalidation of patents and refused to grant as relief mandatory salesof the bulk drug chemical and compulsory licensing of the patents.[122]:56[123] The government appealed to the Supreme Court, whichreversed, in United States v. Glaxo Group Ltd., 410 U.S. 52 (1973).[123]


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Old Ribena bottle, year unknown,made by Beecham Products,Brentford, Middlesex; the label states:"widely used in hospitals and clinics."

Ribena

There were concerns in the 2000s about the sugar and vitamin content of Ribena, a blackcurrant-basedsyrup and soft drink owned by GSK until 2013. Produced in England by H.W. Carter & Co from the1930s, the company's unbranded syrup was distributed to children as a source of vitamin C duringWorld War II, which gave the drink a reputation as good for health. Beecham bought H. W. Carter in1955.[127]

In 2001 the British Advertising Standards Authority (ASA) required GSK to withdraw its claim thatRibena Toothkind, a lower-sugar variety, did not encourage tooth decay. A company poster showedbottles of Toothkind in place of the bristles on a toothbrush. The ASA's ruling was upheld by the HighCourt.[128] In 2007 GSK was fined $217,000 in New Zealand over its claim that ready-to-drinkRibena contained high levels of vitamin C, after it was found to contain no detectable vitamin C.[129]

In 2013 GSK sold Ribena and another drink, Lucozade, to the Japanese multinational Suntory for£1.35 billion.[53]

SB Pharmco Puerto Rico

In 2010 the US Department of Justice announced that GSK would pay a $150 million criminal fineand forfeiture, and a civil settlement of $600 million under the False Claims Act. The fines stemmedfrom production of improperly made and adulterated drugs from 2001 to 2005 at GSK's subsidiary,SB Pharmco Puerto Rico Inc., in Cidra, Puerto Rico, which at the time produced $5.5 billion ofproducts each year. The drugs involved were Kytril, an antiemetic; Bactroban, used to treat skininfections; Paxil, the anti-depressant; and Avandamet, a diabetes drug.[130] GSK closed the factory in2009.[131]

According to the New York Times, the case began in 2002 when GSK sent experts to fix problems cited by the FDA. The lead inspectorrecommended recalls of defective products, but they were not authorized; she was fired in 2003 and filed a whistleblower lawsuit. In 2005federal marshals seized $2 billion worth of products, the largest such seizure in history. In the 2010 settlement SB Pharmco plead guilty tocriminal charges, and agreed to pay $150 million in a criminal fine and forfeiture, at that time the largest such payment ever by a manufacturerof adulterated drugs, and $600 million in civil penalties to settle the civil lawsuit.[131]

China

In 2013 Chinese authorities announced that, since 2007, GSK had funnelled HK$3.8 billion in kickbacks to GSK managers, doctors, hospitalsand others who prescribed their drugs, using over 700 travel agencies and consulting firms.[132] Chinese authorities arrested four GSKexecutives as part of a four-month investigation into claims that doctors were bribed with cash and sexual favours.[133] In 2014 a Chinesecourt found the company guilty of bribery and imposed a fine of $490 million. Mark Reilly, the British head of GSK's Chinese operations,received a three-year suspended prison sentence after a one-day trial held in secret.[134] Reilly was reportedly deported from China anddismissed by the company.[135]

Market manipulation in the UK

In February 2016 the company was fined more than £37 million by the Competition and Markets Authority for paying Generics UK,Alpharma and Norton Healthcare more than £50m between 2001 and 2004, in order to keep generic varieties of Paroxetine out of the NHSmarket. The generics companies were fined a further £8 million. At the end of 2003 when generics were available in the UK the price ofParoxetine dropped 70%.[136]

Miscellaneous

Italian police sought bribery charges in May 2004 against 4,400 doctors and 273 GSK employees. GSK and its predecessor were accused ofhaving spent £152m on physicians, pharmacists and others, giving them cameras, computers, holidays and cash. Doctors were alleged to havereceived cash based on the number of patients they treated with a cancer drug, topotecan (Hycamtin).[137] The following month prosecutors inMunich accused 70–100 doctors of having accepted bribes from SmithKline Beecham between 1997 and 1999. The inquiry was opened overallegations that the company had given over 4,000 hospital doctors money and free trips.[138] All charges were dismissed by the Verona courtin January 2009.[139]

In 2006 in the United States GSK settled the largest tax dispute in IRS history, agreeing to pay $3.1 billion. At issue were Zantac and otherproducts sold in 1989–2005. The case revolved around intracompany transfer pricing—determining the share of profit attributable to the USsubsidiaries of GSK and subject to tax by the IRS.[140]

The UK's Serious Fraud Office (SFO) opened a criminal inquiry in 2014 into GSK's sales practices, using powers granted by the Bribery Act2010.[141] The SFO said it was collaborating with Chinese authorities to investigate bringing charges in the UK related to GSK's activities inChina, Europe and the Middle East.[142] Also as of 2014 the US Department of Justice was investigating GSK with reference to the ForeignCorrupt Practices Act.[143]

Diagram of acquisition history


7 di 14 02/07/17, 14:32

The following is an illustration of the company's major mergers and acquisitions and historical predecessors (this is not a comprehensive list):

GlaxoSmithKline

SmithKline Beecham plc(renamed 1989)

SmithKline Beckman(renamed 1982)

SmithKline-RIT(renamed 1968)

Smith, Kline & French(reorganized 1929 into

Smith Kline and French Laboratories)

French,RichardsandCompany(Acq 1891)

Smith, KlineandCompany(Founded1830)

LeverBrothers(Angio-sealdiv. Acq 1900

Recherche etIndustrieThérapeutiques(Acq 1968)

Beckman Instruments, Inc.(Merged 1982, Sold 1989)

Specialized Instruments Corp.(Acq 1954)

Offner Electronics(Acq 1961)

Allergan(Acq 1982, Sold 1989)

International Clinical Laboratories(Acq 1989)

Reckitt & Colman(Acq 1999)

Stiefel Laboratories(Acq 2000 by SmithKline Beckman)

Sanofi-Synthelabo(Acq 2001)

Beecham Group Plc(merged 1989)

Norcliff Thayer(Acq 1986)

Beecham Group Ltd

S. E. Massengill Company(Acq 1971)

Beecham Group Ltd(Renamed 1945)

C.L. Bencard(Acq 1953)

County Chemicals(Acq 1929)

Glaxo Wellcome(Renamed 1995)

Glaxo(Merged 1995) Glaxo

(Founded 1850)

Joseph Nathan(Acq 1947)


8 di 14 02/07/17, 14:32

Allen & Hanburys(Founded 1715, Acq 1958)

Margarine Unie(Angio-seal div, Acq 1924)

Meyer Laboratories(Acq 1978)

Affymax(Acq 1995)

Burroughs Wellcome(Merged 1995)

McDougall & Robertson Inc(Acq 1959)

Burroughs Wellcome & Company(Founded 1880)

Block Drug(Acq 2001)

CNS Inc.(Acq 2006)

Stiefel Laboratories(Acq 2009)

Laboratorios Phoenix(Acq 2010)

Maxinutrition(Acq 2010)

CellZome(Acq 2011)

Human Genome Sciences(Acq 2013)

Novartis(Vaccine div; Acq 2014)

GSK Cancer division(Sold 2014 to Novartis)

GlycoVaxyn(Acq 2015)

See alsoList of toothpaste brandsIndex of oral health and dental articlesRecherche et Industrie Thérapeutiques (R.I.T.)Galvani Bioelectronics

NotesGlaxo Wellcome was formed from Glaxo's 1995 acquisition of Burroughs Wellcome and SmithKline Beecham from the 1989 merger of the BeechamGroup and the SmithKline Beckman Corporation.

1.

World Health Organization Expert Committee on Drug Dependence, 2003: "The Committee noted the striking number of reports on paroxetine and'withdrawal syndrome' ... The representative of Consumers International reported that a number of patients had experienced difficulty in withdrawingfrom SSRIs in general. It was agreed that withdrawal was indeed a problem in some patients, but there was a difference of opinion on the degree ofdependence that was involved, given the possibility that the need for treatment of resistant or relapsing disease could make these drugs indispensablefor patient care. The Committee expressed concern about the possibility of inappropriate prescribing resulting in the risk of problems of withdrawal

2.


9 di 14 02/07/17, 14:32

outweighing the benefits of treatment with SSRIs."[121]

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External linksOfficial website (http://www.gsk.com/)GlaxoSmithKline companies (https://opencorporates.com/corporate_groupings/GlaxoSmithKline) grouped at OpenCorporatesFinancial Times Quote, profile, and news (http://briefings.ft.com/company/news.html?extelID=00044814&query=UK:GSK&region=&industry=)London Stock Exchange Quote, regulatory filings, and news (https://web.archive.org/web/20070617040743/http://www.londonstockexchange.com/en-gb/pricesnews/prices/system/detailedprices.htm?sym=GB0009252882GBGBXSET10925288GSK)New York Stock Exchange Quote, profile, regulatory filings, and news (http://www.nyse.com/about/listed/lcddata.html?ticker=GSK)

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