GLAXOSMITHKLINE PLC (GSK) is a British pharmaceutical company
The company has a primary listing on the
London Stock Exchange
GSK's drugs and vaccines earned £21.3 billion in 2013. Its
top-selling products that year were
Lamictal . GSK's consumer products, which
earned £5.2 billion in 2013, include
Sensodyne and Aquafresh
toothpaste, the malted-milk drink
Horlicks , Abreva for cold sores,
Breathe Right nasal strips ,
In 2012, GSK pleaded guilty to promotion of drugs for unapproved uses, failure to report 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 drug company.
* 1 History
* 2 Research, products
* 2.1 Pharmaceuticals * 2.2 Malaria vaccine * 2.3 Consumer healthcare * 2.4 Facilities * 2.5 Scientific recognition
* 3 Operations and acquisitions since 2001
* 3.1 2001–2010 * 3.2 2011–present
* 4 Philanthropy and social responsibility
* 5 2012 criminal and civil settlement
* 6 Other controversies
* 7 Diagram of acquisition history * 8 See also * 9 Notes * 10 References * 11 External links
The historic Glaxo factory in Bunnythorpe, New Zealand , with the Glaxo Laboratories sign still visible
Glaxo was founded in the 1850s as a general trading company in Bunnythorpe , New Zealand, by a Londoner, Joseph Edward Nathan . In 1904 it began producing dried-milk baby food, first known as Defiance, then as Glaxo (from lacto), under the slogan "Glaxo builds bonny babies." :306 The Glaxo Laboratories sign is still visible (right) on what is now a car repair shop on the main street of Bunnythorpe. The company's first pharmaceutical product, produced in 1920, was vitamin D. :306
Glaxo Laboratories opened new units in
Burroughs Wellcome ">:18 which served as the US headquarters until
the company moved to
Research Triangle Park in North Carolina in 1971.
The Nobel Prize winning scientists
Gertrude B. Elion
In 1843 Thomas Beecham launched his Beecham\'s Pills laxative in
England, giving birth to the
Beecham Group . In 1859 Beecham opened
its first factory in St Helens ,
John K. Smith opened his first pharmacy in
SmithKline & French merged with Beckman Inc. in 1982 and changed its
name to SmithKline Beckman. In 1988 it bought its biggest competitor,
International Clinical Laboratories, and in 1989 merged with Beecham
to form SmithKline Beecham Plc. The headquarters moved from the United
States to England. To expand R another opened in 1997 in England at
New Frontiers Science Park,
SR One was established in 1985 by SmithKline Beecham to invest in new biotechnology companies and continued operating after GSK was formed; by 2003 GSK had formed another subsidiary, GSK Ventures, to out-license or start new companies around drug candidates that it did not intend to develop further. As of 2003, SR One tended to invest only if the company aligned with GSK's business.
SR One was led by:
* 1985 to 1999: Peter Sears * 1999 to 2001: Brenda Gavin * 2001 to 2003: Barbara Dalton * 2004 to ? Maxine Gowen * ? to ?: Joyce Lonergan * ? to ?: Tamar Howson * 2008 to 2010: Russell Greig * 2010 to 2011: Christoph Westphal * 2011: Jens Eckstein
Further information: List of GlaxoSmithKline products
GSK manufactures products for major disease areas such as asthma,
cancer, infections, diabetes and mental health. Its biggest-selling in
Lovaza , and
Lamictal ; its drugs and vaccines earned £21.3 billion that year.
Other top-selling products include its asthma /
Medicines historically discovered or developed at GSK and its legacy
companies and now sold as generics include amoxicillin and
amoxicillin-clavulanate , ticarcillin-clavulanate , mupirocin , and
ceftazidime for bacterial infections, zidovudine for
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.
In 2014 GSK applied for regulatory approval for the first malaria
As of 2013 RTS,S, which uses GSK's proprietary AS01 adjuvant, was being examined in a Phase 3 trial in eight African countries. PATH reported that "n the 12-month period following vaccination, RTS,S conferred approximately 50% protection from clinical Plasmodium falciparum disease in children aged 5-17 months, and approximately 30% protection in children aged 6-12 weeks when administered in conjunction with Expanded Program for Immunization (EPI) vaccines." In 2014 Glaxo said it had spent more than $350 million and expected to spend an additional $260 million before seeking regulatory approval. A second generation malaria vaccine is being evaluated in Phase 2 clinical trials.
GSK's consumer healthcare division, which earned £5.2 billion in
2013, sells oral healthcare, including
Aquafresh , Maclean's and
Sensodyne toothpastes; and drinks such as
Horlicks , Boost and a
chocolate-flavoured malt drink sold in India. GSK also previously
Ribena brands of soft drinks, but they were
sold in 2013 to
Suntory for £1.35bn. Other products include Abreva
to treat cold sores; Night Nurse, a cold remedy; Breathe Right nasal
strips ; and
As of 2013 GSK had offices in over 115 countries and employed over 99,000 people, 12,500 in R its consumer-products division is in Moon Township, Pennsylvania . :7 Company facilities include:
* R&D sites: England (
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
King of Prussia, Pennsylvania
* Henry Dale , a former student of
OPERATIONS AND ACQUISITIONS SINCE 2001
Andrew Witty , GSK's CEO since May 2008
GSK completed the acquisition of New Jersey-based Block Drug in 2001 for US$1.24 billion. 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.
GSK opened its first R the companies had collaborated on developing the lupus drug Belimumab (Benlysta), albiglutide for type 2 diabetes , and darapladib for atherosclerosis .
In March 2014 GSK paid $1 billion to raise its stake in its Indian
In September 2016 the company announced that Witty would be succeeded
as CEO by
Emma Walmsley in March 2017; Walmsley was a management
professional originally from
PHILANTHROPY AND SOCIAL RESPONSIBILITY
Center City, Philadelphia
GSK has been active, with the
World Health Organization
In 2009 the company said it 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 invest 20 percent of profits from the least-developed countries in medical infrastructure for those countries. Médecins Sans Frontières welcomed the decision, but criticized GSK for failing to include HIV patents in its patent pool and for not including middle-income countries in the initiative.
In 2013 GSK licensed its HIV portfolio to the Medicines Patent Pool
for use in children, and agreed to negotiate a license for
dolutegravir , an integrase inhibitor then in clinical development.
In 2014 this license was extended to include dolutegravir and adults
with HIV. The licenses include countries in which 93 percent of adults
and 99 percent of children with HIV live. Also in 2013 GSK joined
2012 CRIMINAL AND CIVIL SETTLEMENT
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 until then 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 was launched largely on the basis of information from four whistleblowers who filed qui tam (whistleblower) lawsuits against the company under the False Claims Act.
The charges stemmed from GSK's promotion of the anti-depressants Paxil (paroxetine ) and Wellbutrin (bupropion ) for unapproved uses from 1998–2003, 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 ) and Valtrex (valaciclovir ).
The settlement also covered reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program , and kickbacks to physicians to prescribe GSK's drugs. There were all-expenses-paid spa treatments and hunting trips for doctors and their spouses, speakers' fees at conferences, and payment for articles ghostwritten by the company and placed by physicians in medical journals. The company set up a ghostwriting programme called CASPPER, initially to produce articles about Paxil but which was extended to cover Avandia.
As part of the settlement GSK signed a five-year Corporate Integrity
Agreement with the
Department of Health and Human Services
The 2012 settlement included a criminal fine of $242,612,800 for failing to report safety data to the FDA about Avandia (rosiglitazone ), a diabetes drug approved in 1999, and a civil settlement of $657 million for making false claims about it. The Justice Department said GSK had promoted rosiglitazone to physicians with misleading information, including that it conferred cardiovascular benefits despite an FDA-mandated label warning of cardiovascular risks.
In 1999 John Buse , a diabetes specialist, told medical conferences that rosiglitazone might carry an increased risk of cardiovascular problems. GSK threatened to sue him, called his university head of department, and persuaded him to sign a retraction. GSK raised questions internally about the drug'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 cardiovascular risk. From 2001 reports began to link the thiazolidinediones (the class of drugs to which rosiglitazone belongs) to heart failure . In April that year GSK began a six-year, open-label , randomized trial , known as RECORD, to examine rosiglitazone and cardiovascular events. Two GSK meta-analyses in 2005 and 2006 showed an increased risk of cardiovascular problems with rosiglitazone; the information was passed to the FDA and posted on the company website, but not otherwise published. By December 2006 rosiglitazone had become the top-selling diabetes drug, with annual sales of US$3.3 billion.
In June 2007 the New England Journal of Medicine published a meta-analysis that associated the drug with an increased risk of heart attack . GSK had reportedly tried to persuade one of the authors, Steven Nissen , not to publish it, after receiving an advance copy from one of the journal's peer reviewers, a GSK consultant. In July 2007 FDA scientists suggested that rosiglitazone had caused 83,000 excess heart attacks between 1999 and 2007. :4 The FDA placed restrictions on the drug, including adding a boxed warning , but did not withdraw it. (In 2013 the FDA rejected that the drug had caused excess heart attacks.) A Senate Finance Committee inquiry concluded in 2010 that GSK had sought to intimidate scientists who had concerns about rosiglitazone. In February that year the company tried to halt publication of an editorial about the controversy by Nissen in the European Heart Journal.
The results of GSK's RECORD trial were published in June 2009. It confirmed an association between rosiglitazone and an increased risk of heart failure and fractures, but not of heart attack, and concluded that it "does not increase the risk of overall cardiovascular morbidity or mortality compared with standard glucose-lowering drugs." Steven Nissan and Kathy Wolkski argued that the study's low event rates reduced its statistical power. In September 2009 rosiglitazone was suspended in Europe. The results of the RECORD study were confirmed in 2013 by the Duke Clinical Research Institute, in an independent review required by the FDA. In November that year the FDA lifted the restrictions it had placed on the drug. The boxed warning about heart attack was removed; the warning about heart failure remained in place.
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. Paxil had $4.97 billion worldwide sales in 2003. The company conducted nine clinical trials between 1994 and 2002, none of which showed that Paxil helped children with depression. From 1998 to 2003 it promoted the drug for the under-18s, paying physicians to go on all-expenses paid trips, five-star hotels and spas. From 2004 Paxil's label, along with those of similar drugs, included an FDA-mandated boxed warning that it might increase the risk of suicidal ideation and behaviour in patients under 18.
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 efficacy had not been demonstrated, as this would undermine the profile of paroxetine." The company ghostwrote an article, published in 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry, that misreported the results of one of its clinical trials, Study 329 . The article concluded that Paxil was "generally well tolerated and effective for major depression in adolescents." The suppression of the research findings is the subject of Side Effects (2008) by Alison Bass .
For 10 years GSK marketed Paxil as non-habit forming. In 2001 35
patients filed a class-action suit alleging they had suffered
withdrawal symptoms, and in 2002, a Los Angeles court issued an
injunction preventing GSK from advertising that the drug was not habit
forming. The court withdrew the injunction after the FDA objected
that the court had no jurisdiction over drug marketing that the FDA
had approved. In 2003, a
World Health Organization
The company was also fined for promoting Wellbutrin (bupropion ) – approved at the time for major depressive disorder and also sold as a smoking-cessation aid, Zyban – for weight loss and the treatment of attention deficit hyperactivity disorder , sexual dysfunction and substance addiction. GSK paid doctors to promote these off-label uses, and set up supposedly independent advisory boards and Continuing Medical Education programmes.
ANTITRUST CASE OVER GRISEOFULVIN
In the 1960s Glaxo Group Ltd. (Glaxo) and Imperial Chemical Industries (ICI) each owned patents covering various aspects of the antifungal drug griseofulvin . :54, nn. 1–2 They created a patent pool by cross-licensing their patents, subject to express licensing restrictions that the chemical from which the "finished" form of the drug (tablets and capsules) was made must not be resold in bulk form, and they licensed other drug companies to sell the drug in finished form and subject to similar restrictions. :54–55 The effect and intent of the bulk-sale restriction was to keep the drug chemical out of the hands of small companies that might act as price-cutters, and the effect was to maintain stable, uniform prices.
The United States brought an antitrust suit against the two companies— United States v. Glaxo Group Ltd. —charging them with violation of the Sherman Act and also seeking to have the patents declared invalid. :55 The trial court found that the defendants had engaged in several unlawful conspiracies, but dismissed the part of the suit seeking invalidation of patents and refused to grant as relief mandatory sales of the bulk drug chemical and compulsory licensing of the patents. :56 The government appealed to the Supreme Court, which reversed, in United States v. Glaxo Group Ltd. , 410 U.S. 52 (1973).
Old Ribena bottle, year unknown, made by Beecham Products, Brentford, Middlesex; the label states: "widely used in hospitals and clinics."
There were concerns in the 2000s about the sugar and vitamin content
Ribena , a blackcurrant -based syrup and soft drink owned by GSK
until 2013. Produced in England by H.W. Carter
Bactroban , used to
treat skin infections; Paxil, the anti-depressant; and
According to the New York Times, the case began in 2002 when GSK sent experts to fix problems cited by the FDA. The lead inspector recommended recalls of defective products, but they were not authorized; she was fired in 2003 and filed a whistleblower lawsuit. In 2005 federal marshals seized $2 billion worth of products, the largest such seizure in history. In the 2010 settlement SB Pharmco plead guilty to criminal charges, and agreed to pay $150 million in a criminal fine and forfeiture, at that time the largest such payment ever by a manufacturer of adulterated drugs, and $600 million in civil penalties to settle the civil lawsuit.
In 2013 Chinese authorities announced that, since 2007, GSK had funnelled HK$3.8 billion in kickbacks to GSK managers, doctors, hospitals and others who prescribed their drugs, using over 700 travel agencies and consulting firms. Chinese authorities arrested four GSK executives as part of a four-month investigation into claims that doctors were bribed with cash and sexual favours. In 2014 a Chinese court 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. Reilly was reportedly deported from China and dismissed by the company.
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
Italian police sought bribery charges in May 2004 against 4,400 doctors and 273 GSK employees. GSK and its predecessor were accused of having spent £152m on physicians, pharmacists and others, giving them cameras, computers, holidays and cash. Doctors were alleged to have received cash based on the number of patients they treated with a cancer drug, topotecan (Hycamtin). The following month prosecutors in Munich accused 70–100 doctors of having accepted bribes from SmithKline Beecham between 1997 and 1999. The inquiry was opened over allegations that the company had given over 4,000 hospital doctors money and free trips. All charges were dismissed by the Verona court in January 2009.
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 other products sold in 1989–2005. The case revolved around intracompany transfer pricing —determining the share of profit attributable to the US subsidiaries of GSK and subject to tax by the IRS.
The UK's Serious Fraud Office (SFO) opened a criminal inquiry in 2014 into GSK's sales practices, using powers granted by the Bribery Act 2010 . The SFO said it was collaborating with Chinese authorities to investigate bringing charges in the UK related to GSK's activities in China, Europe and the Middle East. Also as of 2014 the US Department of Justice was investigating GSK with reference to the Foreign Corrupt Practices Act .
DIAGRAM OF ACQUISITION HISTORY
The following is an illustration of the company's major mergers and acquisitions and historical predecessors (this is not a comprehensive list):
SmithKline Beecham plc (renamed 1989)
SmithKline Beckman (renamed 1982)
SmithKline-RIT (renamed 1968)
Smith, Kline padding:0;">
French, Richards and Company (Acq 1891)
Smith, Kline and Company (Founded 1830)
Lever Brothers (Angio-seal div. Acq 1900
Recherche et Industrie Thérapeutiques (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 border-left:1px solid;vertical-align:top;text-align:center;">
Stiefel Laboratories (Acq 2000 by SmithKline Beckman)
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)
Allen border-left:1px solid;vertical-align:top;text-align:center;">
Margarine Unie (Angio-seal div, Acq 1924)
Meyer Laboratories (Acq 1978)
Affymax (Acq 1995)
Burroughs Wellcome (Merged 1995)
McDougall border-left:1px solid;vertical-align:top;text-align:center;">
Burroughs Wellcome vertical-align:top;text-align:center;">
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)
GSK Cancer division (Sold 2014 to Novartis)
GlycoVaxyn (Acq 2015)
* Companies portal
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* ^ A B "FDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines". Food and Drug Administration. 25 November 2013.
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