GlaxoSmithKline (GSK)

Executive Summary

GlaxoSmithKline plc (GSK) is a British multinational pharmaceutical company headquartered in Brentford, London. Established in 2000 by a merger of Glaxo Wellcome and SmithKline Beecham, GSK was the world’s sixth largest pharmaceutical company as of 2015, after Pfizer, Novartis, Merck, Hoffmann-La Roche and Sanofi.

GSK’s drugs and vaccines earned revenue of £21.3 billion in 2013. Its top-selling products that year were Advair, Avodart, Flovent, Augmentin, Lovaza and Lamictal. GSK’s consumer products, which earned revenue of £5.2 billion in 2013, include Sensodyne and Aquafresh toothpaste, the malted-milk drink Horlicks, Abreva for cold sores, Breathe Right nasal strips, Nicoderm and Nicorette nicotine replacements, and Night Nurse, a cold remedy. The company developed the first malaria vaccine, RTS,S, which it said in 2014 it would make available for five percent above cost. Legacy products developed at GSK include several listed in the World Health Organization Model List of Essential Medicines, such as amoxicillin, mercaptopurine, pyrimethamine and zidovudine.

History of GSK

GlaxoSmithKline was born out of a merger between Glaxo Wellcome and SmithKline Beecham in January 2000. The merger was completed in December that year. The company’s global headquarters are at GSK House, Brentford, London, officially opened in 2002 by then-Prime Minister Tony Blair. The building was erected at a cost of £300 million.

A year later, GSK acquired US-based Block Drug Co. (the company which formed from Alexander Block’s US drugstore), adding to its portfolio a wider range of consumer products, including Sensodyne toothpaste. In 2009, the company acquired Stiefel Laboratories, which was then the world’s largest independent dermatology drug company, enabling GSK to become a leader in skincare.

In 2009, a unique partnership with Pfizer led to the launch of ViiV Healthcare, a company focused on delivering advances in treatment and care for HIV communities. Using the expertise of both companies and Shionogi, who joined in 2012, ViiV Healthcare now has a portfolio of thirteen HIV treatments.

In 2014, GSK submitted a file to the European Medicines Agency for the world’s first malaria candidate vaccine, and received a positive opinion in 2015. The WHO is now embarking on a pilot implementation of the candidate vaccine involving 750,000 children in Ghana, Kenya and Malawi.

In March 2015, GSK completed a transaction with Novartis to acquire their vaccines business (excluding influenza vaccines), strengthening the company’s position as the world’s leading vaccine manufacturer.

Subsidiaries of Mylan

Among GSK’s notable subsidiaries are:

• Beecham Group plc
• Cellzome, Inc. 
• Coulter Pharmaceutical, Inc. 
• Domantis Limited
• Glaxo Group Ltd. 
• Stiefel Laboratories, Ltd. 
• Wellcome Ltd. 

A full list of subsidiaries may be found here: https://www.gsk.com/media/5349/annual-report-2018.pdf

Popular Pharmaceutical Products of GSK

The top products of GSK are: 

1. Adartrel (ropinirole hydrochloride)
2. Advair (salmeterol, fluticasone propionate)
3. Altabax (retapamulin ointment)
4. Altargo (retapamulin)
5. Amerge (naratriptan)
6. Amoxil (amoxicillin)
7. Anectine (suxamethonium chloride)
8. Argatroban (argatroban)
9. Arixtra (fondaparinux sodium)
10. Arranon (nelarabine)
11. Arzerra (ofatumumab)
12. Atriance (nelarabine)
13. Augmentin (amoxicillin/clavulanate potassium)
14. Avamys (fluticasone furoate)
15. Avandamet (rosiglitazone/metformin HCl)
16. Avandaryl (rosiglitazone maleate / glimepiride)
17. Avandia (rosiglitazone maleate)
18. Avodart (dutasteride)
19. Bactroban (mupirocin)
20. Benlysta (belimumab)
21. Betnovate (betamethasone valerate)
22. Bexxar (tositumomab)
23. Breo (fluticasone furoate/vilanterol)
24. calpol (paracetomol)
25. Ceftin (cefuroxime axetil)
26. Combodart (dutasteride / tamsulosin hydrochloride)
27. Coreg (carvedilol)
28. Coreg CR (carvedilol phosphate)
29. Cutivate (fluticasone propionate)
30. Daraprim (pyrimethamine)
31. Dermovate (clobetasol propionate)
32. Duodart (dutasteride / tamsulosin hydrochloride)
33. Dyazide (hydrochlorothiazide/triamterene)
34. Eumovate (clobetasone butyrate)
35. Flixonase (fluticasone propionate)
36. Flixotide (f988luticasone propionate)
37. Flolan (epoprostenol)
38. Flovent (fluticasone propionate)
39. Fortum (ceftazidime)
40. Horizant (gabapentin enacarbil)
41. Hycamtin (topotecan)
42. Imigran (sumatriptan succinate)
43. Imitrex (sumatriptan succinate)
44. Integrilin (eftifibatide)
45. Jalyn (dutasteride / tamsulosin hydrochloride)
46. Lamictal (lamotrigine)
47. Levitra (vardenafil HCl)
48. Lovaza (omega-3-acid ethyl esters)
49. Malarone (atovaquone and proguanil hydrochloride)
50. Mepron (atovaquone)
51. Mivacron (mivacurium chloride)
52. Naramig (naratriptan hydrochloride)
53. Nimbex (cisatracurium besilate)
54. Otosporin ear drops (polymyxin B sulphate, neomycin sulphate, hydrocortisone)
55. Paxil (paroxetine)
56. Pentostam (sodium stibogluconate)
57. Potiga (ezogabine)
58. Prolia (denosumab)
59. Promacta (eltrombopag)
60. Relenza (zanamivir)
61. Requip (ropinirole hydrochloride)
62. Respontin nebules (ipratropium bromide)
63. Revolade (eltrombopag)
64. Rythmol (propafenone hydrochloride)
65. Rythmol SR (propafenone hydrochloride)
66. Seretide (salmeterol xinofoate, fluticasone propionate)
67. Serevent (salmeterol xinafoate)
68. Seroxat (paroxetine hydrochloride)
69. Staxyn (vardenafil hydrochloride)
70. Tracrium (atracurium besilate)
71. Treximet (sumatriptan and naproxen sodium)
72. Trimovate (clobetasone butyrate)
73. Trobalt (retigabine)
74. Tykerb (lapatinib)
75. Tyverb (lapatinib)
76. Ultiva (remifentanil hydrochloride)
77. Valtrex (valaciclovir hydrochloride)
78. Varubi (rolapitant)
79. Ventolin (salbutamol sulphate)
80. Ventolin HFA (albuterol)
81. Veramyst (fluticasone furoate)
82. Volibris (ambrisentan)
83. Votrient (pazopanib)
84. Wellbutrin (bupropion hydrochloride)
85. Wellvone (atovaquone)
86. Zantac (ranitidine hydrochloride)
87. Zeffix (lamivudine)
88. Zejula (niraparib)
89. Zinacef (cefuroxime)
90. Zinnat (cefuroxime axetil)
91. Zofran (ondansetron hydrochloride)
92. Zovirax (aciclovir)
93. Zyban (bupropion hydrochloride)

GSK also produces the following vaccines:

1. ACWY Vax (for meningococcal polysaccharides serogroups A, C, W135 and Y)
2. Ambirix (for hepatitis A (inactivated) and hepatitis B (rDNA) (HAB))
3. Boostrix (for tetanus toxoid, reduced diphtheria toxoid and acellular pertussis)
4. Cervarix (for human Papillomavirus vaccine (types 16, 18))
5. Engerix-B (for hepatitis B)
6. Fendrix (for hepatitis B (rDNA))
7. Fluarix (for influenza)
8. FluLaval (for influenza)
9. Havrix (for hepatitis A)
10. Hepatyrix (for hepatitis A and typhoid polysaccharide)
11. Hiberix (for haemophilus B)
12. Infanrix (for diphtheria and tetanus toxoids and acellular pertussis)
13. Infanrix IPV (for diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis)
14. Kinrix (for diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus)
15. Menhibrix (for meningococcal groups C and Y and haemophilus b tetanus toxoid conjugate)
16. Menitorix (for Haemophilus influenzae type b and Neisseria meningitidis group C (Hib-MenC))
17. Pandemrix (for influenza)
18. Pediarix (for diphtheria and tetanus toxoids and acellular pertussis, hepatitis B and inactivated poliovirus)
19. Priorix (for measles, mumps and rubella)
20. Rotarix (for human rotavirus)
21. Synflorix (for pneumococcal polysaccharide)
22. Twinrix (for hepatitis A and hepatitis B)
23. Typherix (for typhoid)
24. Varilrix (for varicella)

GSK also produces the following consumer health products:

1. Abreva (Docosanol)
2. alli (Orlistat)
3. Aquafresh (oral healthcare)
4. Astring O Sol (oral healthcare)
5. Beechams Cold & Flu and Night/Day Nurse (cold and flu treatments)
6. Binaca (oral healthcare)
7. Biotene (oral healthcare)
8. Boost (nutritional)
9. Breathe Right (respiratory)
10. Cetebe (vitamins and naturals)
11. Chlorhexamed (oral healthcare)
12. Cholinex (analgesics and respiratory tract)
13. Citrucel (gastrointestinal)
14. Coldrex (cold and flu treatment)
15. Commit Lozenge (smoking cessation)
16. Committed Quitters (nicotine replacement)
17. Corega (oral healthcare)
18. Corsodyl (oral healthcare)
19. Crocin (analgesics and respiratory tract)
20. Dr. Best (oral healthcare)
21. ENO (gastrointestinal)
22. Eumovate (dermatological)
23. Fenbid (analgesics and respiratory tract)
24. Flonase (fluticasone propionate)
25. Formigran (analgesic/triptan)
26. Grand-PA (headache/toothache/pain and fever)
27. Hinds (dermatological)
28. Horlicks (nutritional)
29. Horlicks Promind (nutritional)
30. Junior Horlicks (nutritional)
31. Iodex (pain relief)
32. Iodosan (cold and flu treatment)
33. Macleans (oral healthcare)
34. Maltova (nutritional)
35. Maxinutrition (nutritional)
36. Medacalm (vitamins and naturals)
37. Nicorette (nicotine replacement)
38. NiQuitin CQ/ Nicoderm CQ/ Nicabate (nicotine replacement)
39. Odol (oral healthcare)
40. Odol-med3 (oral healthcare)
41. Os-cal (oral healthcare)
42. Panadeine (analgesics and respiratory tract)
43. Panadol (analgesics and respiratory tract)
44. Parodontax (oral healthcare)
45. Piriton/Piriteze (anti-allergy)
46. Polident (oral healthcare)
47. Poligrip Ultra (oral healthcare)
48. Rutinoscorbin (vitamins and naturals)
49. Scott’s Emulsion (vitamins and naturals)
50. Sensodyne (oral healthcare)
51. Shumitect (oral healthcare)
52. Solpadeine (analgesics and respiratory tract)
53. Super Poligrip (oral healthcare)
54. Super Wernet’s (oral healthcare)
55. Synthol (oral healthcare)
56. Theraflu(Respitory)
57. Tums (gastrointestinal)
58. Viva (vitamins and naturals) Origin: Nepal
59. Zovirax (dermatological)

Product Recalls and Lawsuits

1. In March 2014, GSK voluntarily recalled from warehouses and distributors a number of batches of nicotine lozenges sold globally, after the company detected manufacturing issues affecting some batches. In some cases, the lozenges were larger or smaller than GSK’s manufacturing standards. 
2. In 2013, a baby vaccine supplied by GlaxoSmithKline Australia ($GSK) has been recalled over concerns about bacteria found in the Belgian factory where it was made. About 115,000 doses of Infanrix hexa vaccine–which protects against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b–were recalled due to potential contamination.
3. In 2014, GSK recalled Panadol Advance bottles due to failure to meet child-resistant closure requirement. The bottles were sold exclusively in Puerto Rico.
4. In March 2014 it recalled Alli, an over-the-counter weight-loss drug, in the United States and Puerto Rico because of possible tampering, following customer complaints.
5. In February 2018, GSK voluntarily recalled four lots of Ventolin (Diskus/Accuhaler) and seven lots of Seretide (Diskus/Accuhaler) devices.

The issue, which occurred during the assembly of the devices, involved a foil strip containing the medicine inside the device which may have been damaged, reducing the full number of doses the inhaler may deliver.

Litigation Settlements

1. GSK currently holds the record for the largest settlement between a pharmaceutical company and the United States. In 2012, GSK settled a USD3bn criminal and civil suit that alleged that the company participated in off-label promotion and failed to disclose safety data. The suit also alleged that GSK paid kickbacks to physicians, and made false and misleading statements concerning the safety of Avandia. Moreover the suit also alleged that GSK reported false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program.
2. In 2010, GSK settled a USD 750 million suit that alleged that the company practiced poor manufacturing practices in producing the drugs Kytril/Bactroban and Paxil CR/Avandamet. 
3. GlaxoSmithKline Plc agreed to pay $105 million to settle allegations by 44 U.S. states and the District of Columbia that it promoted its medicines for unapproved uses in 2014. Glaxo was accused by the states of illegally marketing its big-selling asthma drug Advair for use by mild asthma sufferers and the antidepressants Paxil and Wellbutrin for use by children and teenagers without FDA approval. Several antidepressants have been associated with increased risk of suicide in younger patients.

Sources:

https://www.gsk.com/media/5349/annual-report-2018.pdf

https://en.wikipedia.org/wiki/List_of_GlaxoSmithKline_products

https://money.cnn.com/2014/03/27/news/companies/glaxosmithkline-alli-recall

https://www.fiercepharma.com/r-d/gsk-recalls-infant-vaccine-australia

https://www.cpsc.gov/Recalls/2014/gsk-recalls-panadol-advance-bottles