Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News

In the battle against infectious diseases, these drugs are on the frontlines.

Recent advances in the quest for vaccines against MERS, SARS, and other coronaviruses have vaccines front and center in the news again. More ominously, scientists have demonstrated that circulating avian influenza viruses contain all the genetic ingredients needed to lead to the emergence of a virus similar to the deadly 1918 influenza virus.

These are just a few examples of market drivers that have drug makers showing increased interest in vaccine manufacture. Following is a list of 10 vaccines, ranked by sales and representing the 10 top-selling vaccines of 2013. Sales figures come mostly from data disclosed by vaccine developers, except where otherwise noted. Vaccines are listed by their name, their proper name as filed with FDA or furnished by vaccine developers, sales figures for 2013 and 2012, the percentage of year-over-year sales growth, the name of the vaccine developer/sponsor, and indications.

[This list has been corrected from an earlier edition which incorrectly cited a 6.8% year-over-year decline in Merck & Co. sales of RotaTeq. Merck's sales of the vaccine rose 6.6% over 2012].


#10. Varivax

Varicella virus vaccine live

2013 sales: $684 million1

2012 sales: $846 million1

% year-to-year sales growth: -19.1%2

Developer/Sponsor: Merck & Co. and Sanofi Pasteur MSD

Indications: Active immunization of persons 12 months of age and older; optional second dose for children 12 months to 12 years of age.


#9. Synflorix

Pneumococcal polysaccharide conjugate vaccine (nontypeable Haemophilus influenzae [NTHi] protein D, diphtheria or tetanus toxoid conjugates) adsorbed

2013 sales: $688 million (£405 million)

2012 sales: $653 million (£385 million)3

% year-to-year sales growth: 5.2%

Developer/Sponsor: GlaxoSmithKline

Indications: Active immunization of infants and children from six weeks up to five years of age against disease caused by Streptococcus pneumoniae serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteremia, and acute otitis media) and against acute otitis media caused by nontypeable Haemophilus influenzae


#8. RotaTeq

Rotavirus vaccine, live oral, pentavalent

2013 sales: $691 million4

2012 sales: $648 million5

% year-to-year sales growth: 6.6%

Developer/Sponsor: Merck & Co. and Sanofi Pasteur MSD

Indications: Prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3, and G4 when administered as a three-dose series to infants between the ages of six to 32 weeks.


#7. Zostavax

Zoster vaccine live

2013 sales: $826 million6

2012 sales: $651 million6

% year-to-year sales growth: 26.9%

Developer/Sponsor: Merck & Co. and Sanofi Pasteur MSD

Indications: Prevention of herpes zoster (shingles) in individuals 50 years of age and older.


#6. Hepatitis franchise

Includes: Hepatitis A vaccine, inactivated (Havrix); hepatitis A inactivated and hepatitis B (recombinant) vaccine (Twinrix); and hepatitis B vaccine (recombinant)(Engerix-B)

2013 sales: $1.067 billion (£629 million)7

2012 sales: $1.096 billion (£646 million)7,8

% year-to-year sales growth: -2.6%

Developer/Sponsor: GlaxoSmithKline

Indications: Active immunization against disease caused by hepatitis A virus for persons ≥12 months of age (Havrix). Active immunization of persons 18 years of age or older against disease caused by hepatitis A virus and infection by all known subtypes of hepatitis B virus (Twinrix), and immunization against infection caused by all known subtypes of hepatitis B virus (Engerix-B).


#5. Fluzone [Includes Fluzone High-Dose, Fluzone QIV (quadrivalent), Fluzone ID (intradermal), Vaxigrip]

Influenza virus vaccines

2013 sales: $1.258 billion (€929 million)

2012 sales: $1.197 billion (€884 million)2,9

% year-to-year sales growth: 5.1%

Developer/Sponsor: Sanofi and Sanofi Pasteur MSD

Indications: Active immunization of persons six months of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. Fluzone High-Dose is indicated for active immunization of persons 65 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine; Fluzone Intradermal indicated for active immunization for use in adults 18 through 64 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.


#4. Infanrix/Pediarix

Diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B (recombinant) and inactivated poliovirus vaccine combined

2013 sales: $1.463 billion (£862 million)

2012 sales: $1.315 billion (£775 million)10

% year-to-year sales growth: 12.3%

Developer/Sponsor: GlaxoSmithKline

Indications: Active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. Approved for use as a three-dose series in infants born of hepatitis B surface antigen (HBsAg)-negative mothers. May be given as early as six weeks of age through six years of age (prior to the seventh birthday).


#3. PENTAct-HIB

Haemophilus influenzae type B polysaccharide conjugated to tetanus protein, diphtheria, tetanus, pertussis, and inactivated poliovirus vaccines (types 1, 2, and 3)

2013 sales: $1.525 billion11,12

2012 sales: $1.522 billion11,12

% year-to-year sales growth: 0.2%

Developer/Sponsor: Sanofi and Sanofi Pasteur MSD

Indications: Prevention of invasive infections (e.g., meningitis, septicemia, epiglottitis caused by H. influenzae type B, diphtheria, pertussis, tetanus, and poliomyelitis).


#2. Gardasil

Human papillomavirus quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant

2013 sales: $2.122 billion13

2012 sales: $1.895 billion14

% year-to-year sales growth: 11.4%

Developer/Sponsor: Merck & Co. and Sanofi Pasteur MSD

Indications: Prevention of vulvar and vaginal cancer; prevention of the following diseases caused by human papillomavirus (HPV) types 6, 11, 16, and 18: cervical cancer; genital warts (condyloma acuminata) and the following precancerous or dysplastic lesions: cervical adenocarcinoma in situ (AIS); cervical intraepithelial neoplasia (CIN) grade 2 and grade 3; vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3; vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3; and CIN grade 1. Also, prevention of genital warts caused by HPV types 6 and 11 in boys and men nine through 26 years of age; and prevention of anal cancer and associated precancerous lesions due to HPV types 6, 11, 16, and 18 in people ages nine through 26 years.


#1. Prevnar family15

Prevnar 7/Prevenar 7: Pneumococcal 7-valent conjugate vaccine (diphtheria CRM197 protein); Prevnar 13: Pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein)

2013 sales: $3.974 billion

2012 sales: $4.117 billion16

% year-to-year sales growth: -3.5%

Developer/Sponsor: Pfizer

Indications: In adults 50 years of age and older, prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F (Prevnar 7 and 13). In children six years through 17 years of age, for prevention of invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. In children six weeks through five years of age (Prevnar 7 and 13), for prevention of invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F (Prevnar 13); and prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F (Prevnar 7 and 13).
































Sources for indications include the prescribing labels for each vaccine, as well as FDA’s list of Vaccines Licensed for Immunization and Distribution in the U.S. with Supporting Documents, available online on the agency’s website. All non-U.S. currencies converted to U.S. dollars on June 13, 2014 via www.xe.com.

Notes:
1 Figures exclude sales generated by Sanofi Pasteur MSD, which were not disclosed by the joint venture, but do include supply sales by Merck to Sanofi Pasteur MSD. Evaluate Pharma reported $1.377 billion in 2013 global sales; GEN’s list last year did not include Sanofi Pasteur MSD figures. 
2 Figure differs from that published by GEN last year because the 2012 sales figure converted to $1.152 billion on June 27, 2013.
3 Figure differs from that published by GEN last year because the 2012 sales figure converted to $587 million on June 27, 2013.
4 2013 sales figure combines Merck’s reported $636 million with $55 million reported by Sanofi Pasteur MSD.
5 2012 sales figure combines Merck’s reported $601 million with $47 million reported by Sanofi Pasteur MSD.
6 2013 sales figure combines $758 million generated by Merck, and $68 million generated by Sanofi Pasteur MSD, which launched the vaccine in its territories last year. The 2012 figure includes only Merck sales.
7 GlaxoSmithKline does not disclose sales of its hepatitis vaccines individually. Collectively, the hepatitis vaccines account for the second largest component of GSK’s vaccine business, after Infanrix/Pediarix.
8 Figure differs from that published by GEN last year because the 2012 sales figure converted to $986 million on June 27, 2013.
9 Figures exclude sales generated for the vaccine by Sanofi Pasteur MSD, which were not disclosed by the joint venture.
10 Figure differs from that published by GEN last year because the 2012 sales figure converted to $1.183 billion on June 27, 2013.
11 Sanofi does not disclose individual sales of PENTAct-HIB, but the vaccine appears to dominate the “Polio/Pertussis/Hib vaccines” category through which the company combines PENTA-HIB with other products. Polio/Pertussis/Hib finished 2013 with €1.148 billion ($1.554 billion) in combined sales, down 3% from €1.184 billion ($1.603) in 2012. The only recent sales figures for the vaccine come from Evaluate Pharma, which reported the vaccine generated $1.525 billion in 2013, up from its figures of $1.522 billion in 2012 and $1.496 billion in 2011. The 2011 figure was also cited by Deutsche Bank in “European Pharmaceuticals,” a report published August 29, 2012.
12 Sanofi sales figures exclude sales generated by Sanofi Pasteur MSD, a 50–50 joint venture of Sanofi and Merck & Co. (known overseas as MSD), which distributes vaccines of both partners in more than a dozen Western European nations, according to its website (www.spmsd.com), including: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, The Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and U.K.
13 Figure includes $1.831 billion recorded by Merck + $291 million recorded by Sanofi Pasteur MSD and reported in Merck’s Form 10-K annual report for 2013, filed with the U.S. Securities and Exchange Commission.
14 Figure combines $1.631 billion recorded by Merck + $264 million recorded by Sanofi Pasteur MSD and reported in Merck’s Form 10-K annual report for 2013, filed with the U.S. Securities and Exchange Commission.
15 “Prevnar family” consists of Prevnar 13/Prevenar 13 and Prevnar/Prevenar (7-valent), Pfizer’s pneumococcal conjugate vaccines for the prevention of various syndromes of pneumococcal disease.
16 Combines figures Pfizer reported separately in 2012: $3.718 billion in sales on Prevnar 13®/Prevenar 13—and $399 million in sales from Prevnar/Prevenar.

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