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Insight & Intelligence™ : Jul 8, 2013

Top 15 Vaccines of 2012

These top-sellers could be the booster shots the industry needs.

You’ve seen GEN’s list of biosimilars to watch; now, following is a list of 15 vaccines, ranked by sales and representing the 15 top-selling vaccines of 2012. 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 2012 and 2011, the percentage of year-over-year sales growth, the name of the vaccine developer/sponsor, and indications. The source for indications is FDA’s list of Vaccines Licensed for Immunization and Distribution in the U.S. with Supporting Documents, available online on the agency’s website.

The list reveals, first off, how relatively few drug/vaccine developers are responsible for the top sellers. Merck & Co. and Sanofi account for more than half of the vaccines on the list, both individually and collectively; the two companies maintain a joint venture, Sanofi Pasteur MSD, which discloses sales results for only two of its vaccines. Other solid performers in vaccines include GlaxoSmithKline, which placed five vaccines on the list, and Pfizer, whose vaccine Prevnar 13 topped the list with nearly $4 billion in sales last year.

Another pharma giant, Novartis, can be expected to show up on next year’s list given talk earlier this year that it planned in 2013 to launch the meningitis vaccine Bexsero, a Meningococcal Group B Vaccine [rDNA, component, adsorbed] for use against meningococcal serogroup B (MenB); and Flucelvax, the first cell-culture derived influenza vaccine approved in the U.S., designed to protect adults 18 years and older against seasonal flu. The latter is expected to be launched in time for the 2013–2014 flu season. Manufacturing ramp-ups to both launches account for Novartis’ vaccines and diagnostics division finishing last year with a $250 million loss on $1.9 billion in sales.

#15. Prevnar/Prevenar (7-valent)

Pneumococcal 7-valent conjugate vaccine [Diphtheria CRM197 protein]

2012 sales: $399 million

2011 sales: $488 million

% year-to-year sales growth: -18.2%

Developer/Sponsor: Pfizer

Indications: Immunization of infants two, four, six, and 12–15 months of age to prevent invasive pneumococcal disease; immunization of infants and toddlers against otitis media caused by vaccine serotypes

#14. Adacel

Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed

2012 sales: €360 million ($469 million)1,2,3

2011 sales: €314 million ($409 million)1,2

% year-to-year sales growth: 14.6%

Developer/Sponsor: Sanofi and Sanofi Pasteur MSD

Indications: Diptheria, pertussis/whooping cough, tetanus

#13. Rotarix

Rotavirus vaccine, live, oral

2012 sales: £360 million ($549 million)1

2011 sales: £300 million ($458 million)1

% year-to-year sales growth: 20.0%

Developer/Sponsor: GlaxoSmithKline

Indications: Prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9), for use in infants six weeks to 24 weeks of age

#12. Pneumovax®23

Pneumococcal vaccine, polyvalent

2012 sales: $580 million4

2011 sales: $427 million4

% year-to-year sales growth: 16.5%

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

Indications: Vaccination against pneumococcal disease caused by those pneumococcal types included in the vaccine

#11. Synflorix®

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

2012 sales: £385 million ($587 million)1

2011 sales: £350 million ($534 million)1

% year-to-year sales growth: 10.0%

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.

#10. RotaTeq®

Rotavirus vaccine, live oral, pentavalent

2012 sales: $648 million5

2011 sales: $695 million6

% year-to-year sales growth: -6.8%

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

#9. Zostavax

Zoster vaccine live

2012 sales: $651 million4

2011 sales: $332 million4

% year-to-year sales growth: 96.1%

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

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

#8. Menactra

Meningococcal polysaccharide (serogroups A, C, Y, and W-135) diphtheria toxoid conjugate vaccine

2012 sales: €564 million ($735 million)1,2

2011 sales: €427 million ($557 million)1,2,7

% year-to-year sales growth: 32.1%

Developer/Sponsor: Sanofi and Sanofi Pasteur MSD

Indications: Active immunization of individuals nine months through 55 years of age for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135

#7. Varivax

Varicella virus vaccine live

2012 sales: $846 million4

2011 sales: $831 million4

% year-to-year sales growth: 1.8%

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

#6. Hepatitis franchise

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

2012 sales: £646 million ($986 million)1,8

2011 sales: $688 million ($1.050 billion)1,8

% year-to-year sales growth: -6.1%

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®, Fluzone High-Dose and Fluzone Intradermal /Vaxigrip®/ Mutagrip®

Influenza virus vaccine

2012 sales: €884 million ($1.152 billion)1,2

2011 sales: €826 million ($1.077 million)1,2

% year-to-year sales growth: 7.0%

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

2012 sales: £775 million ($1.183 billion)1

2011 sales: £690 million ($1.053 billion)1

% 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

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

2012 sales: $1.522 billion9,10

2011 sales: $1.496 billion9,10

% year-to-year sales growth: 1.7%

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

2012 sales: $1.900 billion11

2011 sales: $1.445 billion12

% year-to-year sales growth: 31.5%

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 human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages nine through 26 years.

#1. Prevnar 13®/Prevenar 13

Pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein)

2012 sales: $3.718 billion

2011 sales: $3.657 billion

% year-to-year sales growth: 1.7%

Developer/Sponsor: Pfizer

Indications: 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 in persons 50 years of age or older; 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 17 years of age; otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F for use in children six weeks through five years of age