Rotarix - WAVEnovaccine.com/wp-content/uploads/2014/02/Rotarix_scary_presentation.pdf120 Rotavirus:...
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Rotarix
Beatrice De Vos, MD, BCPMDirector, Worldwide Medical Affairs
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Rotavirus:a global
market for aglobal need
Rotarix
Rotarixhigh value potential
Rotarixproductprofile
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Rotavirus: A Highly Contagious Virus Leading to Severe Dehydration in Children
• Transmission fecal-oral • Infectious for several days
• First infection is most severe Hospital
FamiliesDay care
Transmission
• Fever, watery diarrhea and vomiting à dehydration
Velazquez FR et al. N Engl. J Med, 1996;335(14):1022-1028
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Rotavirus: Leading Cause of Hospitalizationfor Diarrhea in Children Under 5
• Source of Winter Chaos in Hospitals • Cause of Prolonged Stay in Hospital
Community acquired RV hospitalizations - children < 5 y (Germany)
X 11
Noah, N. and Henderson, B.(2002). Surveillance of bacterial meningitis in Europe 1999/2000. European Bacterial Meningitis Surveillance Project. PHLS Communicable Disease Surveillance Centre.
Verstraeten T et al. Proc 23rd Ann Meeting Eur Soc Paediatric. Infect Dis (ESPID) May 18-21, 2005, Spain
0
2000
4000
6000
8000
10000
12000
Rotavirus Meningitis (any)
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Rotavirus: A Variety of Serotypes with Global Distribution
• Rotavirus comes in many serotypes, however, rotavirus diarrhea is most commonly associated with 4 key serotypes:
– G1P[8], G2P[4], G3P[8] and G4P[8]
Adapted from Parashar et al, Emerg Infect Dis 1998 4(4) 561–570; Gentsch et al, J Infect Dis 1996 174(1) S30–S36. Reproduced with permission from The University of Chicago Press.
53%
11%
5%
14%
3%
14%Global distribution of RV strains G1P[8]
G2P[4]
G3P[8]
G4P[8]
Mixed
Others: NT
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Rotavirus: A Quick-Changing Artist
• Prevalence of the RV serotypes changes yearly
• Newly emerging strain = G9
% UK rotavirus diarrhea caused by RV serotypes over time (1995-2003)
Itturiza-Gómara M et al. Journal of Clinical Microbiology 2000 38(12) 4394-4401
0
25
50
75
100
1995-96 1996-97 1997-98 2000-01 2001-02 2002-03
G1
G2
G3
G4
G9
Other
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Rotavirus Burden is Extensive
Each child will be infected at least once before his 5th birthday, wherever they live and whether they are rich or poor1
Each child will be infected at least once before his 5th birthday, wherever they live and whether they are rich or poor1
1 in 6 will require a physician visit11 in 6 will require a physician visit1
1 in 45 will require hospitalisation11 in 45 will require hospitalisation1
1 Parashar T et al. Emerg Infect Dis 2003 9(5) 565-5722 Verstraeten T et al. Proc 23rd Ann Meeting Eur Soc Paediatr. Infect Dis (ESPID) May 18-21, 2005, Spain
1 in 40,000
1 in 1,000
1 in 500
US1 Middle IncomeCountries Int'l1
Low IncomeCountries1,2
And significant mortality risk varies across the world1:And significant mortality risk varies across the world1:
Ris
k of
mor
taili
tyin
ch
ildre
n un
der
5
1 in 55,000
Europe1
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Lesson from Nature:
Two natural rotavirus infections confer ~ 100% protection against moderate/severe diarrhea and vomiting, regardless
of serotype
Velazquez et al, N Eng J Med 1996 335 1022–1028; Velazquez et al, J Infect Dis 2000 182 1602–1609;
RV Vaccine should mimic the immune response to a natural rotavirus infection in order to:
• Protect against moderate/severe disease
• Prevent hospitalization and death
• Reduce morbidity and socioeconomic burden
Goal of Rotavirus Vaccination
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Rotavirus:a global
market for aglobal need
Rotarix
Rotarixhigh value potential
Rotarixproductprofile
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Striking temporal association
Murphy et al, N Engl J Med 2001 344 564–72. Copyright © 200x [2001] Massachusetts Medical Society. (All rights reserved)
Rotavirus Vaccines: A Bit of History…. Rotashield
• Rhesus-based 4-valent vaccine by Wyeth• Licensed by FDA in August 1998 • Recommended for Universal Use by ACIP/AAP in 1998• Withdrawn in October 1999 due to link with Intussusception
(IS = bowel obstruction)
VaccinationFirst Dose
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GSK’s Rotarix: based on an attenuated single human RV strain to mimic natural protection
- based on most prevalent circulating strain globally- present more relevant antigens- safe as no link between human rotavirus natural infection and IS
Two vaccines – Two different development strategies
Merck’s vaccine: based on an attenuated 5-valent animal (bovine) human reassortant RV strain
- combined with human proteins to increase breadth of protection
Rotavirus Vaccines:Newly Licensed or Late Stage RV vaccines
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Rotarix: Outstanding Efficacy
*Statistically significant**Meta-analysis of studies 004-006-023G4: no data available
Any RV-GE*1
73%
G1*
92%
G9*
91%
G3*
88%
G2**
67%
All G-types2
severe RV-GE*85%
Hosp RV-GE2*
85%
EU studiesEU studies Latin-America studiesLatin-America studies
1 Vesikari T et al, Pediatr Infect Dis J 2004; 23(10):937-9432 Velazquez FR et al, Proc 23rd Annual Meet Soc Paediatr
Infect Dis (ESPID), 2005, abstr 5
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• More than 100,000 doses of Rotarix administered
• No fever, diarrhea or vomiting increase vs placebo
Rotarix: Safe and Evidence of No Increased Intussusception Risk after Vaccination
Treatment Group
IS cases within 30-day
window
IS casesoutside 30-day
window
Total
Rotarixn ~ 31,000
6 3 9
Placebon ~ 31,000
7 9 16
O'RyanM et al Proc 44th ICAAC Washington 2004:14
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Product Profiles: GSK’s Rotarix and Merck’s Bovine based vaccine candidate
Rotarix Merck
üü• Safety
Results show no increased risk for IS
protective
No data communicatedü üü
• ProtectionAny - Severe RV GE:Cross-protection: Oral Polio Virus co-admin:
protective
5• Manufacture
Number of strains 1
Bitter
2 doses, 1 ml 3 doses, 2 ml
Sweet
• ConvenienceNumber of doses, volume Taste
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Rotavirus:a global
market for aglobal need
Rotarix
Rotarixhigh value potential
Rotarixproductprofile
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Precedent For Medical Need and Market Potential
Before withdrawn, Rotashield was: Recommended by ACIP / AAP and was put on Vaccines For Children formulary
• On the market for 10 months • with roughly 1.1 million doses • administered to 600,000 infants • out of 4m birth cohort
• Priced at $38 per dose, 3 per course ($114)
Source: http://www.cdc.gov/nis/pdfs/miscellaneous/khare2003c.pdf
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Rotavirus Market Potential 2010 by Region
Estimated Global Market 2010: £1.0-1.3 billion
GAVI15%
US25%
International
40%
Europe20%
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Rotarix: Dynamic Market Building
US - Europe - International
Low Income Countries
• Market build-up (disease awareness)• Product differentiation
• Manufacture Capacity build-up• Partnership with Public Sector
WHO Recommendation WHO Recommendation
ACIP - Country Recommendation ACIP - Country
Recommendation
One Objective: Universal Mass VaccinationOne Objective: Universal Mass Vaccination
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20062005
LaunchMexico
Q2 06
Rotarix: Key Milestones
Jan Q3-Q4
2007
4Q07
20082004
FileEU
LaunchLatin-America
LaunchEU
Dec Q1 06
• Ongoing FDA Discussion
LaunchAsia Pacific
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Rotarix: Conclusion
ü High medical need demonstrated
ü Rotarix: Broad protection
ü Rotarix: Early protection with 2 doses
ü Rotarix: Excellent safety profile;No increased risk for IS