If Approved, New Candidate Vaccine Could Offer Completion of the Rotavirus
Vaccination Series by Four Months of Age
PHILADELPHIA, Aug. 14 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE:
GSK) today announced that the U.S. Food and Drug Administration (FDA) has
accepted for review its Biologics License Application (BLA) for Rotarix(R),
an oral candidate vaccine for infants to prevent rotavirus gastroenteritis.
Severe, dehydrating gastroenteritis occurs primarily among children aged
three to 35 months. Of children hospitalized with rotavirus, approximately
17 percent are younger than six months old. If approved, the GSK candidate
vaccine could offer completion of the rotavirus vaccination series by four
months of age. The rotavirus candidate vaccine is a live- attenuated
vaccine derived from the most common human rotavirus strain. Published data
show that immunity resulting from natural human rotavirus infection
provides significant protection against moderate to severe disease,
regardless of rotavirus strain.
The BLA for the GSK rotavirus candidate vaccine is based on one of the
largest clinical development plans undertaken by a vaccine manufacturer and
includes data from nearly 75,000 infants. These clinical trials were
conducted in the Americas, Europe, Asia and Africa and reflect an
ethnically diverse population.
"This vaccine, which is designed to protect in a manner similar to
natural human infection, could make a considerable contribution in
protecting very young infants from rotavirus disease, a significant burden
on families and the healthcare system in the U.S.," said Barbara Howe,
M.D., Vice President, North American Vaccine Development, GlaxoSmithKline.
"We also believe it is important to immunize infants against rotavirus as
early as possible."
The Centers for Disease Control and Prevention's (CDC) Advisory
Committee on Immunization Practices (ACIP), the American Academy of
Pediatrics (AAP), and the American Academy of Family Physicians (AAFP)
recommend that infants receive routine vaccination against rotavirus to
prevent rotavirus gastroenteritis with the vaccine currently licensed by
the FDA at two, four, and six months of age.
About Rotarix(R)
The GSK rotavirus candidate vaccine is a live-attenuated oral rotavirus
vaccine licensed in 99 countries around the world. The vaccine is designed
to prevent rotavirus gastroenteritis by mimicking natural rotavirus
infection. Studies have shown that natural rotavirus infection provides
significant protection from moderate to severe disease, regardless of
rotavirus strain. In the file under review by the FDA, it is proposed that
the vaccine would be given in two oral doses beginning at six weeks of age
and completed by 24 weeks of age, with a minimum four-week interval between
the doses. If approved, the vaccine would typically be administered at the
two and four month immunization visits.
About Rotavirus
Rotavirus infects virtually every child worldwide by age five and is
the leading cause of severe acute gastroenteritis in infants and young
children in the U.S. and worldwide. Severe diarrhea and dehydration occurs
from as young as three months of age. In the U.S. each year, 2.7 million
children younger than five years of age suffer from rotavirus disease,
resulting in 410,000 clinic visits and up to 272,000 emergency room visits.
In addition, between 55,000 and 70,000 children are hospitalized each year
and 20-60 die.
GlaxoSmithKline: A Leader in Vaccines
GlaxoSmithKline, with U.S. operations in Philadelphia, PA, and Research
Triangle Park, NC, is one of the world's leading research-based
pharmaceutical and healthcare companies and is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer.
GSK Biologicals (GSK Bio), one of the world's leading vaccine
manufacturers, is headquartered in Rixensart, Belgium, where the majority
of GlaxoSmithKline's activities in the field of vaccine research,
development and production are conducted. GSK Bio employs more than 1,500
scientists, who are devoted to discovering new vaccines and developing more
cost-effective and convenient combination products to prevent infections
that cause serious medical problems worldwide. In 2006, GSK Bio distributed
more than 1.1 billion doses of vaccines to 169 countries in both the
developed and the developing world -- an average of 3 million doses a day.
Of those vaccine doses, approximately 136 million were doses of combination
pediatric vaccines which protect the world's children from up to six
diseases in one vaccine.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities
Litigation Reform Act of 1995, the company cautions investors that any
forward-looking statements or projections made by the company, including
those made in this Announcement, are subject to risks and uncertainties
that may cause actual results to differ materially from those projected.
Factors that may affect the Group's operations are described under 'Risk
Factors' in the 'Business Review' in the company's Annual Report on Form
20-F for 2006.
Inquiries:
U.S. Media Inquiries: Liad Diamond +1 919 483 2839
Nancy Pekarek +1 919 483 2839
Mary Anne Rhyne +1 919 483 2839
U.K. Media Inquiries: Philip Thomson +44 20 8047 5502
Claire Brough +44 20 8047 5502
Joss Mathieson +44 20 8047 5502
U.S. Analyst/Investor
Inquiries: Frank Murdolo +1 215 751 7002
Tom Curry +1 215 751 5419
European Analyst/Investor
Inquiries: Sally Ferguson +44 20 8047 5543
David Mawdsley +44 20 8047 5564
GSK Biologicals: Tobias Viering + 32 2 656 3356
Chris Hunter-Ward + 32 2 656 3075
References
1 Centers for Disease Control and Prevention. Prevention of Rotavirus
Gastroenteritis Among Infants and Children. MMWR. 2006; 55(RR12); 1-13.
Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5512a1.htm.
Accessed on May 31, 2007.
2 Green KY, et al. Homotypic and Heterotypic Epitope-Specific Antibody
Responses in Adult and Infant Rotavirus Vaccinees: Implications for Vaccine
Development. The Journal of Infectious Diseases. 1990;161:667-679.
3 GSK Clinical Trial Register. Available at: http://ctr.gsk.co.uk.
4 Centers for Disease Control and Prevention. Recommended Immunization
Schedule for Ages 0-6 Years - United States 2007. Available at:
http://www.aafp.org/online/etc/medialib/aafp_org/documents/clinical/immuniz
ati on/childsched.Par.0001.File.dat/childsched.pdf. Accessed on July 22,
2007.
SOURCE GlaxoSmithKline
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CONTACT: Liad Diamond, +1-919-483-2839, for GlaxoSmithKline
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