ROTARIX Vaccine Approved by
Mexican Authorities for the Prevention of Severe Gastroenteritis in Infants
July 19, 2004
AVANT Immunotherapeutics, Inc (Nasdaq: AVAN) today reported that its
partner, GlaxoSmithKline (GSK) announced that the Board of Health in Mexico
have approved the Rotarix(R) vaccine for marketing in Mexico for the
prevention of gastroenteritis caused by rotavirus infection. Rotarix(R) has
been in development at GSK Biologicals since 1997 when it was in-licensed
from AVANT.
"We are delighted to announce this initial approval for Rotarix(R), which
marks a significant event for AVANT - the
first commercial approval of a human healthcare product from AVANT's
extensive portfolio of advanced vaccines," said Una S. Ryan, AVANT President
and Chief Executive Officer. "It also marks an important advance in the
fight against rotavirus disease, a major cause of serious illness and
mortality in infants for much of the world."
Rotavirus infection is the leading cause of severe diarrhea and vomiting in
infants and young children between 3-24 months world-wide. If untreated, the
virus can rapidly kill, as the sickest children become dehydrated from 10 to
20 episodes of diarrhea in a single day. Globally, rotaviruses account for
approximately 138 million cases of infantile gastroenteritis each year and
it was recently reported that rotavirus is responsible for approximately
440,000 deaths per year, a child a minute, the majority of which occur in
the Indian subcontinent, sub-Saharan Africa and South America.
Rotarix(R) is an oral, two-dose, live attenuated vaccine developed from a
single human strain designed to provide broad protection against multiple
rotavirus strains and to provide early protection before the onset of
rotavirus illness. The vaccine works by stimulating the body to mimic the
immune response to natural rotavirus infection, which protects against the
subsequent development of moderate to severe rotavirus disease.
More than 70,000 infants have been enrolled in the global clinical
development program, with studies conducted in Europe, the US, Latin America
and Asia to evaluate the safety and efficacy of Rotarix(R). These studies
demonstrate that Rotarix(R) is an effective, safe and well-tolerated
vaccine.
Rotarix(R) has shown up to 90% efficacy against severe rotavirus-related
gastroenteritis in the first year of life, as defined by the well
established and widely used Vesikari 20-point scale, and up to 84% efficacy
in the second year of life against severe rotavirus-related gastroenteritis.
In addition, Rotarix(R) was 86% effective in preventing hospitalizations due
to rotavirus-related gastroenteritis. Rotarix(R) has demonstrated protection
against different circulating strains of rotavirus when compared to the
original strain of the vaccine.
Rotarix(R) has demonstrated a side effect profile similar to that of a
placebo vaccine with only limited reactogenicity observed. To date, there is
no evidence of an increased risk of intussusception. An Independent Data
Safety Monitoring Board (IDSMB), which monitors the safety aspects of the
Rotarix(R) clinical development program, is reviewing the data on an ongoing
basis.
"We are delighted that Mexico has become the first country in the world to
approve Rotarix(R), an important new vaccine to prevent severe
rotavirus-related gastro-enteritis in infants worldwide," said Jean
Stephenne, President and General Manager of GSK Biologicals.