New Data Published In The Lancet Show GSK's ROTARIX(R) Offers Protection Against The Most Common Circulating Rotavirus Types

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Infectious Diseases / Bacteria / Viruses;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 24 Nov 2007 - 0:00 PDT

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New data from a large European clinical trial published in The Lancet show ROTARIX(R), GlaxoSmithKline's (NYSE: GSK) oral rotavirus candidate vaccine to prevent rotavirus gastroenteritis, provides protection against the five most commonly circulating rotavirus types around the world and in the United States (U.S.). The GSK candidate vaccine, if approved by the U.S. Food and Drug Administration (FDA), would enable completion of the rotavirus vaccination series by four months of age. Severe, dehydrating gastroenteritis occurs most commonly among children aged three to 35 months. Of children in the U.S. hospitalized with rotavirus, approximately one in five are younger than six months old.

Results from this multi-center, randomized, double-blind, placebo- controlled phase III clinical trial involving almost 4,000 European infants (candidate rotavirus vaccine n=2,572; placebo n=1,302) demonstrated that two doses of ROTARIX provided highly effective and sustained protection through two consecutive rotavirus seasons (approximately two years of age). The data show that, through two rotavirus seasons, the vaccine was highly efficacious against rotavirus hospitalizations (96%), severe rotavirus gastroenteritis (90%) and against rotavirus gastroenteritis of any severity (79%). Specifically, significant protection was demonstrated against severe rotavirus gastroenteritis caused by types G1 (96%), G2 (86%), G3 (94%), G4 (95%), and G9 (85%), the most commonly circulating rotavirus types around the world and in the United States.

"The candidate vaccine contains a live, weakened form of natural human rotavirus derived from the most common human rotavirus strain with the goal of offering protection against the most commonly circulating and emerging rotavirus serotypes by mimicking the protective effects of natural human rotavirus infection," said David I. Bernstein, MD, MA, Director, Infectious Diseases; Gamble Program at Cincinnati Children's Hospital Medical Center. "These data are important because they confirm that immunization with two doses of the rotavirus candidate vaccine could provide broad protection against rotavirus gastroenteritis caused by emerging types in addition to those that are already commonly circulating."

In an additional analysis, protection against severe rotavirus gastroenteritis in the period between dose one and dose two was observed to be 90%. The protection offered by the two-dose schedule of this rotavirus vaccine observed as early as after dose one is particularly relevant as severe dehydrating rotavirus gastroenteritis can occur in infants as young as three months of age.

Since rotavirus is highly infectious, the spread of the disease may be difficult to control. Vaccination against rotavirus is recognized as the best measure to protect children against rotavirus disease and has been shown to be highly effective in preventing the disease.

The 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 with the rotavirus vaccine currently licensed by the FDA at two, four, and six months of age in order to prevent rotavirus gastroenteritis.

GSK's Biologics License Application (BLA) for the candidate rotavirus vaccine is currently under review by the U.S. Food and Drug Administration (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 could be integrated into the current vaccine schedule at the two and four month immunization visits.

About ROTARIX(R)

The GSK rotavirus candidate vaccine is a live-attenuated oral rotavirus vaccine licensed in more than 100 countries around the world. The vaccine is designed to prevent rotavirus gastroenteritis by mimicking the protective effects of natural human rotavirus infection. Studies have shown that natural rotavirus infection provides significant protection from moderate to severe disease, regardless of rotavirus strain. In clinical trials conducted in support of US licensure, the most common solicited adverse reactions were fussiness, runny nose, fever, loss of appetite, and vomiting. Adverse reactions among recipients of ROTARIX and placebo occurred at similar rates.

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 occur primarily 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 and 20-60 die each year. In the U.S., the rotavirus season begins in the southwest during November- December and spreads to the northeast by April-May.

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.

References:

1. Vesikari T., et al, Human rotavirus vaccine is highly efficacious against rotavirus gastroenteritis during the first two years of life in European infants: results of a randomised double-blind controlled study. The Lancet; 2007

2. American Academy of Pediatrics. Policy Statement: Prevention of Rotavirus Disease: Guidelines for Use of Rotavirus Vaccine.

3. Centers for Disease Control and Prevention. Prevention of Rotavirus Gastroenteritis Among Infants and Children. MMWR. 2006; 55(RR12); 1-13.

4. Centers for Disease Control and Prevention. The Pink Book - Rotavirus Chapter.

5. Dennehy PH. Transmission of rotavirus and other enteric pathogens in the home. Pediatric Infectious Disease Journal 2000; 19 (10 Suppl): S 103-5

6. Centers for Disease Control and Prevention. Rotavirus Disease: What You Need to Know.

7. Centers for Disease Control and Prevention. Recommended Immunization Schedule for Ages 0-6 Years - United States 2007.

8. Green KY, et al. Homotypic and Heterotypic Epitope-Specific Antibody Responses in Adult and Infant Rotavirus Vaccines: Implications for Vaccine Development. The Journal of Infectious Diseases. 1990;161:667-679.

9. GSK data on file.

GlaxoSmithKline
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