Rotarix: First vaccine against rotavirus available in Europe

27 February 2006, London UK and Rixensart, Belgium - The European Commission has granted approval of RotarixTM in the European Union (EU), allowing active vaccination of infants from the age of 6 weeks, against the highly contagious rotavirus. RotarixTM will be the first vaccine available to children in Europefor the prevention of gastroenteritis caused by rotavirus.

Rotavirus disease causes hospitalisation of 87,000 babies and over 700,000 visits to the doctor each year in Europe1. In total an estimated 3.6 million of the 23.6 million children under 5 years of age suffer from rotavirus gastroenteritis (RVGE) in the EU each year2.

RotarixTMis a two-dose, oral vaccine, that is administered at approximately two and four months of age to offer early protection against RVGE before the peak incidence of disease at 6-24 months 3,4,5. RotarixTM can be co-administered with all infant vaccines within the routine infant vaccination schedules across Europe6. RotarixTM has already been licensed in 33 countries and 1.4 million doses of the vaccine have been distributed since its first launch in Mexico in 2005.

“Rotavirus causes great discomfort for children, with diarrhoea and vomiting continuing for several days, which can lead to severe dehydration, and if left untreated can be fatal. The availability of a safe and effective vaccine, like RotarixTM, is exciting news for physicians as it will not only prevent these distressing symptoms that many children suffer, but will also help to reduce the burden on healthcare resources needed in treating outbreaks of the disease,” commented Prof. Dr. Timo Vesikari, University of Tampere, Finland.

Rotavirus is the leading recognised viral cause of diarrhoea-related illness among infants and young children3, with 95% of children worldwide experiencing an episode by the time they reach 3-5 years of age, irrespective of race or socioeconomic status7. Due to the large number of hospitalisations and outpatient visits1, there is a high economic burden associated with RVGE. According to a recent study, the total cost in France is €28 million per year10.

The high infection rate of rotavirus makes it difficult to control the spread of the disease. Therefore, vaccination is recognised as the only control measure to have a significant impact on the incidence of severe RVGE and is considered the optimum first line strategy for disease prevention 8,9.

The global clinical development program has proven that RotarixTM protects against the most common circulating strains (G1 and non-G1 rotavirus strains) including the globally emerging G9 strain2. The vaccines safety was shown in a recent trial that demonstrated that RotarixTM caused fewer serious adverse events (SAEs) compared to placebo. The safety analysis of this trial also showed that there is no attributable risk for intussusception, a complication which was observed with a previous marketed vaccine2.

About Rotarix

RotarixTM has been developed by GlaxoSmithKline Biologicals since 1997. RotarixTM strain RIX4414 derives from the strain 89-12, which was originally developed by Dr Richard Ward at the Children’s Hospitalof Cincinnati, and which was in-licensed from AVANT Immunotherapeutics. It is the first licensed attenuated human rotavirus oral vaccine conferring protection against severe rotavirus diarrhoea with data also showing efficacy against emergent strains. The vaccine is highly immunogenic and can be co-administered with all major infant vaccinations including oral polio vaccine6.

In addition to the European license, an additional 33 licenses have been granted worldwide (16 Latin American countries including Brazil; Philippines and Singapore being the first Asian countries). RotarixTM received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the Scientific Committee which evaluates the quality, safety and efficacy of medicinal products in the European Union on 15 December 2005. The European Marketing Authorisation from the European Commission announced today will make RotarixTM the first rotavirus vaccine available to children in Europe. Furthermore, RotarixTM has been filed for approval in 75 countries. RotarixTM is not approved in the US yet, however GSK is in late stage development discussions with the FDA regarding licensure of RotarixTM for the US market.

Recently, Brazil, Panama and Venezuela included, for the first time, the rotavirus vaccine in their national official vaccination calendars. As part of the government’s paediatric immunization program, vaccination with RotarixTM will be available free at public health clinics in those countries.

GlaxoSmithKline Biologicals

GSK Biologicals, one of the world’s leading vaccine manufacturers, is located 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 research 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 2005, GSK Bio distributed more than 1.2 billion doses of vaccines to 165 countries in both the developed and the developing world, an average of more than 3 million doses per day.

In the next five years, GSK expects to launch more major new vaccines: an HPV vaccine targeting cervical cancer, a vaccine to prevent pneumococcal disease, an improved flu vaccine for the elderly, and a meningitis combination vaccine for infants in the US.

GlaxoSmithKline — one of the world’s leading research-based pharmaceutical and healthcare companies — is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

Notes to editors

Intussusception is the most common abdominal emergency in children younger than one year of age, and occurs when one portion of the intestines slides into the next, like pieces of a telescope. It is now required to perform analysis of data from oral infant rotavirus vaccine trials to assess any potential risk of increased intussusception.

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the US 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 Operating and Financial Review and Prospects in the company’s Annual Report on Form 20-F for 2004.

References

1 Soriano-Gabarro M, et al. Burden of rotavirus disease in European countries. Paed Infect Dis J 2006:25 (1):S7-S11

2 Ruiz-Palacios GM, et al. A trial to assess the efficacy and safety of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med 2006;354 : (1) : 11-22

3 Huilan S et al. Bull WHO, 1991, Vol 69(5):549-555

4 Linhares AC et al. Rotavirus vaccines and vaccination in Latin America. Pan Am J Public Health 2000;8 (5):305-331

5 De Vos B, et al. A rotavirus vaccine for prophylaxis of infants against rotavirus gastroenteritis. Pediatr Infect Dis J 2004;23:S179-8

6 Steele AD. Et al. Concomitant administration of live attenuated oral rotavirus vaccine (RIX4414) with poliovirus vaccines in African infants. Poster presented at ESPID annual meeting, May 2005

7 Parashar UK, et al. Rotavirus. Emerg Infect Dis 1998;4(4):561-570

8 Dennehy PH. Transmission of rotavirus and other enteric pathogens in the home. Pediatr infect Dis J 2000;19(10 Suppl):S103-5

9 Parashar UD, et al. Global illness and deaths caused by rotavirus disease in children. Emerg Infect Dis 2003;9:565-72

10 Melliez H, et al. Mortalité, morbidité et cout des infections à rotavirus en France. BEH, 35/2005, 175-176

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