New Study Results for LYMErix(TM) Demonstrate Individuals can be Immunized Faster

Additional Pilot Study Finds Vaccine Well-Tolerated and Immunogenic in Children

ADVANCE FOR RELEASE AT 12:00 PM EDT FRIDAY, NOVEMBER 13 ADVANCE/ DENVER, Nov. 13 PRNewswire

Three doses of LYMErix(TM) ([Lyme Disease Vaccine (Recombinant OspA)], SmithKline Beecham) when given to adults on an accelerated dosing schedule of 0, 1, 2 months provide a comparable antibody response to that obtained in the LYMErix pivotal efficacy trial, according to a new study presented today at the 36th annual meeting of the Infectious Diseases Society of America (IDSA) in Denver.

In the pivotal efficacy trial, LYMErix demonstrated vaccine efficacy rates of 79 percent against definite Lyme disease (characteristic symptoms with laboratory confirmation) and 100 percent against asymptomatic infection (no symptoms, but laboratory confirmation of infection) when given on a 0, 1, 12 month schedule in individuals 15-70 years of age. The study results presented at IDSA today (0, 1, 2 dosing schedule) are derived from one of a series of trials evaluating accelerated dosing schedules. Accelerated dosing would allow people to complete the full immunization series in a shorter period of time.

"Flexibility of dosing will provide the millions of Americans at risk for Lyme disease a quicker means of becoming immunized," said Vijay Sikand, M.D., adjunct assistant professor of medicine at Tufts University School of Medicine. " The study results demonstrate that LYMErix is well-tolerated and produces high antibody titers when three doses are administered within two months."

Study Demonstrates Shortened Dosing Schedule Yields Similar Results

In the study presented for the first time at IDSA today, individuals receiving LYMErix on a 0, 1, 2 month schedule had antibody responses comparable to those of individuals receiving the vaccine on a 0, 1, 12 month schedule in the efficacy trial. All participants received two injections of LYMErix at 0, 1 months. Half of the individuals were then randomized to receive an additional dose at either month 2 or month 12. Clinical signs and symptoms were recorded on diary cards for four days after each dose. Blood was collected one month after the second and third doses. LYMErix was safe and well-tolerated. Most local and general reactions reported were mild to moderate in severity and self-limited.

Additional Study Shows LYMErix May Benefit Children

Results from a separate study presented at IDSA today indicate that LYMErix, when given on a 0, 1, 2 month schedule, is well-tolerated and immunogenic for children. This pilot study included 250 children ages 5-15 in the Czech Republic who received 15 or 30 mg of OspA. Both vaccine dosages of LYMErix were safe and well-tolerated. A study is currently under way in the United States to determine the safety and immunogenicity of 30 mg of LYMErix in children ages 4 and older.

LYMErix is currently under review by the U.S. Food and Drug Administration (FDA). An FDA Advisory Committee recently found LYMErix safe and effective for the prevention of Lyme disease -- one of the fastest-growing infectious diseases in the United States.

Lyme Disease: A Widespread and Potentially Debilitating Disease Lyme disease

This is a multi-stage disease caused by infection with a spiral-shaped bacterium (called a spirochete) known as Borrelia burgdorferi, which is carried by ticks. Experts believe it may be underreported by as much as 10 times.

The onset of Lyme disease is commonly associated with a characteristic skin rash known as erythema migrans (EM), which can vary in size and location. EM is often accompanied by flu-like symptoms including headache, fever, fatigue, joint aches, muscle aches and a stiff neck. When diagnosed early, Lyme disease can usually be successfully treated with antibiotics without any long- lasting complications. However, diagnosis can be difficult because symptoms may imitate other illnesses. After successful treatment of early Lyme disease, permanent immunity may not develop and reinfection is possible.

If undetected and left untreated, the Lyme bacteria can spread to other parts of the body months to years following a bite and manifests itself as late- stage Lyme disease. The bacteria can affect the joints, tendons, heart or nervous system, potentially resulting in arthritis, heart abnormalities such as heart block and myocarditis (inflammation of the muscular walls of heart) and Bell's palsy (paralysis of one or both sides of the face).

SmithKline Beecham (NYSE: SBH) -- one of the world's leading healthcare companies -- discovers, develops, manufactures and markets pharmaceuticals, vaccines, over-the-counter medicines and health-related consumer products, and provides healthcare services including clinical laboratory testing, disease management and pharmaceutical benefit management. For company information, visit SmithKline Beecham on the World Wide Web at http://www.sb.com.

Source: SmithKline Beecham