SmithKline Beecham Advances Clinical Development of the AVANT Rotavirus Vaccine
NEEDHAM, Mass., March 8 /PRNewswire/ -- AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN - news) announced today that SmithKline Beecham (NYSE: SBH - news) has advanced clinical development of the human-derived, two-dose oral rotavirus vaccine licensed from AVANT. SmithKline presented its clinical development program at a World Health Organization meeting on vaccine development in Geneva, Switzerland. AVANT developed the rotavirus vaccine and licensed it to SmithKline Beecham Biologicals (SB Biologicals) of Rixensart, Belgium. In 1999, SB Biologicals assumed clinical and process development of the vaccine after AVANT successfully completed a Phase II efficacy study in infants.
SB Biologicals has initiated Phase I/II bridging studies in Europe using its newly manufactured rotavirus vaccine, called Rotarix(TM). SB Biologicals is now planning to start Phase III safety and efficacy studies in 2001 after review with health authorities.
``We are very pleased to be working with SB Biologicals in advancing worldwide development of this important pediatric vaccine candidate,' said Una Ryan, Ph.D., President and Chief Executive Officer of AVANT Immunotherapeutics. ``We are confident that SmithKline's expertise as a world- leading provider of vaccines together with their established global distribution franchise will maximize the commercial potential of this product.'
``We are delighted to have achieved these important steps in our collaboration with AVANT, and we will continue to work to develop and commercialize this oral rotavirus vaccine. Our ability to establish the commercial manufacturing process and the demonstrated efficacy of this vaccine candidate in the earlier Phase II trial clearly suggests that we may have an excellent vaccine product for the world,' said Dr. Jean Stephenne, President and General Manager, SmithKline Beecham Biologicals.
The AVANT/SB Biologicals vaccine candidate is an attenuated vaccine derived from a naturally occurring isolate of rotavirus found in children. In the 215 infant Phase II efficacy trial published in The Lancet in July 1999, approximately 90 percent of the vaccinated infants were protected from rotavirus disease with a statistical significance of p < 0.001. Investigators from the Centers for Disease Control (CDC) have reported that natural rotavirus infection is not associated with intussusception, a form of bowel obstruction.
In December 1997, AVANT licensed its rotavirus vaccine exclusively to SB Biologicals for further development and commercialization. Under the agreement, SB Biologicals is responsible for all further development, and AVANT will receive milestone payments at various stages of development and regulatory approval. Also, AVANT will be entitled to royalties upon commercialization of the vaccine.
Rotavirus is a major cause of acute diarrhea and dehydration in infants, which, in the absence of appropriate treatment, can rapidly lead to death. Approximately 500,000 infants in the United States require medical treatment annually, with 10-15% requiring hospitalization. Worldwide, rotavirus infection causes death in an estimated 750,000 children annually, mostly in developing countries.
SmithKline Beecham Biologicals is located in Rixensart, Belgium, and is the center of all SmithKline's activities in the field of vaccine research, development and production. SB Biologicals employs over 600 research scientists who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections which cause serious medical problems worldwide. SB Biologicals produces 700 million doses of vaccines per year for the developing and developed world. Every second, over 20 doses of SB Biologicals vaccines are distributed around the world. SmithKline Beecham -- 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 and disease management.
AVANT Immunotherapeutics, Inc. is engaged in the discovery, development and commercialization of products that harness the human immune response to prevent and treat disease. The company's lead therapeutic program, now entering late stage clinical trials, focuses on compounds that inhibit inappropriate activation of the complement cascade, a vital part of the body's immune defense system. AVANT is also developing on its own a proprietary therapeutic vaccine for the management of atherosclerosis and Therapore(TM), a novel system for the delivery of immunotherapeutics for chronic viral infections and certain cancers. The company and its collaborators are developing vaccines using the proprietary adjuvants, Adjumer© and Micromer©, for the prevention of influenza, Lyme Disease and respiratory syncytial virus (RSV). Through additional collaborations, AVANT is also developing an oral cholera vaccine.
Additional information on AVANT Immunotherapeutics, Inc. and SB Biologicals can be obtained through the companies respective websites: avantimmune.com and sb.com. |
