This is a scientifically proven product which perfectly complements our portfolio of Gastrointestinal Health products. It is based on the same antigen-primed, hyper-immuniz colostrum, and the synergy with our existing know-how will allow us to reliably provide life saving products at relatively low cost
MELBOURNE, Australia & WASHINGTON (PRWEB) March 10, 2008
Each year more than 600,000 children die from rotavirus-caused diarrhea and another two million children are hospitalized, predominantly in developing countries (WHO). The virus is spread through exposure to contaminated food and water. Before age five, every child in the world will suffer at least one episode of rotavirus disease, a condition associated with diarrhea, fever and vomiting. The CDC estimates 55,000 children each year in the United States are hospitalized because of rotavirus diarrhea, and that rotavirus is the most common cause of severe diarrhea in children.
GastroGard-R provides prophylactic treatment of at -risk children aged one month to three years to prevent diarrhea due to rotavirus. Rotavirus is very infectious in young children and outbreaks occur frequently during winter in hospitals, daycare centers, and in the family setting.
Two vaccines have been licensed in the global effort to prevent rotavirus diarrhea related morbidity, Merck's RotaTeq (NYSE: MRK) and GlaxoSmithKline's RotaRix (NYSE: GSK) while several global partnerships have been established, involving non-profit agencies, the CDC and the World Health Organization, to reduce the costs of deploying these expensive vaccines. GastroGard-R is positioned to complement vaccine initiatives as part of this worldwide disease control effort. Providing immediate-acting (so-called "passive") immunity by oral means is especially important for the millions of children without access to these new vaccines, such as children who are too young or old to receive vaccine priority, as well as children at risk from epidemic disease spread in refugee camps, hospitals or daycare centers.
GastroGard-R is a non-sterile, oral powder, consisting of the concentrated proteins, including immunoglobulins, from the pre-milk (colostrum) of hyper-immunised cows. The primary immunoglobulin in the formulation is IgG1.
GastroGard-R has been studied extensively and has been in use throughout Australia for many years but has not been commercialized globally until now. Six hospital-based clinical studies were performed with GastroGardR, four in Australia and two in other countries. Five of these studies were randomized, double blind, placebo-controlled design and the other study was open. Patients were aged from 28 days to three (3) years and combined analysis of these studies demonstrated a statistically significant reduction in the incidence of rotavirus infection in children given GastroGard-R compared with children not given GastroGard-R(R) (p less than 0.001).
A community based clinical study was carried out in South Australia in childcare centers to evaluate the health outcomes associated with the daily use of an equivalent liquid product containing hyper-immune bovine pre-milk with anti-rotavirus antibodies. The study was a double blinded, two-way parallel, cluster randomized design in over 700 children aged less than four years. The analysis showed a statistically significant protective effect for the anti-rotavirus antibody formulation.
The first clinical trial of GastroGard-R was published in 1989 in the Lancet, a leading medical journal. The Government of South Australia built the initial facilities to manufacture this product, which was manufactured in Australia by Numico Research from 1996 until last year. During this period, GastroGard-R was approved by Australia's well-regarded regulatory authority, the TGA, and routinely and safely used throughout Australia. Anadis intends to manufacture GastroGard-R itself and re-register the product.
Anadis will promote GastroGard-R alongside its similar antibody containing formulation proven to prevent enterotoxigenic E. coli (ETEC) virus diarrheal disease. ETEC is the number one cause of travelers' diarrhea worldwide, for which Anadis's Travelan product is now commercially sold in Australia.
Apart from affecting travelers, ETEC is also a major problem throughout the developing world for both adults and children and is responsible for more than 200,000 deaths annually in young children. Of the 1.8 million children who die annually as a result of diarrheal disease in developing countries, ETEC and rotavirus are the two leading causes. In addition, diarrhea is a major contributory cause of malnutrition. No vaccine exists yet to protect children from ETEC bacteria, which are spread through contaminated food and water.
The ETEC and rotavirus products can readily be combined to reduce pediatric death and disease worldwide at a very affordable cost, using child-friendly delivery formats, including their inclusion into various powdered nutritional products, beverages, caplets or chewables.
Dr. Zeil Rosenberg, Anadis CEO said at the Washington D.C. BIO-Gates Foundation meeting, "Rotavirus is a major health problem in developing countries. We plan to work with humanitarian agencies to combine the product with Travelan, our anti-E.coli bacteria formulation, for use in various nutritional products or stand-alone, in order to address this major health problem. "
Dr. Oren Fuerst, the VP Business Development of Anadis said, "This is a scientifically proven product which perfectly complements our portfolio of Gastrointestinal Health products. It is based on the same antigen-primed, hyper-immuniz colostrum, and the synergy with our existing know-how will allow us to reliably provide life saving products at relatively low cost"
The Partnering for Global Health Forum 2008 is sponsored by the Bill and Melinda Gates Foundation and organized by the Biotechnology Industry Organization (BIO) and BIO Ventures for Global Health. It brings together leaders from the biopharmaceutical industry, funders and international health experts to accelerate market based solutions to the neglected diseases of the developing world.
About Anadis ( http://www.anadis.com ):
Anadis Limited (ASX: ANX, OTC:ANDIY) is a biopharmaceutical company producing antibodies and other bioactive proteins as health products. Its all-natural, orally administered and colostrum-derived platform is proven safe and effective, with regulatory classification as GRAS (Generally Regarded as Safe) and BSE-free certification, allowing for rapid progression from concept to market. The company's core technology relies on advanced dairy industry processing methods including immunization of pregnant cows with proprietary antigen specific vaccines, which in turn elicit an immune response by the cow. First-milking colostrum contains more than 35% immunoglobulin and this targeted antibody, along with other immune system bioactive nutrients, is subsequently harvested, fractionated and freeze dried under the highest dairy industry standards. The company is addressing a variety of unmet human health needs with broad market demand, including: Oral and GI Mucositis; Inflammatory Bowel Disease (IBD); Irritable Bowel Syndrome (IBS); Travellers' Diarrhea; Influenza and Rotavirus. The company operates from Melbourne, Australia and New York City.