Anadis announced today its commercialization of a new product, BioGard, intended to maintain gastrointestinal and immune system health. The specific formulation may be of particular clinical benefit in persons undergoing antiretroviral therapy for HIV/AIDS.
The product is intended to enhance current treatment regimens and improve the efficacy of immune system repair during highly active antiretroviral treatment (HAART) treatment. The gastrointestinal immune system is increasingly recognized as having an important role in the progression of HIV-related immune depletion and local gastro-intestinal symptoms have been a great concern to HIV/AIDS patients. The target market for the product includes over 1 million patients in the U.S., 2 million in Europe and Central Asia and more than 30 million worldwide. BioGard is intended to be marketed as a medical food, used under medical supervision, although available for purchase over-the-counter, and is expected to be launched in 2009 following results from a phase IIIb/IV multi-site clinical trial beginning this year that is an advanced stage of planning.
The product's active ingredient is a proprietary oral formulation of antigen-targeted Bovine Colostrum Powder (BCP) that has been approved by Australia's regulatory agency, the Therapeutic Goods Administration (TGA). The product will be first available in tablet format manufactured and packed in a TGA registered GMP tableting facility. Like other Anadis BCP products, the freeze-dried active ingredients in BioGard tablets is obtained from commercial dairy cow herds utilizing the patented Anadis hyper-immunization technology and deploying unique collection processes to assure quality . The BSE free cows in these herds, as well as being vaccinated for routine cattle pathogens, have been vaccinated with a proprietary Anadis vaccine containing important lipopolysaccarides found in gram negative bacterial cell walls that are implicated as key drivers of AIDS pathogenesis. Data supporting this work was first presented recently by scientists from Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, Victoria and the Department of Microbiology & Immunology, University of Melbourne at the Australian Society for Microbiology annual meeting held in Melbourne.