Here are the relevant extracts from the two company's 10-K's:
AQLA:
Quilvax-M(TM) for the Control of Bovine Mastitis Bovine mastitis is an inflammation of a dairy cow's udder. Two pathogens cause the majority of infections resulting in mastitis: Staphylococcus aureus ("S. aureus") and Escherichia coli ("E. coli"). Mastitis is the most costly disease affecting the dairy industry. The economic impact in the United States of bovine mastitis is estimated to be $1.8 billion per year. According to the National Mastitis Council, losses per cow per year are $184 (there are about 9.5 million dairy cows in the U.S.). Mastitis in dairy cows results in lower milk quality and this lowers the economic value of the milk. Many times when an animal develops mastitis, it is simply culled from the herd. As a result, the farmer incurs costs due to animal treatment and replacement. Dairies pay a premium for high milk quality. There are a number of bovine mastitis vaccines on the market, but these are directed towards E. coli only. Aquila's Quilvax-M(TM) bovine mastitis product is bivalent, containing antigens for both S. aureus and E. coli, and is expected to provide broader control of mastitis. The S. aureus component of Quilvax-M(TM) is based on a patented cell surface protein from S. aureus called fibronectin binding protein. Fibronectin binding protein is primarily responsible for attachment of S. aureus to host tissue, in this case the epithelium of the bovine mammary gland. It is believed that this attachment is a critical step in the disease process and results in the inflammation and tissue destruction that characterizes mastitis. In the Company's Quilvax-M(TM) program, fibronectin binding protein is used as the target antigen for development of a beneficial immune response. Antibodies directed against fibronectin binding protein may block the attachment of S. aureus to mammary gland tissue and may help kill infected cells through antibody-dependent mechanisms. The Company has been making use of the ability to experimentally cause S. aureus mastitis by direct challenge of dairy cattle with bacteria deposited in the mammary gland. In a typical challenge experiment, the response of several groups of animals, both treated and non-treated controls, to a S. aureus challenge are compared. Recent studies indicate that Quilvax-M(TM)is safe and that it reduces the inflammatory response that develops upon infection. Measurement of parameters that determine milk quality and the price dairy producers would receive for their milk indicates that milk from animals vaccinated with Quilvax-M(TM) would have a higher value than that from non- treated controls. The E. coli portion of Quilvax-M(TM) is modeled after the E. coli mastitis products currently on the market. The marketed products make use of a mutant strain of E. coli that has slightly altered surface carbohydrate structure. Quilvax-M(TM) makes use of a similar E. coli mutant. Biochemical anlysis of Quilvax-M(TM) and the marketed products indicate that the amount of active component directed against E. coli present in Quilvax-M(TM) is similar to or exceeds that present in the marketed products. In order to receive authorization from the USDA to market Quilvax-M(TM), the Company must conduct formal efficacy trials for both the S. aureus and E. coli components of the product. Following successful completion of these studies, a formal safety study using the product on working dairy farms is required. The Company believes it could add a streptococcal component in a next generation product. The research costs are 50% funded by Virbac. The Company has retained exclusive marketing rights in North America while Virbac has exclusive marketing rights in Europe. The parties share marketing rights in the rest of the world.
NABI:
Recently, Nabi identified a serotype of S. AUREUS, named type 336, that accounts for over 90% of non-type 5 and non-type 8 S. AUREUS clinical infections (about 10-12% of all clinically significant S. AUREUS infections). The Company has identified, purified and characterized a polysaccharide from type 336 S. AUREUS and has prepared a glycoconjugate vaccine that is capable of protecting animals from challenge with clinical isolates of this serotype. During 1998, Nabi was issued a patent on a S. AUREUS 336 antigen, vaccines made from that antigen, and antibodies reactive to the antigen. Subsequent generations of Nabi-StaphVAX(TM) are expected to contain type 336 antigen in addition to type 5 and type 8 antigens. A prototype of this trivalent vaccine against S. AUREUS is currently in studies in dairy cattle under a Cooperative Research and Development Agreement ("CRADA") with the U.S. Department of Agriculture. The veterinary applications of Nabi-StaphVAX(TM) are of interest since S. AUREUS is a major cause of mastitis in dairy cattle worldwide.
Peter |
