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Biotech / Medical : VD's Model Portfolio & Discussion Thread -- Ignore unavailable to you. Want to Upgrade?

To: scaram(o)uche who wrote (7662)	3/5/2000 9:31:00 PM
From: Vector1	Read Replies (3) \| Respond to of 9719

VDers, Any thoughts on NABI. The existing product portfolio of Plama derived niche products is not exciting, however, they have a Staph vaccine in phase III. The valuation is " relatively" cheap. The following is from their web site: Nabi is developing two products for the prevention and treatment of S. aureus infections. Nabi© StaphVAX© is a capsular polysaccharide-based glycoconjugate vaccine which targets the two S. aureus serotypes (Type 5 and Type 8) responsible for over 85% of S. aureus infections. Of the remaining 15%, 98% of those are caused by the so called Type 336 serotype, for which Nabi has patent protection and will be folding into a trivalent vaccine in the future. The current vaccine is based on patented vaccine technology in-licensed by Nabi from the Public Health Service (PHS). Nabi© StaphVAX© seeks to induce specific antibodies in vaccinated individuals that bind to and help kill invading S. aureus bacteria. The second product, Nabi© Altastaph? is a specific human antibody-based product that contains high levels of antibodies against S. aureus. Nabi© StaphVAX© and Nabi© AltastaphTM rely on completely different mechanisms of action than those of systemic antibiotics and, based on preclinical data, these products may be shown to be effective against even antibiotic resistant strains of S. aureus. In addition, since vaccines and antibodies present a different mechanism of action from that of antibiotics, Nabi is attempting to demonstrate that concurrent use of Nabi© StaphVAX© or Nabi© Altastaph? and antibiotics will act synergistically, to combat infection and may reduce the spread of additional antibiotic resistant strains of bacteria in the future. Nabi© StaphVAX© is being developed for patients who are at long term, high risk of infection and who are immunocompetent and thus able to respond to a vaccine. The initial clinical target is hemodialysis patients with end stage renal disease ("ESRD") who are at high risk of S. aureus infections due to their vascular access grafts. Other potential clinical targets for Nabi© StaphVAX© include: (a) at risk patients such as the elderly who are expected to have long stays in medical or extended care facilities; (b) patients undergoing planned surgery who can be vaccinated in advance and in whom staphylococcal infections can have serious consequences; and (c) prosthetic surgery and vascular graft patients whose implants are at long-term risk of staphylococcal infections. Preclinical studies using either rats or mice in several different bacterial challenge models have demonstrated the efficacy of active immunization with Nabi© StaphVAX© and passive immunization with Nabi© Altastaph?. In the prophylactic settings studied, antibodies to Nabi© StaphVAX©, whether actively acquired (through vaccination) or passively acquired (through the use of Nabi© Altastaph?), conferred statistically significant protection against the relevant S. aureus challenge strains. In human clinical trials to date, Nabi© StaphVAX© has been well tolerated and immunogenic. Nabi© StaphVAX© has now completed enrollment in its Phase III pivotal trial in ESRD patients on hemodialysis. In August of 1999, Nabi announced that, based on analysis of interim data from its pivotal clinical trial of Nabi© StaphVAX© , it believes that statistical significance may be achievable at study end given the trend towards protection. Final results should be available by Q3, 2000.