Nabi Biopharmaceuticals announced that the US Food and Drug Administration (FDA) has determined that the company's investigational product, Altastaph [Staphylococcus aureus Immune Globulin (Human)] for immediate protection against Staph aureus infections in low birth-weight infants (neonates) has received a fast track designation. Fast track designation is a term that the FDA ascribes to certain investigational drugs that have the potential to address serious, unmet medical needs. Under this designation, the FDA commits to working closely with the developer of the product to advance it through the drug development process.

"We are very pleased to receive Fast Track Designation for Altastaph," said Henrik Rasmussen, Nabi Biopharmaceuticals' senior vice president of clinical, medical and regulatory affairs. "Staph aureus infections represent a significant cause of illness and death in low birth-weight babies around the world. These babies are at a particularly high risk of developing potentially devastating infections, due in part to a poorly developed immune system, due to the lack of protection from maternal antibodies because of their premature term, and also due to the number of invasive procedures they are exposed to in the neonatal intensive care unit. We look forward to working closely with the FDA to advance the development of this potentially new and innovative treatment option for addressing these devastating infections."

In 2003, Nabi Biopharmaceuticals initiated a Phase II trial in low birth-weight infants designed to measure Altastaph's safety, Staph aureus antibody levels, incidence of infection and to help define endpoints for a Phase III clinical trial in this same population. The company anticipates announcing the results of the Phase II trial by the end of 2004.

Altastaph is an investigational human antibody-based product containing high levels of antibodies to capsular polysaccharides (protective outer sugar coatings on Staph aureus bacteria) from Staph aureus types 5 and 8, which together account for approximately 85 per cent of all Staph aureus infections. These antibodies are the same antibodies that are developed in patients who are vaccinated with Staphvax (Staphylococcus aureus Polysaccharide Conjugate Vaccine), Nabi Biopharmaceuticals' investigational vaccine to prevent Staph aureus infections. Altastaph is being developed to provide short-term, immediate protection to patients, such as neonates (low birth-weight infants), who are at high risk of Staph aureus infection because of the invasive medical procedures they face while hospitalized, patients in intensive care units or burn units, or other patients who cannot wait for the vaccine effect to occur, or whose immune system is not capable of producing an adequate response to a vaccine. As such, Altastaph is being developed as a supplement to Staphvax, Nabi Biopharmaceuticals vaccine against Staph aureus infections that is currently in a confirmatory Phase III clinical trial in end-stage renal (kidney) disease patients.

Hospital-acquired Staph aureus infections represent a significant problem in low birth-weight neonates as these infants have poorly developed immune systems, and typically have not received the usual transfer of maternal antibodies that full-term infants receive. In addition, these infants are often hospitalized for prolonged periods in intensive care pediatric units during which time they often undergo invasive medical procedures that expose them to Staph aureus and other hospital-acquired bacterial infections. Staph aureus infections in neonates are serious, and are associated with a substantial increase in illness and death. Even if these infants survive their infections, their hospital stays are often prolonged. The frequency of antibiotic resistant Staph aureus infections continues to increase and now approaches 60 per cent or more in some health care settings. The recent identification of vancomycin resistance, widely determined to be the antibiotic of last resort in the fight against Staph aureus infections has led to recognition that antibiotic therapy alone is not sufficient to address this growing medical problem and that adjunctive approaches must be developed. Altastaph represents such an approach.