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Altastaph Receives Orphan Drug Status, Treatment for <i>Staphylococcus Aureus</i> Infection

Boca Raton, Florida, February 11, 2004 - Nabi Biopharmaceuticals (Nasdaq: NABI) announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Nabi’s investigational product, Altastaph™ [Staphylococcus aureus Immune Globulin (Human)] for immediate protection against Staph aureus infections in low birth-weight infants. The FDA’s orphan-drug designation encourages companies to develop treatments for diseases that affect fewer than 200,000 U.S. patients, or, as in this case, for preventive drugs that will be administered to fewer that 200,000 patients per year. The designation provides potential incentives such as funding for clinical studies, study design assistance, waiver of FDA user fees, substantial tax credits and up to seven years of marketing exclusivity.

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. Nabi anticipates announcing the results of the Phase II trial by the end of 2004.

"We are very pleased to receive orphan drug designation for Altastaph," said Henrik Rasmussen, MD, PhD, 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 high risk of these potentially devastating infections, partly due to a poorly developed immune system, in part due to the lack of protection from maternal antibodies due to their premature term, and also due to the number of invasive procedures they are exposed to in the neonatal intensive care unit. There is a significant need for new treatment options and Altastaph might represent such an approach.”

About Altastaph
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% 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.

About Staph aureus Infections in Low Birth Weight Infants
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 percent 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.

Source: Nabi Biopharmaceuticals

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