Nabi Biopharmaceuticals Receives FDA Orphan Drug Designation for Altastaph


BOCA RATON, Fla. - Nabi Biopharmaceuticals announces 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."

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 percent 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, 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


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 disease


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.

Nabi Biopharmaceuticals applies its knowledge of the human immune system

to commercialize and develop products that address serious, unmet medical

needs. The company's focus is in the areas of infectious, autoimmune and

addictive diseases.

Source: Nabi Biopharmaceuticals

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