Profile: Nabi Biopharmaceuticals (NABI.O)

Nabi Biopharmaceuticals, incorporated in 1969, is a biopharmaceutical company focused on the development of products in the areas of nicotine addiction and infectious disease. The Company’s products in development are Nicotine Conjugate Vaccine (NicVAX) and Pentavalent S.aureus Vaccine (PentaStaph). NicVAX is an investigational vaccine. NicVAX is designed to stimulate the immune system to produce highly specific antibodies that bind to nicotine. PentaStaph is an investigational vaccine based on technology that it has licensed on an basis from the National Institutes of Health (NIH).

Nicotine Conjugate Vaccine (NicVAX) is an investigational vaccine designed as an aid to smoking cessation, as well as an aid to prevent relapses. NicVAX is designed to stimulate the immune system to produce antibodies that bind to nicotine. Phase IIb clinical trial completed in October 2007. In October 2008, the Company also completed Phase II dose-schedule optimization study. In December 2008, the Company announced that it had reached agreement with the United States Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA), for the pivotal Phase III clinical trial for NicVAX. Earlier clinical trials of NicVAX included four studies: one Phase I clinical trial (Nabi 4502) to evaluate safety in non-smoking adults, one Phase I/II clinical trial in 21 smokers and nine ex-smokers (Nabi 4503), one multi-site, NIDA-funded Phase II clinical trial in 68 smokers (Nabi 4504), and one Phase II dose-ranging clinical trial in 51 smokers (Nabi 4505).

The Company has identified the cell wall Type 336 antigen, found in some Staphylococcus aureus (S.aureus) bacteria, lacking or only partially covered by types five or eight capsular polysaccharides. StaphVAX is an investigational vaccine. The Company has advanced the development of StaphVAX for use in patients who are at risk of S.aureus infection. Once vaccinated, the patient’s immune system produces antibodies to components of S.aureus, which should bind to S.aureus upon subsequent exposure to the bacteria. The pentavalent StaphVAX vaccine is designed to protect against a range of S.aureus strains, as well as to protect against various virulence factors of the S.aureus bacterium. In September 2008, the Company entered into a collaboration agreement with the National Institute of Allergy and Infectious Diseases (NIAID), to conduct pre-clinical toxicology evaluations of two new antigens designed to protect against two of the most virulent and debilitating toxins produced by the bacteria. Additionally, in December 2008, it entered into a research and development agreement with the United States Department of Defense to conduct a series of collaborative clinical trials for PentaStaph.

The Company competes with Pfizer Inc.