ROCKVILLE, Md., Dec. 2, 2008 (GLOBE NEWSWIRE) -- Nabi Biopharmaceuticals (Nasdaq:NABI) announced the receipt of two patents for key components of PentaStaph(tm), the Company's next-generations S. aureus vaccine. The United States Patent and Trademark office issued U.S. Patent No. 7,449,189 entitled "Glycoconjugate Vaccines for Use in Immune-Compromised Populations" for the exclusive use of a vaccine comprised of the two most prevalent surface antigens in Staphylococcus aureus -- capsular polysaccharides (CPS) Types 5 and 8 -- for the prevention of infections in immune-compromised populations through September 2022. Additionally, the European Patent Office issued Patent EP No. 0 925 073 that provides composition-of-matter protection in the EU through September 2016 for vaccines containing the surface polysaccharide component Type 336 which complements the already granted US patent for this same antigen.
"These additional patents represent a significant step in advancing the strategic value inherent in our gram-positive program, specifically in the area of healthcare-associated S. aureus infections," said Dr. Raafat Fahim, President and Chief Executive Officer of Nabi Biopharmaceuticals. "Based on the results of the first pivotal clinical study of Nabi's conjugate bivalent S. aureus vaccine, we believe we can target Types 5 and 8 CPS and help protect against S. aureus infections in dialysis patients. And, our Phase 1 trial to evaluate the safety and immune response of the Type 336 antigen demonstrated that the vaccine was immunogenic and well-tolerated. These three antigens are an integral part of our next-generation vaccine PentaStaph(tm), a five-component vaccine that we believe will provide comprehensive protection against the most clinically significant S. aureus infections known today."
Nabi also holds other patents for components of its gram-positive vaccine program and now has significant patent protection for three of the five S. aureus vaccine components. The Company also has pending applications for two additional toxoid antigens that were filed in 2007 and, if awarded, will provide composition and method of use claims through 2027. These vaccine components are currently undergoing pre-clinical toxicology testing to enable initiation of Phase 1 clinical trials in early 2009.
About PentaStaph
PentaStaph(tm) (Pentavalent S. aureus Vaccine) is a five-component vaccine. Three of the antigen components induce antibodies that target S. aureus capsular polysaccharides Types 5, 8 and the cell wall antigen Type 336, which enhance the immune systems' ability to clear bacteria from the host. Types 5 & 8 capsular polysaccharides are expressed in approximately 80 percent of S. aureus strains, including many of the known MRSA (methicillin-resistant S. aureus) strains. Type 336 polysaccharide accounts for approximately 20% of S. aureus infections that do not form a polysaccharide capsule in the human bloodstream. Two additional antigen components induce antibodies that target two of the most predominant and virulent toxins produced by the bacteria which can significantly debilitate the human immune system: Panton-Valentine Leukocidin found predominantly in community-acquired MRSA, and alpha toxin, produced by almost all S. aureus isolates. This multi-target approach which enhances the immune system's ability to eliminate a broad spectrum of S. aureus strains and neutralizes the bacterial defenses of the most virulent strains has been demonstrated in pre-clinical models to provide optimal efficacy which is hoped would translate into human efficacy.
About Nabi Biopharmaceuticals
Nabi Biopharmaceuticals leverages its experience and knowledge in powering the immune system to develop products that target serious medical conditions in the areas of nicotine addiction and gram-positive bacterial infections. Nabi Biopharmaceuticals is currently developing NicVAX(r) (Nicotine Conjugate Vaccine), an innovative and proprietary investigational vaccine for treatment of nicotine addiction and prevention of smoking relapse, and PentaStaph(tm) (Pentavalent S. aureus Vaccine), a vaccine designed to protect against the most dangerous and prevalent strains of S. aureus bacterial infections. The company is headquartered in Rockville, Maryland. For additional information about Nabi Biopharmaceuticals, please visit our Web site: http://www.nabi.com.
Forward-Looking Statements
Statements in this release that are not strictly historical are forward-looking statements including statements about the strategic alternatives process, development of our product candidates, and clinical trials and studies. You can identify these forward-looking statements because they involve our expectations, beliefs, projections, anticipations or other characterizations of future events or circumstances. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those in the forward-looking statements as a result of any number of factors. These factors include, but are not limited to, risks relating to our ability to: successfully pursue strategic and other alternatives; obtain successful clinical trial results; receive PhosLo milestone and royalty proceeds; successfully partner with third parties to fund, develop, and manufacture our pipeline products, including NicVAX and our gram-positive infections products; realize anticipated cost saving; attract and maintain the human and financial resources to bring to market products in development; depend upon third parties to manufacture our products; achieve approval and market acceptance of our products; enter into and maintain arrangements with third parties to market and sell our products; comply with reporting and payment obligations under government rebate and pricing programs; raise additional capital on acceptable terms, or at all; and re-pay our outstanding convertible senior notes when due. Many of these factors are more fully discussed, as are other factors, in the company's Annual Report on Form 10-K for the fiscal year ended December 29, 2007 filed with the Securities and Exchange Commission.