BOCA RATON, Fla., May 30 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals today announced that the company will participate in the Phacilitate Vaccine Forum Munich 2007 held from May 30 - June 1, 2007 in Munich, Germany.
Dr. Dorothy Hatsukami, Forster Family Professor in Cancer Prevention and Professor of Psychiatry at the University of Minnesota Tobacco Use Research Center, will participate in a roundtable discussion and present “Vaccination as an Aid to Smoking Cessation: Initial Results from a Phase IIb Trial of NicVAX(R) (Nicotine Conjugate Vaccine)” at the conference at 12:15 p.m. local time on Friday, June 1, 2007.
Dr. Hatsukami will discuss the advantages of a vaccine approach to smoking cessation and will outline key conclusions of the recently announced Phase IIb trial:
-- NicVAX is well-tolerated -- The NicVAX trial demonstrated a relationship between high antibody titers and continued smoking abstinence at six months -- NicVAX proof of concept was achieved in the trial
Per the Phacilitate conference guidelines, Dr. Hatsukami’s presentation will be available on the Nabi website after market close on June 1, 2007.
About the NicVAX Phase IIb Trial
The Phase IIb study is an ongoing double-blind, placebo-controlled and dose-ranging study comprised of 301 patients and is designed to establish proof of concept and the optimal dose for the Phase III program. This study was designed in collaboration with the U.S. Food and Drug Administration and other global regulatory agencies and incorporates the most current clinical trial standards and prevailing protocol design for smoking cessation studies.
The trial’s primary endpoint is the rate of carbon monoxide (CO)- confirmed, continuous abstinence from smoking during weeks 19-26 after first vaccination. Full evaluation of abstinence at the six-month primary endpoint will include reported cigarette consumption, chemical markers of nicotine in the bloodstream, and behavioral assessment. Secondary endpoints include the abstinence rate at 12 months, total cigarette consumption, antibody levels, safety and nicotine dependency.
About NicVAX and NIDA
In September 2005, the company announced that it received a $4.1 million grant from the National Institute on Drug Abuse (NIDA) which is part of the National Institutes of Health. NIDA has also funded, in part, the costs for toxicology testing and earlier clinical trials in the U.S. and contributed scientific and clinical expertise to the program overall.
About Nabi Biopharmaceuticals
Nabi Biopharmaceuticals leverages its experience and knowledge in powering the immune system to develop and market products that fight serious medical conditions. The company has one product on the market today: Nabi-HB(R) [Hepatitis B Immune Globulin (Human)]. Nabi Biopharmaceuticals is focused on developing products that address unmet medical needs and offer commercial opportunities in our core business areas: Hepatitis and transplant, Gram- positive bacterial infections and nicotine addiction. The company recently announced that it intends to form two strategic business units: Nabi Biologics and Nabi Pharmaceuticals. Nabi Biologics will have responsibility for the company’s protein and immunological products and development pipeline, including Nabi-HB. Nabi Pharmaceuticals will have responsibility for the NicVAX(R) (Nicotine Conjugate Vaccine) and StaphVAX(R)-Pentavalent (Staphylococcal Polysaccharide Conjugate and Toxoid Vaccine) development programs, as well as for the continuing milestone-related clinical development obligations following the sale of PhosLo(R) (calcium acetate). For a complete list of pipeline products, please go to: http://www.nabi.com/pipeline/index.php. The company is headquartered in Boca Raton, Florida. 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 and include statements about reorganization of our current business into two new business units, 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 partner with third parties to fund, develop, manufacture and/or distribute our existing and pipeline products, including NicVAX and our Gram- positive infections products; obtain successful clinical trial results; generate sufficient cash flow from sales of products or from milestone or royalty payments to fund our development and commercialization activities; attract and maintain the human and financial resources to commercialize current products and bring to market products in development; depend upon third parties to manufacture or fill our products; obtain regulatory approval for our products in the U.S. or other markets, including approval of Nabi-HB Intravenous; realize sales from Nabi-HB due to patient treatment protocols, the number of liver transplants performed in HBV-positive patients and competitive products; achieve market acceptance of our products; expand our sales and marketing capabilities or enter into and maintain arrangements with third parties to market and sell our products; effectively and/or profitability use, or utilize the full capacity of, our vaccine manufacturing facility; manufacture NicVAX or other products in our own vaccine manufacturing facility; 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 31, 2006 and our Quarterly Report for the quarter ended March 31, 2007 on Form 10-Q with the Securities and Exchange Commission.
Nabi Biopharmaceuticals
CONTACT: Investor Relations of Nabi Biopharmaceuticals, +1-561-989-5800
Web site: http://www.nabi.com/
