Nabi Biopharmaceuticals Announces U.S. Fast Track Designation for NicVAX(R)
ROCKVILLE, Md., March 9 /PRNewswire-FirstCall/ — Nabi BiopharmaceuticalsÃ‚Â today announced that NicVAXÃ‚Â® (Nicotine Conjugate Vaccine), the company’s novel, innovative and proprietary investigational vaccine being developed to treat nicotine addiction and prevent smoking relapse, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA).
Under the FDA Modernization Act of 1997, Fast Track regulations facilitate the development of products that treat serious diseases where an unmet medical need exists. Fast Track regulations are also designed to expedite the review process for
designated products, including the potential for companies to ask for priority review.
“We believe this is the first Fast Track Designation for a smoking cessation product candidate, which is unprecedented, and provides further validation for our unique approach to addressing nicotine addiction,” stated Henrik S. Rasmussen, M.D., Ph.D., senior vice president, clinical, medical and regulatory affairs, Nabi Biopharmaceuticals. “Smoking is the number one preventable cause of death in the western world, yet current smoking cessation therapies do not effectively treat the root cause of the addiction. We believe the vaccine approach inherent to NicVAX will provide clear patient advantages and a strong differentiation from currently marketed and development-stage products.”
How NicVAX is Designed to Work
NicVAX is designed to cause the immune system to produce antibodies that bind to nicotine and prevent it from entering the brain. It is believed that these nicotine antibodies will act like a “sponge” soaking up nicotine as it circulates in the bloodstream and preventing it from reaching the brain. The positive stimulus in the brain that is normally caused by nicotine is no longer present, thereby eliminating the addictive properties of smoking and, consequently, helping people to quit. Unlike current therapies, such as nicotine patches and gums, smokers will not be able to eliminate the effects of NicVAX by stopping their treatment. In addition, because these antibodies are expected to be long lasting, it is believed NicVAX will also be effective in preventing smoking relapse, a significant challenge with existing smoking cessation therapies.
Progress to Date and Next Steps
Nabi Biopharmaceuticals has completed four Phase I/II studies, totaling close to 200 patients, for NicVAX. These studies demonstrated that NicVAX is well tolerated, highly immunogenic, produced dose-dependent increases in antibody titers, and showed a good indication of efficacy at the 200 ug dose with a 33 to 40 percent quit rate versus nine percent for smokers dosed with a placebo.
In September 2005, Nabi Biopharmaceuticals announced that it had received a $4.1 million grant by the U.S. National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, for partial funding of the development program for NicVAX. Partnering remains Nabi Biopharmaceuticals’ strategic goal for NicVAX.
Nabi Biopharmaceuticals will next conduct a Phase II “proof-of-concept” study for NicVAX, which is expected to commence during the second quarter of 2006. The study will be comprised of approximately 300 patients, a large enough sample size to establish both proof-of-concept and optimal dose identification for the company’s Phase III program. The study results are anticipated in the second half of 2007.
Importantly, the vaccine manufactured for this Phase II study has been manufactured at commercial scale in an optimized formulation at the company’s vaccine manufacturing facility in Boca Raton, Florida. This further demonstrates the significant advancements that have already been achieved in the development of Nabi Biopharmaceuticals’ nicotine addiction program. The study design will incorporate recommendations from a newly formed scientific advisory panel. The panel is comprised of scientific and clinical experts in smoking cessation. The panel will also provide input to the company on other aspects of the NicVAX development program.
Nabi Biopharmaceuticals has also met with the FDA, as well as the European Medicines Agency (EMEA), to ensure all key regulatory requirements are built into the NicVAX Phase II trial design and overall development program.
Cigarette Smoking: A Growing Global Health Challenge
Smoking is a global healthcare problem, and The World Health Organization estimates that there are 1.3 billion smokers worldwide and nearly five million tobacco-related deaths each year. According to the U.S. Centers for Disease Control and Prevention (CDC), tobacco use is the single leading preventable cause of death in the United States and is responsible for more than 440,000 deaths each year. They estimate that approximately 70 – 80 percent of smokers in the U.S. want to quit, but less than five percent of those who try to quit remain smoke-free at 12 months. In addition, they estimate that tobacco use causes $75.5 billion in excess medical costs and $81.9 billion in illness- related productivity losses each year in the U.S. To learn more about NicVAX and how it works, please visit our website at: http://www.nabi.com/pipeline/pipeline.php?id=3 .
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 three products on the market today: PhosLoÃ‚Â® (calcium acetate), Nabi-HBÃ‚Â® [Hepatitis B Immune Globulin (Human)], and Aloprim(TM) (allopurinol sodium) for Injection. Nabi Biopharmaceuticals is focused on developing products that address unmet medical needs and offer commercial opportunities in our core business areas: Gram-positive bacterial infections, hepatitis, kidney disease (nephrology) and nicotine addiction. 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 website at http://www.nabi.com .
Statements in this press release about the company that are not strictly historical are forward-looking statements and include statements about our marketed products, products in development, demand for our products, clinical trials and studies, licensure applications and approvals, assessment of the StaphVAX Phase III trial results, and alliances and partnerships. You can identify these forward-looking statements because they involve our expectations, beliefs, projections, 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 the company’s ability to advance the development of products currently in the pipeline or in clinical trials; complete the assessment of the StaphVAX Phase III clinical trials during the first half of 2006; maintain the human and financial resources to commercialize current products and bring to market products in development; obtain regulatory approval for its products in the U.S., Europe or other markets; successfully develop, manufacture and market its products; realize future sales growth for its biopharmaceutical products; prevail in patent litigation; raise additional capital on acceptable terms; re-pay its 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, 2005 filed with the Securities and Exchange Commission.