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Nabi Biopharmaceuticals Announces U.S. Fast Track Designation for NicVAX(R) Thursday March 9, 10:26 am ET
ROCKVILLE, Md., March 9 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals (Nasdaq: NABI - News) today announced that NicVAX� (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."