Nabi's NicVAX for nicotine addiction receives FDA fast track designation

By Lisa Kerner

Erie, Pa., March 9 - Nabi Biopharmaceuticals said NicVAX (Nicotine Conjugate Vaccine), its novel and proprietary investigational vaccine being developed to treat nicotine addiction and prevent smoking relapse, has received fast track designation from the Food and Drug Administration.

Fast track regulations facilitate the development of products that treat serious diseases where an unmet medical need exists, expedites the review process and allows the company to request a priority review, according to a company news release.

"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," senior vice president of clinical, medical and regulatory affairs Henrik S. Rasmussen said in the release.

"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."

NicVAX causes the immune system to produce antibodies that bind to nicotine and prevent it from entering the brain, eliminating the stimulating and addictive properties of smoking. Unlike nicotine patches and gums, smokers will not be able to eliminate the effects of NicVAX by stopping treatment, and the long-lasting antibodies in NicVAX are believed to prevent smoking relapse, the company said.

Nabi has completed four phase 1/2 studies for NicVAX with a total of 200 patients.

The studies demonstrated that NicVAX is well tolerated and produced dose-dependent increases in antibody titers. The results also showed a good indication of efficacy at the 200 µg dose, with a 33% to 40% quit rate versus 9% for smokers who received a placebo.

The company plans to conduct a phase 2 proof-of-concept study for NicVAX with about 300 patients in the second quarter of this year.

Nabi develops products that address unmet medical needs, including gram-positive bacterial infections, hepatitis, kidney disease and nicotine addiction. The company is based in Boca Raton, Fla.

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