Pharmacy News Article

4 November 2009 - US biopharmaceutical company Nabi Biopharmaceuticals (NASDAQ: NABI) said yesterday it has started the first of two pivotal Phase III studies of NicVAX (Nicotine Conjugate Vaccine), its proprietary vaccine to treat nicotine addiction and prevent smoking relapse.

This study is being funded in part with a USD10m (EUR6.8m) grant from US National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH). The US Food and Drug Administration (FDA) has agreed with Nabi on the study design, protocol and end points through a Special Protocol Assessment (SPA). The SPA forms a basic foundation to support approval of a New Drug Application (NDA). The company said it has also received scientific advice from the European Medicines Agency (EMEA) that confirms and supports the trial protocol, increasing the possibility of a positive outcome.

The initial Phase III study for NicVAX is a double-blinded, placebo-controlled study comprised of approximately 1,000 patients. The primary endpoint of the study is the abstinence rate at 12 months. Abstinence will be evaluated by several measures, including self-reported cigarette consumption, and exhaled carbon dioxide. Secondary endpoints include the abstinence rate at various time intervals, safety and immunogenicity, and the effect of NicVAX on withdrawal symptoms, cigarette consumption, smoking satisfaction and nicotine dependency. Study results are anticipated by the third quarter of 2011.

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