Nabi Biopharmaceuticals and the US National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, announced that NIDA has agreed to extend its support for the continued development of NicVAX, Nabi's proprietary vaccine to treat nicotine addiction and prevent smoking relapse. NIDA has granted the company $10 million under the American Recovery and Restoration Act of 2009 (ARRA) to fund partially the first pivotal clinical trial. In conjunction with the grant, the company has decided to proceed with the first pivotal phase-III trial, while advancing strategic partnering discussions for the future development and commercialization of NicVAX.

"We are very pleased to be awarded this generous grant from NIDA which enables us to proceed with the first pivotal phase-III trial for NicVAX," said Dr Raafat Fahim, president and chief executive officer of Nabi Biopharmaceuticals. "We understand that this grant is the largest ever given by NIDA and we believe that it further validates the potential for NicVAX to help solve the global healthcare problems attributable to smoking. Over the years, NIDA and the academic smoking cessation research community have contributed scientific and clinical expertise to the program. This grant will defray a significant portion of the expense of the first phase-III study."

This award continues the public-private sector collaboration that began in 2001 between NIDA and Nabi with a pre-clinical research grant and subsequently in 2005 with a grant awarded for the phase-IIb clinical proof of concept of NicVAX.

"We are immensely encouraged by the results of this innovative research that promises to change the way we treat nicotine addiction in this country. A vaccine that can stimulate the immune system to produce antibodies to drug molecules and prevent their entry into the brain could dramatically improve our ability to prevent relapse in smokers trying to quit," said NIDA director Dr Nora Volkow.

In March 2006, Nabi Biopharmaceuticals announced that NicVAX had received Fast Track Designation from the US Food and Drug Administration (FDA), which facilitates the development of products that treat serious diseases where an unmet medical need exists. Nabi successfully completed the phase-IIb proof-of-concept trial in late 2007 where NicVAX showed statistically significant improvement in the rates of smoking cessation and continuous long-term smoking abstinence as compared to placebo.

In addition, the vaccine was safe and well-tolerated. In 2008, the Company conducted an immunogenicity study that confirmed that higher antibody levels can be achieved earlier with an optimized dosing schedule while maintaining a favourable safety profile. Also in 2008, Nabi reached agreement with the FDA on a Special Protocol Assessment (SPA) for the phase-III trial protocol and specific primary and secondary endpoints that forms the foundation to support approval of a New Drug Application. In June 2009, Nabi received scientific advice from the European Medicines Agency that confirms and supports the trial design agreed to by the FDA in the SPA. These milestone accomplishments have steadily increased the value of NicVAX and advanced the development of NicVAX while significantly reducing the clinical and regulatory risk of the programme.

NicVAX is an innovative and proprietary investigational vaccine being developed by Nabi to treat nicotine addiction and prevent smoking relapse.

Nabi Biopharma leverages its experience and knowledge in powering the immune system to develop products that target serious medical conditions in the areas of nicotine addiction and gram-positive bacterial infections.