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"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 U.S. 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 favorable 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 program.
About NicVAX
NicVAX(R) is an innovative and proprietary investigational vaccine being developed by Nabi to treat nicotine addiction and prevent smoking relapse. NicVAX(R) is designed to stimulate the immune system to produce antibodies that bind to nicotine. A nicotine molecule attached to an antibody is too large to cross the blood-brain barrier. Therefore, NicVAX(R) blocks nicotine from reaching its receptors in the brain and prevents the highly-addictive pleasure sensation experienced by smokers and users of nicotine products. Pre-clinical and previous clinical data show that NicVAX(R)'s ability to block nicotine from reaching the brain could help people quit smoking. Because the body's immune system can be boosted to produce long-lasting antibodies, Nabi believes NicVAX(R) also could be effective in preventing smoking relapse. Relapse is a significant challenge facing smokers and, with currently-available smoking cessation therapies, relapse rates can be as high as 90% in the first year after a smoker quits.
About Nabi Biopharmaceuticals
Nabi Biopharmaceuticals 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. Nabi Biopharmaceuticals is currently developing NicVAX(R) (Nicotine Conjugate Vaccine), an innovative and proprietary investigational vaccine for treatment of nicotine addiction and prevention of smoking relapse, and PentaStaph(TM) (Pentavalent S. aureus Vaccine), a vaccine designed to protect against the most dangerous and prevalent strains of S. aureus bacterial infections. The company is headquartered in Rockville, Maryland. For additional information about Nabi Biopharmaceuticals, please visit our Web site:http://www.nabi.com.
Forward-Looking Statements
Statements in this release that are not strictly historical are forward-looking statements and include statements about products in development, results and analyses of clinical trials and studies, research and development expenses, cash expenditures, licensure applications and approvals, and alliances and partnerships, among other matters. You can identify these forward-looking statements because they involve our expectations, intentions, beliefs, plans, projections, anticipations, 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 our ability to: successfully close the sale of PentaStaph and complete the PentaStaph sale milestones; partner with third parties to fund, develop, manufacture and/or commercialize our products in development; defend against indemnification claims by Biotest; initiate and conduct clinical trials and studies; raise sufficient new capital resources to fully develop and commercialize our products in development; attract, retain and motivate key employees; collect further milestone and royalty payments under the PhosLo Agreement; obtain regulatory approval for our products in the U.S. or other markets; successfully contract with third party manufacturers for the manufacture and supply of NicVAX and PentaStaph; and comply with reporting and payment obligations under government rebate and pricing programs. Some of these factors are more fully discussed, as are other factors, in our Annual Report on Form 10-K for the fiscal year ended December 27, 2008 and our Quarterly Report on Form 10-Q for the periods ended March 28, 2009 and June 27, 2009 filed with the Securities and Exchange Commission.
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Nabi Biopharmaceuticals
CONTACT: Nabi Biopharmaceuticals Investor Relations 301-770-3099 www.nabi.com
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