- Smoking Cessation Immunotherapy Failed to Meet Primary Endpoint
- Board of Directors retains Piper Jaffray to assist with Strategic alternatives
ROCKVILLE, Md., Nov. 7, 2011 (GLOBE NEWSWIRE) -- Nabi Biopharmaceuticals (Nasdaq:NABI) today announced that NicVAX® (Nicotine Conjugate Immunotherapeutic) did not meet its primary endpoint in the company's second of two confirmatory Phase III clinical trials. A preliminary assessment of the trial data showed that the primary end point was not met and there was no statistical difference between the NicVAX and Placebo groups. As in previous trials, NicVAX was well-tolerated with a clinically acceptable safety and tolerability profile. These results are not different from the results of the first Phase III trial that were reported in July 2011, which had a similar design and protocol.
The study was a double-blinded, placebo-controlled trial of approximately 1,000 subjects. The primary endpoint of the study was the abstinence rate for 16 weeks ending at 12 months. Abstinence was evaluated by self-reported cigarette consumption and biologically verified by exhaled carbon monoxide. Secondary endpoints included 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. A clinical study testing NicVAX in combination with varenicline (Chantix) remains ongoing in the Netherlands with results expected in the second half of 2012.
"We are clearly disappointed with the results of this second NicVAX Phase III trial but not completely surprised," Raafat Fahim, President and Chief Executive of Nabi Biopharmaceuticals said. "This Phase III trial was a mirror image of the first trial in terms of design and protocol so it is logical to get similar results from the two trials. The Board of Directors has retained Piper Jaffray to assist with its exploration of the strategic alternatives available to the company to enhance shareholder value. This includes but not limited to, joint ventures, strategic alliances, recapitalization, the sale or merger of all or part of the company or liquidation. Our goal is to move expeditiously to maximize the value of the company's assets while continuing our effort to reduce our operating expenses."
There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions. The company does not intend to disclose developments with respect to the exploration of strategic alternatives unless and until its Board of Directors has made a decision regarding a specific transaction.
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® (Nicotine Conjugate Vaccine), an innovative and proprietary investigational vaccine for treatment of nicotine addiction and prevention of smoking relapse. The company is headquartered in Rockville, Maryland. For additional information about Nabi Biopharmaceuticals, please visit 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 conduct and obtain successful results from our two Phase III clinical trials for NicVAX; GSK's failure to exercise its option for and successfully commercialize NicVAX; GSK's failure to successfully develop and commercialize any future generation candidate nicotine vaccine; our ability to commercialize NicVAX if GSK does not exercise its option for NicVAX; our ability to raise sufficient new capital resources to fully develop and commercialize NicVAX if GSK does not exercise the NicVAX option; our ability to attract, retain and motivate key employees; our ability to collect any further milestones and royalty payments under the PhosLo agreement; the ability to obtain regulatory approval for NicVAX and any future generation candidate nicotine vaccine in the U.S. or other markets; our ability to successfully contract with contract manufacturing organizations for the manufacture and supply of NicVAX; our ability to comply with reporting and payment obligations under government rebate and pricing programs; and loss of full use of our net operating loss carry forwards. These factors are more fully discussed, as are other factors, in our Annual Report on Form 10-K for the fiscal year ended December 25, 2010 filed with the Securities and Exchange Commission.