NicVAX Investigator Dr. Dorothy Hatsukami to Discuss Phase IIb Data on June
1, 2007
BOCA RATON, Fla., May 30 /PRNewswire-FirstCall/ -- Nabi
Biopharmaceuticals (Nasdaq: NABI) today announced that the company will
participate in the Phacilitate Vaccine Forum Munich 2007 held from May 30 -
June 1, 2007 in Munich, Germany.
Dr. Dorothy Hatsukami, Forster Family Professor in Cancer Prevention
and Professor of Psychiatry at the University of Minnesota Tobacco Use
Research Center, will participate in a roundtable discussion and present
"Vaccination as an Aid to Smoking Cessation: Initial Results from a Phase
IIb Trial of NicVAX(R) (Nicotine Conjugate Vaccine)" at the conference at
12:15 p.m. local time on Friday, June 1, 2007.
Dr. Hatsukami will discuss the advantages of a vaccine approach to
smoking cessation and will outline key conclusions of the recently
announced Phase IIb trial:
-- NicVAX is well-tolerated
-- The NicVAX trial demonstrated a relationship between high antibody
titers and continued smoking abstinence at six months
-- NicVAX proof of concept was achieved in the trial
Per the Phacilitate conference guidelines, Dr. Hatsukami's presentation
will be available on the Nabi website after market close on June 1, 2007.
About the NicVAX Phase IIb Trial
The Phase IIb study is an ongoing double-blind, placebo-controlled and
dose-ranging study comprised of 301 patients and is designed to establish
proof of concept and the optimal dose for the Phase III program. This study
was designed in collaboration with the U.S. Food and Drug Administration
and other global regulatory agencies and incorporates the most current
clinical trial standards and prevailing protocol design for smoking
cessation studies.
The trial's primary endpoint is the rate of carbon monoxide (CO)-
confirmed, continuous abstinence from smoking during weeks 19-26 after
first vaccination. Full evaluation of abstinence at the six-month primary
endpoint will include reported cigarette consumption, chemical markers of
nicotine in the bloodstream, and behavioral assessment. Secondary endpoints
include the abstinence rate at 12 months, total cigarette consumption,
antibody levels, safety and nicotine dependency.
About NicVAX and NIDA
In September 2005, the company announced that it received a $4.1
million grant from the National Institute on Drug Abuse (NIDA) which is
part of the National Institutes of Health. NIDA has also funded, in part,
the costs for toxicology testing and earlier clinical trials in the U.S.
and contributed scientific and clinical expertise to the program overall.
About Nabi Biopharmaceuticals
Nabi Biopharmaceuticals leverages its experience and knowledge in
powering the immune system to develop and market products that fight
serious medical conditions. The company has one product on the market
today: Nabi-HB(R) [Hepatitis B Immune Globulin (Human)]. Nabi
Biopharmaceuticals is focused on developing products that address unmet
medical needs and offer commercial opportunities in our core business
areas: Hepatitis and transplant, Gram- positive bacterial infections and
nicotine addiction. The company recently announced that it intends to form
two strategic business units: Nabi Biologics and Nabi Pharmaceuticals. Nabi
Biologics will have responsibility for the company's protein and
immunological products and development pipeline, including Nabi-HB. Nabi
Pharmaceuticals will have responsibility for the NicVAX(R) (Nicotine
Conjugate Vaccine) and StaphVAX(R)-Pentavalent (Staphylococcal
Polysaccharide Conjugate and Toxoid Vaccine) development programs, as well
as for the continuing milestone-related clinical development obligations
following the sale of PhosLo(R) (calcium acetate). For a complete list of
pipeline products, please go to: http://www.nabi.com/pipeline/index.php.
The company is headquartered in Boca Raton, Florida. 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 reorganization of
our current business into two new business units, and clinical trials and
studies. You can identify these forward-looking statements because they
involve our expectations, beliefs, 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 partner with third parties to fund, develop,
manufacture and/or distribute our existing and pipeline products, including
NicVAX and our Gram- positive infections products; obtain successful
clinical trial results; generate sufficient cash flow from sales of
products or from milestone or royalty payments to fund our development and
commercialization activities; attract and maintain the human and financial
resources to commercialize current products and bring to market products in
development; depend upon third parties to manufacture or fill our products;
obtain regulatory approval for our products in the U.S. or other markets,
including approval of Nabi-HB Intravenous; realize sales from Nabi-HB due
to patient treatment protocols, the number of liver transplants performed
in HBV-positive patients and competitive products; achieve market
acceptance of our products; expand our sales and marketing capabilities or
enter into and maintain arrangements with third parties to market and sell
our products; effectively and/or profitability use, or utilize the full
capacity of, our vaccine manufacturing facility; manufacture NicVAX or
other products in our own vaccine manufacturing facility; comply with
reporting and payment obligations under government rebate and pricing
programs; raise additional capital on acceptable terms, or at all; and
re-pay our outstanding convertible senior notes when due. Many of these
factors are more fully discussed, as are other factors, in the company's
Annual Report on Form 10-K for the fiscal year ended December 31, 2006 and
our Quarterly Report for the quarter ended March 31, 2007 on Form 10-Q with
the Securities and Exchange Commission.
SOURCE Nabi Biopharmaceuticals
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Related links:
http://www.nabi.com
CONTACT:
Investor Relations of Nabi
Biopharmaceuticals, +1-561-989-5800
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