ROCKVILLE, Md., Jan. 25 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals
(Nasdaq: NABI) today provided an update on the strategic direction of
NicVAX(TM) (Nicotine Conjugate Vaccine), the company's novel, innovative and
proprietary investigational vaccine being developed to treat nicotine
addiction and prevent smoking relapse.
The company completed its Phase II dose-ranging study for NicVAX, which
was designed to assess tolerability and antibody response of the vaccine at
higher doses than those used in previous studies; the results showed that
NicVAX was well tolerated. The vaccine used in the study was manufactured
with a lower level of adjuvant in an attempt to further optimize the
formulation. An adjuvant is an additive that is often used in vaccines to
enhance the immune response.
Next Steps
Based on this Phase II dose-ranging study and in line with the company's
product development strategy to best prepare for its Phase III study, Nabi
Biopharmaceuticals will next conduct a full Phase II proof-of-concept study.
Importantly, the vaccine manufactured for this Phase II study has been
manufactured at commercial scale in an optimized formulation at the company's
vaccine manufacturing facility in Boca Raton, Florida. This further
demonstrates the significant advancements that have already been achieved in
the development of Nabi Biopharmaceuticals' nicotine addiction program. The
study design will incorporate recommendations from a newly formed scientific
advisory panel. The panel is comprised of scientific and clinical experts in
smoking cessation. The panel will also provide input to the company on other
aspects of the NicVAX development program.
Nabi Biopharmaceuticals has also met with the U.S. Food and Drug
Administration (FDA), as well as the European Medicines Agency (EMEA), to
ensure all key regulatory requirements are built into the NicVAX Phase II
trial design and overall development program. Enrollment in the proof-of-
concept Phase II study will commence during the second quarter of 2006 and
will be comprised of approximately 210 patients, a large enough sample size to
establish both proof-of-concept and optimal dose identification for its Phase
III program. The study results are anticipated in the second half of 2007.
Thomas H. McLain, chairman, chief executive officer and president, Nabi
Biopharmaceuticals, stated, "Nabi Biopharmaceuticals is the only company able
to produce commercial-scale manufacturing quantities of the vaccine, making
NicVAX the most clinically advanced product candidate in development for
smoking cessation. Furthermore, we have generated positive results to date
for NicVAX, garnered important scientific evidence to support NicVAX's
mechanism of action, hold strategically important patents in major global
markets, and will have in place a good body of clinical data that will be
aligned with our Phase III protocol."
Henrik S. Rasmussen, M.D., Ph.D., senior vice president clinical, medical
and regulatory affairs, Nabi Biopharmaceuticals, stated, "Findings from the
Phase II proof-of-concept study will be key determinants in the advancement of
NicVAX and will also allow us to design an optimal Phase III program. So far,
the development program established for the vaccine is based on extensive
input and comprehensive discussions with the FDA, the EMEA, the National
Institute on Drug Abuse, as well as leading external consultants. We have a
clear sense of the focus shared by regulators on an optimal smoking cessation
product; and we believe NicVAX will be strongly differentiated from currently
marketed, as well as development-stage, products."
NicVAX is designed to cause the immune system to produce antibodies that
bind to nicotine and prevent it from entering the brain. It is believed that
these nicotine antibodies will act like a "sponge" soaking up nicotine as it
circulates in the bloodstream and preventing it from reaching the brain. The
positive stimulus in the brain that is normally caused by nicotine is no
longer present, thereby eliminating the addictive properties of nicotine and,
consequently, helping people to quit. Because these antibodies are expected
to be long lasting, it is believed NicVAX will also be effective in preventing
smoking relapse, a significant challenge with existing smoking cessation
therapies. By preventing the pleasurable response that occurs when nicotine
reaches the brain, NicVAX takes away what is believed to be the main physical
reason that most people cannot stop smoking.
Early clinical data indicates that NicVAX, if approved, could potentially
be one of the most efficacious smoking cessation products available. In a
Phase II clinical trial, NicVAX achieved a 33 percent quit rate in smokers who
received the highest dose level versus 9 percent in the placebo group. These
results represented a vaccine-only effect, as patients were not given any
supplemental treatments, behavioral support or counseling. It is expected that
the response rate would be further improved as behavioral support and
counseling are built into the program.
In September 2005, Nabi Biopharmaceuticals announced that it had received
a $4.1 million grant by the U.S. National Institute on Drug Abuse (NIDA), part
of the National Institutes of Health, for partial funding of the development
program for NicVAX. Partnering remains Nabi Biopharmaceuticals' strategic
goal for NicVAX.
About the Phase II Dose-Ranging Study
The Phase II dose-ranging study was comprised of 50 healthy smokers, who
were randomized to receive one of four dose levels (100, 200, 300 and 400
mcg), administered as five injections and given on days 0, 21, 42, 56 and 182.
A total of 20 patients received the 200 mcg dose, with ten patients receiving
each of the other dose levels. The study was undertaken to assess the
tolerability and antibody response at higher doses (300 and 400 mcg),
recognizing that the top dose used in previous studies (200 mcg) was well
tolerated.
Cigarette Smoking: A Growing Global Health Challenge
Smoking is a global healthcare problem, and The World Health Organization
estimates that there are 1.3 billion smokers worldwide and nearly 5 million
tobacco-related deaths each year. According to the U.S. Centers for Disease
Control and Prevention (CDC), tobacco use is the single leading preventable
cause of death in the United States and is responsible for more than 440,000
deaths each year. They estimate that approximately 70 - 80 percent of smokers
in the U.S. want to quit, but less than 5 percent of those who try to quit
remain smoke-free at 12 months. In addition, they estimate that tobacco use
causes $75.5 billion in excess medical costs and $81.9 billion in illness-
related productivity losses each year in the U.S.
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. We are focusing on developing products addressing commercial
opportunities in our core business areas: Gram-positive bacterial infections,
hepatitis, kidney disease (nephrology), and nicotine addiction. We have three
products on the market today: PhosLo(R) (calcium acetate), Nabi-HB(R)
[Hepatitis B Immune Globulin (Human)], and Aloprim(TM) [Allopurinol sodium
(for injection)] and a number of products in various stages of clinical and
pre-clinical development. The company also filed Marketing Authorization
Applications (MAA) in Europe to market Nabi-HB(R) Intravenous [Hepatitis B
Immune Globulin (Human) Intravenous] under the trade name HEBIG(TM) for the
prevention of hepatitis B disease in HBV-positive liver transplant patients;
and for PhosLo, which is already marketed in the United States. The company's
products in development include NicVAX(TM) (Nicotine Conjugate Vaccine), a
vaccine to treat nicotine addiction, and Civacir(TM) [Hepatitis C Immune
Globulin (Human)], an antibody for preventing hepatitis C virus re-infection
in liver transplant patients. For additional information on Nabi
Biopharmaceuticals, please visit our website: http://www.nabi.com.
This press release contains forward-looking statements that reflect the
company's current expectations regarding future events. Any such forward-
looking statements are not guarantees of future performance and involve
significant risks and uncertainties. Actual results may differ significantly
from those in the forward-looking statements as a result of any number of
factors, including, but not limited to risks relating to the company's ability
to: advance the development of products currently in the pipeline or in
clinical trials; complete the assessment of the StaphVAX Phase III clinical
trials during the first half of 2006; maintain the human and financial
resources to commercialize current products and bring to market products in
development; obtain regulatory approval for its products in the U.S. or other
markets; successfully develop manufacture and market its products; utilize the
full capacity of its manufacturing facility; realize the value of its
acquisition of PhosLo; realize sales from Nabi-HB due to patient treatment
protocols and the number of liver transplants performed in HBV-positive
patients; realize the value from its vaccine manufacturing facility; realize
future sales growth for its biopharmaceutical products; prevail in patent
litigation; raise additional capital on acceptable terms; re-pay its
outstanding convertible senior notes when due; and the company's dependence
upon: third parties to manufacture its products and a small number of
customers. 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 25, 2004 filed with the Securities and Exchange Commission.
SOURCE Nabi Biopharmaceuticals
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Related links:
http://www.nabi.com
CONTACT:
Thomas E. Rathjen, Vice President, Investor
Relations of Nabi Biopharmaceuticals, +1-561-989-5800
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