- Study Failed to Show that StaphVAX Prevents S. aureus Infections in Kidney
Disease Patients -
- Company to Increase Focus on Other Pipeline Products -
ROCKVILLE, Md., Nov. 1 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals
(Nasdaq: NABI) today announced that StaphVAX(R) [Staphylococcus aureus
Polysaccharide Conjugate Vaccine] failed to meet its primary endpoint in the
company's confirmatory Phase III clinical trial.
The study, a randomized, double-blinded, placebo-controlled trial of 3,600
patients on hemodialysis, found no reduction in S. aureus types 5 and 8
infections in the StaphVAX group as compared to the placebo group. The
company will immediately initiate an assessment to determine the factors
causing this outcome, including the vaccine target (S. aureus polysaccharide
capsule) and the quality of the antibody generated by the vaccine. Results
will be available within the next few months. It is important to note,
however, that StaphVAX was highly immunogenic, confirming that Nabi
Biopharmaceuticals' vaccine conjugation technology is effective in producing
and sustaining high levels of specific antibodies.
Thomas H. McLain, chairman, president and chief executive officer, Nabi
Biopharmaceuticals, stated, "We are obviously surprised and very disappointed
with the results of the StaphVAX confirmatory Phase III trial. While we
complete our assessment over the next few months, we will re-focus our
capabilities in developing vaccine and antibody products in other areas of
significant medical need. This includes advancing other bacterial vaccines in
development; NicVAX(TM), a vaccine for smoking cessation; and Civacir(TM), an
antibody product for the prevention of hepatitis C post-liver transplant. At
the end of the third quarter, we had cash and marketable securities totaling
$137 million and we will continue to generate cash margins earned on product
sales. This assures our ability to accelerate the development of these
programs, which are closely aligned with our business strategy and core
competencies."
Next Steps
While the company completes its assessment of the Phase III trial results,
it will halt further development of StaphVAX and will withdraw its Marketing
Authorization Application (MAA) to market StaphVAX in the European Union.
The company will also halt the development of Altastaph(TM)
[Staphylococcus aureus Immune Globulin Intravenous (Human)], its
investigational product for the prevention and treatment of S. aureus
infections, as it is based on the same capsular polysaccharide technology as
StaphVAX.
The significant majority of the company's development spending in 2005 has
been directed toward pre-launch and clinical activities for StaphVAX and
Altastaph. Spending on these activities will stop during the fourth quarter
of 2005.
In addition, the company expects to advance the development of its other
vaccine programs, including: NicVAX (Nicotine Conjugate Vaccine), which is
currently in Phase IIb clinical trials; its non-capsular
polysaccharide-based vaccine for S. aureus (type 336) in Phase I clinical
trials; its S. epidermidis vaccine in Phase I clinical trials; and, its
community-acquired S. aureus program (PVL) and Enterococcal vaccine in
pre-clinical development.
The company also plans to advance the clinical development of its antibody
product, Civacir [Hepatitis C Immune Globulin (Human)] for the prevention of
hepatitis C after liver transplant.
About NicVAX
NicVAX is Nabi Biopharmaceuticals' novel, innovative and proprietary
investigational vaccine being developed to treat nicotine addiction and
prevent smoking relapse. The company was recently awarded 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 company's
development program for NicVAX.
By the end of 2005, Nabi Biopharmaceuticals intends to announce
preliminary safety and immunogenicity results from a Phase IIb clinical study
in Europe. These results will define the next clinical development steps for
NicVAX. The company will manufacture NicVAX in its own vaccine facility in
Boca Raton, Florida.
About Civacir
Civacir is an investigational human polyclonal antibody product that
contains antibodies to the hepatitis C virus (HCV). Civacir is being developed
for the prevention of hepatitis C after liver transplant.
The National Institutes of Health (NIH) has funded and conducted a Phase
I/II clinical trial of Civacir in HCV-positive liver transplant patients at
four study sites in the U.S. This randomized, controlled study evaluated the
safety of dosing patients with Civacir during and after transplant surgery,
the level of HCV-specific antibodies in trial subjects following dosing, liver
enzyme levels (a measure of liver damage) and HCV levels in the transplanted
livers.
Management will hold a conference call to discuss today's results at 8:30
AM, Eastern time. To access the conference call in the U.S., please dial:
1-877-569-0953, passcode: 2058652; for international callers, please dial:
706-634-4967, passcode: 2058652. A replay of the call will be available
until November 14, 2005, midnight, eastern time. For the replay, US callers,
please dial: 1-800-642-1687, passcode: 2058652; international callers,
please dial: 706-645-9291, passcode: 2058652.
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 poised to capture large 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, a vaccine to treat nicotine addiction, and Civacir, 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; the company's ability to maintain the human
and financial resources to commercialize current products and bring to market
products in development; likelihood of the company to announce preliminary
safety and immunogenicity results from its Phase II NicVAX study by the end of
2005; the ability of the company to manufacture NicVAX in its own vaccine
facility; the possibility that the company may not realize the value of its
acquisition of PhosLo; the ability of the company to prevail in patent
litigation; ability to raise additional capital on acceptable terms; the
company's dependence upon third parties to manufacture its products; the
company's ability to utilize the full capacity of its manufacturing facility;
the impact on sales of Nabi-HB from patient treatment protocols and the number
of liver transplants performed in HBV-positive patients; reliance on a small
number of customers; the future sales growth prospects for the company's
biopharmaceutical products; and the company's ability to obtain regulatory
approval for its products in the U.S. or abroad or to successfully develop,
manufacture and market its products. These factors are more fully discussed
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:
Constance C. Bienfait, Vice President,
Investor Relations of Nabi Biopharmaceuticals, +1-561-989-5800
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