- Data Presented for the First Time at 43rd Infectious Diseases Society of
America Annual Meeting -
ROCKVILLE, Md., Oct. 7 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals
(Nasdaq: NABI) announced today, for the first time, data showing that patients
treated with Altastaph(TM) [Staphylococcus aureus Immune Globulin Intravenous
(Human)] had a shorter duration of bacteremia (bloodstream infections) and
fever versus the placebo group. As previously reported, the treated group
also left the hospital sooner. Altastaph is Nabi Biopharmaceuticals'
investigational human antibody-based product in development to treat adult in-
hospital patients with persistent S. aureus bacteremia.
Mark E. Rupp, M.D. from the University of Nebraska Medical Center,
presented the full Phase I/II results at the 43rd Infectious Diseases Society
of America (IDSA) Annual Meeting in San Francisco, California.
"Infection due to Staphylococcus aureus is a significant medical problem
that is, unfortunately, increasingly observed," stated Dr. Rupp. "The growing
prevalence of antibiotic-resistance in staphylococci reinforces the need for
new antibiotics and innovative measures, such as Altastaph. This Phase I/II
study showed that Altastaph was generally well tolerated, similar to other
IVIG products. Patients treated with Altastaph had high levels of antibodies,
which result in the killing of bacteria. Additional studies are warranted to
further define the efficacy of Altastaph, a promising therapeutic agent."
Dr. Rupp's presentation focused on the results of the Altastaph U.S. Phase
I/II clinical trial in treating adult in-hospital patients with persistent S.
aureus bacteremia. In this study there was a 36 percent reduction in median
time from administration of the study drug to hospital discharge in the
Altastaph-treated patients as compared to the placebo-treated patients (nine
days in the Altastaph group versus 14 days in the placebo group). This
substantial reduction in the length of hospital stays for the Altastaph-
treated group indicates that S. aureus antibodies provided by Altastaph could
be associated with considerable medical as well as health economic benefit in
the treatment of persistent S. aureus infections.
The study results also showed a shorter duration of bacteremia (one day in
the Altastaph group versus two days in the placebo group) and fever (two days
in the Altastaph group versus seven days in the placebo group).
Dr. Rupp's oral presentation took place today, Friday, October 7, 2005,
from 5:30 to 5:45pm PT at The Moscone Center, San Francisco, California. Dr.
Rupp is one of the principal investigators for the Altastaph clinical trials.
Henrik S. Rasmussen, M.D, Ph.D., senior vice president, clinical, medical
and regulatory affairs, Nabi Biopharmaceuticals, stated, "The IDSA is a
premier organization with a history of communicating some of the most
important scientific advances in infectious disease prevention and treatment.
We are delighted to have an opportunity to present this data showing
additional benefits of Altastaph in the treatment of patients with staph
infections. Based on these results, we anticipate initiating a larger 'proof-
of-concept' Phase II study by the end of this year or early next year."
About Altastaph
Altastaph is an investigational human antibody-based product containing
high levels of antibodies to capsular polysaccharides (protective outer sugar
coatings on S. aureus bacteria) from S. aureus types 5 and 8, which together
account for approximately 85 percent of all S. aureus infections. Altastaph
is produced by immunizing healthy volunteers with StaphVAX(R) (Staphylococcus
aureus Polysaccharide Conjugate Vaccine), Nabi Biopharmaceuticals' vaccine
being investigated for the prevention of S. aureus infections.
In the U.S., Altastaph has been designated an orphan drug and has received
Fast Track Designation for providing immediate protection against S. aureus
infections in low-birth-weight infants (neonates). Altastaph is also being
developed for prophylactic use to provide short-term, immediate protection to
patients who either cannot wait for the vaccine effect to occur or whose
immune systems are too compromised to mount an adequate response to a vaccine.
Patients in intensive care units and burn units may also benefit from
Altastaph in conjunction with standard-of-care therapy, including antibiotic
treatment.
In September 2005, Nabi Biopharmaceuticals received a favorable opinion in
Europe regarding Orphan Medicinal Product (OMP) designation for Altastaph for
the treatment of Staphylococcus aureus bacteremia. OMP designation
acknowledges the significant medical need for a product and provides a number
of development and commercialization advantages. Based upon this favorable
opinion, Nabi Biopharmaceuticals expects to receive the formal OMP designation
from the European Commission later this year.
StaphVAX and Altastaph: A Powerful Combination
Candidate products StaphVAX and Altastaph share a common mechanism of
action. When antibodies to S. aureus attach to the outer capsule of the
bacteria as it circulates in the blood, they trigger an immune response,
enabling the body's white blood cells to recognize the bacteria and destroy it
before it leads to a serious secondary infection.
Nabi Biopharmaceuticals is pursuing a combination therapy approach to
address an array of bacterial pathogens that affect a variety of at-risk
patients. A combination approach that uses Altastaph (for treatment of S.
aureus) and StaphVAX upon hospital discharge (for long-term prevention from
relapse) will offer important therapeutic and preventive benefits to patients
afflicted with these life-threatening infections. Clinical data from Brigham
and Women's Hospital in Boston, Massachusetts showed that patients treated for
a serious S. aureus infection and released from the hospital face a very high
risk (approximately 30 percent) of recurrence within the initial 18 months
after discharge.
About S. aureus Infections
S. aureus is the most common cause of serious hospital-acquired
bloodstream infections. Staphylococcal infections are difficult to treat
because the bacteria, in most cases, are resistant to available antibiotics.
This rise of antibiotic resistance has markedly curtailed options for treating
S. aureus infections. According to the current estimates by the U.S. Centers
for Disease Control and Prevention (CDC), more than two million patients in
the U.S. each year contract an infection as a result of exposure to a pathogen
while receiving care in a hospital. S. aureus can spread from the blood
(bacteremia), to the bones (osteomyelitis), or the inner lining of the heart
and its valves (endocarditis), or cause abscesses in internal organs such as
the lungs, liver and kidneys. People most at risk for these infections are
surgical patients, trauma or burn victims, newborns whose immune systems are
not yet developed, and patients with chronic illnesses such as diabetes,
cancer, or lung or kidney diseases. People whose immune systems are
suppressed due to disease, chemotherapy, or radiation therapy are generally
more susceptible to these bacterial infections.
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 opportunistically in nicotine addiction. We have
three products on the market today: PhosLo (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
preclinical development. The company filed its Marketing Authorization
Application (MAA) in Europe for its product candidate, StaphVAX(R)
[Staphylococcus aureus Polysaccharide Conjugate Vaccine], in December 2004.
The application was accepted for review in January 2005. StaphVAX is
currently in a confirmatory Phase III clinical trial in the U.S. StaphVAX is
designed to prevent the most dangerous and prevalent strains of S. aureus
bacterial infections. S. aureus bacteria are a major cause of hospital-
acquired infections and are becoming increasingly resistant to antibiotics.
The company also filed MAA's 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(R) (calcium acetate), which is already
marketed in the U.S. The company's other products in development include
Altastaph(TM) [Staphylococcus aureus Immune Globulin Intravenous (Human)], an
antibody for prevention and treatment of S. aureus infections, 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 at
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 possibility that
our confirmatory Phase III clinical trial for StaphVAX or our plans to
commercialize StaphVAX in the European Union and U.S. may not be successful;
the possibility that we may not realize the value of our 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, Nabi, +1-561-989-5800
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