- Key Milestone Achieved Toward Broadening Clinical Application of StaphVAX;
First Patient Population to Receive Cambrex-Manufactured Vaccine -
- The Company Provides Update on Status of StaphVAX U.S. Phase III
Confirmatory Study in Dialysis Patients -
ROCKVILLE, Md., Sept. 29 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals
(Nasdaq: NABI) announced today positive results of its U.S. immunogenicity
study for StaphVAX(R) (Staphylococcus aureus Polysaccharide Conjugate Vaccine)
in patients undergoing orthopedic surgery with a prosthetic device implant.
Orthopedic patients are an at-risk group for S. aureus infections in
conjunction with their surgery.
The study demonstrated that 94 percent of patients achieved antibody
levels above the estimated protective levels. This compares favorably to the
80 percent of immunocompromised end-stage renal disease (ESRD) patients who
achieved similar protective levels, as previously reported. Antibody levels
observed in the current study are also consistent with the levels achieved in
patients undergoing cardiovascular surgery.
The company also announced today that it is currently continuing to
compile the data from the confirmatory U.S. Phase III trial for the prevention
of S. aureus bloodstream infections in ESRD patients, and now expects to
release top line data sometime in late October or early November. The company
is on schedule to file the U.S. Biologics License Application (BLA) for
StaphVAX in the fourth quarter of 2005.
StaphVAX is being developed to prevent S. aureus infections in at-risk
patients. This includes patients on dialysis, patients undergoing
cardiovascular, orthopedic and other surgeries, immunocompromised patients
such as the elderly, diabetics, cancer patients undergoing chemotherapy, and
patients who have previously been treated for S. aureus infections.
Patients who participated in the orthopedic study were the first to
receive Cambrex-manufactured vaccine. Cambrex Bio Science Baltimore, Inc.
(Cambrex), the company's manufacturing partner and an experienced contract
manufacturer of licensed biological products, has a facility that has been
successfully inspected by EU, U.S. and Canadian regulators. Cambrex also has
sufficient capacity to manufacture StaphVAX for Nabi Biopharmaceuticals'
anticipated launch in Europe and the U.S.
"The results of this study are aligned with Nabi Biopharmaceuticals'
commercial strategy to build a leading franchise for the treatment and
prevention of staph infections in a broad array of at-risk patient groups,"
stated Thomas H. McLain, chairman, chief executive officer and president, Nabi
Biopharmaceuticals. "Equally important, these results provide support for the
quality and consistency of our manufacturing processes as we continue to
prepare for the expected European and U.S. commercial launches of StaphVAX."
Raafat E.F. Fahim, Ph.D., senior vice president, research, technical and
production operations, Nabi Biopharmaceuticals, stated, "The results of the
study also validate Nabi Biopharmaceuticals' ability to transfer the
manufacturing of StaphVAX to Cambrex. The results demonstrate that the
quality of the product was consistent in the various at-risk populations, and
provide further support of the company's efforts to commercialize StaphVAX."
Management also noted that today's results would be included in the
company's U.S. StaphVAX BLA filing, scheduled for the fourth quarter of 2005.
Clinical Need in Orthopedic Surgery Patients
Due to the invasive nature of the procedures they undergo, orthopedic
surgery patients are at risk of developing S. aureus bacteremia and other S.
aureus infections. S. aureus is the most common cause of hospital-acquired
infections, which are also becoming increasingly resistant to antibiotics.
Approximately two-thirds of infections in patients who have received surgical
implants are caused by S. aureus or coagulase-negative staphylococci
(predominantly S. epidermidis).
Treatment costs associated with S. aureus bacteremia in this patient
population total $56,000 per case in 2005 dollars, consistent with results of
a Duke University study, conducted in 2003. Costs associated with the
increasing prevalence of methicillin-resistant S. aureus (MRSA) infections in
this population would be expected to be even higher.
About the Study
This study, conducted in 120 patients who underwent either hip or knee
replacement, evaluated the safety and immune response of StaphVAX over a six-
week period. The study was designed to provide evidence that this at-risk
group can achieve antibody levels equal to, or greater than, the levels shown
to be protective in immunocompromised ESRD patients.
In this double-blinded study, subjects were vaccinated prior to their
orthopedic procedure in order to assess their antibody levels during the
period of greatest risk of an S. aureus infection. Substantial increases in
antibody levels were achieved in the vaccine recipients by day seven, and by
day 14, the levels were largely above the estimated protective antibody levels
measured in immunocompromised ESRD patients.
On day 14, 94 percent of the patients had antibody levels above the
estimated protective levels. This compares favorably to the approximately 80
percent of immunocompromised ESRD patients who achieved similar protective
levels. The vaccine was very well tolerated. No serious adverse events were
attributed to the vaccine. The events seen with the vaccine were generally
mild and of short duration, similar to events seen with other vaccines.
The study was part of a series of immunogenicity studies evaluating
StaphVAX in additional patient populations at risk for S. aureus infections,
and the results are consistent with the findings of Nabi Biopharmaceuticals'
similar study of StaphVAX in cardiovascular patients. Nabi Biopharmaceuticals
reported the results of the cardiovascular study in July 2005.
The unblinded phase of the orthopedic study is still in progress. Once
completed, it will provide a more comprehensive assessment of the duration of
the vaccine effect in this population by following patients for up to 12
months.
"These results are encouraging not only because they met the primary
endpoints of safety and immune response, but also because they are consistent
with Nabi Biopharmaceuticals' earlier studies for StaphVAX in ESRD and cardiac
patients," stated Henrik S. Rasmussen, M.D., Ph.D., senior vice president,
clinical, medical and regulatory affairs, Nabi Biopharmaceuticals. "This
consistency supports the ability of StaphVAX to elicit high antibody levels in
various populations and validates Nabi Biopharmaceuticals' general approach to
the treatment and prevention of infections in an increasingly broader patient
population. "
About StaphVAX
StaphVAX is currently in a U.S. confirmatory Phase III trial designed to
show that it can prevent S. aureus infections in ESRD patients. Patients with
ESRD are at a high risk of developing S. aureus bacterial infections and are
among the most difficult patients to treat because they are immune-compromised
due to their debilitating, underlying disease, and because dialysis raises the
risk of getting bloodstream bacterial infections.
About Nabi Biopharmaceuticals' Hospital-Acquired Infections Franchise
The annual economic cost of hospital-acquired infections totals
approximately $30 billion in the U.S. alone. Nabi Biopharmaceuticals is
building a franchise of products to prevent and treat the approximately
5 million patients who get these infections in the EU and U.S. each year. The
company's strategy to advance this franchise is three-fold:
Prevent and Treat the Clinical Problem: Infections keep patients in the
hospital longer and greatly increase illness, death and cost. Nabi
Biopharmaceuticals is pursuing a combination approach, with Altastaph(TM)
(human Staphylococcus aureus immunoglobulin) and StaphVAX, to offer patients
prevention and treatment for hospital-acquired bacterial infections and, upon
hospital discharge, prevention of longer-term relapse after an infection. This
innovative approach, initially focused on S. aureus infections, will be
expanded to include S. epidermidis, Enterococcus and Gram-negative infections.
Leverage the Technology: Nabi Biopharmaceuticals believes it has a core,
patented technology that will overcome the resistance challenges associated
with current antibiotics.
Build a Risk-balanced Platform: Nabi Biopharmaceuticals is developing a
portfolio of products to address the most prevalent and dangerous hospital-
acquired infections, including S. aureus, S. epidermidis, Enterococcus,
Pseudomonas and other Gram-negative bacteria and fungi, for the broadest array
of at-risk patients.
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, and 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 United States.
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 United States. 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 United States 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 United States 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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