-- Results Show Company's Proprietary Conjugate Technology is Highly Effective
in Stimulating Antibody Response; Moving into Phase II Testing --
ROCKVILLE, Md., Feb. 7 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals
(Nasdaq: NABI) today provided an update on the development of its Gram-
positive infections program, which includes several product candidates for the
prevention and treatment of S. aureus, S. epidermidis and enterococcal
infections. Together these bacteria account for two-thirds of healthcare-
associated infections reported annually.
Nabi Biopharmaceuticals announced positive data from Phase I studies of
the company's S. epidermidis PS-1 vaccine and its S. aureus Type 336 vaccine.
Both Phase I studies evaluated the safety and immune response of these
vaccines in healthy volunteers. The data support that escalating doses of the
vaccines were well tolerated and resulted in significant dose-related
increases in levels of antibodies against S. epidermidis PS-1 and S. aureus
Type 336. The results of these studies also support the company's conjugation
technology in stimulating antibody responses. High antibody titers against
specific targets are critical in conferring protection to patients against
these infections.
Thomas H. McLain, chairman, chief executive officer and president, Nabi
Biopharmaceuticals, stated, "Clinically, Nabi Biopharmaceuticals is focused on
addressing a large, unmet medical need. Collectively, S. epidermidis and S.
aureus represent approximately 80 percent of all Gram-positive hospital-
acquired bacterial infections. Commercially, we are focused on developing
products that address a large, underserved market. It is estimated that by
2008 the market for new hospital anti-bacterial products will reach
$10.1 billion. Our product, growth and business strategies remain aligned
with global trends and policies that have defined the critical need for
effective and cost-efficient treatments and preventative solutions. In this
way, Nabi Biopharmaceuticals is uniquely and strategically positioned to
capitalize on its technology and expertise to develop a portfolio of vaccines
and antibody products via our own resources and, when appropriate, with
strategic partners."
These results and the direction of the company's Gram-positive program are
important for several reasons, including the clinical and commercial potential
of vaccines to prevent S. epidermidis and S. aureus infections, as well as
antibody and other innovative approaches that Nabi Biopharmaceuticals plans to
develop products to treat and prevent these infections:
The Clinical and Economic Challenges
S. epidermidis and S. aureus are Prevalent and Resistant to Antibiotics.
Current preventative and treatment approaches fall short of adequately
addressing S. epidermidis and S. aureus infections, which are increasingly
becoming resistant to antibiotics. These bacteria often live transiently or
permanently in the nasal passages or on the skin of humans; and can spread to
the blood through breaks in the nasal membranes or skin.
S. aureus and S. epidermidis infections are prevalent in hospitals and
account for the majority of bloodstream infections. There are approximately
2.6 to 2.8 million hospital-associated infections reported annually. The mean
cost is estimated at $13,973 per infection or a range of $36.3 - $39.1 billion
annually. The estimated overall mortality rate associated with hospital-
associated (nosocomial) bloodstream infections and pneumonia are 23.8 percent
to 50 percent and 14.8 percent to 71 percent, respectively.
It is estimated that healthcare-associated treatment costs associated with
S. epidermidis infections total almost $600 million each year. To add to the
economic burden, methicillin-resistant S. epidermidis (MRSE) rates have
reached approximately 80 percent, and over 50 percent of S. epidermidis
infections are also resistant to other currently administered anti-microbials.
Associated S. epidermidis mortality rates total over 20 percent.
Type 336 accounts for approximately 20 percent of S. aureus infections
that do not form a polysaccharide capsule in the human bloodstream. In
addition, another 30 percent of S. aureus bacteria are partially encapsulated
and Type 336 may also have benefit in preventing and treating infections
caused by those bacteria. Since its initial identification in the 1960s,
hospital-associated methicillin-resistant S. aureus (MRSA) rates have climbed
to 57 percent in the ICU and to over 40 percent in non-ICU in-patient settings
by 2002. It is estimated that over 30 percent of the adult population at any
given time are colonized with S. aureus.
A Multi-faceted Solution
Both vaccines are the first-of-their kind in development to prevent S.
epidermidis and S. aureus Type 336 in patients, including those undergoing
certain types of invasive surgery, patients in intensive care or shock-trauma
units, patients receiving cancer chemotherapy or other immune suppressive
treatments, dialysis patients and patients in long-term care facilities.
The PS-1 antigen is found on approximately 60 to 70 percent of all S.
epidermidis strains. Immunization with PS-1 results in the production of
antibodies that attack a cell wall structure of the bacteria. The mechanism
of action of the Type 336 vaccine is independent of the polysaccharide capsule
targeted by the company's S. aureus Types 5 and 8 vaccine approach, in that it
attacks a structure in the cell wall of the bacteria, not the polysaccharide
capsule outside the cell wall. Our research indicates that what we target in
S. aureus Type 336 is cross-reactive to S. epidermidis. As an example, data
already support that Type 336 antibodies are cross reactive with the majority
of S. epidermidis bacteria. The results announced today clearly support
moving these programs into Phase II clinical testing.
Raafat E.F. Fahim, Ph.D., senior vice president research, technical and
production operations, Nabi Biopharmaceuticals, stated, "Nabi
Biopharmaceuticals' R&D pipeline is deep as we plan to develop several unique
approaches to Gram-positive infections. In addition to the capsular and non-
capsular approaches to S. aureus and the proprietary targets to S.
epidermidis, we are also developing novel vaccines and antibody products to
enterococci, community-acquired MRSA, as well as anti-infective approaches to
nasal colonization, skin and soft tissue Staph infections."
Dr. Fahim continued, "We are also fortunate to have the manufacturing
capabilities to produce these vaccines and antibody products in our own Boca
Raton facilities."
Upcoming Milestones
During 2006, the company will further study these vaccine candidates as
stimulating agents to produce antibody products active against these dangerous
bacteria. Antibodies can be used for prevention in patients at immediate risk
for infection and may act synergistically with antibiotics in the treatment of
active infections.
Based on the Phase I clinical trial results announced today and the
potential to develop these vaccines and antibodies in a variety of ways, Nabi
Biopharmaceuticals will advance its S. epidermidis PS-1 and S. aureus Type 336
programs into a Phase II clinical trial designed as a "proof-of-concept"
study. The company expects to initiate this clinical trial in the first half
of 2007 and it will evaluate the benefit of a multi-valent product in reducing
or treating infection in patient populations at-risk for infection. The
company will work with its Gram-positive infections advisory panel to both
define the study population and advise whether the vaccine or antibody product
should first advance into late-stage clinical study. Based on the outcome of
the StaphVAX(R) [Staphylococcus aureus Polysaccharide Conjugate Vaccine]
assessment, this trial may or may not involve combination with capsular
polysaccharide Types
5 and 8. Nabi Biopharmaceuticals anticipates that the next trial will be
conducted in both U.S. and EU sites.
About the S. epidermidis PS-I Study
The S. epidermidis PS-I Phase I study was a double-blinded, placebo-
controlled study evaluating safety and antibody responses of the vaccine in
36 patients at three different dosage levels. Within each of these three dose
groups there were 12 patients, nine receiving the S. epidermidis vaccine and
three receiving placebo. The doses were administered in an escalating manner.
About the Type 336 Study
The Type 336 Phase I study was a double-blinded, placebo-controlled study
evaluating safety and antibody responses of the vaccine in 48 patients at four
different dosage levels. Within each of these four dose groups there were
12 patients, nine receiving the Type 336 vaccine and three receiving placebo.
The doses were administered in an escalating manner.
Henrik S. Rasmussen, M.D., Ph.D., senior vice president, clinical, medical
and regulatory affairs, Nabi Biopharmaceuticals, stated, "A growing number of
patients, such as patients with indwelling catheters, patients in intensive
care units, patients receiving cancer chemotherapy, surgical patients
receiving implantation of various devices, dialysis patients and premature
babies, develop staphylococcus bacterial infections, either S. aureus or S.
epidermidis. To add to this problem, these bacteria are becoming increasingly
resistant to a number of different antibiotics. As a result, S. aureus and S.
epidermidis infections often lead to severe illness and death. Consequently,
new and more effective solutions, such as vaccines and antibodies, are
urgently needed."
Mr. McLain concluded, "Our Gram-positive infections program is robust, and
aligned with the company's business strategy to develop clinically relevant,
efficacious and cost-effective products in areas of significant unmet medical
need. We are pleased with today's S. aureus Type 336 and S. epidermidis PS-1
results, as they support our strategic approach in advancing our Gram-positive
infections program. This approach would be combined with our S. aureus Types
5 and 8 program to develop a next generation product, if the outcome of our
ongoing assessment is positive."
The company also announced that progress continues in its investigation of
results from a recent Phase III study of its S. aureus Types 5 and 8 vaccine
candidate, StaphVAX. The company confirmed that it expects to review the
results of the investigation with its outside advisory panel and define plans
for this element of its Gram-positive infections program in the first half of
2006.
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, Nabi Biopharmaceuticals, +1-561-989-5800
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