- Vaccine Tested in Three Lots at Cambrex Manufacturing Facility Elicited High
Levels of Anti-Staphylococci Antibodies and Showed Consistency and
Reproducibility -
BOCA RATON, Fla., Oct. 12 /PRNewswire-FirstCall/ -- Nabi
Biopharmaceuticals (Nasdaq: NABI) today announced positive results from its
StaphVAX(R) [Staphylococcus aureus Polysaccharide Conjugate Vaccine]
consistency lots study, which was an open-labeled study testing the safety and
immune response of three commercial scale lots of StaphVAX produced by the
company's contract manufacturer, Cambrex Bio Science Baltimore, Inc.
StaphVAX was given to 354 healthy adults at three study sites in the U.S.
The data gathered from this study demonstrated that StaphVAX can elicit
high levels of anti-staphylococci antibodies, and that it can be consistently
and successfully manufactured. The data also demonstrated that the
manufacturing process is both well controlled and reproducible.
Thomas H. McLain, chairman, chief executive officer and president, Nabi
Biopharmaceuticals, stated, "This study supports our success in advancing
toward the commercialization of StaphVAX in Europe and the U.S. Ensuring that
we have developed a reliable manufacturing process and adequate capacity to
support the launch of StaphVAX is critical to assuring that we can meet
patient needs. This goal is one of Nabi Biopharmaceuticals' highest
priorities. In addition, the completion of the consistency lots study is an
important step toward the submission of our Biologics License Application this
quarter."
Raafat E.F. Fahim, Ph.D., senior vice president, research, technical and
production operations, Nabi Biopharmaceuticals, stated, "The results of this
study are particularly impressive due to the complexity of manufacturing
vaccines in general and mark a significant milestone for Nabi
Biopharmaceuticals and Cambrex."
Dr. Fahim continued, "In addition to working with Cambrex Bio Science,
Nabi Biopharmaceuticals has constructed a new vaccine manufacturing facility
at our Boca Raton, Florida location. This facility has been designed
specifically to manufacture StaphVAX, as well as our next generation Gram-
positive vaccine products and other products in our pipeline. We believe a
dual manufacturing strategy is the most prudent approach in preparing for the
anticipated global launch of StaphVAX."
About StaphVAX
StaphVAX is an investigational polysaccharide conjugate vaccine that
presents a novel approach to the prevention of S. aureus infections. Nabi
Biopharmaceuticals is developing StaphVAX for patients who are at high risk of
S. aureus infections and who are able to respond to a vaccine by producing
their own antibodies. StaphVAX is designed to stimulate a patient's immune
system to produce antibodies to S. aureus for active, long-term protection
from S. aureus types 5 and 8, which are responsible for approximately 85
percent of all S. aureus infections.
About Nabi Biopharmaceuticals' Hospital-Acquired Infections Franchise
Hospital infections add $28 billion to $30 billion to the Nation's health
costs each year.(1) Nabi Biopharmaceuticals is building a franchise of
products designed to protect the approximately five 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)
[Staphylococcus aureus Immune Globulin Intravenous (Human)] 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, kidney
disease (nephrology), and opportunistically in 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
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 MAAs 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 .
About Cambrex Bio Science Baltimore, Inc.
Cambrex is a global, diversified life sciences company dedicated to
providing innovative products and services to accelerate drug discovery,
development, and manufacturing processes for its customers focused on health
and the prevention of disease. The company employs approximately 2,200
worldwide. Cambrex subsidiaries in Baltimore, Maryland and Hopkinton,
Massachusetts (Cambrex Biopharmaceutical Business Unit) are leading contract
manufacturers of bulk biopharmaceuticals. The companies provide pre-clinical,
Phase I to III development and commercial scale production services of
biopharmaceutical vaccines and therapeutics. Ancillary services include
formulation development, stability studies, process and analytical validation
and regulatory support. For more information, please visit their website at
http://www.Cambrex.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.
(1) Weingart, Saul N., Iezzonbi, Lisa I. "Looking for Medical Injuries
Where the Light is Bright." Journal of the American Medical Association.
2003 October; vol. 290, no. 14. Cassandro D. Salgado and Barry M. Farr, "MRSA
and VRE: Preventing Patient-to-Patient Spread." Infectious Medicine. 2003;
vol. 20, no. 4. (The costs are derived thus: 2,000,000 infected patients x
$14,000 to $15,000 average cost of treating an infection) Roberts, et.al.,
"Hospital-Acquired Infection Economic Modeling." Clinical Infectious Diseases.
Vol. 36, no. 11 puts the cost at $15,275; P.W. Stone, et. al., "A Systematic
Audit of Economic Evidence Linking Nosocomial Infections and Infection Control
Interventions 1990-2000," American Journal of Infection Control (2002) puts
the cost at $13,973.
SOURCE Nabi Biopharmaceuticals
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Related links:
http://www.nabi.com
http://www.Cambrex.com
CONTACT:
Constance C. Bienfait, Vice President,
Investor Relations, Nabi Biopharmaceuticals, +1-561-989-5800
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