BRAY, Ireland, Sept. 22 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals
(Nasdaq: NABI) today announced that it received a favorable opinion in Europe
regarding Orphan Medicinal Product (OMP) designation for Altastaph(TM) (human
Staphylococcus aureus immunoglobulin) for the treatment of Staphylococcus
aureus bacteremia. OMP designation acknowledges the significant medical need
for a product and can provide 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.
OMP designation is reserved for medicines being developed for rare
diseases. Orphan medicinal products are used to diagnose, prevent or treat
life-threatening or very serious conditions that generally affect no more than
five people out of every 10,000 people in the European Union.
The OMP designation will result in reduced Marketing Authorization
Application (MAA) fees, free access to scientific advice from the European
Medicines Agency (EMEA) and other potential research and development
incentives. Further, if a product with an OMP designation is first to receive
marketing authorization in Europe for its designated indication, the product
will be entitled to 10-year market exclusivity, barring a similar drug from
receiving authorization for the same indication during this period.
"The OMP designation marks another important step in advancing our
comprehensive combination approach to treating and preventing S. aureus
infections with Altastaph and StaphVAX," said Henrik S. Rasmussen, M.D.,
Ph.D., senior vice president, clinical, medical and regulatory affairs, Nabi
Biopharmaceuticals.
Dr. Rasmussen continued, "We are particularly pleased about getting this
designation because it acknowledges the persistent increase of staph
infections on the European continent. Together with Altastaph's Fast Track
designation in the U.S., the OMP status promises to accelerate the drug's
development and reduce our development costs."
This is the second recent positive opinion regarding OMP designation for
Nabi Biopharmaceuticals product candidates. On June 22, 2005, Nabi
Biopharmaceuticals announced that it received the OMP designation for
Civacir(TM) [Hepatitis C Immune Globulin (Human)], the company's product
candidate for the prevention of recurrent hepatitis C virus-induced liver
disease in liver transplant recipients.
About S. aureus Infections and Resistance Issues
Worldwide, over 95 percent of patients with S. aureus infections no longer
respond to first-line antibiotics, such as penicillin or ampicillin.
Methicillin resistance typically symbolizes broad-spectrum resistance to a
multitude of antibiotics. In early 2005, a study in The Lancet revealed that
the overuse of antibiotics in Spain, Greece, Italy, Portugal and France is
causing high rates of antibiotic resistance.
In the U.K., for example, where hospital-acquired infection rates are
among the worst in Europe, bloodstream infections resulting from S. aureus are
increasing with a 44 percent resistance to methicillin, according to 2004
statistics. Each year, approximately 300,000 people in the U.K., or nine out
of every 100 people, who go into hospital, will pick up an infection there.
Of these, about 5,000 will die.
About Altastaph(TM)
Altastaph(TM) [Staphylococcus aureus Immune Globulin Intravenous (Human)]
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% 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 January 2005, Nabi Biopharmaceuticals announced positive results of its
U.S. Phase I/II clinical trial using Altastaph to treat adult in-hospital
patients with persistent S. aureus bloodstream infections (bacteremia). This
study found a 36% 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). The Altastaph patients were sicker than the placebo
group, according to well-accepted and objective clinical parameters. The most
frequent study-drug related adverse events were generally mild to moderate
fever and chills, which are well-documented adverse events associated with
intravenous immune globulin products.
This substantial reduction in the length of hospital stay for the
Altastaph-treated group indicates that S. aureus antibodies provided by
Altastaph could be associated with considerable medical benefit in the
treatment of persistent S. aureus infections.
Altastaph has been designated an orphan drug in the U.S. and has received
Fast Track Designation for providing immediate protection against S. aureus
infections in low-birth-weight infants. 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.
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 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(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 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 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 United States may not be
successful; the possibility that we may not realize the value of our
acquisition of PhosLo; the company's 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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