- Company to Focus on Launching its Lead Products in Europe -
BOCA RATON, Fla., Dec. 19 /PRNewswire-FirstCall/ -- Nabi
Biopharmaceuticals (Nasdaq: NABI) announced today changes to its European
commercialization strategy as it conducts an assessment of confirmatory Phase
III clinical trial results for StaphVAX(R) [Staphylococcus aureus
Polysaccharide Conjugate Vaccine] announced on November 1, 2005, and in an
effort to reduce expenses. In line with the company's decision to withdraw
its Marketing Authorization Application (MAA) in Europe, it has also closed
its operations in Europe. Nabi Biopharmaceuticals remains committed to
advancing the commercialization of PhosLo(R) (calcium acetate) and HEBIG(TM)
in Europe and, upon their approval, the company's focus will be on the launch
of these two critical therapies through a sales distributor or
commercialization partner.
PhosLo is a prescription phosphate binder indicated for the control of
hyperphosphatemia (elevated serum phosphorus levels) in patients with end-
stage renal failure (ESRD). HEBIG is the European trade name for Nabi-HB(TM)
Intravenous [Hepatitis B Immune Globulin (Human) Intravenous] designed to
prevent re-infection of hepatitis B disease in HBV-positive liver transplant
patients. Both products are in advanced stages of regulatory review within
Europe under the Mutual Recognition Procedure and approvals are expected in
the first half of 2006. Future clinical infrastructure and marketing support
for PhosLo and HEBIG can be provided by the applicable Nabi Biopharmaceuticals
teams based in the U.S.
"Europe remains an important part of our business and commercialization
strategy, and there is a significant need for these products. Each provides
unique patient value when compared to products on the market today," stated
Thomas H. McLain, chairman, president and chief executive officer, Nabi
Biopharmaceuticals. "Our goal is to create additional opportunities for our
two lead marketed products by extending their reach outside the U.S. and into
markets in Europe and around the world. Because of the niche orientation of
these products, we believe that can be best accomplished by leveraging another
company's infrastructure.
"There are a substantial number of ESRD patients in Europe that require
dialysis and need phosphate binder therapy," Mr. McLain continued. "This
patient population is large and growing due to overall aging of the
population, and an increase in diabetes, obesity and hypertension. We believe
that PhosLo in particular will be ideally suited to patients due to its
demonstrated efficacy and significant cost effectiveness, which is an
extremely high priority in Europe. We believe that the market opportunity
will expand based on our expectation for a positive outcome from our ongoing
EPICK study of PhosLo to control hyperphosphatemia in chronic kidney disease
patients in the U.S. and Europe. We expect to report the results of this
trial in the second half of 2006 and then be able to file for label expansion
in Europe in the first half of 2007."
Mr. McLain concluded, "Hepatitis B is also a major global healthcare
concern and the rates of HBV in Europe are similar to those in the U.S.
Recurrence of HBV infection following liver transplant is almost universal if
left untreated, and most often leads to rapid deterioration of liver function,
often resulting in death or the need for re-transplantation. Hepatitis B
immune globulin therapies such as HEBIG have proven to be the cornerstone for
preventing recurrent HBV following liver transplant."
With respect to the investment in European operations, the company had
only made a minimal investment in office space and personnel prior to its
decision to close its European headquarters. The cost of severance, write off
of depreciable assets and cancellation of any leases in Europe is expected to
be approximately $1.3 million. Through November 2005, the company incurred
direct expenses of $7.2 million in Europe for the license application and
planned launch of StaphVAX.
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 focused on capturing large 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 vaccines and antibodies to prevent and treat Gram-positive bacterial
infections, NicVAX(TM) (Nicotine Conjugate Vaccine), a vaccine to treat
nicotine addiction, and Civacir(TM), 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; the company's ability to maintain the human and financial
resources to commercialize current products and bring to market products in
development; likelihood of the company to announce preliminary safety and
immunogenicity results from its Phase II NicVAX study by the end of 2005; the
ability of the company to manufacture NicVAX in its own vaccine facility; the
possibility that the company may not realize the value of its 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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