BOCA RATON, Fla., Sept. 27 /PRNewswire-FirstCall/ -- Nabi
Biopharmaceuticals (Nasdaq: NABI) announced today that it has filed a lawsuit
against Roxane Laboratories, Inc. for infringement of its PhosLo(R) (calcium
acetate) gelcap patent. The lawsuit was filed in the United States District
Court for the Southern District of Ohio.
The Company filed this lawsuit under the Hatch-Waxman Act in response to a
Paragraph IV Certification letter submitted by Roxane to the Company
concerning Roxane's filing of an Abbreviated New Drug Application (ANDA) with
the U.S. Food and Drug Administration (FDA) to market a generic version of the
Company's PhosLo(R) (calcium acetate) GelCaps. PhosLo is a prescription
phosphate binder currently indicated for the control of hyperphosphatemia in
patients with end-stage renal (kidney) disease (ESRD).
The Company filed the lawsuit on the basis that Roxane Laboratories'
submission of its ANDA and its proposed generic product infringe a patent held
by the Company. The patent expires in 2021. The Company remains committed to
protecting its intellectual property and will take all appropriate steps to
vigorously protect its patent rights.
Under the Hatch-Waxman Act, FDA approval of Roxane Laboratories' proposed
generic product will be stayed until the earlier of 30 months or resolution of
the patent infringement lawsuit.
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 of Nabi Biopharmaceuticals, +1-561-989-5800
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