BOCA RATON, Fla., Aug. 3 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals
(Nasdaq: NABI) today announced it has launched the PhosLo Share Program(TM),
an initiative that will expand access of PhosLo(R) (calcium acetate) to a
broader population of uninsured end-stage renal (kidney) disease (ESRD)
patients on dialysis. There are currently over 330,000 dialysis patients in
the U.S. with this number expected to double within the next 10 years.
As of August 1, 2005, the PhosLo Share Program will provide PhosLo Tablets
to Medicare-eligible ESRD patients who do not have prescription drug coverage,
but require treatment with a phosphate binder. ESRD patients often suffer from
high levels of phosphorous in their blood, a condition called
hyperphosphatemia. Without dietary or medical intervention, phosphorous can
rise to dangerous levels in people with ESRD. Nabi Biopharmaceuticals' PhosLo
is a prescription phosphate binder that helps patients maintain acceptable
levels of phosphorus in their blood.
The new PhosLo Share Program allows for easy and efficient patient access.
The one-page enrollment form, signed by the physician or other authorized
healthcare provider, will serve as the prescription for PhosLo, and physicians
or other providers can also authorize refills. Once accepted into the program,
patients will receive a 60-day supply of PhosLo within two to five business
days.
The PhosLo Share Program will supplement the current PhosLo Patient
Assistance Program (PAP), which will continue for those patients currently
enrolled in it. The PhosLo Share Program will process applications for new
PAP patients and enroll all new uninsured patients.
"We believe PhosLo is a critically important and beneficial treatment
option for patients who suffer from the debilitating effects of kidney disease
and their dialysis treatments," said LeRoux Jooste, senior vice president,
global sales and marketing, Nabi Biopharmaceuticals. "Providing broader
access to PhosLo is key to helping more patients improve their quality of
life. We are committed, through this program, to expeditiously provide PhosLo
to those patients who urgently need and can immediately benefit from our
product."
About the CARE Studies
In May 2004, the results of Nabi Biopharmaceuticals' Calcium Acetate
Renagel Evaluation (CARE study) were published in Kidney International. The
CARE study is the first and only randomized, double-blinded, controlled trial
comparing PhosLo with Renagel(R), a competitive prescription product. The
results of the study clearly demonstrated PhosLo's superiority in controlling
elevated serum phosphorus levels and calcium-phosphorus product as defined by
the K/DOQI guidelines released by the National Kidney Foundation (NKF) for the
treatment of hyperphosphatemia in patients with Stage 4 Chronic Kidney Disease
(CKD).
Nabi Biopharmaceuticals' CARE 2 Study, in compliance with the National
Cholesterol Education Board's guidelines, is designed to demonstrate that when
lipid levels are kept constant with Lipitor, there will be no difference in
cardiovascular calcification in patients treated with PhosLo versus Renagel.
The results of the study would, if positive, strengthen PhosLo's position as
the treatment of choice for ESRD patients, and provide evidence that a
combination of PhosLo and a statin will provide cost-effective control of
cardiovascular risk factors in ESRD patients.
About the EPICK Study
The EPICK study, which is following a randomized, double-blinded, placebo-
controlled design, will evaluate a total of 86 patients in approximately 15
U.S. sites who have Stage 4 CKD and, consequently, develop hyperphosphatemia.
The study is designed to evaluate PhosLo's ability to safely and effectively
control serum phosphorus levels (s-P), parathyroid levels (PTH), serum calcium
levels (s-C) and calcium phosphorus product (Ca x P) in CKD patients.
About PhosLo
PhosLo is administered orally, and when given with food, it combines with
dietary phosphate to form insoluble calcium phosphate complexes that are
eliminated from the body, thereby reducing phosphorus absorption, helping to
prevent excess blood phosphorus levels. Patients should have serum calcium
levels closely monitored and their dose of PhosLo adjusted or terminated to
bring levels to normal. PhosLo is contraindicated in patients with
hypercalcemia. No other calcium supplements should be given concurrently with
PhosLo. PhosLo is well tolerated. Nausea, hypercalcemia, and pruritus
(itching) have occasionally been reported during PhosLo therapy.
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 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'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 in the 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; 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 Bienfait, Vice President, Investor
Relations, Nabi Biopharmaceuticals, +1-561-989-5800
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