ROCKVILLE, Md., Nov. 21 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals
(Nasdaq: NABI) announced the results of a study conducted by Charles Nolan,
M.D., professor, medicine and surgery, University of Texas Health Science
Center at San Antonio. The related abstract entitled, "Frequent Calcium
Supplementation in a Large Group of Hemodialysis Patients Treated with
Sevelamer" was published in the American Society of Nephrology's abstract book
at the ASN's recent Annual Meeting. The results of Dr. Nolan's study showed
that a large proportion of patients with end-stage renal disease (ESRD), who
receive treatment with Renagel(R) (sevelamer) to control hyperphosphatemia
(abnormally high levels of phosphorus in the blood), also receive calcium
supplementation to avoid hypocalcemia (abnormally low levels of calcium in the
blood).
Dr. Nolan's study findings are important because:
-- The Renagel Treat-to-Goal Study (Chertow, et. al; KI 62:245, 2002)
claims that calcium, from calcium-containing binders such as PhosLo(R)
(calcium acetate), plays a role in cardiovascular calcification (CVC) in
kidney disease patients on hemodialysis.
-- A substantial proportion of Renagel patients receive supplemental oral
calcium, calling into question the Treat-to-Goal Study's hypothesis that
ingested calcium contributes to CVC.
Dr. Nolan stated, "Based on the results of our study, a conclusion that
calcium-based phosphate binders account for CVC in this patient group cannot
be drawn. We know that there are multiple factors that contribute to CVC, and
prevention of hyperphosphatemia is the key to the prevention of calcification.
Therefore, studies that evaluate the role of calcium loading on CVC, such as
the Treat-to-Goal, should control for factors that affect serum calcium
levels, such as vitamin D therapy, and frequent calcium supplementation in
patients treated with Renagel."
About Dr. Nolan's Study
Dr. Nolan evaluated the frequency of reported calcium supplementation in a
large cohort of kidney disease patients, enrolled as part of Nabi
Biopharmaceuticals' Phase III study for a vaccine against S. aureus
infections, in more than 200 dialysis units throughout the U.S. Approximately
1,400 patients were treated with Renagel for control of hyperphosphatemia, and
of those, 37 percent reported receiving concurrent treatment with over-the-
counter calcium-containing supplements or PhosLo.
Dr. Nolan continued, "We believe that the CARE 2 study, currently
underway, will show that there is no difference in the rate of CVC when lipid
levels are equivalent in patients treated with PhosLo and Lipitor(R) or with
Renagel and Lipitor."
Nabi Biopharmaceuticals' CARE 2 study, in compliance with the National
Cholesterol Education Program guidelines, is designed to demonstrate that when
lipid levels are kept constant with Lipitor, there will be no difference in
CVC 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 offer the most cost-effective control of cardiovascular risk
factors in these patients.
Importantly, the CARE 2 study controls for vitamin D, dialysate calcium
content and lipid levels to <70 mcg/dL, which support a well-designed, well-
controlled study to objectively determine calcium and its relationship to CVC.
The Calcium Hypothesis; The Importance of Phosphate Control
Scientific Evidence; Best Clinical Practice
* Cardiovascular disease is and has been common in kidney disease
patients; and a large body of scientific and clinical evidence demonstrates
the role of many risk factors (such as age, smoking, hyperlipidemia, diabetes
and family history, as well as risk factors related to impaired kidney
function, including hyperphosphatemia, chronic inflammation and duration of
dialysis) in the development of CVC.
* A large body of scientific and clinical evidence compiled over many
years demonstrates the relationship between serum phosphorus and CVC. CVC was
reported decades before calcium-containing phosphate binders ever came into
widespread use.
* According to the National Kidney Foundation's Kidney Disease Outcomes
Quality Initiative (K/DOQI) fact-based guidelines, maintaining phosphate
control in kidney disease patients is critical to their health.
* To date and in line with the K/DOQI guidelines, PhosLo effectively
controls phosphate in kidney disease patients.
* The recently presented results of the DCOR study, which failed to meet
its primary or secondary endpoints, showed no difference in mortality or
morbidity between calcium-containing binders and sevelamer. There were 265
deaths on sevelamer versus 274 deaths of Calcium binders, which was
statistically identical. The study, designed to demonstrate superiority of
sevelamer on overall cardiovascular mortality and morbidity, provides
additional evidence that calcium from calcium binders does not contribute to
CVC. This is further supported by results from the DOPPS study, presented at
the recent ASN meeting, which compared overall mortality and cardiovascular
disease mortality in ~9,000 patients, treated for up to two years with
sevelamer or calcium binders. This study demonstrated that there was no
difference in mortality between the groups, when adjusted for differences in
underlying risk factors.
Clinical Study
* In the study results presented by Dr. Nolan, approximately 40 percent of
Renagel-treated patients received supplemental calcium. Assuming that this is
representative of clinical practice (which is believed to be the case, as more
than 200 dialysis units throughout the U.S. participated in the study), this
finding calls into question the main conclusions of the Treat-to-Goal study,
specifically the influence of ingested calcium intake on CVC in the treatment
arm.
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 focusing on developing products addressing 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 NicVAX, a vaccine to treat nicotine addiction,
and Civacir, 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; maintain the human and financial resources to commercialize
current products and bring to market products in development; obtain
regulatory approval for its products in the U.S. or other markets;
successfully develop manufacture and market its products; utilize the full
capacity of its manufacturing facility; announce preliminary safety and
immunogenicity results from its Phase II NicVAX study by the end of 2005;
manufacture NicVAX in its own vaccine facility; realize the value of its
acquisition of PhosLo; realize sales from Nabi-HB due to patient treatment
protocols and the number of liver transplants performed in HBV-positive
patients; realize the value from its vaccine manufacturing facility; realize
future sales growth for its biopharmaceutical products; prevail in patent
litigation; raise additional capital on acceptable terms; re-pay its
outstanding convertible senior notes when due; and the company's dependence
upon: third parties to manufacture its products and a small number of
customers. Many of these factors are more fully discussed, as are other
factors, 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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