- Findings Provide Additional Support for Use of PhosLo as First-Line
Therapy; Company Announces Update on EU Regulatory Approval Process for
PhosLo -
ROCKVILLE, Md., July 18 /PRNewswire-FirstCall/ -- Nabi
Biopharmaceuticals (Nasdaq: NABI) today announced the results of a study
which provided further demonstration that PhosLo (calcium acetate) provides
superior control of serum phosphorus when compared to sevelamer. Serum
phosphorus is a key determinant of morbidity and mortality among end-stage
renal disease (ESRD) patients. The findings of the study were presented in
poster format on July 16, 2006 at the European Renal Association and the
European Dialysis and Transplant Association (ERA-EDTA) Congress in
Glasgow, Scotland. The abstract is entitled: "Control of Serum Phosphorus
in Incident Hemodialysis Patients: A Comparison of Sevelamer and Calcium
Acetate."
Henrik S. Rasmussen, M.D., Ph.D., senior vice president clinical,
medical and regulatory affairs, Nabi Biopharmaceuticals, remarked, "The
results of this study add to the growing body of evidence supporting the
use of PhosLo as a first-line therapy for hyperphosphatemia in dialysis
patients. By demonstrating the superior ability of calcium acetate to
control serum phosphorus versus sevelamer over a twelve-month period, this
study both confirms and expands upon the conclusions from the original CARE
study, which produced similar results over an eight-week period. This study
also builds upon notable research that was published in 2005, including the
D-COR and the DOPPS studies, which demonstrated that there is no
statistically significant difference in mortality between patients treated
with calcium-containing binders and sevelamer, when adjusted for
differences in other underlying risk factors. The D-COR study also showed
that a larger proportion of patients on sevelamer than on
calcium-containing binders discontinued treatment due to side effects. We
expect to further advance the body of clinical evidence supporting the use
of PhosLo as a first-line therapy with the release of the results of the
CARE-2 study later this year."
The company also announced that it has received an updated timetable
from European regulators related to the inspection of the PhosLo
manufacturing facility, which is the last step required for approval for
PhosLo in the EU. This inspection was anticipated to have been conducted by
the Reference Member State in the second quarter of 2006, but is now
expected to take place during the second half of 2006. Thomas H. McLain,
chairman, chief executive officer and president, Nabi Biopharmaceuticals,
stated, "We are satisfied that we have done everything possible to achieve
a timely decision by regulators for PhosLo and anticipate that the
manufacturing inspection is the final step needed before an approval
decision is made. The Reference Member State, which reviewed our
application for PhosLo, has already recommended its approval to the five
other member states selected, contingent upon this inspection. We will
continue to aggressively pursue this approval, which would allow us to
bring the demonstrated benefits of PhosLo to patients in Europe."
Study Methodology and Findings
The authors of the study, "Control of Serum Phosphorus in Incident
Hemodialysis Patients: A Comparison of Sevelamer and Calcium Acetate,"
analyzed data from 1,000 adult patients admitted to large commercial
hemodialysis provider clinics for initiation of dialysis. Of the 1,000
initial patients, 181 patients were treated exclusively with sevelamer and
321 patients were treated exclusively with calcium acetate. Patients who
received calcium carbonate only, patients who received both sevelamer and
calcium acetate, and patients who received phosphate binders were excluded
from the analysis.
The analysis of these data indicated that the patients treated
exclusively with calcium acetate during the first year of hemodialysis
showed superior control of serum phosphorus and calcium phosphorous product
compared to patients treated with sevelamer. That was the case whether
analyzing mean changes in serum phosphorus levels, or whether analyzing the
number of patients who achieved serum phosphorus levels and
calcium-phosphorus product in accordance with K/DOQI guidelines. Averaged
serum phosphorus over a one- year period was 5.05 +/- 1.14 mg/dL in the
calcium acetate group and 5.42 +/- 1.22 mg/dL in the sevelamer group
(p=0.0097); the averaged calcium-phosphorus product was 44.94 +/- 10.62
mg2/dL2, and 49.85 +/- 11.44 mg2/dL2 in the groups respectively (p=0.0008).
There were no significant differences in serum calcium, or bio-intact PTH
between the two groups.
About the CARE-2 Study
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 cardiovascular calcification in patients treated with PhosLo
versus Renagel(R) (sevelamer hydrochloride). 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.
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. The company has 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. Nabi
Biopharmaceuticals is focused on developing products that address unmet
medical needs and offer commercial opportunities in our core business
areas: Gram-positive bacterial infections, hepatitis and transplant, kidney
disease (nephrology) and nicotine addiction. For a complete list of
pipeline products, please go to: http://www.nabi.com/pipeline/index.php .
The company is headquartered in Boca Raton, Florida. For additional
information about Nabi Biopharmaceuticals, please visit our Web site:
http://www.nabi.com .
Forward-Looking Statement
Statements in this press release about the company that are not
strictly historical are forward-looking statements and include statements
about our products in development, the market for such products, and
regulatory approval of our product candidates. You can identify these
forward-looking statements because they involve our expectations, beliefs,
intentions, plans, projections, or other characterizations of future events
or circumstances. These forward-looking statements are not guarantees of
future performance and are subject to risks and uncertainties that may
cause actual results to differ materially from those in the forward-looking
statements as a result of any number of factors. These factors include, but
are 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., Europe or other markets;
successfully develop, manufacture and market its products; successfully
partner with other companies; realize future sales growth for its
biopharmaceutical products; maintain sufficient intellectual property
protection or positions; raise additional capital on acceptable terms;
re-pay its outstanding convertible senior notes when due. 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 31, 2005 and
Quarterly Report on Form 10-Q for the Quarter ended April 1, 2006 filed
with the Securities and Exchange Commission.
SOURCE Nabi Biopharmaceuticals
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Related links:
http://www.nabi.com
http://www.nabi.com/pipeline/index.php
CONTACT:
Thomas E. Rathjen, Vice President, Investor
Relations, Nabi Biopharmaceuticals, +1-561-989-5800
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