Healthcare Industry News: hemodialysis
News Release - July 18, 2006
Nabi Biopharmaceuticals Releases New Data which Demonstrate Superior Serum Phosphorus Control with PhosLo(R) (calcium acetate) over SevelamerFindings 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 (HSMN NewsFeed) -- 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® (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.
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® (calcium acetate), Nabi-HB® [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 .
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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