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Nabi Biopharmaceuticals Initiates PhosLo(R) Epick Study in Chronic Kidney Disease Patients

Posted on: Tuesday, 10 May 2005, 18:00 CDT

BOCA RATON, Fla., May 10 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals today announced the initiation of its PhosLo(R) (calcium acetate) EPICK study in Chronic Kidney Disease (CKD) patients suffering from Stage 4 kidney disease. The study is designed to demonstrate that PhosLo is effective and safe in controlling elevated phosphorus levels (hyperphosphatemia) in Stage 4 CKD patients without causing very low calcium levels (hypocalcemia), or high levels of acidity in the blood (metabolic acidosis). Results from the EPICK study will be used to support license applications in the United States and the European Union for the use of PhosLo in these pre-dialysis patients. PhosLo is a prescription phosphate binder currently indicated for the control of hyperphosphatemia in patients with end- stage renal (kidney) disease (ESRD). The company currently markets PhosLo in the United States and has filed a Marketing Authorization Application (MAA) to market the product in Europe for the ESRD indication.

Stage 4 CKD is an increasing global healthcare challenge with over 400,000 patients in the U.S. alone. Those patients are expected to progress to Stage 5 (requiring dialysis). The CKD patient population is expected to grow significantly, partly due to the general aging of the population and partly due to dramatic increases in factors such as hypertension, diabetes and obesity. As kidney function deteriorates, patients suffering from CKD almost inevitably develop elevated phosphorus levels, which have been associated with morbidity and mortality, mainly from cardiovascular disease.

"Hyperphosphatemia is a serious problem among Chronic Kidney Disease patients who currently have no licensed treatment options," said Henrik S. Rasmussen, M.D., Ph.D., senior vice president, clinical, medical and regulatory affairs, Nabi Biopharmaceuticals. "The National Kidney Foundation's K/DOQI guidelines recommend use of calcium-containing binders, such as PhosLo, as the treatment of choice for CKD patients. The EPICK study is designed to generate data to support a supplemental license application for the use of PhosLo in Stage 4 CKD patients. With positive results from the EPICK study, we believe PhosLo is poised to capture this large, growing and underserved commercial opportunity. In addition, by providing better control of phosphorus levels, we believe it is possible that the need for additional and more expensive treatment modalities, such as Vitamin D analogues, could be reduced."

LeRoux Jooste, senior vice president, global sales and marketing, Nabi Biopharmaceuticals, added, "Starting treatment with a cost-effective phosphate binder, like PhosLo, in pre-dialysis patients should help drive market share overall. We would expect physicians to continue to prescribe PhosLo when these Stage 4 patients eventually progress to the dialysis stage. Clearly, as we look at emerging trends in the United States and Europe focused on demonstrated benefits and cost effectiveness, this opportunity to broaden the use of PhosLo will further establish its value as a first-line therapy in the treatment of hyperphosphatemia."

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.

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 four 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 preclinical development. Nabi Biopharmaceuticals has advanced StaphVAX(R) [Staphylococcus aureus Polysaccharide Conjugate Vaccine] to Phase III clinical development. StaphVAX is designed to prevent the most dangerous and prevalent strains of Staphylococcus 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 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; 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.

Nabi Biopharmaceuticals

CONTACT: Mark Soufleris, Vice President, Investor & Public Relations,Nabi Biopharmaceuticals, +1-561-989-5800

Web site: http://www.nabi.com/

Source: PRNewswire-FirstCall

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