Nabi Biopharmaceuticals Release: Large Proportion Of Patients On Renagel(R) Receive Calcium Supplementation To Avoid Abnormally Low Levels Of Calcium In Their Blood

ROCKVILLE, Md., Nov. 21 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals 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.

Nabi Biopharmaceuticals

CONTACT: Constance C. Bienfait, Vice President, Investor Relations, Nabi,+1-561-989-5800

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