Healthcare Industry News: chronic kidney disease
News Release - October 16, 2006
Nabi Biopharmaceuticals Announces Positive Results From PhosLo(R) EPICK StudyStudy of Stage 4 Kidney Disease Patients Achieves Both Primary and Secondary Endpoints
BOCA RATON, Fla., Oct. 16 (HSMN NewsFeed) -- Nabi Biopharmaceuticals (Nasdaq: NABI ) today announced positive results from the PhosLo® (calcium acetate) EPICK study in chronic kidney disease (CKD) patients suffering from Stage 4 kidney disease. The findings were presented on October 13, 2006 in poster format at the International Society of Nephrology (ISN) Symposium in Copenhagen, Denmark.
The EPICK study was designed to demonstrate that PhosLo is effective and safe in controlling hyperphosphatemia in Stage 4 CKD patients without causing very low calcium levels (hypocalcemia), or high levels of acidity in the blood (metabolic acidosis). The study achieved its primary endpoint of superior serum phosphorus control versus placebo with a P-value equal to 0.0003. The study also achieved its secondary endpoints by demonstrating that attaining a parathyroid level (PTH) target of 70 - 110 pg/mL is more likely with PhosLo than with placebo and by showing that attaining a calcium phosphorus product (CA x P) of 23 - 43 mg2/dL2 is more likely with PhosLo than with placebo.
PhosLo is a prescription phosphate binder currently indicated for the control of elevated phosphorous levels (hyperphosphatemia) in patients with end-stage renal (kidney) disease (ESRD). The positive EPICK study results will support license applications in the United States and European Union and are expected to be filed during 2006. These license applications will seek approval for the broader use of PhosLo in pre-dialysis patients. If successful, PhosLo would be the only phosphate binder on the US market that has a labeled indication for Stage 4 CKD patients.
Henrik S. Rasmussen, M.D., Ph.D., senior vice president, clinical, medical and regulatory affairs, Nabi Biopharmaceuticals, stated, "These results support the role of PhosLo in controlling hyperphosphatemia in Stage 4 CKD patients, a serious problem among this growing patient population. We are pleased to have delivered on our goals of completing this study on schedule and achieving both the primary and secondary endpoints."
On October 12, 2006, Nabi Biopharmaceuticals announced that it had entered into an agreement to sell PhosLo and related assets to Fresenius Medical Care. This transaction is expected to close within thirty days.
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: hepatitis and transplant, kidney disease (nephrology), Gram-positive bacterial infections 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 website: http://www.nabi.com.
Statements in this press release about the company that are not strictly historical are forward-looking statements and include statements related to our plans to explore strategic alternatives and prospects. 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; and identify and complete transactions that represent strategic alternatives and opportunities. 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 July 1, 2006 filed with the Securities and Exchange Commission.
Source: Nabi Biopharmaceuticals
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