Nabi Biopharmaceuticals has submitted a filing in Europe to obtain registration for the use of PhosLo (calcium acetate) in controlling elevated phosphorus levels (hyperphosphatemia) in patients with end-stage renal (kidney) disease (ESRD). Nabi Biopharmaceuticals currently markets PhosLo in the United States for this indication.

The filing uses the Common Technical Document (CTD) format, which is widely accepted on a global basis. Under this format, the filing can be readily submitted in other countries around the world, facilitating Nabi Biopharmaceuticals' ability to expand the marketing of PhosLo in key ESRD markets beyond Europe and the United States, the company release said.

"The filing of the PhosLo CTD under the Mutual Recognition Procedure allows Nabi Biopharmaceuticals to approach one of the EU member states and file in that country," stated Henrik S. Rasmussen, senior vice president, clinical, medical, and regulatory affairs, Nabi Biopharmaceuticals. "When the registration is successful in that country, we can then use the approval as a foundation for licensure in other EU countries on a more accelerated timeline," he added.

Dr. Rasmussen continued, "The file that we submitted consists of the original NDA supported by an extensive safety database developed over 13 years of marketing PhosLo in the United States. The application also includes the compelling efficacy data from the Calcium Acetate Renagel Evaluation (CARE) study, a randomized, double-blinded, well-controlled trial demonstrating PhosLo was significantly better in controlling serum phosphorus and the calcium phosphate product levels than Sevelamer, an agent recently approved throughout the European Union."

Management also noted that the PhosLo filing is one of three filings in Europe the company has made or plans to make this year. In June 2004, Nabi Biopharmaceuticals announced it filed for registration of Nabi-HB [Hepatitis B Immune Globulin (Human)] and before year-end the company plans to file for registration of StaphVAX in the EU, the release added.

PhosLo is a calcium acetate-based product, distinct from the prescription calcium carbonate products that dominate the ESRD market in Europe today. Clinical studies have demonstrated that calcium acetate is a superior binder and results in significantly lower calcium intake and absorption than calcium carbonate products.

ESRD is an increasing global healthcare challenge with an estimated one million patients around the world requiring renal replacement or dialysis therapy today. Approximately 230,000 of these patients reside in the five major markets in Europe (UK, Germany, France, Spain and Italy).