Press Release Source: Nabi Biopharmaceuticals
Nabi Biopharmaceuticals Files for European Regulatory Approval for StaphVAX(R) to Prevent S. Aureus Infections in End-Stage Renal Disease Patients
Tuesday December 21, 9:23 am ET
-- Filing Is 24 Months Ahead of Original Schedule; Marks Key Milestone in Advancing Company's Global Nephrology Franchise and Building Global Reach --
ROCKVILLE, Md., Dec. 21 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals (Nasdaq: NABI - News) today announced that it has submitted a Marketing Authorization Application (MAA) to the European Agency for Evaluation of Medicinal Products (EMEA) under the Centralized Procedure for approval to market StaphVAX® (Staphylococcus aureus Polysaccharide Conjugate Vaccine) within the European Union (EU). The indication sought under this initial EU license application is for the prevention of S. aureus bacteremia in patients with end-stage renal disease (ESRD) on hemodialysis for up to 40 weeks. The MAA filing will be based on data from the previously completed Phase III clinical trial of StaphVAX in ESRD patients. Results of that trial were published in the February 2002 issue of The New England Journal of Medicine (NEJM 2002; 346: 491-96). As a result of the filing, the EMEA Committee for Medicinal Products for Human Use (CHMP) will evaluate the company's application to determine whether to approve the marketing of StaphVAX. Upon approval, Nabi Biopharmaceuticals would be allowed to market StaphVAX in all 25 member states of the European Union (EU) once reimbursement approval for each country has been obtained.
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"This filing represents a very significant milestone in our transformation to become a fully integrated biopharmaceuticals company," stated Thomas H. McLain, chairman, chief executive officer and president, Nabi Biopharmaceuticals. "This is our first application for a vaccine product and first application for a product developed fully from bench top to license submission by Nabi Biopharmaceuticals."
Mr. McLain continued, "This filing is also an important milestone for advancing our nephrology franchise and for building our commercial presence in Europe. Staph aureus infections represent one of the EU's most pressing public healthcare concerns. Nabi Biopharmaceuticals remains committed to helping patients around the world who continue to be at risk for these life- threatening infections. We believe that preventing Staph aureus infections before they harm patients may become an important standard of care in the EU and around the world."
Nabi Biopharmaceuticals plans to file a supplemental MAA in the EU upon approval of this initial application that incorporates data from its second Phase III clinical trial in the United States and data from a number of immunogenicity studies in other at-risk patient populations conducted in the EU and the United States. The supplemental MAA filing will seek a broader indication for StaphVAX in preventing S. aureus bacteremia in other at-risk adult patient populations.
About S. aureus infections in Europe and worldwide
The issues of S. aureus resistance and the effective treatment of staph infections pose significant challenges for healthcare providers in the EU. The incidence of methicillin-resistant Staph aureus (MRSA) has significantly increased over the last decade in Europe as well as throughout the developed world. Recent data have shown dramatic increases in most European countries, including an increase from 30 percent to 44 percent in the U.K., and an increase from 22 percent to 28 percent in Belgium. Data from a recent survey in the United States involving 49 major academic medical centers showed that the rate of MRSA had increased from 22 percent in 1995 to 57 percent in 2002. The situation is even more dire in certain Asian countries, with rates of MRSA in Japan, Hong Kong and Taiwan reaching 72 percent, 74 percent and 61 percent, respectively.
Protecting patients against the effects of these infections is becoming increasingly difficult as the incidence of MRSA continues to accelerate. The medical challenge has been further complicated by the documented occurrence of strains of Staph aureus bacteremia that are resistant to vancomycin, the antibiotic of last resort. Increased resistance to vancomycin has been described in Europe, as well as in Japan and the United States.
About StaphVAX
StaphVAX® (Staphylococcus aureus Polysaccharide Conjugate Vaccine) is an investigational vaccine designed to prevent S. aureus infections in at-risk patients. This novel application of Nabi Biopharmaceuticals' vaccine technology stimulates the patient's immune system to build antibodies to the most common forms of S. aureus infections without the development of resistance. StaphVAX is currently in a confirmatory Phase III clinical trial. This double-blinded, placebo-controlled and randomized trial is being conducted in end-stage renal disease patients undergoing hemodialysis. The 3,976-patient study is designed to demonstrate statistical significance with a clinical reduction of 50 percent or more in types 5 and 8 S. aureus infections. In the United States, the company plans to file a Biologics License Application with the U.S. Food and Drug Administration by the end of 2005.
About Nabi Biopharmaceuticals' Nephrology Franchise
Kidney disease is a growing, global public health problem due to the fact that diabetes, obesity and hypertension are on the rise around the world. In the United States alone, it represents a $4 billion market. Nabi Biopharmaceuticals is committed to pursuing nephrology as a core value driver for the company, leveraging its commercialization strengths, including: proven success in launching five products since 1995; building successful brands and market leadership positions in nephrology and transplantation products; and growing an in-house specialty sales force and competencies to support a growing global infrastructure. Furthermore, Nabi Biopharmaceuticals' acquisition of PhosLo® (Calcium Acetate) for the treatment of patients at risk for hyperphosphatemia, a common problem associated with end-stage kidney disease, represents a significant addition to Nabi Biopharmaceuticals' nephrology franchise. Combined, StaphVAX and PhosLo will favorably position Nabi Biopharmaceuticals to compete in the large and growing global nephrology market.
About Nabi Biopharmaceuticals
Nabi Biopharmaceuticals applies its knowledge of the human immune system to commercialize and develop products that address serious, unmet medical needs. The company's focus is in the areas of infectious, autoimmune and addictive diseases. In addition to four marketed products (PhosLo®, Nabi- HB®, WinRho SDF®, Aloprim(TM)), the company has several products in various stages of preclinical and clinical testing. Nabi Biopharmaceuticals has advanced StaphVAX® 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), an antibody for prevention and treatment of S. aureus infections, currently in Phase II testing, NicVAX(TM), a vaccine to treat nicotine addiction, and Civacir(TM), an antibody for preventing hepatitis C virus re-infection in liver transplant patients. For additional information on Nabi Biopharmaceuticals, please visit our Website at: nabi.com .
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