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European Medicines Evaluation Agency Accepts StaphVAX Filing
Acceptance of the StaphVAX MAA for review indicates the company's submission has been administratively validated by the EMEA and the regulators believe the required information is complete and ready for review. The EMEA's Committee for Medicinal Products for Human Use (CHMP) will evaluate the company's application to determine whether to recommend approval for the marketing of StaphVAX in all 25-member states of the European Union (EU). In addition, the CHMP has officially approved the trade name StaphVAX for this product.
Based on the normal schedule for reviewing submissions using the centralized procedure, Nabi Biopharmaceuticals anticipates coordinating an inspection at the contract manufacturers' facility and responding to questions about the research, clinical and manufacturing data during 2005. If the company's responses are adequate, the EMEA should respond to the submission before the end of 2005.
If that response is an approval, the company must then file for reimbursement in individual markets in the EU based on data supporting the incidence and costs of S. aureus infections in that country. Upon reaching a decision on pricing, the company can begin commercialization in that individual market.
"Acceptance of our StaphVAX MAA filing starts the timing for an important review process and provides further validation of the quality and completeness of the StaphVAX data package that was submitted to the regulatory authorities," stated Thomas H. McLain, chairman, chief executive officer and president, Nabi Biopharmaceuticals. "Staph aureus infections represent one of the EU's most pressing public healthcare concerns, and we believe that StaphVAX could offer a new and innovative approach to prevent the deadly consequences of infections caused by this organism. We look forward to working closely with the European regulatory authorities toward the licensure of StaphVAX."
This MAA filing is based on data from the previously completed U.S. Phase III clinical trial of StaphVAX in ESRD patients. Results of that trial were published in The New England Journal of Medicine in February 2002. Nabi Biopharmaceuticals also plans to file a supplemental StaphVAX MAA in the EU for the prevention of S. aureus bacteremia in at-risk adults. The filing will include data from the company's second U.S. Phase III clinical trial along with data from its U.S. and EU immunogenicity studies conducted in other at- risk patient populations.
About S. aureus infections in Europe
The issue of S. aureus resistance and an effective treatment for S. aureus infections pose significant challenges for healthcare providers in the EU. As reported by the European Antimicrobial Resistance Surveillance System, the rate of methicillin-resistant S. aureus (MRSA) has increased drastically throughout Europe as demonstrated by an increase from 33% to 44% in the United Kingdom from 1999 to 2004. Protecting patients against the effects of these infections has consequently become increasingly difficult. The medical challenge has been further complicated by the documented occurrence of strains of S. aureus bacteremia that are resistant to Vancomycin, the antibiotic of last resort, in Europe as well as in Japan and the United States.
StaphVAX 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 U.S. Phase III clinical trial. This double-blinded, placebo-controlled and randomized trial is being conducted in ESRD patients undergoing hemodialysis. The 3,600-patient study has completed enrollment and 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 (BLA) with the United States Food and Drug Administration by the end of 2005.
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, developed through 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. The acquisition of PhosLo® (calcium acetate) for the treatment of patients at-risk for hyperphosphatemia, a common problem associated with ESRD, represents a significant advancement in Nabi Biopharmaceuticals' commercial position in the nephrology market place. Combined, StaphVAX and PhosLo will favorably position Nabi Biopharmaceuticals to compete in the large and growing global nephrology market.
Source: Nabi Biopharmaceuticals