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BOCA RATON, Fla. -- Nabi Biopharmaceuticals announced that its StaphVAX(R) (Staphylococcus aureus Polysaccharide Conjugate Vaccine) Marketing Authorization Application (MAA) has been accepted for review by the European Medicines Evaluation Agency (EMEA). The company submitted its MAA filing with the EMEA using the centralized procedure to request marketing approval for StaphVAX for the prevention of S. aureus bacteremia in patients with end-stage renal disease (ESRD) on hemodialysis for up to 40 weeks.
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.
Source: Nabi Biopharmaceuticals