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ROCKVILLE, Md. -- Nabi Biopharmaceuticals today announced it is significantly accelerating its timeline for licensing and commercializing its lead development product, StaphVAX (S. aureus polysaccharide conjugate vaccine).
StaphVAX is an investigational vaccine being developed to prevent S. aureus blood stream infections. Based on the outcome of meetings in Europe with several key regulatory authorities, the company now plans to file its first license application for StaphVAX in the European Union (EU) using the centralized approval process by the end of 2004. This significant advance in the timeline for launching StaphVAX will not delay the company's plan for commercializing the product in the U. S. Nabi Biopharmaceuticals' target for filing its Biologics License Application for StaphVAX in the U.S. during the fourth quarter of 2005 remains unchanged.
"Our primary strategic objective is to make this innovative approach to preventing serious bacterial bloodstream infections available to physicians and their patients who are at risk from Staph aureus infection as quickly as possible. Clearly by commercializing StaphVAX in the fastest and most cost- effective way possible, we will also maximize the value of this important product opportunity for our investors," said Thomas H. McLain, chief executive officer and president of Nabi Biopharmaceuticals. "Our recent discussions with important European regulatory authorities have affirmed the urgent clinical need for this product. We are very excited that our current clinical data can be used to accelerate our plans for licensure of StaphVAX in the EU."
The license application for the EU is required to include laboratory testing data generated from the production of consistency lots of StaphVAX. The critical element in completing this submission in 2004 is to successfully manufacture consistency lots of StaphVAX in a facility that complies with EU regulatory requirements. To achieve this, Nabi Biopharmaceuticals also announced today that it has signed a 10-year manufacturing agreement, including a renewal term, with Cambrex Bio Science Baltimore, Inc., a subsidiary of Cambrex Corporation.
Cambrex Bio Science, an experienced contract manufacturer of licensed biological products has a facility that has been successfully inspected by EU, U.S. and Canadian regulators with immediately available capacity to manufacture StaphVAX for its launch in Europe and the U. S.
"Cambrex Bio Science has an excellent reputation in contract manufacturing and is the right manufacturing partner for Nabi Biopharmaceuticals," said Raafat E.F. Fahim, PhD, senior vice president, technical and production operations. "Their facility has been successfully inspected by EU regulators, as well as by the FDA and Canadian authorities for the manufacture of biological products including products that require bacterial fermentation and purification such as StaphVAX." Fahim continued, "This is an ideal time to make the transition to Cambrex Bio Science for StaphVAX manufacturing. Results from the immunogenicity study announced in September of this year confirmed that the process development and transfer from our research and development facility was successful. Now Cambrex Bio Science will continue the manufacturing development process by completing the scale-up work in their facility this year, the important next step in driving toward the accelerated launch of StaphVAX in Europe."
Cambrex Bio Science is expected to begin production of the consistency lots required for EU approval in early 2004, significantly ahead of previous timelines. Nabi Biopharmaceuticals and Cambrex Bio Science have already produced a proof of concept lot of StaphVAX under this new manufacturing relationship.
The target for filing a Marketing Authorization Application (MAA) in the EU by the end of 2004 is two years earlier than originally planned. The MAA will be based on data from the previously completed Phase III clinical trial of StaphVAX in end stage renal disease (ESRD) patients. Results of that trial were published in the New England Journal of Medicine in February 2002. This first MAA in the EU will be for an indication that StaphVAX prevents Staph aureus bacteremia in patients with end-stage renal (kidney) disease on hemodialysis for up to 40 weeks. If the product is designated for priority review, it could be approved for sale for this indication by the end of 2005.
The issues of Staph aureus resistance and the effective treatment of staph infections pose significant challenges for health care providers in the EU. As reported by the SENTRY Antimicrobial Surveillance Program, 1997-1999, the rate of methicillin resistant Staph aureus (MRSA) was 26.3 percent for Europe, compared to 34.2 percent for the U.S. Protecting patients against the effects of these infections is becoming increasingly difficult as the incidence of MRSA continues to accelerate, with resistance rates of up to 80 percent in some European countries today. The medical challenge has been further complicated by the documented occurrence of strains of Staph aureus bacteria that are resistant to Vancomycin, the antibiotic of last resort, in Europe as well as in Japan and the United States.
"Staph aureus infections, particularly methicillin resistant Staph aureus infections, are one of the major clinical hazards of the foreseeable future, " said Dr. Gordon R.B. Skinner, chairman of the U.K. Vaccine Research Trust. "The problem is of significant concern in most European countries such as the United Kingdom, where approximately 40 percent of pathogenic Staph aureus isolates are resistant to methicillin and are responsible for 5,000 deaths per year. The present and potential global morbidity and mortality of MRSA disease is virtually incalculable and the development of a safe and efficacious vaccine should be one of the most urgent research and development priorities of the decade."
Source: Nabi Biopharmaceuticals