Nabi Biopharmaceuticals Accelerates Commercialization Plans for its investigational vaccine StaphVAX(R)

EU Filing Expected by Year-end '04 Using Previously Completed Phase III Clinical Results; Agreement Signed with New Contract Manufacturer for Europe and U.S.

10-Oct-2003

Nabi Biopharmaceuticals 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." New Contract Manufacturing Partner 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 ten-year manufacturing agreement, including a renewal term, with Cambrex Bio Science Baltimore, Inc., a subsidiary of Cambrex Corporation (NYSE:CBM) . 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. In conjunction with establishing this new manufacturing relationship with Cambrex Bio Science, Nabi Biopharmaceuticals has ended its contract manufacturing agreement with Dow Biopharmaceutical Contract Manufacturing Services. As a result of this action, the company will write off costs it has capitalized in prior periods relating to the right to manufacture StaphVAX in Dow's facility. The company will record a non-cash charge of approximately $14 million in the fourth quarter of 2003 to write off an intangible asset related to manufacturing at Dow. "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." Dr. 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. "We are very pleased that Nabi Biopharmaceuticals has selected Cambrex Bio Science Baltimore as their contract manufacturer of choice," commented Peter van Hoorn, Cambrex President Biopharmaceutical Business Unit. "Our agreement with Nabi Biopharmaceuticals illustrates the value we can provide to our clients: technology, manufacturing and regulatory expertise, and a keen commitment to quality and accelerating customer clinical timelines."

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