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Published on 12/19/2005 in the Prospect News Biotech Daily.

Nabi closes European operations to save expenses in response to StaphVAX phase 3 failure

By E. Janene Geiss

Philadelphia, Dec. 19 - Nabi Biopharmaceuticals announced Monday that it closed its operations in Europe in conjunction with its withdrawal of its Market Authorization Application for StaphVAX in an effort to reduce expenses.

The company said it remains committed to advancing the commercialization of PhosLo (calcium acetate) and Hebig in Europe and will likely look to partner with a sales distributor on commercialization partner for these two products upon their approval, according to a company news release.

"Europe remains an important part of our business and commercialization strategy, and there is a significant need for these products. Each provides unique patient value when compared to products on the market today," Thomas H. McLain, chairman, president and chief executive officer, said in the release.

The company said it only made a minimal investment in office space and personnel at its European headquarters. The cost of severance, write off of depreciable assets and cancellation of any leases in Europe is expected to be about $1.3 million.

Through November 2005, the company incurred direct expenses of $7.2 million in Europe for the license application and planned launch of StaphVAX.

On Nov. 1, the company announced that it would halt development of StaphVAX after it failed to meet its primary endpoint in the company's phase 3 clinical trial.

The randomized, double-blinded, placebo-controlled trial of 3,600 patients on hemodialysis found no reduction in the S. aureus types 5 and 8 infections in the StaphVAX group as compared to the placebo group.

The company said it continues to assess the phase 3 results.

Nabi, based in Boca Raton, Fla., is a biopharmaceutical company focused on powering the immune system to fight serious medical conditions.


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