News + Font Resize -

Nabi accelerates commercialization plans for StaphVAX
Maryland | Friday, October 10, 2003, 08:00 Hrs  [IST]

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."

Post Your Comment

 

Enquiry Form