FDA Grants Fast Track Designation for Bavarian Nordic’s Third Generation Smallpox Vaccine Candidate IMVAMUNE™
Bavarian Nordic today announces that it has received fast track designation by the U.S. Food and Drug Administration for its Investigational New Drug Application covering the company’s third generation smallpox vaccine candidate IMVAMUNE™ (MVA-BN®). IMVAMUNE™ is the first and only smallpox vaccine candidate to receive this designation.
The fast track designation gives priority review status to a license application and allows filing portions of license applications ahead of others. It facilitates frequent and ongoing commu¬nication with the FDA and is intended to facilitate development and expedite the review of new therapies that are intended to treat serious or life-threatening conditions.
Bavarian Nordic is currently conducting an extensive clinical development programme with its third generation vaccine candidate IMVAMUNE™. Ongoing studies are designed to evaluate the immune response of the vaccine in comparison to Dryvax® as well to evaluate the vaccine in special populations for which Dryvax® is contraindicated.
Peter Wulff, President and CEO of Bavarian Nordic, said, “We are pleased with the fast track designation for IMVAMUNE™, which recognises the importance of developing a safer smallpox vaccine. The fact that IMVAMUNE™ is the first and only smallpox vaccine candidate that has received fast track designation confirms that IMVAMUNE™ is the leading candidate for the development of a safer smallpox vaccine.”
This fast track designation follows other key successes including the recent signing of an agreement with GlaxoSmithKline for the production and marketing of IMVAMUNE™ and the grant of a patent covering the company’s MVA-BN® virus and associated technology. Together, these milestones demonstrate Bavarian Nordic’s position as the leading developer of next generation smallpox vaccines.
The fast track designation will not impact the company’s financial projections for 2004 of revenues of DKK 400 million and earnings before tax of DKK 60-80 million.
