FDA Grants Fast Track Designation for Bavarian Nordics Third Generation Smallpox Vaccine Candidate IMVAMUNE

COPENHAGEN, Denmark and WASHINGTON -- Bavarian Nordic has announced that it has received fast track designation by the U.S. Food and Drug Administration (FDA) for its investigational new drug application covering the companys 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 communication 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 program 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 companys MVA-BN® virus and associated technology.

Source: Bavarian Nordic