Novavax Expands Pipeline With Preclinical Results for Two New Compounds

Novavax has announced additional positive results from preclinical studies applying its proprietary micellar nanoparticle (MNP) technology to transdermally deliver two nonhormone drugs.

The drugs tested were NX-303 oxybutynin, for urinary and bladder complications, and NX-401, an undisclosed antihistamine.

The MNP technology allows fast, low-cost product development compared with typical development of new chemical entities. From proof of principle in a validated preclinical model through advancing into a Phase I study in humans requires approximately 12 months to complete.

Novavax intends to file two investigational new drug applications (IND) with the FDA by the end of the fourth quarter of 2005 for two nonhormone product candidates. The selection of product candidates to advance to the IND stage will incorporate the technical and market analysis of its streamlined development model.