Exelbine™ is a novel emulsion formulation of the chemotherapy drug, vinorelbine. Navelbine®, a branded formulation of vinorelbine, is approved in the U.S. to treat advanced non-small cell lung cancer as a single agent or in combination with cisplatin, and approved in the European Union to treat non-small cell lung cancer and advanced or metastatic breast cancer.

Background and Potential Benefits

Navelbine and its generic equivalents are vesicants and often associated with injection site reactions, including phlebitis, erythema and pain at the site of injection. As reported in the Navelbine label, injection site reactions occurred in approximately one-third of 365 patients treated in three clinical studies with Navelbine as a single agent, with 5% of these reactions categorized as severe.

Exelbine was designed to be a bioequivalent formulation of Navelbine that may reduce the incidence and severity of injection site reactions to Navelbine. Our formulation emulsifies vinorelbine into a homogeneous suspension of nanoparticles that is designed to reduce the interaction between vinorelbine and the venous endothelium during administration into a peripheral vein, thereby reducing irritation associated with administration of the drug.

Development Status

In November 2010, the Company submitted a new drug application (NDA) for Exelbine to the U.S. Food and Drug Administration (FDA), and in August 2011, it received a complete response letter from the FDA stating that it could not approve the Exelbine NDA in its present form.The letter stated that the bioequivalence trial on which the NDA was based would need to be repeated. The Company has discontinued making significant additional capital investments into the Exelbine program and is seeking a partner or outside investor for the program.