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ContraVir hepatitis medicine secures US FDA orphan drug designation

ContraVir Pharmaceuticals Inc.'s lead investigational drug candidate received the U.S. Food and Drug Administration's orphan drug status to treat hepatitis B in children.

The company is studying tenofovir exalidex as a treatment option for children of up to 11 years of age. Tenofovir is the active component of two hepatitis B drugs marketed by Gilead Inc.: Vemlidy and Viread.

ContraVir's take on tenofovir is meant to reduce the potential renal and bone side effects of the medicine, which has already completed a phase 2 trial.

Chronic hepatitis B virus affects more than 350 million people worldwide and infection rates are high in children infected early or at birth, ContraVir said.

An orphan drug designation is granted to medication intended for use in rare diseases that affect fewer than 200,000 people in the U.S. The designation may also be given to treatments for diseases that affect more people if sales are expected to be low.

Securing the designation results in several benefits for the company, including tax credits.