Orphan drug designation entitles ViroPharma to seven years of market exclusivity in the US. Other potential advantages include protocol assistance, the potential for priority review, tax credits, and other financial incentives.
Cytomegalovirus (CMV) is a member of the herpes virus group, which includes the viruses that cause chicken pox, mononucleosis, cold sores, and genital herpes. Like other herpes viruses.
“We have made excellent progress with maribavir over the last 12 months. We demonstrated in a phase II clinical trial that the drug appears to be well tolerated with impressive anti-CMV activity in stem cell transplant patients, which has allowed us to initiate our international phase III development program,” commented Colin Broom, ViroPharma's chief scientific officer.