Protein Design Labs Inc. announced that its human antibodyagainst cytomegalovirus (CMV) received orphan drug statusfrom the FDA for treatment of CMV retinitis in AIDS patientsand for prevention of CMV infections in patients undergoingorgan transplantation.
The Mountain View, Calif., company (NASDAQ:PDLI) alsoreceived orphan drug status for its human antibody againsthepatitis B for prophylaxis of hepatitis B reinfections inpatients undergoing liver transplantation secondary to end-stage chronic hepatitis B infection.
Phase I/II trials have been completed for each of theseindications.
Orphan drug status confers seven years of marketingexclusivity as well as potential tax benefits for themanufacturer if the product is the first of its structure toreceive FDA marketing approval.
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