February 11, 2014
Scancell Holdings Plc, the developer of novel immunotherapies for the treatment of cancer, is pleased to announce that the United States Food and Drug Administration (‘FDA’) has granted orphan drug designation to its SCIB1 ImmunoBody® (‘SCIB1’) for the treatment of metastatic melanoma.
Orphan drug status in the United States qualifies the development of SCIB1 for a 50% tax credit for clinical trials, a waiver of the prescription drug user fee for the drug approval procedure and a period of seven years of market exclusivity following drug approval by the FDA. During the orphan market exclusivity period, the FDA cannot approve a NDA (new drug application) or a generic drug application for the same product including the principal molecular structure features of the drug and for the same rare disease indication.
The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.1
See the press release here.