Genmab A/S announced that HuMax-CD4 for the treatment of Cutaneous T-cell Lymphoma (CTCL) has been designated an orphan drug by the European Agency for the Evaluation of Medicinal Products (EMEA).
The filing for this status was completed as part of an overall plan to obtain orphan drug protection for Humax-CD4 to treat CTCL. At present Genmab's primary rights for HuMax-CD4 are in North and South America, and Genmab does not hold rights to Humax-CD4 in Europe.
Under the EMEA's Regulation (EC) No. 141/2000 an orphan drug designation gives companies access to protocol assistance and guidance on preparing a dossier that will meet European regulatory requirements and thereby maximize the chance of success at the time of marketing authorization. Once approved, an orphan drug is also granted 10 years of market exclusivity during which directly competitive similar products cannot normally be placed on the market.
The EMEA grants orphan drug designation based upon several criteria: the life-threatening and debilitating nature of the condition; the medical plausibility of the proposed orphan indication; a prevalence in Europe of less than 5 cases for each 10,000 of population; no satisfactory method of diagnosis, prevention or treatment exists or if such method exists the medicinal product will be of significant benefit to those affected by that condition.
"The EMEA has granted orphan drug status to HuMax-CD4 on the basis of the available safety and efficacy data which shows the antibody may be of significant benefit to CTCL patients," said Lisa N. Drakeman, CEO of Genmab. "The orphan designation strengthens our chances of bringing HuMax-CD4 to patients who desperately need alternative methods of treatment."