The FDA has granted Targretin gel orphan drug designation for the treatment of patients with CTCL, and Ligand has requested priority review status of the NDA filing. If the Targretin gel NDA is granted priority review status, the FDA is expected to complete its review of the application within six months of the submission. Ligand has the worldwide rights to Targretin capsules. Ligand will market and sell Targretin capsules in the U.S., Canada and selected European markets through its specialty oncology sales and marketing group. In Spain, Portugal, Greece, and Central and South America, Ferrer Internacional, S.A., will market and distribute, if approved in the respective jurisdictions, Targretin capsules and other oncology products.
Ligand expects to have additional distribution partners for select European and Asian markets.
The prognosis for CTCL is based in part on the stage of the disease when diagnosed. CTCL is most commonly a slowly progressing cancer, and many patients live with the complications of CTCL for 10 or more years after diagnosis. Some patients, however, have a much more aggressive form of this disease, and the median survival for late-stage patients is less than three years. Currently available approved treatment options for CTCL are limited. CTCL continues to be a devastating, highly-symptomatic, very visible, chronic malignancy often characterized by years of deforming symptomatic skin lesions that culminate in ulceration with secondary infection and visceral tumor invasion.