Generic drug company Banner Pharmacaps has positioned itself to be first in line to market a generic version of Eisai skin cancer drug Targretin.
The High Point, North Carolina company has filed with the Food and Drug Administration an abbreviated new drug application for Bexarotene 75 mg gelatin capsules. Targretin was approved to treat cutaneous T-cell lymphoma, or CTCL, a rare type of skin cancer. In CTCL, T-cells that normally fight infections become cancerous, affecting the skin and blood. An estimated 2,000 CTCL cases are diagnosed in the United States annually.
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Banner said that it believes it is the first applicant to file an ANDA with the FDA. If its generic version of Targretin is approved by regulators, being first to file gives Banner a head start over other generics with 180 days of marketing exclusivity.
Eisai makes Targretin in a capsule. Banner’s drug delivery platform makes drugs in gelatin-based capsule dosage forms that the company says enhances and controls the absorption of poorly soluble active pharmaceutical ingredients.
Targretin was developed by San Diego biotech company Ligand Pharmaceuticals (NASDAQ:LGND), which received FDA approval on the drug in 1999. Eisai acquired Targretin and three other cancer products from Ligand in 2006 for $205 million. Targretin’s patents expire in 2016.
