Soligenix announced that the Office of Orphan Products Development of the United States (U.S.) Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient hypericin for the treatment of T-cell lymphoma, extending the target population beyond cutaneous T-cell lymphoma (CTCL), as previously granted.

The U.S. Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders.  In addition to providing a seven-year term of market exclusivity upon final FDA approval, orphan drug designation also positions Soligenix to be able to leverage a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees for the potential submission of a New Drug Application (NDA), and certain tax credits.

"The FDA's decision to grant and expand our hypericin orphan drug designation beyond CTCL signifies an important step for Soligenix as we continue to advance the program toward NDA filing in the first half of 2022," stated Christopher J. Schaber, PhD, President & Chief Executive Officer of Soligenix. HyBryte’s biological activity was demonstrated in the positive Phase 3, pivotal FLASH (Fluorescent Light Activated Synthetic Hypericin) study in patients suffering from early-stage CTCL.  The marketing exclusivity that this broadened orphan drug designation imparts adds significantly to the existing patent estate surrounding hypericin."