Ligand Pharmaceuticals Inc. said it will file a new drug application (NDA) for Panretin gel, a topical treatment for AIDS-related Kaposi's sarcoma, by the end of May, based on final analysis of results from an international Phase III trial of the drug.
The trial was stopped at 82 patients in August 1997, when a planned interim analysis showed a 42 percent response rate with Panretin gel, compared with 7 percent response to placebo. In the final analysis, 37 percent of patients (23 of 62) treated with Panretin gel experienced complete or partial response, compared with 6.9 percent of patients (five of 72) using a placebo.
Results of a North American Phase III trial, reported in December 1997, brought similar good news. (See BioWorld Today, Dec. 12, 1997, p. 1.)
At the time, Ligand said it expected to file an NDA in the first quarter of this year. Now, a company spokeswoman said, the date has been pushed back four to six weeks, to the end of May or sooner.
The company aims to bolster its already accumulated data with the new results, thus simplifying the review process and making it quicker, the spokeswoman said. Whether Panretin gel will be granted expedited review by the FDA has not yet been determined.
Ligand's (NASDAQ:LGND) stock closed Friday at $15.625, up $0.562. — Randall Osborne