Ligand Pharmaceuticals' Panretin Gel for Aids-Related KS to Receive FDA Priority Review

Business Wire, July 13, 1998

SAN DIEGO--(BW HealthWire)--July 13, 1998--Ligand (LYE-gand) Pharmaceuticals Incorporated (NASDAQ:LGND) has announced that the company's New Drug Application (NDA) for Panretin(R) gel (alitretinoin) 0.1% for the topical treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma (KS) has been accepted for priority review by the U.S. Food uires the FDA to review and act on the NDA within six months of the NDA submission date by issuing to the comcessary to place the application in condition fseven years of exclusive marketing rights.

"We are very pleased with the FDA's decision to accelerate the review process for Panretin gel," said Ligand chairman, president and chief executive officer David E. Robinson. "Panretin gel, if approved, will be the first topical drug for cutaneous AIDS-related KS. We believe it has the potential to improve the quality of life for patients and will aid physicians in the care, management and treatment of these patients. We are prepared to work closely with the FDA to facilitate their review, and if approved, to make the product available to patients perhaps as soon as the end of this year."

KS is the most frequent AIDS-related malignancy seen in patients and is often characterized by multifocal, widespread lesions at the onset of illness, and may involve the skin, oral mucosa, lymph nodes and visceral organs, such as the lung and gastrointestinal tract. The company estimates that between 30,000 and 50,000 patients in the United States and Western Europe, where Ligand intends to be the primarSubmission filing in Canada are currently under preparation for submission this year.

Since 1989, Ligand Pharmaceuticals Incorporated has established a leadership position in gene transcription technology, particularly intracellular receptor (IR) technology and Signal Transducers and Activators of Transcription (STATs). Ligand has applied IR and STATs technology to the discovery and development of small molecule drugs to enhance therapeutic and safety profiles and to address unmet patient needs in cancer, women's and men's health and skin diseases, as well as osteoporosis, metabolic, cardiovascular and inflammatory disease.

This news release may contain certain forward looking statements by Ligand and actual results could differ materially from those described as a result of factors including, but not limited to, the following. There can be no assurance that Panretin gel or any product in the Ligand pipeline, will be successfully developed, that results from more advanced clinical trials will be consistent with earlier results, thatata, that regulatory approvals will be granted i.

Ligand undertakes no obligation to update the statements contained in this press release after the date hereof.

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