SAN DIEGO--(BW HealthWire)--Nov. 30, 1998--Ligand Pharmaceuticals Incorporated (Nasdaq:LGND - news)
announced today that the U.S. Food and Drug Administration (FDA) has issued an approvable letter regarding the
New Drug Application (NDA) for Panretin® gel (alitretinoin) 0.1% for the topical treatment of cutaneous
lesions in patients with AIDS-related Kaposi's sarcoma (KS).
The final approval is pending review of additional chemistry information submitted by the Company as requested
by the FDA and upon final labeling agreement. The Company expects following the approvable letter to receive a
final action letter on marketing approval by the end of December.
''We are pleased to receive the FDA approvable letter following only nine days after the 8 to 1 vote from the
Oncologic Drugs Advisory Committee recommending NDA approval to the FDA,'' said Ligand Chairman,
President and CEO David E. Robinson. ''We look forward to continuing to work closely with the agency to
finalize labeling such that we can supply the product to patients with KS in the U.S. as soon as possible.''
Panretin gel was assigned priority review status by the FDA, which requires the FDA to review and act on the
NDA within six months of the NDA submission date. The action letter may indicate approval or may detail
specific deficiencies of the NDA and the actions necessary to place the application in condition for approval.
The FDA received the NDA for Panretin gel on May 27, 1998 and the approvable letter was received by Ligand
on Nov. 25, 1998.
Since 1989, Ligand Pharmaceuticals Incorporated has established a leadership position in gene transcription
technology, particularly intracellular receptor (IR) technology and STATs technology. 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 major unmet patient needs in cancer, women's and men's health, skin diseases,
osteoporosis, and metabolic, cardiovascular and inflammatory diseases.
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 any product in the Ligand pipeline will be successfully developed, that results from more advanced
clinical trials will be consistent with earlier results, that drug candidates will show efficacy in all indications
currently being studied, that regulatory approvals will be granted in a timely manner, or at all, that patient
physicians' acceptance of these products will be achieved, or that Ligand will successfully hire a sales force.
Ligand undertakes no obligation to update the statements contained in this press release after the date hereof.
Note: If you would prefer to receive Ligand's press releases via e-mail please inform us at
investors@ligand.com and request to be placed on our priority e-mail list. You may visit Ligand's website at
ligand.com.
Contact:
Ligand Pharmaceuticals Incorporated
Mary Kenny, 619/550-7536 |
