To: Sam Ferguson who wrote (21735 ) 12/29/1999 3:00:00 PM From: Paul Moerman Respond to of 53068
LGND popping right now on big volume. FDA approval of Targretin capsules as a therapy for cutaneous T-cell lymphona. Following excerpt from www.ligand.com: ( BW)(CA-LIGAND-PHARMACEUTICALS)(LGND) FDA Approves Ligand's Targretin Capsules for Early and Advanced-Stage Refractory CTCL; Marks Ligand's Third Commercial Cancer Product Approval in 1999 Business Editors & Health and Medical Writers SAN DIEGO--(BW HealthWire)--Dec. 29, 1999--Ligand Pharmaceuticals Incorporated (Nasdaq:LGND) announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Targretin(R) (bexarotene) capsules with once daily oral administration for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma (CTCL) in patients who are refractory to at least one prior systemic therapy. The indication includes patients diagnosed with all stages of refractory CTCL. At the request of the FDA, Ligand has agreed to conduct certain post approval Phase IV clinical and pharmacokinetic studies. "We are extremely pleased with the FDA decision to rapidly approve Targretin capsules for refractory patients of all stages of CTCL," said Ligand Chairman, President and CEO David E. Robinson. "Our efforts have resulted in the availability of a major new oral cancer drug that offers significant benefits for the treatment of these early- and advanced-stage CTCL patients suffering from a chronic, largely incurable, debilitating malignancy. "This has been a momentous year for Ligand's product pipeline. With the approval of Targretin capsules by the FDA, we have accomplished another significant milestone in our strategic business plan, our third new drug approval during the course of 1999 (in February 1999, Panretin(R) gel and ONTAK(R) received FDA marketing approvals). These three products and Targretin gel, currently under review by the FDA, provide us with the product assets which our commercial organization requires to move the company towards profitability in 2000. During the fourth quarter of this year, we completed the doubling of our sales force from 20 to 40 representatives in order to support the Targretin launch and accelerate ONTAK growth. The approval of Targretin capsules for both early- and late-stage refractory CTCL is a welcome sign of progress for suffering patients as well as very positive for the company."