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Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?

To: Henry Niman who wrote (26004)	10/5/1998 5:48:00 PM
From: celeryroot.com	Read Replies (1) \| Respond to of 32384

BW0610 OCT 5,1998 14:26 PACIFIC 17:26 EASTERN ( BW)(LIGAND-PHARMACEUTICALS)(LGND) Ligand Files New Drug Submission for Panretin Gel in Canada SAN DIEGO--(BW HealthWire)--Oct. 5, 1998--Ligand Pharmaceuticals Incorporated (Nasdaq:LGND) today announced the filing of a New Drug Submission (NDS) with the Health Protection Branch (HPB) of Canada for Panretin(R) gel (alitretinoin) 0.1% for the treatment of cutaneous lesions of patients with AIDS-related Kaposi's sarcoma (KS). The NDS for Panretin gel has been accepted for priority review in Canada. If approved by the HPB, Panretin gel will be the first topical therapy in Canada for KS, a cancer common in people who have AIDS. The NDS filing is based on Canadian, U.S., European and Australian safety and efficacy data that was also included in the New Drug Application (NDA) filed with the U.S. Food and Drug Administration (FDA) for Panretin gel in May 1998. Panretin gel was accepted for priority review by the FDA, and has also received orphan drug designation in the U.S. "The NDS for Panretin gel represents our first international filing and is an important milestone," said Ligand Chairman, President and Chief Executive Officer David E. Robinson. "We are looking forward to working closely with the Canadian HPB during the review process, and to preparing for product launch in Canada, assuming regulatory approval, to make Panretin gel available to KS patients who can most benefit from its therapeutic effects." The NDS is based on two multicenter, randomized, double-blind, vehicle-controlled Phase III clinical trials; one conducted internationally at 30 sites in Europe, Australia and the U.S., and one conducted at 35 sites in North America. KS is the most frequent AIDS-related malignancy and is usually characterized by multifocal, widespread lesions at the onset of illness. The disease may involve the skin, mouth, lymph nodes and visceral organs, such as the lung and gastrointestinal tract. The Company estimates that between 30,000 and 50,000 people in North America and Western Europe are affected by KS. A Marketing Authorization Application (MAA) filing for Europe, where Ligand intends to be the primary marketer for Panretin gel, is currently under preparation for submission late this year or early next. 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. Ligand Pharmaceuticals' releases are available via fax at no charge by calling 888/329-9832 or on the world wide web at www.businesswire.com/cnn/lgnd.htm. 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, that drug candidates will show efficacy in all indications currently being studied, that final data will be consistent with interim data, that regulatory approvals will be granted in a timely manner, or at all, that final results will be supportive of regulatory approvals required to market products, or that patient and/or physician's acceptance of these products will be achieved. Ligand undertakes no obligation to update the statements contained in this press release after the date hereof. --30--xx/sd CONTACT: Ligand Pharmaceuticals Incorporated Mary Kenny, 619/550-7536 (Media) Cheryl Monblatt, 619/550-7777 (Investors)

To: Henry Niman who wrote (26004)	10/5/1998 6:17:00 PM
From: B.D.	Respond to of 32384

"between 30,000 and 50,000" for all of North America (US + Canada) and Western Europe (Spain, Portugal, France, Luxembourg, Belgium, UK, Sweden, Norway, Finland, Germany, Italy, Leichtenstein, Austria...) Um, so like how many _exactly_ in Canada? I'd guess maybe 500? Tops? In other words, no big deal.