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

To: Machaon who wrote (26532)	11/16/1998 2:53:00 PM
From: dwight martin	Respond to of 32384

does anyone think the stock'll rise when trading resumes?

To: Machaon who wrote (26532)	11/16/1998 2:54:00 PM
From: WTDEC	Read Replies (2) \| Respond to of 32384

Bob, the AIDS patient report in from Reuters. Regards, Walter

To: Machaon who wrote (26532)	11/16/1998 3:21:00 PM
From: Andrew H	Respond to of 32384

Another version: Monday November 16, 2:52 pm Eastern Time Company Press Release Ligand's NDA for Panretin Gel Recommended for Approval by FDA Advisory Committee For Topical Treatment of AIDS-Related KS SAN DIEGO--(BW HealthWire)--Nov. 16, 1998--Ligand Pharmaceuticals Incorporated (Nasdaq:LGND - news) announced today that the Oncologic Drugs Advisory Committee to the U.S. Food & Drug Administration (FDA) in a series of 8 to 1 votes determined Panretin® gel (alitretinoin) 0.1% to be safe and effective for the topical treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma and that the New Drug Application (NDA) is approvable. In a related question the committee voted unanimously to include in the package insert the beneficial response rate for the drug, based upon the FDA's own analysis of patient photographs presented by Ligand. The FDA is expected to consider the committee's recommendation for approval in its review of the NDA for Panretin gel. While the FDA is not bound by the committee's decision, the agency usually follows committee advice. If Panretin gel is cleared for marketing, it will be the first topical treatment approved by the FDA specifically for the treatment of patients with cutaneous AIDS-related KS. ''We are very pleased with the panel's decision,'' said David E. Robinson, Ligand Chairman, President and CEO. ''We appreciate the FDA's guidance during this process and we intend to continue to work closely with the FDA to obtain marketing approval in order to make Panretin gel available to patients as soon as possible.'' The NDA for Panretin gel was submitted by Ligand in May 1998 and granted priority review status by the FDA in August. Panretin gel has also received orphan drug designation in the U.S. The NDA is based on two multicenter, randomized, double-blind, vehicle-controlled Phase III clinical trials; one conducted internationally at 22 sites in Europe, Australia and the U.S., and one conducted at 35 sites in North America. These two trials plus the Phase I/II clinical program included 385 patients who were treated with Panretin gel. Kaposi's sarcoma 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 early next year. Ligand filed a New Drug Submission (NDS) in Canada in September 1998, which was given priority review status. 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 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 filings will be made in a timely manner, or at all, that regulatory approvals will be granted in a timely manner, or at all, that patient physicians' acceptance of these products will be achieved, that Ligand will successfully hire a sales force, or that final results will be supportive of regulatory approvals required to market products. 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.