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

To: Alper H.YUKSEL who wrote (27773)	2/3/1999 8:50:00 AM
From: celeryroot.com	Respond to of 32384

( BW)(CA-LIGAND-PHARMACEUTICALS)(LGND) Ligand Receives FDA Marketing Clearance for Panretin Gel for Treatment of Patients with AIDS-Related Kaposi's Sarcoma Business Editors SAN DIEGO--(BUSINESS WIRE)--Feb. 3, 1999-- Panretin Gel Ligand's First Commercial Product Ligand Pharmaceuticals Incorporated (Nasdaq: LGND; pronounced LYE-gand) announced today that the U.S. Food and Drug Administration (FDA) has granted marketing clearance for Panretin(R) gel (alitretinoin) 0.1% for the topical treatment of cutaneous lesions of patients with AIDS-related Kaposi's sarcoma (KS). Panretin gel is Ligand's first approved product and is the first topical therapy approved for KS, a cancer common in people who have AIDS. Within five business days of FDA approval, Ligand expects to ship Panretin (pronounced pan-RET-in) gel to its distributor, Integrated Commercialization Solutions, for distribution to wholesalers across the United States. Ligand will market Panretin gel in the United States with its already established specialty oncology and HIV-center sales force of 26 people. "Panretin gel is the first patient-applied treatment for AIDS-related KS and represents a significant new option to the traditional management of this disease. Panretin gel offers patients a self-administered, non-invasive alternative to currently available therapies," said Steven Miles, M.D., Associate Professor of Medicine, UCLA C.A.R.E. Center, and a leading clinical investigator in the Panretin gel trials. Patients may apply Panretin gel to their KS skin lesions in the privacy of their homes twice a day or as instructed by their physicians. This application regimen is expected to save patients significant time and money compared to other therapies, which require periodic visits to the doctor's office, clinic or hospital and the administration of the treatment by a doctor or nurse (collectively called "collateral costs"). The cost of Panretin gel for a four to six month course of therapy will range between $3,900 and $5,800. While there are no other approved topical therapies for KS, current intravenously-administered liposomal anthracycline formulations used to treat Kaposi's sarcoma have a cost for a standard course of therapy ranging between $8,000 and $12,000, not including collateral costs. "AIDS-related KS is a disease that adversely affects the quality of life of thousands of people in the United States because of unsightly, and sometimes painful, skin lesions. We are pleased to have worked closely with the FDA during the eight-month priority review process to make Panretin gel available to people with KS as soon as possible. Panretin gel, a topical treatment for this disease, is Ligand's first approved product," said Ligand Chairman, President and CEO David E. Robinson. FDA clearance followed a review by its Oncologic Drugs Advisory Committee on November 16, 1998, at which the Committee recommended Panretin gel approval in a series of 8 to 1 votes. In making that recommendation, the Committee reviewed data from two 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 earlier human studies included 385 patients. In August 1997, Ligand stopped accepting new patients into the international trial after efficacy data from the first 82 patients demonstrated that the activity of Panretin gel as compared to the vehicle gel satisfied the protocol-defined early stopping rule. Thirty-six percent (the FDA-confirmed response rate) of patients in the Panretin gel treatment group showed a response to therapy compared to only seven percent of those in the study's vehicle gel treatment arm. Final results of the North American trial, which were released in December 1997, demonstrated that 35 percent of patients treated with Panretin gel experienced complete or partial response compared to 16 percent of patients applying vehicle gel (p = 0.0012). Both Phase III trials were designed to evaluate safety and efficacy of Panretin gel in patients with cutaneous AIDS-related KS. Protocols for the trials called for patients to be treated with either Panretin gel or vehicle gel, applied two to four times daily to KS skin lesions for at least 12 weeks. Patients were assessed at two, four, eight and 12 weeks. Responses were defined using AIDS Clinical Trials Group (ACTG) criteria as applied to topical therapy of designated KS index lesions. After 12 weeks, qualifying patients could continue treatment with open-label Panretin gel. In clinical trials to date, Panretin gel was generally well tolerated. Side effects were primarily mild to moderate and included in most patients erythema (redness) or skin irritation occurring nearly exclusively at the application site. Skin toxicity, including more intense erythema, edema (swelling) and vesiculation (blistering), caused only seven percent of the patients to withdraw from the studies. In both studies, responses occurred in patients with a wide range of baseline CD4+ lymphocyte counts, including patients with CD4+ lymphocyte counts less than 50 cells/mm3. Nearly all patients received concomitant combination antiretroviral therapy. Ligand has established a program that will assist all patients with KS seeking reimbursement or other financial assistance for the purchase of Panretin gel. Specific information on the assistance program will be provided to physicians by Ligand's Senior Oncology Sales Specialists. In Canada and Europe, Ligand is also pursuing approval of Panretin gel for the treatment of cutaneous lesions of patients with AIDS-related KS. Ligand filed a New Drug Submission (NDS) with the Health Protection Branch of Canada in October 1998 and is currently preparing a European Marketing Authorization Application for submission in early 1999.

To: Alper H.YUKSEL who wrote (27773)	2/3/1999 8:59:00 AM
From: Henry Niman	Read Replies (4) \| Respond to of 32384

I think that the market will respond, because LGND has greased the skids for sales and they should come close to anticipated revenue for 1999, which is required to meet profitability requirements for this year. I agree that most expected approved ("problems with the drug nonsense on this thread not withstanding), but its still a major milestone, especially since LGND reported the DISCOVERY of the hormone (9-cis retinoic acid)just 7 years ago (se below). Bringing a drug from discovery to the pharmacy shelf in 7 years is quite a accomplishment and LGND employees should be quite proud of such a feat. Cell 1992 Jan 24;68(2):397-406 9-cis retinoic acid is a high affinity ligand for the retinoid X receptor. Heyman RA, Mangelsdorf DJ, Dyck JA, Stein RB, Eichele G, Evans RM, Thaller C Ligand Pharmaceuticals, Inc., San Diego, California 92121. All-trans retinoic acid (RA) has previously been shown to modulate the transcriptional properties of the retinoic acid receptor (RAR) and retinoid X receptor (RXR). The inability of all-trans RA to bind to RXR suggests that it may be metabolized to a more active high affinity ligand. We report here an experimental approach that has identified 9-cis RA as an RXR ligand. It is up to 40-fold more potent than all-trans RA in transfection assays and binds with high affinity. The production of 9-cis RA in cultured cells and the identification of this molecule in liver and kidney demonstrates the existence of this molecule in living organisms. The discovery of this novel hormone points to the key role retinoid metabolism may have in generating new signaling pathways. PMID: 1310260, UI: 92127596