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


To: Neenny who wrote (30302)1/17/2000 2:25:00 PM
From: Henry Niman  Respond to of 32384
 
Not sure what drug you are referring to, but LGND is batting 1000 as far as fast tracking drugs are concerned. LGND has had three drugs approved by the FDA, topical Panretin, injected ONTAK, and oral Targretin and all three drugs have received fast track status and all three have been approved. LGND has submitted a fourth drug, topical Targretin, and it too has received fast track status and will be before the FDA advisory committee this spring. Approval is also expected.

The approved drugs are in clinical trials for additional indications. In general these are Phase II trials. If the data looks good, LGND will be filing for Phase III trials and I expect them to request fast track status when the NDAs are filed.

ONTAK has been approved for CTCL and is in a government sponsored Phase II trial for non-Hodgkin's lymphoma. The drug has also generated some initial psoriasis data.

Oral Targretin has also been approved for CTCL and is in Phase II trials for psoriasis and breast cancer. It may also be under consideration for non-Hodgkin's lymphoma.

An NDA has been filed for topical Targretin for CTCL and advanced trials for oral panretin for psoriasis, Acute Promyelocytic Leukemia, and Kaposi's sarcoma are underway.

LGND also has a license for ELN's morphine compound, which is in advanced trials and is just about ready for NDA submission.