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


To: medsunman who wrote (28417)2/27/1999 9:54:00 AM
From: Henry Niman  Respond to of 32384
 
I think that there is some confusion about "orphan" drug status. I believe that LGND has orphan drug status on Targretin (for CTCL), Panretin and ONTAK (for CTCL). Orphan drug status is designed to encourage companies to develop drugs for diseases that affect small target populations, However, it does not limit other, unrelated drugs.

LGND's strategy is to gain approval for small target populations, and make most of their money on off-label uses for larger populations (and eventually gain approval for the larger populations).

ONTAK targets advanced CTCL patients. Targetin oral and topical will target earlier stage populations.

I haven't seen any of the SuperGen data on CTCL.

I suspect that elevated triglycerides would limit Targretin for prevention of breast cancer, but doubt that it would impact treatment of early stage disease, which develops into a fatal disease if not treated. Its all based on risk/reward and in the clinical data is anywhere close to the mouse data, the treating early stage breast cancer with Targretin rewards will far outweigh the elevated triglyceride risk.



To: medsunman who wrote (28417)2/27/1999 10:03:00 AM
From: Henry Niman  Respond to of 32384
 
A list of orphan drugs can be found at:
verity.fda.gov

Here's the orphan data on ONTAK:
Generic Name: Denileukin diftitox

Trade Name: Ontak

Orphan Indication: Treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express
the CD25 component of the IL-2 receptor.

Sponsor: Seragen, Inc.

Address: Hopkinton, MA

Contact: Dr. Jill Hiller

Phone: (508) 435-2331

Fax: (508) 435-9805

Designation Date: 08/21/1996

Here's Panretin oral:
Generic Name: 9-cis retinoic acid

Trade Name: Panretin

Orphan Indication: Treatment of acute promyelocytic leukemia.

Sponsor: Ligand Pharmaceuticals, Inc.

Address: San Diego, CA

Contact: Dr. Howard Holden

Phone: (619) 550-7600

Fax: (619) 625-9524

Designation Date: 04/10/1992
Here's panretn Topical:
Generic Name: Alitretinoin***

Trade Name: Panretin

Orphan Indication: Topical treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma.

Sponsor: Ligand Pharmaceuticals Inc.

Address: San Diego, CA

Contact: Dr. David Furlano

Phone: (619) 550-7600

Fax: (619) 550-1827

Designation Date: 03/24/1998



To: medsunman who wrote (28417)2/27/1999 10:15:00 AM
From: Henry Niman  Read Replies (1) | Respond to of 32384
 
I haven't been able to come up with the Targretin orphan drug info.
For CTCL, I found filings by SRGN, BGEN, BCRX, SUPG, IMGN