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

To: Wallace Rivers who wrote (29473)	11/24/1999 5:09:00 PM
From: Henry Niman	Respond to of 32384

I would disagree with you. Mudcat seems to be implying that last year's approval of Panretin was delayed, and LGND should now be able to do better with Targretin. His comments last year were off base as is his supposition this year. The Panretin approval went very smoothly. LGND was granted priority review, the advisory board vote 8-1 for approval, and the FDA issued an approvable letter within the 6 month time period and the final approval was granted a few months later. I believe that there was some stability data required for defining the expiration date to be placed on the label and the wording of the label had to reflect the advise of the advisory committee who had met a few weeks prior to the approval letter. Mudcat posted a series of complaints after the approval letter was issued last year and now he is hoping that LGND will be able to do a better job. I posted a reminder of the moaning and groaning posted last year, which was totally off base. I was not surprised to see similar posts again this year. LGND has done quite well with FDA approvals (2 out of 2 with a combined vote of 20-1 for approval) and I would expect them to continue to submit required information in a timely manner. The publication on the discovery that Panretin was a natural hormone came out in 1992 and LGND was granted an FDA approvable letter in 1998. Very few companies came claim a faster track from drug discovery to FDA approval.

To: Wallace Rivers who wrote (29473)	11/24/1999 5:14:00 PM
From: Henry Niman	Respond to of 32384

Here is the abstract for the discovery of 9-cis retinoic acid (Panretin): 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 moreactive high affinity ligand. We report here an experimental approach that has identified 9-cis RA as an RXR ligand. It is up to40-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

To: Wallace Rivers who wrote (29473)	11/24/1999 5:18:00 PM
From: Henry Niman	Read Replies (1) \| Respond to of 32384

Here's the link to the press release on the Panretin approval vote by the advisory committee: businesswire.com Two weeks later they issued a press release on the approvable letter: businesswire.com And just over 2 months later they received marketing approval businesswire.com It doesn't get much better than that. I hope that Targretin goes as smoothly.