Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

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

To: Hippieslayer who wrote (26030)	10/7/1998 12:26:00 PM
From: Cheryl Galt	Read Replies (1) \| Respond to of 32384

Hi steve, >> One has to wonder if Pan. is effective in treating [psoriasis], why didn't they push it for this "large" disease instead of KS? Here's my take on the subject: ---------------------------- For one thing, Ligand got expedited review for the KS drug, because of the AIDS connection, and the fact that there was no comparable drug available, and none at all that can cure KS. I think it's clear (at least to me and some other skeptical longs) that Ligand has been operating under cash-poor conditions. I suspect Ligand needed to take advantage of the provisions of the Orphan Drug Act in order to get this first product to market. A big pharma with deep pockets would surely, as you say, have pushed for the "large" disease instead of KS. I also presume, that if Ligand had had more cash it WOULD have been simultaneously testing Panretin gel for psoriasis. However, once the gel is approved, it should be relatively easy to test for psoriasis, given that the safety data is already in. As I read the new FDA rules for off-label use (which I'll post separately to keep THIS post from getting too over-long), Ligand WILL eventually be REQUIRED to test for this off-label psoriasis use. ---------------------------------- Beside the seven year exclusivity, the Orphan Drug Act provides many other incentives. The details on the FDA's website are well worth the read, IMO. Here are some EXERPTS from a complete article, which is at fda.gov ------------- The most powerful incentive is the act's marketing exclusivity clause ..... Once an orphan drug is approved, exclusivity gives sponsors legal protection against introduction of an identical competing product for seven years.... "Large firms need exclusivity to convince management to invest capital," she explains. "And small-to-medium-sized companies need it to ensure stockholders that the product won't be infringed upon by competitors." Among other provisions for orphan-designated products are: Grants--The act funds a total of $12 million worth of clinical research grants annually. [ I doubt Ligand has benefited from this provision, but the NEXT one should have been helpful for this, Ligand's first NDA.] Protocol assistance-- FDA helps orphan sponsors design research that conforms to regulatory requirements and shows them how to deal with the FDA review system. Sponsors, especially small companies with little regulatory experience, can save time and money using this service. Steve, I'm SURE you'll like this next one. <VBG> Tax credits--A sponsor may claim 50 percent of clinical trial costs as a credit against taxes owed. --------------------- Just my .02 Regards. Cheryl