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: Abuckatatime who wrote (9943)	10/21/1997 6:16:00 PM
From: Henry Niman	Read Replies (1) \| Respond to of 32384

Greg,I have to do some revisions myself because of the ALRI deal as well as the diabetes deal. Here's a quick outline which probably requires some revision. The next big clinical piece should be the pivotal Phase III topical Panretin data for KS. This North American study is essentially the same as the halted International study (except it does contain an interim look at the innitail patients, but did have a placebo check which indicated that the placebo response was less than 10%, as expected). Data may not be quite as dramatic as International, but it should meet the minimum delta requirement of 15% and make approval a slam dunk. This should come out this quarter with a NDA filed within 2-3 months after unblinding. I'll add much more later, but have to go check out more playoff games.

To: Abuckatatime who wrote (9943)	10/22/1997 8:28:00 AM
From: Henry Niman	Respond to of 32384

Greg, In addition to favorable Phase III data on topical Panretin for KS, LGND will be finishing up Phase III data for topical and oral Targretin for CTCL next year. The topical trial is a pivotal Phase III trial and was started about 7 months after topical Panretin. The Phase II data was a strong and Iexpect similar numbers for the Phase III to be complete around the middle of next year. I suspect that it will be 2-3 months to file the NDA, so a filing in the second half of next year is expected. There are also two Phase II/III trials for oral Targretin. This is very important for diabetes, since approval of oral Targretin for CTCL will allow for off-label use for diabetes. Last month LGND put out stellar interim data (virtually all patients resonded by showing disease stabilization, partial remission, or complete remission) suggesting that additional trials will not be required (the two trials target earlier and more advanced disease and both patient populations responded well to the oral treatment). Although the street responded weakly to this news (LGND had already moved quite a bit to the ALRI call and the upcoming diabetes deal), I think it is definitely the most significant clinical news (because of off label diabetes use while the diabetes trials are still ongoing). Since the two oral trials began about the same time as the topical trial (and all three trials require 60 patients each), I expect the approval for topical Targretin to follow a time table similar to topcal Targretin (completion around mid year and filing of NDA by the end of next year with sales in 1999,the year LGND expects to become profitable).

To: Abuckatatime who wrote (9943)	10/22/1997 9:18:00 AM
From: Henry Niman	Read Replies (2) \| Respond to of 32384

Greg, In addition to the 4 Phase III or II/III trials which I think will be used for NDAs for 4 indications (topical Panretin for KS, topical Targretin for CTCL, and oral Targretin for ealy and advanced CTCL), LGND should be getting ready to release Phase II/III data for stabilizing lung cancer with oral Targretin. I'm not sure if stabiliztion is an apprvalable end point, so I'm not sure about the status of an NDA filing. However, release on the data should be at the end of this year, beginning of next. Advancing ALRT1550 trials should be on a similar timetable. Phase I should be just about complete and data should be announced soon. LGND still has to choose indications to target, so I expect those announcements to come early next year. PFE has two compouds in trials (Droloxifene and CP-366,156) and both should be moving forward (although PFE likes to keep such info close to the vest, so LGND and shareholders may hear about these advances until after the fact). Droloxifene should be finishing up Phase III for breast cancer and Phase II for osteoporosis. I think movement of the compound to the next level will generate one or two milestone payments. Similarly, CP-366,156 should be finishing up Phase I for osteoporosis and movement to Phase II should also create a milestone payment. I expect these advances next year, some of them early next year. Additional clinical data could come from the European diabetes deal. LGND should have interim data, but I don't know what LLY's policy is. I think that their policy will dictate the release of such data. Other clinicals that may come out by the end of this year or beginning of next include topical Panretin data for psoriasis as well as movement into a Phase III trial. The oral Phase III trial for APL should come out in early 1999. For early 1998, I expect several announncements associated with the diabetes deal. I believe that potential diabetes patients in Canada have already been screened. A similar screening in the US would not surprise me. Therefore, I expect North American diabetes trials for Targretin to begin early next year. I also expect INDs to be filed for the other two rexinoids mentioned in the press release (LGD1268 and LGD1324). All of the above should result in milestone payments from LLY. Similarly, I expect LGND to exercise its option to sell a LLY compound, and I expect that decision to be announced early next year also. In addition to INDs for LGND's rexinoids, I expect AGN to file INDs for its rexinoids soon. Moreover, an AGN diabetes deal early next year would not surprise me. LGND was definitely talking to several companies, and now that a LGND diabetes deal is done, I think that several will talk to AGN and they will be interested in moving forward as quickly as possible. The ALRI split-up allows for competition in all areas, and I expect such a structure to speed develop of LGND and AGN compounds (and of course LGND gets royalties from the AGN compounds).