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Biotech / Medical : OSI Pharmaceuticals (OSIP) - formerly Oncogene

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To: LLCF who wrote (52)7/30/1999 10:08:00 PM
From: Miljenko Zuanic  Read Replies (3) of 447
 
To all:

I have very, very little free time, so this is cumulative respond to Gordon and John (from yahoo SUGN board, discussion about OSIP, posts 3233, 3240, 3246, and for interest of regular follower.

Few extract parts:
Gordon: <<I don't know if you read their abstracts from ASCO, but there was one there that really caught my eye - it described successful safety results from a trial that was testing a chronic oral dosing regimen. Chronic oral EGFr inhibition - almost peed my pants... :-) Some of those people took the drug for quite a long time. Of course, I scoured the abstracts for efficacy results but there were none. You know I'm a big IMCL bull right now, but ultimately, further down the road, I wouldn't be surprised if OSIP/PFE end up with the biggest drug for EGFr.>

John: <<I did the exact same thing and found the same absence of efficacy data, which troubled me, especially given IMCL's stunning efficacy in small populations. I know it was only Phase I, but something bugged me about it.>>...
<<Also, from closer reading of OSIP's business plan, it is clear that they are dedicated to screening their libraries against third-party-supplied targets. I had been under the mistaken impression that OSIP was identifying its own targets, in a way similar to SUGN. I am now beginning to wonder whether they should be relegated to the toolkit company tier, like PCOP and ARQL. I missed this initially, but upon closer thought it seems to be true.>>

Gordon: << Something that's bugged me more than lack of published efficacy is my impression, possibly incorrect due to hurried analysis, that PFE hasn't left much but scraps for OSIP from this program, (got a similar feeling from their other programs that I glanced at), let me know if I'm looking at this wrong (jibes with what you say about them doing a lot of partnering at or before Phase II...). So I concluded a brief initial analysis liking the discovery approach but unclear about what items in the pipeline might be expected to blossom into big earnings drivers for OSIP in the foreseeable future. Found the website to be particularly unhelpful, perhaps they've spiffied it up since then...

I know Miljenko likes OSIP, perhaps he'll offer some additional info if he drops by and sees this...>>

John: << I think one thing that OSIP still has to themselves is a "target" (no leads, just a target) for met-resistant Staph, but according to their business plan, stated in their 10-K and website, they will probably partner that one as well. I guess they are hoping to get maybe a 5-15% royalty stream from several different major drugs? Could happen, I suppose, but as neblo has said here, there are a lot of cheap biotechs with promising proprietary compounds out there right now.>>
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First, let me say that (regards the OSIP/PFE EGFr inhibitor) good preclinical information on drug candidate can be find at AACR 1996/97 abstracts, while I have reviewed poster reprints from 99 ASCO. The points of the initial (PI) pharmacokinetic/safety/bioavailability studies (variety type cancer pts) was to determine MTD and at the some time asses pharmacokinetic parameters to see does drug CHRONIC administration (in two different protocols: daily and weekly) have hidden toxic effects. Drug therapeutic effects (at 150 mg daily as MTD) was disease stabilization in several pts in that cohort group. Drug has side effects: rush as most prevalent and is dose limiting.

Comparing this results with IMCL C225 recent result (in combination with chemo or radiation, in the condition where this stand alone therapy already have good results and C225 only potentate clinical response rate but didn't give any significant benefit in disease free time or remission time) is unrealistic and misleading. C225 didn't had any significant efficiency in any *drug alone* clinical trials.

OSIP business plan is combination of five parts: 1) Discovery and validation of the new therapeutic target (in house and in collaboration with research institution), 2) assay designee and screen setting (patents), 3) natural compounds libraries (acquisition and in house), 4) diagnostic, and 5) cosmotherapeutic. So they are not focused platform bt company, more like diversified approach. However, they didn't yet capitalize (not significantly) on any of this point (diagnostic and patents license are first to generate revenue).

Regards the several other targets/candidates (in PFE cancer collaboration) RASr and VEGFr inhibitors are close to enter PI clinical trials (by end of this year). OSIP CEO claims that OSIP/PFE VEGFr inhibitor candidate is at least 100 times more potent than SUGN 5416 and more selective (no PDGFr and/or bFGFr activity, this may be negative as well, not positive???). It is ATP competitive and bind to catalytic pocket (like one from WL-PD or Zeneca). Ras inhibitor is something to keep close aye on it (here fernesyl transferase may be good answer, but I didn't yet detect any promising results to make me hot).
So, OSIP cancer programs (for now) are progressing very slow (PFE conservatism, or cautious approach, or full of BS, ???). However, diagnostic collaboration with Bayer will bear first fruit by year end, and this is more than sufficient to justify current capitalization. Everything else is discount or free at current stock price, imo.

AIA, yes Miljenko is high on OSIP (or full of BS if you wish) and patient. Will this ever be MLNM or GILD or SEPR or ... (I will not mention SUGN, grrrrrr) type return???? Hold breath. But, it may as well be: as Miljenko told early...

I guess at this point *regular* investor are at best neutral on EGFr program???

Miljenko

PS: Now, is anyone willing to take shot on SIBI/PFE patent litigation? Is OSIP part of it??? Or, it is solely PFE responsibility, regards the note in recent OSIP 10-K file???
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