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Biotech / Medical : Alliance Pharmaceutical -- Ignore unavailable to you. Want to Upgrade?


To: Oak Tree who wrote (533)8/24/2001 1:57:34 PM
From: Cacaito  Read Replies (1) | Respond to of 548
 
There were no "toxicities" in Oxigent trials. There were actually "historically expected" rates of hemorrhagic stroke, and less so on placebo group. The analysis (as per ALLP) of the trial results DOES NOT implicate Oxygent as causation, excess hemodilution beyond the allowed dilution as per protocol SEEMS to be the problem and apparently not in all the centers (center "noise").

Hemorrhagic strokes are very common during cardiac bypass procedures, it is a must to use ANTICOAGULANTS to move the blood in the extracorporeal oxygenation machines (ECMO), heparin, aspirin, reopro, tpa and many others are used in combination to keep blood thin from clotting in the system, this is the known cause of the bleeds, add to that the hemodilution (always use) and the blood recovery harvest(very common) during the bleeds in the surgical cuts and the result is a decrease in the plasma components necessary for blood clotting!

These problems are the plague of ECMO and cardiac bypass, many procedures are done without ECMO (not the Allp trials) to avoid the brain bleeds (there is also less need for Oxygent in the non-ECMO procedures).

I posted before about a new ECMO device that is much smaller (0.2 litters vs current several litters of volume needed) already in human research phase (American company did 6 subjects in Argentina) and getting ready to start in the US. This system uses less or no anticoagulant (they could also lower the need for Oxygent), and there are new anticoagulants in the market with less bleeding side effects (from MDCO: angiomax, from Genentech: TNKplase...).

And the fact that there has been zero hemorrhagic strokes complications in the general surgery trials, or any other trials including the phase II cardiac bypass trials! all with more than 3,000 subjects, more evidence of the lack of "toxicities".

The damage to the stock price is done, Baxter is committed albeit guarded and cautious but still with $41 millions down the drain (or up the investment if it goes well) and $19 millions more to come, insuring funding for the coming new general surgery phase III, continuation of the bypass phase III or both by the end of the year.

The coming FDA permit to market (drug is approved) before end of the year and market sales will provide first with milestones dollars from Schering AG and sales royalties later.

Allp owns INHL shares (some $6M), some royalties to the pulmospheres, and the recent money from selling the Optisom rights ($5M) and selling NY plant ($1M) put the company in a position to survive first and prosper later. Even the stop in the Liquivent research is for the short term good since there are no expenses for it.

Allp at $1.6 is a great bargain. Just the ultrasound contrast business could bring the stock to $6 -$8 ranges (conservative estimates). If one looks at the Optisom sales (just $16M annualized) but this is before the Medicare decision for reimbursement at 95% wholesale price as a "drug" (other insurance usually follow on) and the estimated price per dose of approximately $125 generates cost savings (avoidance of repeat echocardiogram testings...) The new Medicare "drug" designation will bring ultrasound contrast to the mass market.