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Biotech / Medical : Cardiome -- CRME -- Ignore unavailable to you. Want to Upgrade?

To: keokalani'nui who wrote (150)	5/7/2007 5:31:39 PM
From: tuck	Read Replies (1) \| Respond to of 285

Thanks to another biofreak, I have come across some info regarding the recent inlicensing. Fisher and Cipriani were at Lilly, and the former led development of Xigris. So they were aware of development of the 2nd generation compound. GED-aPC is supposed to have 11 times less thrombinase activity than Xigris. Cardiome is hoping this will mean less bleeding, which was a definite problem for Xigris. It's also supposed to have stronger anti-inflammatory properties, but I have no details on that parameter. Cardiogenic shock has been likened to sepsis of the heart, and occurs in over 5% of patients with acute MIs. There were 60,000 cases of cardiogenic shock last year. So there's your market size. Cardiome might well outlicense the compound for non-cardiovascular indications, such as sepsis. The hope is that with improved anti-inflammatory properties and less bleeding, it could win a wider label than Xigris and be more of a commercial success. Cardiome is gunning for a meeting with the FDA such that it can start a P1 in the second half of this year in cardiogenic shock, with a P2 in the first half of next year. Xigris is given only to patients who are determined to be high risk as measured by the Acute Physiology and Chronic Health Evaluation II system, which is apparently a pretty complicated system that physicians have hard time using. Cardiome would have to agree with the FDA that some other easier system can be used for GED-aPC in cardiogenic shock, IMO. I have no idea how different sepsis is from cardiogenic shock in terms of mortality risk and whether mortality is likely to come earlier in one condition versus the other, or if more desirable to avoid bleeding in one condition versus the other; seems like bleeding would be a bad thing in both. If the risk of death is more immediate in cardiogenic shock, perhaps an APACHE-like requirement would be waived. Obviously, avoiding an APACHE-like requirement in the sepsis indication would have to be likely if it is to be pursued by someone. We should revisit Xigris research to see if any effects might be lurking aside from bleeding that could potentially torpedo this next generation compound. I had been watching the stock prior to this deal, but didn't know enough to decide whether or not the resulting sell-off was a buying op. Still not sure, but a little more comfortable with the deal given the advantages now known to me of GED-aPC over Xigris. I'll try to look for relevant research, but am busy with plenty of other things, so any help is appreciated. Cheers, Tuck