News Focus
News Focus
icon url

Lewis R Goudy

06/04/08 10:33 PM

#11492 RE: rustyboy #11489

We had a pretty good chat about it a month ago.
I agree that this could come back to the front burner.
I thought Jesse's remark about how the locus of tissue
damage exceeded that of actual ischemia was clearly
important.

Dew mentioned that the heparin fiasco may have adjusted
some attitudes at the FDA. Just how much of our initial
misadventure re CABG was medical/legal/ethical/political
is not clear to me but I believe the medical part got
short shrift and that might well be revisited, perhaps soon.

This isn't really content, I'm just jacking my jaws saying
I'll second that, especially the part about $100M being a
very conservative lower bound and several $B reasonable in
the best case.

Assuming we survive. I'm very much convinced that AT was
the proper avenue to birth our tech, and that we will see
continued good news from the clinic re its therapeutic scope.
I might be fingering my rosary mounting the gallows--it's hard
not to--but I think your intuition, that CABG will figure in
our news flow over say the next two years, is right where
mine is.

Your post reminds me again that AT's heparin affinity is
strongly conditioned by chain length, so that we have to be
careful about speaking/reading about "heparin" in a generic
sense, at least when tossing numbers around. The wiki article
explains this angle very well.




icon url

DewDiligence

06/05/08 12:27 AM

#11495 RE: rustyboy #11489

>who would use plasma [antithrombin] when you've got a safe recombinant product?<

The answer is twofold:

1. If there is an ample supply of plasma-derived AT that is cheaper than ATryn, some hospitals will deem the plasma product “safe enough” and use it to save money. GTC concedes that this is happening to some degree with Leo’s HD launch in Europe.

2. If either: a) ATryn is priced at par to plasma-derived AT; or b) plasma-derived AT is in short supply and is cumbersome to order; then the answer to your question is that no one will opt to use plasma-derived AT. Case 2b holds in the US market.
icon url

MTB

06/05/08 11:12 AM

#11504 RE: rustyboy #11489

Hello Rusty,

It is a great thought. Off the cuff, I can't speak to how commonly ATIII dosing is required for CABG patients in the situation described. I'll be happy to talk with cardiac surgery friends to get an idea.

If ATIII were given commonly during CABG, it would certainly make for a large, stable market -- that in the near future when ATIII is FDA approved, could be easily used off-label. With a relatively brisk follow on indication further supporting this use, a partner could make significant amounts of money.

As to the plasma vs recombinant product question, certainly in the U.S. (and I think increasingly around the world), the safety profile of recombinant product is just too much superior to allow continued use of pooled product. As we've seen in the news over the last months, even in the modestly well-controlled porcine heparin product supply line, the risk of introducing unintended contaminants is both real and large. I think of it as the difference between sweeping the street and then trying to carefully pick up the pieces you want to be clean vs. manufacturing them in a carefully controlled environment. One is inevitably far safer than the other.

With all 'dew' deference, unless the cost is simply ridiculous, or the hurdles to obtaining it overwhelming (which better not be the case, LEO!) even the Europeans will accept this logic and start regularly using recombinant product to the exclusion of pooled serum.
icon url

DewDiligence

06/08/08 10:40 PM

#11575 RE: rustyboy #11489

Treating Heparin Resistance With Antithrombin or Fresh Frozen Plasma

http://www.ncbi.nlm.nih.gov/pubmed/18498854

>>
Ann Thorac Surg. 2008 Jun;85(6):2153-60.

Spiess BD.

Department of Anesthesiology, Virginia Commonwealth University Reanimation Engineering Shock Center, Richmond, Virginia 23219, USA.

Heparin resistance occurs in up to 22% of patients undergoing cardiac surgery requiring cardiopulmonary bypass and it is associated with decreased levels of antithrombin. Treatment options for heparin resistance include administration of antithrombin or fresh frozen plasma.

A systematic review revealed no clinical trials directly comparing antithrombin with fresh frozen plasma as heparin resistance treatment during cardiopulmonary bypass. Thus, the aim of this review is to discuss the limited number of published reports assessing antithrombin or fresh frozen plasma in managing heparin resistance and to present emerging data regarding fresh frozen plasma safety issues and practical considerations for antithrombin treatment in patients with heparin resistance undergoing cardiopulmonary bypass.
<<
icon url

DewDiligence

06/26/08 7:55 PM

#12245 RE: rustyboy #11489

Re: Newfound interest in CABG indication

I’ve reread the transcripts from some of GTC’s old CC’s to get a feel for when the company’s interest in the CABG indication was reignited. Clearly, it happened during the past two years: as of Aug 2006, CABG did not even warrant a mention in the following exchange from the 2Q06 CC (#msg-12468464):

>>
Roy Friedman: [In] the U.S., at what point does GTC start thinking about an acquired-deficiency indication and is there a strong case to be made for hedging the Company's bets by selecting an indication other than DIC/sepsis?

Dr. Geoffrey Cox: Clearly, we could initiate further studies and other indications. We've talked in the past about burns, and severe burns remains an interesting area for us. I just think at this juncture we still have to be quite cautious about the cost of investment in these clinical studies, and I think certainly for the next year or so we would like to see the outcome of the DIC study before we kick off a range of other indications.

<<