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Replies to #86289 on Biotech Values
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DewDiligence

11/14/09 3:38 PM

#86298 RE: rkrw #86289

PYMX:

[heparin reversal] is used in 100% of cardiopulmonary bypass surgery. The only time it wouldn't be used is when heparin isn't used, say a patient is allergic to it.

I think we’re on the same wavelength but some readers of this board may not be, so let me try to summarize.

There’s an unmet need in CABG for a better heparin-reversing agent. (I would describe this as a relatively minor need, but some people may disagree.) Most cardiac procedures performed today are PCI, not CABG, and PCI does not routinely require heparin reversal. (Thanks to Angiomax, many PCI procedures do not use heparin at all.) If Peter’s 2.6% figure for protamine-induced SAE’s in CABG is accurate, the rate of protamine-induced SAE’s in cardiac procedures as a whole should be less than 1%.

In CABG, specifically, the commercial opportunity for PYMX’s PMX-60056 could be attractive if PMX-60056’s own rate of SAE’s is close to nil. Because the absolute numbers here are small, I don’t think PMX-60056’s merely being statsig safer than protamine will be sufficient for PYMX to garner an attractive ASP (unless heparin’s ASP goes up due to new supply problems).

Another requirement for PMX-60056 to be commercially successful in CABG is that the new oral anticoagulants do not make major inroads against heparin in this setting. This seems like a relatively safe assumption given the MoA’s of the new oral agents, although some of these drugs (e.g. Xarelto) are currently being tested in ACS.