On seeing today’s New York Times article “Seeking Alternative to Animal-Derived Drugs,” my first thought was that it could’a/should’a mentioned the January 2008 approval of the first recombinant human thrombin, which has the potential to replace bovine- and plasma-derived equivalents now on the market. But as noted in stories in IN VIVO and The RPM Report this month, ZymoGenetics, the developer of recombinant thrombin, can’t seem to catch a break these days, especially from Wall Street analysts.
But despite the implicit logic that a recombinant product is safer, for various reasons, it’s near impossible to directly correlate bleeding and bovine thrombin, and therefore there's no baseline with which to measure improvement in patient outcome, which poses a problem for reimbursement. As a surgical adjunct, recombinant thrombin also has to make its way through hospitals’ Pharmacy & Therapeutics Committees before it’s stocked, which takes time.
Plus, because Recothrom is a biotech product (and as a biotech company, ZymoGenetics is covered by biotech analysts with little experience following the launch of such a device-like medical product), there appears to be even more uncertainty over how to gauge the product’s trajectory in the market.