Is there room in the market for a recombinant thrombin?

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The answer is probably a conservative, "Yes." At the very least, additional thrombin products are needed to fill the void when bovine thrombin shortages occur. Erin Fox, Pharm.D., handles the drug shortage Web site for ASHP. According to Fox, bovine thrombin products have suffered shortages since about 2001, when the number of bovine thrombin manufacturers decreased from several to one. King Pharmaceuticals is now the sole maker of bovine thrombin (Thrombin-JMI). Since 2001, there has been a bovine thrombin shortage in every year except 2007, Fox said. According to J. David Owens, senior VP of hospital sales and marketing for King, there was no shortage in 2007 because the company has revamped its manufacturing facilities to meet increased demand.

Aside from shortages, another issue with bovine thrombin is the risk of immune response. In the 1980s, studies revealed that patients developed antibodies to bovine thrombin following exposure to the drug. Although no cross-reactivity with human thrombin was observed, immune responses to other plasma proteins did occur. In 1990, one case was reported in which a patient developed antibodies to bovine thrombin and to bovine factor V. This response turned out to be cross-reactive with human factor V, and life-threatening bleeding was the result. By 2001, some experts were suggesting a recombinant human thrombin was needed.