Stryker Misses the Goal with OP-1

01 Feb 2001

Analysts watching the progress of Stryker's OP-1, the first orthobiologic device to deliver a manufactured bone growth-inducing protein, have long been aware that the design for the product's pivotal clinical trial had its shortcomings. Nonetheless, a US approval appeared likely, especially after the CPMP unanimously recommended the product for European approval on January 3. But three weeks later, FDA sent Stryker a not-approvable letter. As it turned out, however, the OP-1 news, coincident with the company's announcement of strong financial results for 2000, barely put a dent in its stock price.

Analysts watching the progress of Stryker Corp. 's OP-1, the first orthobiologic product to deliver a manufactured bone growth-inducing protein, have long been aware that the design for the product's pivotal clinical trial had its shortcomings. Only 100 patients were enrolled, the label indication—for the treatment of tibial nonunion fractures—was narrow, and both the treatment and control arms of the study used nails to fix the fractures, making it more difficult to ascribe any clinical benefit directly to OP-1.

Nonetheless, a US approval appeared likely, especially after the CPMP unanimously recommended OP-1(osteogenic protein-1, also known as bone morphogenetic protein-7...