In Brief: Creative Biomolecules/Stryker
This article was originally published in The Gray Sheet
Executive Summary
Creative Biomolecules/Stryker: Extend development and commercialization agreement for OP-1 for orthopedic reconstruction with an investment of $12 mil. in new funding from Stryker. Filing of a premarket approval application is anticipated in "late 1997," CBM says. Target patient accrual in the pivotal trial of OP-1 for non-union fractures was completed in January 1996 and treated patients are in the required follow-up period, CBM says. Stryker also is conducting a supplemental study of OP-1 for "all long bone non-union fractures." Additional clinical studies in "a broadening array of orthopedic indications" are expected to be initiated in the U.S. and other countries "over the next 12 months"...