Osiris' New Biosurgery Division to Focus on Bone Repair
BY ARIELLA P. GOLOMB, MD, AUGUST 5, 2009
Osiris Therapeutics has been at the forefront of developing stem-cell-based products in orthopedics, most notably with their commercialization of Osteocel. That product line was sold to NuVasive last year, leaving Orthofix (who had previously distributed Osteocel under the name Trinity) to develop their own stem cell line. Orthofix subsequently partnered with MTF to develop Trinity Evolution, which was initially released back in May, but has been met with supply constraints. These product lines consist of stem cells harvested from donors and are regulated as allograft tissue, with supply therefore constrained based on available donors. With these limitations noted, Osteocel is projected to generate $30 million in revenues for NuVasive this year, and Orthofix has guided between $18-20 million in Trinity/Trinity Evolution revenues.
Now Osiris is leveraging its know-how (physician advisors, manufacturing, R&D) to develop a stem cell line that is culture-expanded to target bone repair. The company's newly-created Biosurgery division will develop and market high-end surgical biologic products and will focus on the "XC project," a line of osteogenic orthopedic products. Development will center on culture-expanded cells, the benefits of which include alleviating supply constraints and allowing for potentially higher concentrations of desired cells. This will also enable the selection of particular cells to be delivered to the patient. There are significantly more regulatory requirements on these cells lines over allograft tissue, which implies that there will be supportive clinical evidence for these products when they are introduced into the marketplace.
XC project will not be Osiris' first foray into expanded stem cell treatment of orthopedic conditions. The company is developing a product called Chondrogen, which is currently being evaluated as an intra-articular injection following meniscectomy. Phase I/II data proved somewhat disappointing after initial results demonstrated that the primary endpoint of meniscal volume increase was not met. However, the trial did demonstrate a decreased likelihood that Chondrogen-treated patients will develop bony changes associated with osteoarthritis and a statistically significant improvement in pain. The company subsequently announced a partnership agreement with Genzyme for the commercialization of Chondrogen (and Prochymal as well), and Genzyme's commitment suggests that there is sufficient data to support Chondrogen's continued development.
Osiris is not the only company developing culture expanded cells for orthopedic indications. Mesoblast is already testing its expanded stem cell product in the cervical spine (an indication where BMPs are unable to compete.)
