Olympus Biotech International, an Olympus Corporation Company, announced the availability of its eptotermin alfa product "Opgenra" for European patients. Opgenra is indicated for posterolateral lumbar spinal Fusion (PLF) in adult patients with spondylolisthesis where autograft has failed or is contraindicated. The active ingredient, recombinant human bone morphogenetic protein-7 (rhBMP-7 or eptotermin alfa), stimulates natural bone regeneration by actively recruiting stem cells from the surrounding tissue and blood supply, initiating the bone formation cascade. Opgenra will be available in the UK and Germany in July with other European Countries to follow later in the Year.
Eptotermin alfa has 10 years of use in clinical practice as an osteoinductive agent in supporting the Regeneration of Bone with regulatory approvals in the US, Canada, Australia and Europe..
"We are proud to announce that shortly after the acquisition of all BMP-7 bone-related product rights from Stryker, we are able to make Opgenra available to European patients", says Florian Kemmerich, president of Olympus Biotech International. Opgenra is a medicine that contains the active substance eptotermin alfa. It is supplied as two vials, one containing eptotermin alfa and another containing a substance called carmellose. The two powders are made up into a 'suspension' (a liquid with solid particles in it) with a putty-like consistency, which is implanted in the body
Opgenra is placed between the transverse processes of the spine to promote fusion. Once implanted in the body, Opgenra stimulates natural bone regeneration by actively recruiting stem cells from the surrounding tissue and blood supply, initiating the bone formation cascade. Through many years of research, the mechanism of action by which this molecule works inside the body has been explored extensively. Eptotermin alfa based products are approved in the United States of America by the FDA under a Humanitarian Device Exemption (HDE), Canada and also Australia.
Olympus Biotech was established in December, 2010 as a wholly owned company of Olympus Corporation. The vision of Olympus Biotech is to improve the patient Quality of Life by developing and distributing Regenerative Medicine that stimulate the intrinsic healing capacity in the living body by the technological development of growth factors and biomaterials.