Olympus Biotech Launches Opgenra, Formerly OP-1 (written by Lauren Uzdienski @ HealthPointCapital)
Olympus Biotech announced this week that the company launched their BMP-7 product, which they’ve named Opgenra, in Europe. Olympus acquired Opgenra, formerly OP-1, from Stryker late last year, paying $60 million for the OP-1 portfolio and the New Hampshire facility that manufactures it.
Opgenra is indicated for posterolateral lumbar spinal Fusion (PLF) in adult patients with spondylolisthesis where autograft has failed or is contraindicated. The product will be available in the U.K. and Germany this month, and the release will be expanded to other Euroepan countries this year.
There was no mention of marketing plans outside Europe. In the U.S., where the product is still available under an HDE (limiting its use to 4,000 patients per year), there is something of a dark cloud over the former OP-1. Stryker was denied broader FDA approval twice, once over a decade ago for tibial non-union fractures and again in April 2009, when the company pursed a spinal fusion indication. At the time, it appeared they would have to start over with a new clinical trial if they wanted to achieve PMA approval. The regulatory pathway for Opgenra has been complicated further now that Infuse, or BMP-2, is under such scrutiny. Certain Infuse investigators have been accused of bias in their studies and under-reporting certain adverse events, which could incline the FDA toward more aggressive oversight of a similar product.