OLYMPUS HALTS OP-1 EFFORT (Orthopedics This Week)
Olympus Biotech Corporation has put a fork into its efforts to commercialize OP-1.
After paying $60 million to Stryker Corporation in 2010 for the biologic product that has snake-bitten everyone who has attempted to commercialize the protein, Olympus announced on June 18, 2014 that it will close its 120-employee manufacturing plant in West Lebanon, New Hampshire, because it has been unable to find a buyer for the past four months.
OP-1 was a disaster for Stryker as the company failed to get FDA approval for the product, paid millions in fines for the way it marketed the product and several former employees received jail time for lying about those marketing practices. It was an albatross around former Stryker CEO Steve MacMillan’s neck when Olympus Biotech came along to try and breathe life into the product.
The product was even part of a U.S. Senate investigation as Senator Chuck Grassley tried to exercise his uninformed medical clinical judgment by saying that OP-1 could have been used as a substitute for Infuse in a clinical trial at the University of Minnesota.
Olympus Corp: Cameras to Bio
Olympus Biotech was formed four years ago by the Japanese camera giant, Olympus Corp. to focus on products for regenerative medicine. It bought the rights to the protein-based putty used to regenerate bones for treating spinal, hip and knee conditions. Shortly after the purchase, Olympus underwent its own investigation by securities regulators in Japan. OP-1 left no one unscathed.
The company reportedly said the closure was “purely a financial decision…and is not related to the performance, quality or safety of our OP-1 family of products.” The regenerative medicine industry took a hit late last year when a change in the Medicare and Medicaid reimbursement drastically lowered rates for many wound treatments.
In March, company officials continued to defend OP-1 even while announcing the pending shutdown of Olympus Biotech.
“We are proud of OP-1’s legacy in the market and its significant contributions to regenerative medicine and the quality of life in patients worldwide,” David Renker, company chief operating officer, said in a news release. The company is providing severance benefits and access to outplacement services to its employees, as well as making them aware of open positions at other Olympus Corp. locations.
While this specific effort to commercialize bone morphogenetic protein 7 (OP-1) has fizzled, it’s unlikely that the science which explains the key role the protein plays in the transformation of mesenchymal cells into bone and cartilage will be discarded. The International Society for Molecular and Cell Biology and Biotechnology Protocols and Research named bone morphogenetic protein 7 as the 2011 Molecule of the Year.
The question isn’t whether another commercial effort will be made, but who will have the courage to take another bite of the apple?