What are the Viscogliosi Brothers (VBs) up to?
In the course of the last 30 days, two significant and interesting press announcements crossed our desks, one from South Carolina-based Bioventus LLC and the other from New York City-based Ember Therapeutics, Inc.
The Bioventus announcement said that the legendary Viscogliosi Brothers Family Investment Firm was acquiring a portfolio of next generation BMP2 assets and the Ember Therapeutics announcement said they were also acquiring the BMP7 product family and related patent assets including the OP-1 Implant, OP-1 Putty, Opgenra and Osigraft.
Together, the two announcements describe transactions which would make the VBs and their investment partners owners of the largest intellectual property estate (more than 450 patents and other related IP) for the two major forms of recombinant human bone morphogenic protein—BMP2 and BMP7.
Indeed, when these transactions close, the newly minted VB Biotechnology firm will be the first major competitor to Medtronic’s rhBMP near-market monopoly since Stryker Biotech left the business in 2010.
“VB is looking at where the next $1 billion in single product revenues is going to be generated in the orthopedic industry and it is not going to be the next medical implant.” Explained VB Partner Anthony Viscogliosi to OTW when we asked him the question—”What are the Viscogliosi Brothers up to?”
“VB is making a strategic decision that a large component of future orthopedic industry growth will be and is regenerative medicine.”
$500 Million rhBMP Sales in 2017
One company, Medtronic Spine, pioneered the use of recombinant bone morphogenic proteins in spine care and, arguably, laid the foundation for other companies to develop products based on bone morphogenic proteins to improve bone grafting efficacy and safety.
The FDA approved the first rhBMP product for commercial use in October 2008.
In the hierarchy of bone graft products, recombinant BMP is at the top—both in terms of single product revenues and clinical effectiveness. BMP literally stimulates bone production. The most famous study of BMP placed the molecule under the skin of a mouse—where no bone exists—and bone spontaneously[1] developed.
But that very effectiveness was also the source of the greatest concerns regarding these powerful proteins. Numerous studies over the years have detailed cases of ectopic growth in places where bone growth was not intended by the surgeon. As we detailed in our critique of The Spine Journal’s seriously flawed studies of BMP, the rate of complications associated with the use of BMP in spine fusion surgery has declined over the years as, in our opinion, physicians walked up the learning curve in terms of patient selection and implant technique and Medtronic Spine improved its associated BMP carriers and instruments.
Since it was first approved by the FDA for commercial use, BMP has been used, we estimate, in more than 1.7 million procedures.
While Medtronic was the first company to bring an rhBMP product to market, it soon faced competition from Stryker Corporation—which, in 2004 introduced to the market a related, but different bone morphogenic protein—BMP7 or OP-1.
There are several versions of bone morphogenic protein: BMP1, BMP2, BMP3, BMP4, BMP5, BMP6, BMP7, BMP8B and BMP15.
The FDA approved Stryker’s OP-1 in 2004 as “… an alternative to autograft in compromised patients requiring revision posterolateral (intertransverse) lumbar spinal fusion, for whom autologous bone and bone marrow harvest are not feasible or are not expected to promote fusion. Examples of compromising factors include osteoporosis, smoking and diabetes.”
At the time Stryker sold OP-1 to Olympus Corporation in 2010, the product was generating an estimated $100 million in sales.
Olympus never was able to adequately support OP-1 and by 2014 it was gone from the U.S. market.
Today, Medtronic is effectively the only company with an FDA-approved bone morphogenic protein on the market and in 2017, generated more than half a billion dollars in sales of its brand of BMP2—Infuse.
