University of Colorado Health Sciences Center
Name: Michael Bristow
Position: Graduate school faculty member, University of Colorado Health Sciences Center; professor of medicine (cardiology), University of Colorado School of Medicine; co-director, University of Colorado Cardiovascular Institute; Director, chairman, and chief science and medical officer, Arca Discovery
The University of Colorado Technology Transfer Office scored a major win last October when Gilead Sciences acquired CU spin-out Myogen for $2.6 billion. Based on research conducted in the lab of CU professor Michael Bristow, Myogen had developed a lead product candidate for pulmonary arterial hypertension.
Myogen’s development and its eventual acquisition by Gilead was perhaps one of the most successful examples of transferring basic research into dollars in CU’s history, despite the fact that CU was running a fairly “rudimentary” tech-transfer office at the time, according to Bristow.
Bristow now has a new company, Arca Discovery, which is looking to capitalize on some pharmacogenetic-based technologies licensed from Myogen, and CU’s improved OTT is betting that it has another success story on its hands.
Bristow took a few moments last week to discuss Myogen, Arca, and the CU OTT with Biotech Transfer Week.
Take me through the basic science upon which your first company, Myogen, was founded.
Myogen’s founding goes back to 1996. It was founded on IP from the University of Colorado related to the discovery that there was a molecular mechanism at the basis of myocardial failure and pathologic hypertrophy. That molecular mechanism was known to operate in small animals, particularly rodents, and not known to operate in humans. In 1995 and 1996, we discovered that it did operate in humans, and we thought it was important enough that we ought to go after things that would change that mechanism for the better.
Then we had discoveries in terms of how to utilize a drug that we thought had a lot of potential in heart failure, and the logical extension of that was to in-license a drug that would work through the mechanisms that we’d identified. We proceeded to do that, and by 1996 we had a pretty good handle that we would be able to do that. We had sort of a late-stage clinical licensing approach in Myogen as part of the business plan, and then an early-stage development component. Those components remained throughout the development of the company, and are still in place in Gilead in Colorado.
What made you decide that you wanted to go the route of a start-up company as opposed to licensing the IP out to larger pharmaceutical companies? There must have been companies interested in that.
I had spent a long time – almost my entire career – working with pharmaceutical companies and helping them develop their products, giving them advice, discussing with them things they ought to do, and trying to interest them in things coming out of our laboratory. My conclusion after more than 15 years of doing that was that it’s very difficult to deal with large pharma, for a whole variety of reasons, as an academic laboratory. It is, in a sense, much easier to start your own company and develop your own IP. I had come to that conclusion the hard way, by actually trying to get big pharma interested in things they ought to be [interested in], whether it was my stuff or somebody else’s. I concluded that they don’t know the area that I’m interested in, they aren’t going to be able to properly evaluate opportunities, they have their own agenda, and you’re much better off as an academician to start your own company.
What kind of a role did the University of Colorado tech-transfer office play in Myogen? It sounds like in your case, because you had so much pharma experience, that you may have done a lot of this legwork yourself.
In 1996, the tech-transfer office at the University of Colorado was really quite rudimentary. It was really not as highly developed as it is now, and certainly not as highly developed as some of the major research universities’ tech-transfer offices were at that time. But I had been at Stanford during my training, and stayed on the junior faculty there, and I had a fair amount of experience in this area, including starting up my own company with two other folks in 1982 in California. My company was actually sold in 1994, so I’ve sort of been through all the basics, and felt pretty comfortable with how you do it. I didn’t really need the tech-transfer office to get started, but Myogen ultimately had to work out a relationship with the University of Colorado, a quite complicated, in-depth relationship in terms of licensing the IP, and supporting work back in the lab, because Myogen took a position of having first right of review of material coming out of our laboratory. All that had to be worked out on paper, and we did that in 1996 and 1997 with the University of Colorado, and negotiated a reasonable situation, which also led to their taking an equity position in Myogen at that time.
Gilead purchased Myogen last year for $2.5 billion. It sounds like your early success with founding Myogen would be a major feather in the cap of the University of Colorado tech transfer office.
They certainly count Myogen in their win column.
Were there any complicated IP issues that you had to meddle through?
We set up what seemed to be the logical way to do it, which was that the IP would be declared, and it would be quickly offered to Myogen for review. They had a certain amount of time to evaluate it, and if they wanted to pick it up, they would pay for the patenting process and take a license. We had a blanket amount of support – an unrestricted gift, essentially – that would come back to the university and to my laboratory to give them this right. We figured out that the most efficient way to do this would include not spending a lot of time bogging down the IP, so that we could go ahead and disclose it and get the patents moving, and move ahead in terms of publishing things. We set up a system that to this day works pretty well.
You are no longer on the board of Myogen/Gilead, but your laboratory maintains a collaborative relationship with Gilead. What is the nature of that?
Gilead still has the right of review of our IP, so we have to offer it to them first. They decide whether to take up a license or not, and unfortunately they’re a lot slower than Myogen was, so that’s a bit of an issue. But my new company actually has the next rights, so if Gilead doesn’t claim it, it gets offered to ARCA Discovery. But there are certain things that go straight to ARCA as worked out in a contract between ARCA and Myogen in 2005.
When Myogen and I spun out ARCA from Myogen, we worked all that out, and it was a little more complicated than I originally anticipated, because there were a lot of issues that needed to be worked out.
What is the scientific background of ARCA Discovery?
Myogen had licensed from us and the University of Colorado certain personalized medicine pieces of IP that were sitting at Myogen doing nothing. In addition, we had new IP around the pharmacogenetic targeting of bucindolol that we had ready to go. In essence, Myogen decided it was not going to get into the personalized medicine business, and that all that IP would be available for sub-licensing, or licensing straight to ARCA from the university, in the case of the bucindolol pharmacogenetics. That all got put into this contract, so some IP moved from Myogen to ARCA; ARCA was able to de novo take some stuff out of the university that Myogen essentially passed on. Then Myogen took an equity position in ARCA, which Gilead has now retained. The university, of course, also took an equity position in ARCA. So it’s one big happy group now.
Do you think that the type of technology ARCA is dealing in might be as attractive for the type of buyout that happened with Myogen?
Well, of course. Our goal is to build a free-standing, integrated company with valuable products. In our case, we’re just focused on pharmacogenetic targeting, primarily. There is no doubt in my mind that in four to eight years, we’re going to have a whole range of things in development, some of which will be on the market, and we’ll end up building a company that will be just as valuable, if not more so, than Myogen. We’re just doing it in a slightly different way.
Where does ARCA stand now?
ARCA is rolling along. It’s submitting a [new drug application with the US Food and Drug Administration] for [the beta-blocker] bucindolol with pharmacogenetic targeting. We’re right in the middle of that NDA process. We’re also looking for other opportunities that are pharmacogenetically based, and we have identified some of those and are trying to bring them into the company. At the same time, we have to raise more money, as you always do. We raised a series A round in February of last year, and we’re beginning to work on a series B round right now.
How has the tech-transfer office played into the development of ARCA?
The tech transfer office is now a very sophisticated operation. They actually helped me start ARCA. I got more help with ARCA than I got with Myogen. They helped me work with the business plan. Even though I’d done one before, I really wasn’t very good at it. Every step of the way, they were there to help, and they are really terrific at helping faculty start companies.
There are a lot of companies in development that are successful so far in raising money and developing partnerships. GlobeImmune is one, started by [University of Colorado Health Sciences Center professor of medicine] Richard Duke. They started nine companies last year, and I think 13 the year before. They really do a good job of this. They’re not very restrictive or very punitive. It’s easy to do this here. The culture is go, go, go, let’s help you out. Those of us who have started companies end up giving advice to those who want to start. We spend a lot of time working on these things around here because we think that’s what should be done. It’s one thing to discover stuff, but if it never sees the light of day, and isn’t offered out to the public, there’s no point to it, in a sense.