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Clinical Data’s Makeover: CEO Discusses PGx Focus, New Acquisitions, and Products

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This article has been updated from a previous version to correct the spelling of Genaissance.

 

Drew Fromkin
President and CEO
Clinical Data
Name: Drew Fromkin
Position: President and CEO, Clinical Data
Experience: President and CEO, DoctorQuality; President and CEO, Endo Surgical Devices; Vice President, Business Development, Merck-Medco Managed Care
 

 
Clinical Data recently spent $11.8 million to acquire Germany’s Epidauros Biotechnologie for its portfolio of genetic biomarkers, expertise in genetic biomarker discovery, relationships with “leading” diagnostic companies, and its “fast-growing” pharmacogenomics services business.
 
Epidauros’ intellectual property portfolio includes genes and other biomarker relating to “prominent” drug transporters such as MDR1, OCT1, MRP1, and cytochrome P450 drug metabolizing genes including CYP2B6 and CYP2D6.
 
According to Clinical Data, Epidauros will also provide the company with “additional scientific expertise, biotechnology partnering capabilities, and a deep understanding of European clinical markets.”
 
As part of the acquisition, Epidauros CEO Michael Lutz will join Clinical Data’s PGxHealth division as senior vice president of pharmacogenetic partnerships.
 
Simultaneously this week, Clinical Data saw advances in its internal R&D pipeline, with the investigational antidepressant vilazodone meeting its primary and secondary efficacy endpoints in a pivotal Phase III study. The study separately identified candidate biomarkers for a potential companion diagnostic to test for patient response to vilazodone.
 
Moving forward, the company appears to be employing a strategy of selling divisions that do not relate specifically to personalized medicine and the development diagnostics, bolstering internal R&D, and acquiring companies like like Genaissance, Icoria, Genome Express, and now Epidauros that buttress its stated strategy to become a more PGx-focused company.
 
CEO Drew Fromkin has said he expects the Epidauros buy “will enhance Clinical Data's ability to bring valuable, proprietary pharmacogenetic tests to market.” In an interview with Pharmacogenomics Reporter this week, Fromkin outlined the company’s plans for moving headlong into the PGx space.
 
Could you discuss how you plan to become a more PGx-focused company?
 
As we’ve discussed previously, the company has been around for some time in the in vitro diagnostic businesses, clinical chemistry, reagents, analyzers. That was the history of Clinical Data. Over the last number of years, with Randal J. Kirk [who holds a 46-percent stake in Clinical Data], and now our new management team, we have refocused the company through acquisitions in the pharmacogenomic area. With our acquisition of Genaissance, Icoria, Genome Express, and now Epidauros, we have brought in a number of different companies that bring a number of significant assets to us in this area. Simultaneously, upon turning some of those assets around, we began to divest our IVD business. In June of this year, we divested our Clinical Data sales and services division, our IVD business in the US, and prior to that we had divested of our Australian distribution group, Vital Diagnostics. So people are seeing the company transform from what it was prior to the acquisitions in this area to what it is now.
 
How does Epidauros specifically fit into your strategy to become a PGx-focused company? Is it significant that this is your third acquisition in Europe?
 
In Europe, our previous acquisitions are Lark UK, which came with the Genaissance acquisition. We had bought Genaissance in October of 2005, and prior to the acquisitions we had rolled up a number of companies, including DNA Sciences and Lark, primarily in the area of sequencing. We picked up the UK facility through that acquisition and followed that with the acquisition of a small firm in the pharmacogenomics services area in France.
 
I think Epidauros has elements of those past acquisitions, but looks a lot more like a mini-Genaissance in that it has a combination of pharmacogenetic services, which lines up very nicely with our Cogenics unit. But the primary driver for this acquisition had a lot to do with the intellectual property that Epidauros has developed in the past and more recently has brought to the market. They have a number of different markers, primarily in the area of drug transport. These markers include MDR1, OCT1, MRP1, and they also have some important cytochrome P450 variants. Some of the older variants that they have had for some time, have been licensed out. Roche uses it on their AmpliChip, TM Biosciences and others also use those markers. But the more recent markers in drug transport … these markers have not been licensed out. And our intention is to utilize these markers in our pharmacogenetic testing, in many of our tests that we have brought to market and certainly in those that are in our pipeline. MDR1 and some of these other markers are candidate genes for these tests. Secondly, these markers allow us to look at other tests that we likely would not have been able to bring to market ...
 
And last but not least, you can see as our company emerges here as kind of a pure play in this area, that these markers are focused on either drug metabolism, or drug transport, which many consider the key elements of how drugs are utilized in the body in terms of efficacy and toxicity. These markers also bridge our opportunities to have additional interactions on the pharma side, some with respect to companion diagnostics and to some extent potentially looking at other therapeutic candidates.
 
Is Clinical Data planning to have more interaction with pharma?
 
I can’t disclose any specific names or plans. But because of our Cogenics unit we work with pharma and biotech all the time in providing molecular and pharmacogenomic services. What this continues to do is, both with the Epidauros acquisition and markers that we acquired through Genaissance, allow us to work with pharma beyond helping them identify markers for their drug discovery. It also allows us to work with pharma potentially in taking it all the way through to companion diagnostics with respect to their NDA strategy. And to some extent, it actually assists us in having those discussions in that we bring, beyond the services, very strong intellectual property, which for them may be [for pharma] an integral part of their ability to bring certain drugs to market.
 
I think it enhances our discussions and now as you can see today we’ve had some great news on our initial drug franchise with vilazodone. I think these markers not only assist us potentially with vilazodone, but they also become an exciting intersection with other drugs that are in other pharma companies’ pipelines, or [represent] opportunities for us as a company.  
 
Do you see pharma companies getting more interested in developing drug/diagnostic combinations?
 
Oh, yes. I think pharma has been enlightened to this for some time. Much of the work pharma has done previously has really been investigative and as part of their trials to understand their compounds. More and more, with these side effect issues we’ve seen in the market and drug programs being eliminated in late stage because of side effect issues or efficacy issues, pharma companies are proactively integrating these studies and markers into their NDA strategies. To the extent that that becomes more of a proactive approach, beyond just for research and knowledge and now really more for commercialization, yes, I see a number of pharma companies becoming active in that area.
 
Clinical Data announced this week that vilazodone had met its primary and secondary efficacy endpoints in a Phase III clinical trial. Can you discuss this data?
 
I think the press release is as far as we’re going to go for a number of reasons. We will be at the Bear Sterns meeting next week, where we will release some additional data. … But we’ve met our primary and secondary endpoints for our pivotal trial and we have identified some genetic markers that may be important for predicting response to vilazodone. Those were the two key milestones that we needed to meet in this study … Meeting the endpoints, without the genetics, shows the drug has value in its own right.
 
Additionally, this molecule is very different from the other SSRIs that are already out on the market in that it has a 5HT1A partial agonist component. This makes it the only compound on the market that combines two mechanisms that are often used for first- and second-line treatment for mood disorders and depression.
 
Also, we have identified markers ... We’ve certainly been working with pharma and biotech companies for almost a decade doing this successfully and now we’ve been able to demonstrate this in our own program. That’s very valuable, not only to vilazodone, but valuable to our attempting to do the same thing with [pharma] or on our own …
 
Are you planning on launching any new products in the near future?
 
We’ve talked about launching a test this fall for [cathecholaminergic polymorphic ventricular tachycardia], which is a follow-on to what we’ve done with our long QT product. This is another cardiac channelopathy test, and many of our electro-physiologists and cardiologists have been asking for that test as a follow on. So we expect that we’ll have that test out likely by the middle of the fourth quarter.
 
Secondarily, we now have other products with the Epidauros acquisition in our pipeline that are keyed up for [launch in] the next six months. We’ve not announced these publicly right now. It’s just a little premature to do that.
 
What disease areas are these launches in?
 
Generally, more in the cardiovascular space is where we’re looking at. Also, there are series of products in other areas, some of which are too specific to mention, but I think generally, our primary focus is in central nervous system and cardiovascular. With our Rituxan assay, we’ve entered into the oncology space and now, with MDR1 and other markers we have, we think that’s an interesting space. We’ll bring tests out on our own, enhance our tests, or partner. But I’d also say that there are opportunities for us to do things in inflammatory disease or in pain, as well.
 
It seems you’ve taken to acquisitions as a strategy in expanding your PGx business. Are you planning on any other acquisitions in the near term?
 
We’re opportunistic in that way. Our Chairman R.J. Kirk and his firm and my background speak to mergers and acquisitions work. At the same time, we’re going to do that very selectively. Epidauros was one of many acquisitions that were available to us. We felt like their intellectual property estate was very unique and strong. … It was absolutely in our mind that a presence in Germany is important. I would also argue that in Germany for us to be able to do CLIA testing – in Germany it’s not really CLIA testing as we know it in the States but testing for patients versus research – is an important step for us. We have assays in the US we’ve been running that we’d like to run overseas, as well. We have partners now in the UK and in four other countries that are selling our Familion [cardiac channelopathy test], and will be selling our other tests. So, having a local ability to run these tests is important.
 
We gained in the Epidauros acquisition a great group of individuals, not only on the scientific side but also on the lab side. The CEO of Epidauros, Michael Lutz, has worked with Novartis in corporate development and has good experience in terms of working with pharma. Therefore, [his background] should help us enhance our companion diagnostic discussions and potentially discussions around specific drug candidates.

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