Roche Partnering: Shafique Virani on CNS Deals and Strategy




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Video title: Roche Partnering: Shafique Virani on CNS Deals and Strategy
Released on: November 04, 2010. © PharmaTelevision Ltd
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In this episode of PharmaTelevision News Review, Fintan Walton talks to Shafique Virani, Global Head of CNS Partnering, about the partnering strategy of Roche and key focus areas of CNS for deals. They discuss:

• How does Roche balance and differentiate between late stage vs Early stage?

• Approach to CNS from a functional domain perspective

• Partnering strategy and prioritisations

• Importance of deal with ReMynd for Roche

• Drivers and preferences for M&A

• Shafique Virani Perspective: Opportunities for CNS deals and future of Biotech
Partnering strategy of Roche and key focus areas of CNS for deals
Fintan Walton:
Hello and welcome to PharmaTelevision News Review here at BioPharm America in Boston. On this show I have Shafique Virani, who is Global Head of CNS Partnering at Roche, welcome to the show.
Shafique Virani:
Thank you Fintan Walton, pleasure to be here.
Fintan Walton:
Shafique Virani, CNS is obviously your remit tell us about what your partnering strategy is for Roche? What sort of products you are looking for?
Shafique Virani:
Sure, so my group basically is responsible for the whole spectrum of CNS partnering and by that I mean we are interested in early stage collaborations especially in areas that are of key focus to us, and I will go into that in a minute, but also the more traditional product licensing and further to that we also look at companies that have fairly CNS centric portfolios and of course we are open to deal structures that encompass M&A for example as well, so it's across the whole spectrum of partnering.
Fintan Walton:
Right, so across the spectrum where within CNS are you specifically looking for deals?
Shafique Virani:
Okay, so perhaps if I start off with areas of focus for us and that I can give you some flavor as to at what stage we would typically look at programs. So within CNS we have the two areas of neurology and psychiatry, we are active in both areas I am glad to say and this is a very exciting time in CNS because when we look at the level of unmet need within this particular area the need is great especially in terms of disease modification in neurology and really trying to meet some of the clinical unmet needs within psychiatry. So within neurology our focus is on neurodegeneration and by that I mean primarily in Alzheimer's disease and Parkinson"s disease, but we also go further than that, we also look at ALS for example where we believe that there is you know tremendous unmet need, and within this area of neurodegeneration our focus is primarily on disease modification, but we also have programs in our portfolio that tackle symptomatic treatment and certainly trying to create a paradigm shift in optimal symptom control. Within psychiatry typically the approach we take is addressing unmet need from a clinical perspective so here we are looking at refractory disease stage such as treatment resistance depression, we are looking at negative symptoms it's schizophrenia for which we have an exciting late stage program and also we look at psychosis in general as well, and one area that I haven"t mentioned within neurology which is also a key focus for us is MS for which we have a late stage program in our portfolio.
How does Roche balance and differentiate between late stage vs Early stage?
Fintan Walton:
Right, now clearly as you described a lot of those areas are of clear unmet clinical need?
Shafique Virani:
That's right.
Fintan Walton:
So from your perspective how do you differentiate between or prioritize late stage versus early stage, because obviously the whole area is evolving very very rapidly our understanding of the mechanism of disease itself is unfolding as on a day-to-day basis, so how do you balance that between early stage and late stage?
Shafique Virani:
Sure, and here you know the (indiscernable) at Roche is very much looking at future medicines that will impact on patients lives and really by this what I mean is affecting the natural progression of disease, so we are a very biologically driven group as you know the science the biology is absolutely critical, we have to look at targets that are first-in-class and perhaps even best-in-class to move forward. So for the areas that I highlighted as being of core focus to us, we are open to looking at opportunities at the preclinical stage for example where we have good evidence of effect in the validated preclinical models and ideally we would like to see some level of reproducibility between species, and then also evidence of drug ability, and I think when we talk about CNS it's important that we consider critical aspects like blood brain barrier penetration and really understand what the PK profile PK/PD relationship is in the brain or in the compartment where we decide the effect, but again really the focus is that can we develop medicines that will ultimately make a difference. I think that's a key point, because in CNS there is a lot of work going on in the late stage that's looking at addressing perhaps compliance, tolerability issues there is a wide perception that almost 60% of the medications don"t even work, so we"re trying to do two things, get medicines that are more effective and also with our personalized healthcare strategy also doing a lot of work within our biomarker and imaging groups to identify the right patient for whom that medicine should be tailored.
Fintan Walton:
Right, and that's clearly very important for all these disease areas?
Shafique Virani:
Absolutely.
Approach to CNS from a functional domain perspective
Fintan Walton:
So, but the other thing is within the area of CNS is as you mentioned you know the interspecies different or the differences between the species in terms of testing these molecules and these drugs, the fundamental plan understanding the mechanisms of the disease, so how much of your activity is looking for technologies that let you understand the disease state rather than give rise to specific drugs itself?
Shafique Virani:
And that's important to us very important to us, because as recently as about four to five-years ago we really started looking at CNS in a different light and we started looking as opposed to looking at if from perhaps more of an indication specific matter or a therapeutic area or therapeutic indication specific matter we moved into looking at it from you know the functional domain perspective. So we look at cognition, we looked at motor symptoms, we look at memory and these are basic fundamental functional domains at CNS for which then the downstream indications could be varied, so I think that approach has helped us and at the same time I think it's very important also to understand what the molecular target is at an early stage, because you know one of the other paradigms we prescribe to strongly is early intervention in disease, so we are targeting a set of patients that are relatively well constitutionally so it is important that the safety profile is absolutely a fairable one. So I think you know homing in on the molecular target at an early stage so then we can understand what the down streams effects would be that's very important to us.
Fintan Walton:
And it's important because obviously within the areas of CNS the failure, drug failure rate is much higher than other areas simply because the reproducibility all the way through into clinical is difficult to achieve?
Shafique Virani:
Absolutely, trial design is challenging, the outcome measures are constantly been redefined you know we always asking ourselves the question are we measuring the right effect in the right type of patient be it functional effects, be it biomarker effects and those all have implications in terms of how we design our early stage trials perhaps using some of the surrogate markers by then also how that translates into late stage clinical trial design.
Partnering strategy and prioritisations
Fintan Walton:
Right, so when we translate that into your partnering strategy so what types again going back to that original question what types of companies you are looking at? Are you looking at companies that are bringing in really novel ideas around a potential therapy others maybe just bringing in ideas about better understanding the disease and you may want to partner with them or they may be coming up with new ways to measure the symptoms of particular disease, so what's your partnering strategy and how do you prioritize that?
Shafique Virani:
Yes, there is a big focus for innovation and by innovation usually we look at targets that are poorly understood today novel targets that come up, but at the same time I think we are also cognizant of the fact that knowledge of the path of physiology of the disease progresses, so I think we will be ill-advised not to keep tabs on the understanding of the disease itself and that often leads to the reverse cycle of then trying to revisit the molecular pathways and seeing exactly which pathway may be involved, I mean the classical example is one of the recent deals we did literally last week which was announced with ReMynd [PharmaDeals ID = 37353] a company in Belgium, which is a very exciting approach we feel in a different way to look at Alzheimer's and Parkinson"s disease. So here traditionally we've looked at proteins in the brain, we've looked at the amyloid plaques, we've looked at tau tangles and really what we are doing here with this particular science is taking a step back and looking at how proteins misfold and how they are cleared. In addition to that what are the downstreams some of the downstream toxic effects in this proteins, so that gives us another very distinct approach towards disease modification in these two devastating diseases.
Importance of deal with ReMynd for Roche
Fintan Walton:
Right, so even a company ReMynd is a spin out company from the university very early stage company?
Shafique Virani:
That's right.
Fintan Walton:
And you are partnering with that type of company, so you"ve just started to describe what that deal is about and when we read the headlines it's big money involved could you just give us some little bit more insight into that deal and why it's important to Roche?
Shafique Virani:
Okay, ReMynd have done some amazing work to-date in understanding how proteins misfold in the brain and what's some of the possible clearance mechanisms might be and what the downstream toxic effects are. This company uses a technology that utilizes gene deletion libraries and then validates it in neuronal stem, neuronal cell lines. So as I said this gives us a very unique and different approach from what we have traditionally worked on, so if we look at the Alzheimers landscape for example today we know there is antibody programs, passive immunization programs, there is active immunization programs there are programs that trying to tackle the enzymatic casket with gamma secretase with beta secretase which all are fine and to be honest the whole high pothesis needs validation and I think there is enough commentary in the press about that, but at the same time I think it's also important to continue building on our understanding of what exactly happens to these proteins in the brain, you know today till today we still have no validation between presence of plaque for example and cognition until some of the key Phase III programs read out it we won"t get that sense of comfort, so I think we've got to keep on taking steps back and really try and understand this basic mechanisms, so the collaboration is early very much in keeping with our strategy that in areas of key focus to us we will look at programs that are early stage. So here this collaboration is very much about ReMynd continuing to do the excellent preclinical pharmacological profiling that that they are doing with libraries and where Roche will add value in competence is in the optimization process. So we will add in medicinal chemistry resources and really undertake that whole drug optimization process forward, hope is that you know we will have the first compound in clinical full in the 2012, 2013 timeframe.
Fintan Walton:
Right, so it sets a platform from which new drugs can be identified?
Shafique Virani:
Absolutely.
Fintan Walton:
At the same time understanding the potential mechanisms of the disease?
Shafique Virani:
Absolutely and also understanding some potentially novel targets as well that may M&A from that. And I think you know what's interesting about this particular program moving forward is that it also gives us a unique opportunity to understand Parkinson"s disease, we haven"t really talked much about Parkinson"s disease, but all the recent data on the role of synuclein and Alpha-synuclein in Parkinson's disease it is very little biomarker validation done compared to what's been done with beta-amyloid for example or the beta. So I think that's an area that we very excited about , we'll potentially will be in a situation of this collaboration to really lead the way in understanding the changes of Alpha-synuclein in some of the CNS compartments such as CSF for example.
Drivers and preferences for M&A
Fintan Walton:
Right, you've also mentioned in the beginning that M&A is on your within your agenda going forward?
Shafique Virani:
Thats right.
Fintan Walton:
Now clearly that would be that's a bigger decision, it's much more about I suppose high risk use of money for the company, so the concept of doing an M&A would be for a company that's already got a reasonable number of products or a significant platform, what would be the basis in other words of your decision to do an M&A?
Shafique Virani:
Sure and within my group within the CNS group again I think we have to really try and identify company that has a portfolio of interesting assets. So you know the primary driver from my group would be a very exciting novel CNS platform for example of compounds or also of products for that matter, clearly within the whole Roche Partnering Group you know there is a dedicated group that looks at M&A on a broader scale, but again for CNS there would be two things would need to happen, one the company needs to have a similar approach, similar belief in quality science and at the same time also have the company ideally should be working in the areas where that are of strategic interest to us as well, I think that fit needs to be there. On the other hand within CNS there are other areas such as pain , anxiety, depression et cetera, it's not to say that we have closed the doors on these programs we felt we feel that the need is relatively well met out there in the market, so we are clearly interested in evaluating these programs, but our preference is really to see to look for clinical signal first, so typically we would look at those programs after Phase II proof of concept data. So it's not to shut the door on them on opportunistic partners as such.
Shafique Virani Perspective :Opportunities for CNS deals and future of Biotech
Fintan Walton:
Just one another area that I want to cover is the current situation with biotech and so forth from your perspective are there still enough opportunities out there for you to do deals, are there enough companies being well funded so that they can mature their technology or mature their products so they become of interest to Roche or are do you have a concern about that future?
Shafique Virani:
There is an element of concern, because I think CNS as we touched before is an area that's been viewed as being traditionally difficult, the development pathway is challenging. Some of the specifics related to CNS for example the high placebo response in psychiatry trial you often see a 30 to 40% placebo response, the difficulty in designing the correct outcome measures in identifying the correct patient pool in which to test these drugs. So I think when we look at grass root level investment for example from the venture community you know typically it's CNS is deemed as a risky area, at the same time I think there is a dedicated group of companies, academic institutions and also major pharma who have still got programs progressing within CNS, because it comes back to the point the unmet need is absolutely huge. So we are excited that the science is progressing very quickly and there is a lot of good work been done in companies at the early stage and which we are following very closely and as soon as you know we get some evidence of proof of mechanism data or evidence of drug ability then clearly we are very keen to talk to these groups sooner rather than later.
Fintan Walton:
Shafique Virani, thank you very much indeed for coming on the show.
Shafique Virani:
Thank you very much Fintan Walton, it was a pleasure.
Fintan Walton
Dr Fintan Walton is the Founder and CEO of PharmaVentures . After completing his doctoral research on the genetics of cell proliferation at the University of Michigan(US)and Trinity College (Dublin, Ireland), Dr Walton gained broad commercial experience in biotechnology in management positions at Bass and Celltech plc (1982-1992).
Shafique Virani
Global Head
As Head of CNS Partnering, Shafique Virani leads Roche's search for external innovation in the Central Nervous System disease area. His team is responsible for driving forward the CNS deals that hold the most promise for patients and their careers coping with devastating diseases such as Alzheimer's, Parkinson's and schizophrenia. Having been Director of Global Business Development for CNS in Nutley since 2006, Shafique has played a leading role in many CNS partnering evaluations, including platform technologies, research agreements, as well as product licensing and M&As. Shafique joined Roche Welwyn in 2004 and worked as Senior Medical Advisor for the hepatitis franchise, where he was recognised with several awards for his contribution to the business in the UK. His commercial career began in 2002 at PPD Development in Cambridge, UK, where he was a consultant for neuroscience development. Prior to that Shafique Virani's medical experience was in neurosurgery, which was gained from 1994 at Addenbrooke's Hospital, University of Cambridge, UK, and Massachusetts General Hospital, Harvard Medical School, USA. He has a medical degree from the University of Nottingham Medical School, UK, and is a Fellow of the Royal College of Surgeons in England.
PharmaVentures
PharmaVentures is a corporate finance and transactions advisory firm that has served hundreds of clients worldwide in relation to their strategic deal making in the pharmaceutical, life science and healthcare sectors. Our key offerings include: Transactions / deal negotiations; Product / technology valuations; Deal term advice; Due diligence & expert reports; Strategy formulation; Alliance management; and Expert opinion for litigation/arbitration cases. PharmaVentures provides the global expertise to ensure our clients generate the highest possible return on investment from all their deal making activities. We have experience of all therapeutic areas and can offer advice on both product and technology commercialisation.
F. Hoffmann La Roche Ltd
The F. Hoffmann La Roche Ltd is a Swiss global health-care company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel and the company has many sites around the world including: Nutley, NJ, Palo Alto, California, Pleasanton, Branchburg, Fishers, Indiana, Florence, South Carolina, Boulder, Colorado and Ponce, Puerto Rico in the US, Welwyn Garden City and Burgess Hill in the UK, Clarecastle in Ireland, Mannheim and Penzberg in Germany, and Shanghai in China. The company also owns the American biotechnology company Genentech, which is a wholly owned subsidiary, and the Japanese biotechnology company Chugai Pharmaceuticals.