PharmaTelevision - Great Science Driving New Medication. Roche-Genentech: Joe McCracken & James Sabry

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Video title: Great Science Driving New Medication. Roche-Genentech: Joe McCracken & James Sabry

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In this episode of PharmaTelevision News Review, Fintan Walton talks to Joe McCracken, Global Head, Business Development & Licensing, Roche and James Sabry, Vice President Genentech Partnering.

Roche's colloboration with Merck in the area of Hepatitis C

Fintan Walton:

Hello and welcome to PharmaTelevision News Review here in London. On this show I have two gentlemen from the Roche Group James Sabry who is Vice President in Genentech Partnering and Joe MCCracken who is Global Head of Business Development & Licensing at Roche based in Nutley New Jersey, welcome to you both.

James Sabry :

Thank you. Pleasure to be here.

Joe Mccracken :

Thanks for inviting us.

Fintan Walton:

We often talk you've been both have been on PharmaTelevision and we have talked about the merger of Genentech with Roche [PharmaDeals ID = 30853] and I think most people are familiar with that and I suppose one of the things Joe is you are ex Genentech guy now you are firmly within the Roche Group holding a very important position. But let's just today explore what's happened to Roche over the last year because I think there are number of landmark events that took place with I think describes the shape and the strategy of Roche's intentions going forward. So let's just look at one area in particular which is the area of Hepatitis C again this is a disease area that has great unmet clinical need and this is where I suppose Joe where Roche have gone into a collaboration with another major company, could you tell us a little bit about the collaboration first of all.

Joe Mccracken :

So this is a collaboration it's a commercial collaboration with Merck and this is to co-promote or work together in promoting the Boceprevir from Merck [PharmaDeals ID = 42013] and [PharmaDeals ID = 40819] and our Pegasys so they are approved for their use together and just then opportunity for us to leverage our respective strengths in the market place to make these products available to patients.

Fintan Walton:

Right and again this is a combination of products?

Joe Mccracken :

Well the two products are approved for your service the protease inhibitor is approved for use in combination with pegylated interferon and we produce pegylated interferon they produce the protease inhibitor and we collaborate in making this product available and information available to physicians.

Significance of acquisition of Anadys Pharmaceuticals

Fintan Walton:

Okay now the other component to Hepatitis C story which happened last year is the acquisition of Anadys Pharmaceuticals [PharmaDeals ID = 43574], could you tell us a little about that as well and why that is important to the Hepatitis C story?

Joe Mccracken :

So I think looking ahead I think that almost everyone in the field agrees now and may be this wasn't the case a year ago that this field is really evolving towards the use of combinations of direct acting agents and most likely in without the use of interferons. I think that offers great patient benefits what exactly are the best combinations I don't think is clear to anyone it may be several years of clinical use before we really know but if you want to be serious in this field I think you have to have a portfolio of direct acting agents against different targets so that you can explore synergies and then offer the best combination therapies for patients and it may vary from patient to patient depending upon either the patients genomic signature or the viral signatures.

Strategy on personalised medicines

Fintan Walton:

Okay so that really brings us on to the personalized medicine story and I suppose James you know Genentech has always been a scientifically based organization, its origins are very much firmly in that area well I suppose one of the common themes that overall Roche strategy is this personalized medicines and I suppose one example of that is the area of Melanoma and the drug that has been now approved in both USA and Europe, do you want to tell us a little bit about that and the strategy.

James Sabry :

Yes so the strategy of using the companion diagnostics to molecularly define a subset of patients that are most likely going to respond to drugs is a key part of the Roche strategy Fintan, obviously Genentech has historically been part of this Herceptin [PharmaDeals ID = 2910] which really is the first molecularly defined new targeted agent for the treatment of cancer but now with the fusion of these two companies and the bringing of Genentech under a group that includes the largest diagnostics company in the world the Roche Diagnostics really allows us to accelerate the development of companion diagnostics with new therapeutics and as you point out Zelboraf a BRAF inhibitor was a great example of this. This is a drug that is a very effective drug for patients with metastatic melanoma who have a specific mutation the V600E mutation and the drug was approved of the same day of the diagnostic test that Roche runs through its diagnostic division for that mutation so patients with the mutation when given Zelboraf actually have a dramatic response to the agent. I think you gonna see much more of this where drugs are targeted to specific individual patients with a molecular signature being required for the drug use being part of the label for the drug.

Erivedge: scientific basis and treatments

Fintan Walton:

And of course Roche's attempt to acquire Illumina [PharmaDeals ID = 45002] is another dimension to Roche intent going forward but may be going back to the science again another product that's been launched is the Hedgehog inhibitor pathway product called Erivedge I understand that's been just launched recently that's got a scientific basis so what is the approach there and why is this going to be a success?

James Sabry :

Its exactly another story where great science is driving a new medication so in the case of Erivedge which is an inhibitor of a protein called Smoothened in the hedgehog pathway it was known through work that was actually carried out both in academic roles and (indiscernable) lab at Genentech that this pathway is unusually activated in most patients with basal cell carcinoma and a specific type of inherited syndrome called Gorlin syndrome which basal cell carcinoma is part of what they have so we went ahead and developed our first small molecule inhibitor and it was an inhibitor of the smoothened protein in this pathway and it turns out to be extremely effective in the treatment of basal cell carcinoma not something that commercially you may go after immediately but in this case the science was so compelling that allowed us to develop an agent that is highly effective and it moved very quickly through development and was approved just last week by the FDA for treatment of patients with either unresectable locally invasive basal cell carcinoma or metastatic basal cell carcinoma.

Fintan Walton:

And you can actually see these shrinkage?

James Sabry :

Its dramatic and these are patients that some of them who have hundreds of tumors and the stories that we are hearing from the clinic are just remarkable.

Colloboration with PTC and SMA Foundation foundaton in spinal muscular atrophy.

Fintan Walton:

So Joe again on the theme of targeted looking at very specific diseases the other story that happened over the last year is the collaboration of PTC [PharmaDeals ID = 44261] and in the area of spinal muscular atrophy. Could you tell us a bit about that story and strategy there?

Joe Mccracken :

I think the strategy is really the same I mean this is a terrible terrible disease and the biology is extremely well understood PTC in collaboration with the SMA Foundation [PharmaDeals ID = 29172] and our agreement is really in collaboration as a tripartite agreement with the Disease foundation, with PTC [PharmaDeals ID = 44261] and with the Roche Group together we've worked to understand the basic biology it's very clear and we have a product candidate that actually works on the specific to alter the specific molecular disregulation and at least in the animal models provides tremendous compelling benefits so it's a very much a biology driven project just like the project that James just mentioned the biology is well understood, it's a serious disease there is not an effective treatment we love projects like that and really are proud to be associated with them.

Types and colloboration activities with academia

Fintan Walton:

Right and of course it's also driven by the SMA Foundation as well which has put lot of money into the science behind that and I suppose the next thing I would like to talk about we are really on the science subject here and the other thing I would like to discuss may be back to you James is the type of collaborations you are doing with academia and may be you can give us some examples of some of the activities that you have been involved in.

James Sabry :

Well I would say that most of the underlying foundation of science for drug development these days originates in academic labs and as such having a dialogue with those academic labs is an important part of the Genentech and Roche strategy Fintan. We have a series of partnerships with whole group of academics worldwide on a project by project basis. We number of years ago created a master agreement with UCFS [PharmaDeals ID = 35660] a nearby academic center well actually the academic center from which Genentech was originally birthed for specific laboratory relationships there we believe that having strong relationships with academic is an important part our strategy going forward.

Fintan Walton:

Okay now you've also not just only in the United States but also in Europe there is also a new translational research center set up in Zurich which is going to look at the whole area of RNA in the disease and metabolism, well Joe make some comments on that.

Joe Mccracken :

Just that we have translational medicine centers in France in Holland and in Switzerland, Singapore really all over the world we have established collaborations that leverage the unique strengths of the academic institutions they are all little bit different they are all built for special purpose as opposed to a template that apply in different places they are all little bit different one that we have done most recently is somewhat unique and that's in China and China has as everyone knows tremendous capabilities for medicinal chemistry drug development tremendous human resources there that can be applied to projects but some of the biology is still evolving and what we did was we took a project from Harvard University and together with Harvard University we took a project that had very sound and interesting biology and actually moved out to China and we placed it in the hands of a consortium that involved an economic development agency academic institution and then Harvard and Roche [PharmaDeals ID = 34871] and some contract research organizations where we will all work together to really advance the biology and to advance the discovery and development of products that could be important in a number of diseases.

Fintan Walton:

So it comes back to this theme that you need to be creative in the way you think about collaboration when obviously the issue for lot of biotechnology companies is financing still there some great biotechnology companies getting funding others are struggling so how important then are these academic relationships are they becoming more important to Roche as a result of this?

James Sabry :

I think they have always been important to Genentech and Roche they are increasing in importance to the extent that the science in academia isn't getting out of academia into biotech companies because of the contracted amount of venture capital and so giving thus an environment that's reality right now they are growing in importance to us.

Fintan Walton:

Well James and Joe thank you very much indeed for coming on the show.

James Sabry :

Thank you.

Joe Mccracken :

Thanks for inviting us.

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).

Joe Mccracken

Global Head

At the time of this PTV interview, Joe Mccracken serves as the Global Head for Business Development & Licensing for Roche Pharma Partnering. In this role Dr. McCracken is responsible for Roche Pharma's in-licensing and out-licensing activities, and he is currently based in Nutley, New Jersey. Prior to joining the Roche Pharma Partnering organization, Dr. McCracken held the position of Vice President, Business Development at Genentech for more than 10 years. At Genentech Joe was responsible for all business development activities at the Company, including the identification and negotiation of collaboration and licensing agreements with academic institutions, biotechnology companies and pharmaceutical companies throughout the world. Dr. McCracken returned to Genentech in 2000 after a seven-year absence, during which he held positions as President of Technology Licensing and Alliances at Aventis, and Vice President of Worldwide Business and Technology Development at Rhone-Poulenc Rorer S.A During his earlier time with Genentech, Dr. McCracken served in many capacities, culminating in positions as Director of Business Development and Representative Director of Genentech Ltd, Genentech's wholly owned subsidiary in Japan. Dr. McCracken has more than 25 years of experience in technical, business development and market development roles with biotechnology and pharmaceutical companies. He holds a Bachelor of Science in Microbiology, a Master of Science in Pharmacology and a Doctorate of Veterinary Medicine from The Ohio State University.

James Sabry

Vice President

At the time of recording this PTV interview James Sabry serves as Vice President, Genentech Partnering. Dr. James Sabry , MD, PhD., has been the Chief Executive Officer and President of Arete Therapeutics Inc since July 2008. Dr. Sabry co-founded Cytokinetics, Incorporated, in August 1997 and has been its Consultant since April 1, 2008. He serves as Vice President of Partnering at Genentech Inc. He has a wealth of drug discovery, development, and biotechnology management experience. Dr. Sabry served as the Chief Executive Officer of Cytokinetics, Incorporated, from August 1997 to January 2006 and also as its President from August 1997 to February 2006. He has been the Chairman of Scientific Advisory Board at Cytokinetics, Incorporated, since April 1, 2008. Dr. Sabry served as an Executive Chairman of Cytokinetics, Incorporated, from January 22, 2007 to March 31, 2008 and also served as its Chairman from April 1, 2008 to March 16, 2010. He is a Member of Dean's Council of the Kennedy School of Government at Harvard University. He serves as a Director of HopeLab and Arete Therapeutics Inc He served as an Executive Director of Cytokinetics, Incorporated from August 1997 to March 16, 2010. He serves as a Member of Advisory Boards of California Institute of Quantitative Biosciences. He held faculty positions at the University of California, San Francisco, from 1989 to 1998 and Harvard Medical School from 1984 to 1987. Dr. Sabry received a M.D. from Queen's University and a PhD in Cell Biology from the University of California, San Francisco.

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.

Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2010, Roche had over 80'000 employees worldwide and invested over 9 billion Swiss francs in R&D. The Group posted sales of 47.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan.

Genentech

Considered the founder of the biotechnology industry, Genentech has been delivering on the promise of biotechnology for more than 35 years, using human genetic information to discover, develop, manufacture and commercialize medicines to treat patients with serious or life-threatening medical conditions. Today, Genentech is among the world's leading biotech companies, with multiple products on the market and a promising development pipeline. In March 2009, Genentech became a member of the Roche Group. As part of their merger agreement, Roche and Genentech combined their pharmaceutical operations in the United States. Genentech's South San Francisco campus now serves as the headquarters for Roche pharmaceutical operations in the United States. Genentech Research and Early Development operates as an independent center within Roche.