Rentschler Biotechnologie: Klaus B. Schoepe




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Video title: Rentschler Biotechnologie: Klaus B. Schoepe
Released on: March 16, 2011. © PharmaTelevision Ltd
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In this episode of PharmaTelevision News Review, Fintan Walton talks to Klaus B. Schoepe, Senior Vice President Client Relations at Rentschler Biotechnologie
History of Rentschler Biotechnologie
Fintan Walton:
Hello and welcome to PharmaTelevision News Review here in Munich at BIO-Europe 2010. On this show I have Klaus B. Schoepe , who is Senior Vice President of Client Relations at Rentschler Biotechnologie.
Klaus B. Schoepe :
Happy to be here.
Fintan Walton:
Klaus, Rentschler is now quite a famous company it's very well known as a company involved in manufacturing biologics particularly, but could you tell us just little bit about the history of Rentschler and how it developed over the years, because it's quite an old company?
Klaus B. Schoepe :
Indeed it is, I mean we were founded, you wouldn't believe this way back in 1927 obviously not as a biotech company, but as a traditional pharmaceutical company a local company founded by what was the grandfather of our current CEO together with his brother they developed the idea of producing medicines on an industrial level and came out with variety of what you would call today over the counter drugs which they produced and the company has been involved into all sorts of different areas after the war we were to some extend involved in vaccines and animal vaccines and out of that developed the idea in the 70's to get into interferons which was really the foundation of Rentschler Biotechnologie or Biotechnology as it is today and so we then had for more than 20-years history of interferon developments. We were the first company that ever got an interferon product approved worldwide in Germany and that was developed by made by Recombinant DNA technology but by cell culture of human cells which were induced to produce interferon and then that interferon was harvested and purified the product is still on the market called Fiblaferon in Germany as it is licensed for viral infections. Well then in the late 90's we sort off were looking strategical view what to do with this business and then we developed the concept of no longer going after own proprietary products but to take our assets, take our knowledge and everything and offer that to third parties as a service and so since then we've been providing services to the biotech and biopharmaceutical industry and that has laid the foundation of a very nice growth path for the company at that time we were less than a 100 people now we are more than 600, our revenues have gone up to close to 88 million euro nowadays. So this been a very nice and constant growth organic growth all over the years with tremendous expansion, new facilities and a lot of commitment from our shareholders which is still is the Rentschler family basically to invest all sorts of money's into this business at the same time we divested all the other business lines including what was the foundation of Rentschler as a company including our OTC products which went away in 2006. So now a days we are 100% CMO, 100% service company for the biopharmaceutical industry and we think this is a very good business position and we like what we do.
Fintan Walton:
Right, so but what's interesting about that history is how the company has adapted over time to the various market opportunities, so it is followed in the sense the pharmaceutical industry itself obviously the importance of biologics way back even in the 70's were important.
Klaus B. Schoepe :
Correct.
Rentschler's advantages as a CMO in Biologics
Fintan Walton:
Identified that, so now clearly it has built up this reputation in the area of particularly biologics as a CMO, when well now of course in 2010 biologics are a very important part of the market pharmaceutical market and lots of pharmaceutical companies would like to have more biologics, what is the advantage for a pharmaceutical company or a biotech company to go to a company like Rentschler for it's manufacturing? What, why should they even consider it?
Klaus B. Schoepe :
Well I guess for some is they have no choice for some. The majority of our clients come from the small, middle biotech segment and those are companies that just don't have enough of a pipeline or a product portfolio to support own manufacturing infrastructure. So when it comes to GMP Manufacturing of proteins using the recombinant technologies and cell culture and in under GMP they are just completely dependent on a service provider that has the experience and the expertise to doing that, otherwise they would have to spend a lot of money you know for building up that infrastructure themselves it would set them back by many years, they would not be sure whether they can utilize the infrastructure that they are building up, so there would be left with the huge investments and the uncertainty of whether this would be utilized or not, not a smart business decision frankly. So it's much better to turn to somebody who has that infrastructure, who has the experience, who has the expertise and who can reliably and with a good track record provided such a company with the products in GMP quality.
Fintan Walton:
Right.
Klaus B. Schoepe :
And then of course there are the other companies we also have bigger companies and even what we would call big pharma on our client list, and those for those companies it is something that were just they sometimes just have bottlenecks and if they just wait you know until they have capacity themselves to deal with the project that would put the project behind if they can't handle themselves internally they go for outsourcing.
Rentschler's scope and ability in mammalian cells
Fintan Walton:
So when it comes to the business of Rentschler what is the scope of its ability, so I mean obviously you've got animal mammalian cell culture capability does that include microbial systems and so forth, so what is the scope?
Klaus B. Schoepe :
Right, okay we do not work with microbial systems we focus entirely on mammalian cells, but everything around mammalian cells starting from cell line development, process development, GMP manufacturing fill and finish formulation development, analytical service, ability studies pretty much everything that is in the CMC area we can provide as a one stop shop, if it comes to microbes we pass then this is not our business, but if it's the mammalian cells and 80, 90% is CHO based today that's really what we know well and what we can do.
Fintan Walton:
And the expression systems as you use are they proprietary to you or do you use other people expression system?
Klaus B. Schoepe :
We use our own expression system and then we also use other people's expression systems so we have a collaboration with Boehringer Ingelheim [PharmaDeals ID = 30341] so we've access to their BI-HEX system through that collaboration but we also have customers who team up with companies that provide cells expression systems and they license them in the use of the technology and then they come, we also run for example manufacturer protein that's based on the lonzaGS-System, so I mean all of these systems then of course the client has to make sure that they got the freedom to operate we don't have any licenses ourselves to into such systems.
Fintan Walton:
Right, okay so in another word it's reasonably you are reasonably flexible within what you can do with those?
Klaus B. Schoepe :
In fact we are very flexible.
Klaus B. Schoepe 's views: Changes in market in the area of Biologics
Fintan Walton:
Okay, you've also described how, you know you provide these services just beyond being a core CMO you are the analytical services and so forth, so from a Rentschler point of view how do you see the market changing, I mean the industry you know biologics as we just said you know is much more accepted their block buster drugs these days, so you know what sort of changes have you seen recently that tells you the world is changing and particularly in the area of biologics?
Klaus B. Schoepe :
Well I mean we obviously more and more companies the pharma traditional pharma companies that in the past were really focusing on small molecules half now turned to biologics, so there is more and more demand for products based on biologics biological products and they those products are not generated just through in-house discovery but a lot of these companies work through collaborations with small start-ups and that has created a whole industry of start-ups as you know and I mean those then there is more and more of those and more and more companies around products and those products then as I earlier said are really dependent and they want to get into the clinic they want to show the proof of concept for their molecule and for this they need product in GMP quality and for this they need a CMO, because they just don't have the experience I think to structure themselves.
Fintan Walton:
So you provide clinical materials?
Klaus B. Schoepe :
Yes, actually the majority of what we do is work for investigational medicinal products we have a couple of products that are in the market that we provide, but the majority is really for these investigational medicinal products and the demand is still increasing for those.
Biosimilar projects
Fintan Walton:
Right, and as we see the transformation of the industry obviously biotech companies are finding it more difficult to get funding these days, is has does that had an affect on your company?
Klaus B. Schoepe :
I mean not really I must say, I mean we've had constant demand for the type of services, because the pharmaceutical industry is in need for new products they I mean there will be patent expiries and the likes you know so they have to replace mature products by new products this is their they are in this they are trapped in this so if you want, and in-house discovery doesn't provide enough molecules so they go elsewhere and therefore I mean other companies are out there obviously the pharma companies and the investors have become more selective so not every business idea gets funded as was may be at the beginning of the decade, but good and sound business ideas with good well proven biology behind that still get fund don't have problems getting funded that's what we experienced.
Fintan Walton:
I am sure some companies may have asked you would you be prepared to take some of the risk in taking some of these products forward?
Klaus B. Schoepe :
Yes that question gets we get it comes up every once in a while.
Fintan Walton:
And what is the answer?
Klaus B. Schoepe :
The answer is no, we don't do that I mean this would mean that Rentschler apart from being a CMO would also become an investor and we don't have first of all we don't have the experience and the expertise to evaluating these opportunities and then finding out you know what would be a good return or whatever I mean we don't have the expertise in the pathology, we don't have the expertise in the disease area and we cannot really judge you know what is the probability of success of such a project. I mean what we deliver we know very well and we can control, but when it comes to the pharmacology to the disease (indiscernable) we will be pretty naive and we would need that expertise in order to relieve evaluate this opportunity, and then of course it to some extent it could also comprise our independence.
Fintan Walton:
Sure.
Klaus B. Schoepe :
I mean we are you know sometimes my project managers ask me Klaus, what are the top priority product projects? What are the low priority projects? And I say I can't tell you, for me all projects are of equal importance, because every customer is of equal importance, if we come to a situation where we have constraints and we have to make choices we will make decisions inevitably, but I am not slating a particular project as a low priority project right from the beginning because that would mean that this project always will suffer so and I really wanna be when I retain that independence I don't want to have you know stakes or vested interest in a particular project and if we were investing in one of them that would be the case, so I am really reluctant and we wanna stay away from that.
Fintan Walton:
Okay, so obviously most of the companies had come to are product with products which are innovative the whole area of biosimilars is the subject of a topic of interest?
Klaus B. Schoepe :
Yes, and we have no problems in we have already run several biosimilar projects for clients, we have no problems in doing that. We respect obviously confidentialities and there are always certain exclusivity arrangements that go together with that that's fine for the time as we perform work for a biosimilar molecule for one party we would not work for another party at the same time that's clear, but we also have no problems in doing such budgets and we have done some of them already.
Fintan Walton:
Right, so they have the equal priority to other projects that come through as well?
Klaus B. Schoepe :
Absolutely, yes.
Fintan Walton:
And do you see that as a growing part of your business?
Klaus B. Schoepe :
It will eventually come, I mean now there are some interesting products out there where the patents will expire and they've those products have are their lead blockbuster, so there is obviously an interest in coming with follow-on molecules. If you know things like personalized medicine or so will kick in then we will probably in the future have less of the blockbusters and so it will be more products that have a very specific market and not such a high volume then the question will be well can you still afford doing a biosimilar version of that particular molecules because it's completely different game to develop a biosimilar as opposed to developing a generic small molecule, I mean this is the investment is by far higher so it's only very few companies can afford that and the question is do we get back what you have to invest, so that's but that's further down the road for the time being I think there are some very interesting opportunities out there of company of products that will expire over the next six to eight-years and I am sure some big companies already working on those.
Does Rentschler extend services into solutions for formulational delivery?
Fintan Walton:
Yes, and the other issue of course because you are involved in producing proteins for companies one of the issues that they have to face is formulation delivery?
Klaus B. Schoepe :
Yes.
Fintan Walton:
So does your do your services extend into providing solutions for formulational delivery?
Klaus B. Schoepe :
To some extent, I mean we have recently builtup in-house expertise to at least be able to provide our customers with liquid formulations for proteins that are suitable for early state clinical development that's and the reasons for that being simply that we can expedite the development to that extent and we note that this doesn't end up on the critical path, so time to market, not time to market time to proof of concept is so important for most of our clients and we felt okay if we can do something else to speed this up then we will jump into that. We are not a drug delivery company, we are not a protein delivery company we've specialized if the client has special requirements for that we work with other companies as partners, we have a you know a good relationships to some of these companies that are active in this area and we are happy to refer our customer to such companies but we do fill and finish of liquid formulations and peripheral syringes we offer that as a regular service also as a standalone service.
Future plans
Fintan Walton:
Okay, so what's the future then, I mean for companies like yours obviously there is continued growth in the area of biologics where do you see your future growth?
Klaus B. Schoepe :
Well interestingly we're just at the point where we are having an internal discussion about that, and so the question on the table is will we be manufacturing proteins in 20-years down the road in 2027 Rentschler will become 100-years, right, so we have an internal project workshop 2027 to remind ourselves that this is not that far away. I personally will be retired by then, but that's not the problem. So this is indeed what we are looking at is this going in which direction this is going, is this going into vaccines, is it going into cell therapy, gene therapy so we are watching these developments very carefully and we will move try to move very quickly if any of these things technologies become so mature that it will be a significant demand for them in the marketplace that's definitely some of the things occur, we are looking at we haven't made any decisions yet, but we are carefully watching what's going on in the industry.
Fintan Walton:
Klaus B. Schoepe , thank you very much indeed for coming on the show.
Klaus B. Schoepe :
It was great, thanks a lot.
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).
Klaus B Schoepe
Senior Vice President
Dr. Klaus B. Schoepe , Senior Vice President Projects, Rentschler Biotechnologie, Germany. Klaus B. Schoepe studied Chemistry and Pharmacy in Berlin, Freiburg and Heidelberg. He is a licensed pharmacist and obtained a Dr. rer. nat. in Biochemistry at the German Cancer Research Center (Heidelberg, Germany). He started his career in the pharmaceutical industry with Boehringer Mannheim GmbH. He subsequently worked for Hoffmann La Roche AG (Basel, Switzerland), ASTA Medica AG (Frankfurt/Main, Germany which later became Baxter Oncology GmbH) and Merckle GmbH (Ulm, Germany). In 2005 he joined Rentschler Biotechnologie GmbH. In 2007 he was appointed to his current position with responsibility for Project Management, Regulatory Affairs and Quality Assurance.
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.
Rentschler Biotechnologie
Rentschler Biotechnologie GmbH is a global full-service contract manufacturer with more than 30 years experience in development, production and approval of biopharmaceuticals in compliance with international standards of good manufacturing practice (GMP, Good Manufacturing Practice). Rentschler Biotechnologie has nine independent GMP suites with volumes of 30, 50, 250, 500 and 2,500 liters to produce material for clinical trials (phase I to III) and for market supply. Rentschler also provides regulatory advice, protein analysis, quality control and the sterile filling of syringes and vials. The company employs about 500 people.