Innovacell: Ekkehart Steinhuber. Developing personalized, cell-based therapies




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Video title: Innovacell: Ekkehart Steinhuber. Developing personalized, cell-based therapies
Released on: January 14, 2013. © PharmaTelevision Ltd
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In this episode of PharmaTelevision News Review, filmed at BioEurope 2012 in Hamburg, Germany, Fintan Walton talks to Ekkehart Steinhuber, CEO at Innovacell
Origin of the Innovacell Biotechnologie's business
Fintan Walton:
Hello and welcome to PharmaTelevision News Review here at BioEurope, in Hamburg, in 2012. On this show I have Ekkehart Steinhuber, who is CEO of a company called Innovacell Biotechnologie which is based in Innsbruck, in Austria. Welcome.
Ekkehart Steinhuber:
Good morning.
Fintan Walton:
Good morning to you. Ekkehart, Innovacell is a I suppose a very novel company, it was founded back in 2000, could you tell us a little bit about the origins of the business?
Ekkehart Steinhuber:
The Company actually was founded by three scientists of the University Hospital of Innsbruck. It was a pharmacist, and a biologist and a medical doctor, and actually the pharmacist was capable of doing the cell expansion in vitro, and the biologist then managed to scale up the process so that it could be industrially used, and the medical doctor he had the idea where to use these cells and him being an urologist here his first product idea was that it's used for the treatment of stress urinary incontinence in women, so it's in the seven major markets we have got about 40 million women suffering from stress urinary incontinence and a part of it could be treated with this technology.
Innovacell's key technology platform and product concept
Fintan Walton:
Right, so the key thing here of course is the technology, because there is a combination of innovations that surround the whole approach that your company takes, so could you tell us a little bit more detail on how the, what sort of a therapeutic approach you've taken to try and actually cure stress urinary incontinence?
Ekkehart Steinhuber:
Yes, as of the technology is made up of two elements, one is the medicinal product and the other one is the device, and it's regenerative medicine, so what it works that we take a biopsy actually here from either the upper arm or from here the biopsy has got the size of about 5/5 millimeters, then this biopsy is shipped in containers to our manufacturing facility. We isolate from this biopsy the progenitor cells, progenitor cells through the myoblast and then we expand them in under sterile conditions, highly sterile condition, the expansion takes about 16 days on average, plus or minus two days, and then we harvest the cells and we cryopreserve them in nitrogen, and then we do all the quality testing which takes about three weeks, so we do sterility testing, we do viral testing, we do both in CSA testing so there is quite a test battery on the cells. And then after five weeks the product is actually ready for injection and we, the cells, the cell suspension, we cryopreserve this, then shipped in a dry shipper, these are standard containers filled with the nitrogen in the evaporated phase, and we ship in these containers to the hospitals. In the hospital the cell suspension is taken out of the container and then it takes about five minutes to thaw and then the product is actually ready for use, so you add one ml of sterile water, you constitute it and then the suspension is ready for injection. The muscle on the urethra is a tiny little muscle which is about 12 millimeters long and has got the wall thickness of about 2 millimeters, so by standard endoscopic method it's for the physician extremely challenging actually to get the cell suspension into the target tissue and therefore we have developed ourselves an ultrasound guided injection device which makes sure that the physician when he is doing the injection actually sees the urethra on the TV screen so he actually knows exactly whether he is in the target area for the injection and he also sees the wall thickness of the urethra on the TV screen so he can do an very precise injection into the target tissue, and actually we do ten injections in one round, so it's tiny little depose of about 100 microlitres, 100 microlitres we start injecting at the 7 o'clock position and then we go around to the 5 o'clock position to do this 10 injections, then we pull back about 5 millimeters and then we do a second round of injection of this cell suspension. So the procedure is minimally invasive, it takes about 8 to 12 minutes, yes it depends on.
Fintan Walton:
Relatively quick?
Ekkehart Steinhuber:
It's very quick, it's very quick and then these injected cells actually integrate into the tissue into the sphincter and after six weeks you have a regeneration of the muscle tissue and the muscle is functional again.
Fintan Walton:
Right, so in terms of the patient the patient gets, she doesn't have to stay in hospital or anything it's a basically they are going to just turn up to hospital to get the treatment and go home?
Ekkehart Steinhuber:
Yes, so you can do that, you can do it like that in the clinical trial setting of course, we keep the patients overnight.
Fintan Walton:
Of course you keep them for observation?
Ekkehart Steinhuber:
Exactly for observational purpose, but you could do this also in an outpatient procedure also that you bring the patient in, you treat them, and after treatment they can leave, yes.
Overview of Innovacell's medical device development strategies
Fintan Walton:
Now the key thing here in what you've described is that there are basically three components to this I would say, if I suggest one is obviously the cell element, taking the cells and been able to grow those cells, which is basically an autologous system, and then the other bit is the obviously the device itself, the skill of the device, and presumably you've got patents in intellectual property both around both those types of procedures, then finally you have to have the skilled surgeon who can then actually do the actual procedure itself. So Ekkehart in terms of, where you are in terms of developing this particular device and procedure could you tell us where you are now?
Ekkehart Steinhuber:
We are currently in the Phase III for the first product, for the ICES13, we started recruiting in May this year and we expect that we will be able to finish recruiting towards the end of first quarter next year or beginning second quarter, then we do an interim analysis three months after the last patient in, so this most probably will take place in the third quarter next year, and in October the same year we will submit at the EMEA for approval of the product.
Fintan Walton:
Right, so all the clinical trials are focused in Europe at the moment?
Ekkehart Steinhuber:
Yes, all of them, yes.
Fintan Walton:
Right, and the type of approval you are getting is, presumably you have get approval for both the device and the procedure itself, is that correct?
Ekkehart Steinhuber:
The device is not part of the product, so the device on which we have the IP is a separate product which is CE marked, and then you have to get the medicinal part, so in the registration these are two different parts.
Production and logistics strategies of Innovacell
Fintan Walton:
I understand, yes. Now in terms of the device itself presumably you are manufacturing that yourselves or what is the business model for that?
Ekkehart Steinhuber:
And so we have got an Austrian company which is manufacturing this device for us, it was developed by us they manufacture it and it is a single use device.
Fintan Walton:
Okay.
Ekkehart Steinhuber:
Yes, it's a single use device, which is actually also part of the product solution which we supply to the clinics there, so they get the cell suspension and they get the medical device for the injection.
Fintan Walton:
Right, so just looking at it from a business perspective, in the future when this product is available, this therapy is available, the model is that specialist doctors who are treating the patients with stress related urinary incontinence, stress urinary incontinence, will be able to get this device and learn how to use it and how to use the procedure, but presumably also there is an element of service behind this as well, because obviously the cells have to be taken from the patient and they have to be sent back to the laboratory, is that correct?
Ekkehart Steinhuber:
Yes, that's absolutely correct. So there you have got three elements in it, you have got the logistics element in it, which because we take the biopsy, the biopsy needs to be shipped within the time window of 48 hours and we can manage to get biopsies from places as far as Australia, which is really at the end, at the end and to get them within this 48 hours to our manufacturing facility and then the product is shipped when it's ready for use, so these are our standard cryo containers and in this cryopreserved containers the product is stable for two weeks and this is an enormous advantage, because it gives you the flexibility when you do the implantation, because when you ship a product here the you have got, may be weather conditions where the truck is not on time there, you can have the patient has gone is sick, the operation theatre is not available, so you can have all problems you can think of and when you ship live cells here you have also to do the implantation within this 48 hours, and we cryopreserve the live cells and therefore we have got the quite a long period and we can do within these 14 days at one of these days the implantation, so this is de-stressing the logistics enormously.
Fintan Walton:
So basically it's got, you've got the appropriate technology around the frozen cells?
Ekkehart Steinhuber:
Exactly.
Strategies and business model for product commercialization
Fintan Walton:
That allows you to ultimately allow for some error that will potentially come into any sort of procedure there in terms of logistics. And so Ekkehart you are also then at this stage looking for suitable commercialization partners, so what's in your, how does that work in terms of your own business model?
Ekkehart Steinhuber:
So our business model is a E2B business model, and so this procedure will be done by specialized clinics, and the reason behind is that it's tissue which we are taking and treating, and reimplanting, so you have to comply with the European regulations on tissue manipulation, and this is a separate license and in order to qualify for this license you need to have a lot of procedures in place, and therefore most probably it will be only those clinics which anyway focus on treatment of patients which are suffering from urinary incontinence, usually you have got specialist centers, for example in Germany, or in France, or in UK, you have got in each of these countries about 50 clinics which specialize on these ones and therefore to cover a market in Europe, the five key markets which is Germany, UK, France, Italy, and Spain, you need about 40 to 50 key account managers calling on these centers there. So in Europe we are going to do this product marketing, we are going to market our product ourselves and we are looking for license partners for the US and Japan.
Fintan Walton:
Excellent, okay. So then obviously there is, the other element of this is the faecal incontinence as well, because this application can be adapted to that as well?
Ekkehart Steinhuber:
Yes, so faecal incontinence is the second product which we develop. Faecal incontinence is actually more frequent than we assume, so you have got in the seven key markets worldwide you have got about 200,000 new patients for which our treatment would be the treatment of choice, and with this product we are currently in the Phase II and we expect to have the approvals to start after the final amendment, which were requested by the different authorities in Europe, we are going to, we expect to start with the clinical trial in the first quarter of next year.
Future prospects of Innovacell
Fintan Walton:
Okay, and then so looking into the future, the key milestones that you see happening now Ekkehart over the next few years?
Ekkehart Steinhuber:
So the first key milestone are this three months data of our product for treating of stress urinary incontinence and this will be in the third quarter of next year. And then the next milestone is how do the twelve months data look, and then the final milestone is the approval in the European Union, which we expect to happen towards the end of 2014, 2015, so this are the near term milestones, and then we at the same time as we are submitting now for approval of our clinical trials in the US. So we have submitted for the Pre-IND meeting, Pre-IND meeting will take place January, February next year and we expect that we will get an approval for the clinical trial in the US also in the third quarter of 2013.
Fintan Walton:
Ekkehart Steinhuber, thank you very much indeed for coming on the show.
Ekkehart Steinhuber:
It was my 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).
Ekkehart Steinhuber
Chief Executive Officer
At the time of this PTV interview Ekkehart Steinhuber serves as Chief Executive Officer at Innovacell Biotechnologie. Dr. Ekkehart Steinhuber has been the CEO of Innovacell AG since 2007. He spent 25 years at Sandoz at the executive and senior management level. His recent roles were CEO Hungary; Global Co-ordinator, Pandemic Preparedness; Divisional Director of Pharmaceuticals, responsible for development, production, logistics and quality assurance in Austria; and CEO at Sandoz Representative Office in Vietnam. Dr. Steinhuberearned his Ph.D. in business administration and studied at the universities of Innsbruck and Vienna.
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 commercialization.
Innovacell Biotechnologie
Innovacell Biotechnologie AG is an innovative biotechnology company that develops personalized cell therapies for treatment of ?incontinence.? Innovacell is running multinational clinical trials for its two 'tissue-engineered' products in development, ICES13 and ICEF15. Using Innovacell's innovative 'ultrasound-guided' injector, patients benefit from a minimally invasive surgery. More than 500 patients have been treated since 2002.