Promethera: Eric Halioua. Developing innovative treatment based on allogeneic adult stem cell technology




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Video title: Promethera: Eric Halioua. Developing innovative treatment based on allogeneic adult stem cell technology
Released on: December 19, 2012. © PharmaTelevision Ltd
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In this episode of PharmaTelevision News Review, filmed at BioPartnering Future Europe in Brussels, Fintan Walton talks to Eric Halioua, CEO of Promethera
Focus on cell based therapies
Fintan Walton:
Hello and welcome to PharmaTelevision News Review here at BioPartnering Future Europe, in Brussels. On this show I have Eric Halioua, who is CEO of a company called Promethera, based here in Belgium, welcome.
Eric Halioua:
Thank you, welcome Fintan.
Fintan Walton:
Look, your company is a very interesting company, it's a cell based therapy company?
Eric Halioua:
Yes.
Fintan Walton:
And cell based therapy companies are fascinating, fascinating for several reasons, one is it is one of the emerging areas for healthcare, for real a breakthrough in therapy, it's also a difficult space because it's obviously one that's not fully adopted yet, so first of all just let me know how did you found a company called Promethera and why did you focus on cell based therapies?
Eric Halioua:
Okay, so Promethera has been founded three-years ago in 2009, in Belgium as a spin-off of Universite Catholique de Louvain, it's one of the French speaking university based in Brussels, here in Belgium, and in fact I've been in contact with the founders of, the founder of the company, Professor Etienne Sokal ,during one of the due diligence we were conducting, and this company was really exciting, because the focus in orphan disease, ultra orphan disease and liver, you know because we are treating genetic disease of the liver using the stem cell, was something extremely promising and we have already some attractions from big interesting VC's based here in Belgium. So the story started in 2009 and we co-founded the company, we've the founder Professor Etienne Sokal, in February 2009. Then the company started to grow, we raised the first round of financing in October 2009. I was based, I should say I was based in US, so I joined the company in full time in April, in April 2009 and we succeeded to raise the first round of financing in October. So we moved from two persons to 46 now, so it has been a big growth that we have to sustain, because we decided to internalize the manufacturing, the GMP manufacturing of the cells, it was one of the key strategic decision that has been taken in the beginning of the foundation of the company.
Fundings from VC's
Fintan Walton:
Right, so let's just look then at there at the business, because obviously you in your first round of funding you managed to get what sort of fund behind you?
Eric Halioua:
Yes, we got 5.3 million Euros of VC backed money and at the top of that we get four, a bit more than 4 million Euros of grants and the refundable loan of from the Walloon Regions, the French speaking region here in Belgium. So it has been extremely important in the beginning to sustain the two, first two and a half years, first years of development of the company, so that's, we got this money in October, 2009 and after that in March this year we got the second round of financing and we have been able to get the approval for the clinical trials Phase I,II in Belgium, France, and UK for our stem cells to treat the genetic disease and we got 23.6 million Euros of B round of financing in end of March, and out of this 23.6 million Euros we have 17 in capital, in VC backed money, and 6.6 again of refundable loan from the Walloon Regions.
Fintan Walton:
Right, so just to be clear then just on the fundings, we will come on to the science and clinical element of this, your funding comes from traditional VC's, you've also got Boehringer Ingelheim Venture Fund, you've got Shire involved, so you've got a mixture of financing into your business?
Eric Halioua:
That's right, yes in fact in the beginning we get mainly local investor, some business angels, and Vesalius Biocapital, with purely biotech VC focused, the scope being Belgium, France, et cetera. Second round of financing we had a level of interesting new investors, two corporate VC, what we call corporate VC Shire, the strategic investment vehicle of Shire, and there is a lot of synergy between the activity of Shire and what we do, and Boehringer Ingelheim Venture the giant pharmaceutical German, from German origin, but at the top of that we get two of our very interesting investors, Mitsui, a Japanese investor, Mitsui Global Investments that to enter, and ATMI, ATMI is a US company developing bioreactors, you know they work to develop bioreactor for the manufacturing of cells and stem cells, and we have a R&D collaboration with them and we decided to enter into capital of the company, so it's a nice mix.
Science and technology of HepaStem
Fintan Walton:
Okay, I will come back to some of the funding, because it's just fascinating the mix of funding you've got, let's just go into the science, because you've got this the underlying science as I understand it is a HepaStem is that correct?
Eric Halioua:
It is.
Fintan Walton:
Yes, could you tell us what is HepaStem and what makes it so valuable to that investors who are prepared to put money behind it?
Eric Halioua:
Okay, so just let's talk about unmet need today and the patients we are treating are patients that have genetic disease affecting hepatocyte, which is a specific cells of the liver, and the liver is a vital organ and any mutations, based on your parents unfortunately, and it's your parents that provide you the genetic mutation ,any mutation on the enzyme of these cells have a dramatic impact on the quality of life of the kids. We are, today we are focusing on two of these indications, there is more than 200 what we call metabolic disease, and so 200 different disease related to different enzyme mutations, we are targeting to the two of them Crigler-Najjar syndrome, and urea cycle disease. In the Crigler-Najjar syndrome for example the kids having this pathology cannot conjugate the pigment called the bilirubin, it what makes the jaundice in new born, you know in the premature new born, unfortunately if when it's a genetic disease you have the gene link or the jaundice all your life and you need to spend all your life 10 to 12 hours per day under UV to destroy the bilirubin, so you can imagine the quality of life you can have. The only way to treat these patients is liver transplantations, so the objective of Promethera, due to the shortage of liver and evolution of the pathology, is to be able to infuse cells in the portal vein of the patient instead of changing the full piece and changing the liver. So we are using the stem cell coming from the liver, that we are expanding, purifying and expanding, and again re-infusing in the portal vein of patient having a genetic defect.
Fintan Walton:
Right, so these obviously are stem cells coming from another source obviously not from the patient themselves or the parents obviously?
Eric Halioua:
Exactly, it is what we call allogeneic cell therapy.
Fintan Walton:
Allogeneic, yes.
Eric Halioua:
If it's from the parent it's still allogeneic, but in general it's the liver today at least it coming from cadaveric donor, you know the liver that fits the transplantations criteria, there is a network in Europe called EuroTransplant that collects these livers, but sometime the liver is not transplanted, because the kids or the patient doesn't come, or the doctor is not ready and we can collect from the Tissue Bank In Brussels can collect these livers and it has the ability to isolate the cells from this liver and they provide to us hepatocyte bag, it is the raw materials we are using in our GMP facility in Mont-Saint-Guibert in south of Brussels. And we have been GMP approved and the manufacturing process we have in-house is the ability from this raw material hepatocyte bag to purify the cells which is present in very, very small quantity and to amplify, so to multiply hundreds and hundreds of cells.
Fintan Walton:
So you are actually amplifying the stem cells themselves or you are creating the stem cells?
Eric Halioua:
No we amplify the stem cells present in the hepatocyte bag.
Fintan Walton:
Okay.
Eric Halioua:
All the other cells in fact die, because mature hepatocytes do not survive in culture and stem cell can proliferate, we have the special media.
Fintan Walton:
So that's the underlying technology, that's your capability to do that?
Eric Halioua:
Exactly, exactly and the ability as well to freeze these cells, because these cells can be frozen in liquid nitrogens and the key advantage of these expansions is to be able to treat hundreds of kids with one liver instead of one kid one liver.
Fintan Walton:
Sure, okay, so fascinating and so where are you in the clinical testing of this?
Eric Halioua:
So today we are in Phase I/II of clinical trials, meaning we are assessing safety and preliminary efficacy of the cells of the treatment in two indications Crigler Najjar and urea cycle disease.
Fintan Walton:
Okay, so obviously in that case you are dealing with directly with the patients themselves?
Eric Halioua:
Exactly, we are infusing the cells to patients, kids, it's a pediatric indications there so we are only targeting kids of different ages, we have three cohorts of age, the very, the infants and up to the teenagers that are considered below 18 years old you are still in the pediatric setting.
Fintan Walton:
Okay, so give us some idea of the scale of this, when do you expect to get the results from these clinical trials?
Eric Halioua:
We started the clinical trials end of March of this year, so we are expecting one year for the enrollment and one year of follow-up, so let's say mid 2014, to have some space, we should have the results of this first clinical trial.
Fintan Walton:
You are not differentiating between the two different disorders?
Eric Halioua:
In fact today we are assessing safety in both, okay but the efficacy we can differentiate, we can differentiate as the end points will be different.
Why did Boehringer Ingelheim and Shire invest in Promethera?
Fintan Walton:
Right, fascinating. Why did Boehringer Ingelheim and Shire invest in your company?
Eric Halioua:
It's a good question, but we ask this question of course, it's, so I believe for Shire, let's start by Shire, Shire is already involved in orphan disease even ultra orphan as we are, you know these diseases are fortunately extremely rare, and they have as well a cell therapy business unit, they have done two acquisitions currently and we are strongly involved in cell therapy, so I believe the focus, the space of Promethera makes sense for Shire and anyway it's a strategic investment also, it's not a, it's like a corporate based investment, so it's a way for them to make some profits if the company is sold to someone else, but as well to have access to some information I believe. For Boehringer Ingelheim it's a strategic investment, it's a company not involved today in orphan disease andcell therapy, so I believe it's for them a way as well to get knowledge and access to new therapeutic area, you know cell therapy or new technology, cell therapy or orphan disease, so I think for them it's more a way to have access to some information but as well to make some investments.
Importance of types of financing, loans and fundings
Fintan Walton:
Yes, yes it is fascinating, but also I think what also is clear, we are here in Belgium, biotech's have done reasonably well in Belgium ,and I am trying to get understand the financing, because you've mentioned you know that you were able to get financing from, from basically not for profit areas from both regional bodies, not for profit areas, you are also getting funding in the form of grants, but you are also getting in the form of debt financing loan, long-term loans, how important is that type of funding to an organization like yours and how can you, is that something that can be replicated in other parts of the world?
Eric Halioua:
It could be replicated, and to answer your question, the thing is the politic focus, you know today in the, at least in the French speaking parts of Belgium, they have implemented three or four-years ago a master plan to re-structure the economy of the Walloon Regions and they decided to really focus the investments, the public investments in some area and biotech has been there clearly defined as one of these area, there is a cluster, a biocluster called BioWin which is functioning quite well, and they have put money on the tables and significant amount of money, while talking for Promethera up to now around 12 million Euros, you know it's a lot of money because it's soft money so it's important for the investors.
Fintan Walton:
Excellent, it's non-dilutive?
Eric Halioua:
Well yes, exactly yes, it's not diluting and this money is extremely important in the beginning and afterward, because the 4 million Euros we got in 2009, you know 2009 was not the best year on to for our first round of financing and these non-dilutive money was extremely important for the sustainable development of the company.
Fintan Walton:
And these loans are what sort of, what are the conditions to those loans?
Eric Halioua:
So you are assessed by a jury there is the Walloon Regions it depends if you pass through the Biocluster BioWin there is an international jury, you know it's people that assess, you need to file, make an application.
Fintan Walton:
So a panel assesses the application for the loan?
Eric Halioua:
Exactly, the panel assess the applications, and if you fit to criteria they have defined you can get the money, you need to be R&D focused of course, you have applied research, more fundamental research and you need to be involved with another company for some of these grants or loans and or with an academic lab or you can as well, you have different typology of grants, so you can have direct access to the money for yourself.
Fintan Walton:
Right and then, and the loans are they, are the interest rates particularly high or they just normal interest rates, and what is the expectation for repayment of the loan?
Eric Halioua:
Okay, I would try to see to be exact in this to answer to your questions in fact a part of the money you get need to be reimbursed at from the end of the projects, but it's during a 10-years periods and I think it's 20%, let I will check about these numbers, and after the 80% the rest of the money is reimbursed, with specific rates when you commercialize the products, of course when you commercialize the product it's a problem you don't, it's a problem you like to have any way.
Fintan Walton:
Yes, absolutely, but there is no obligation to pay the remaining 80% if you don't commercialize?
Eric Halioua:
No.
Fintan Walton:
So it's a loan at risk?
Eric Halioua:
Exactly it's a loan at risk and even the 20% if you don't, if you decide, because the result are not here, to stop the project you don't have to reimburse, but in this case they can have a license to the patent, if a patent is involved.
Fintan Walton:
Excellent. Well Eric, thank you very much for coming on the show.
Eric Halioua:
Thank you.
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).
Eric Halioua
CEO
At the time of recording this PTV interview Eric Halioua serves as Chief Executive Officer at Promethera Biosciences. Eric Halioua is the CEO of the Belgian Biotechnology company Promethera Biosciences. Promethera Biosciences' mission is to discover, develop and commercialize cell therapy products to treat liver diseases in an innovative way using stem cell from healthy human livers. Eric is co-founder of two biotechnology companies called Myosix and Murigenetics. Myosix is a tissue engineering company specializing in musculoskeletal cells culture used in the regeneration of the heart muscle. The company has been sold to Genzyme mid-2002. Murigenetics is a Biotechnology company developing therapies for genetic disorders. Eric was also a Board Member of a French public biotechnology company called Vivalis, which specializes in the production of avian stem cells lines for the production of vaccines and recombinant proteins. Eric was as well principal of the international life sciences practice of Arthur D. Little based in Paris and Boston during 11 years. He has led work in the areas of strategy, M&A and technology & innovation management for biotechnology and pharmaceutical companies. Eric also worked as a strategic marketing manager for the "Centre Europeen de Bioprospective" and as project leader in the corporate R&;D centre of Zeneca in UK. Eric holds two master degrees (DEA and Magist"re) in Pharmacology and Molecular Biology and a MBA from ESSEC business school (Paris, France), with an advanced degree from the Health Care ESSEC chair.
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.
Promethera Biosciences
Promethera Biosciences is a biopharmaceutical company, spin-off of the Universite Catholique de Louvain that develops innovative treatments based on allogeneic adult stem cell technology. Promethera Biosciences was founded in 2009 based on the results of the research of the lab of Professor Etienne Sokal, a leading expert in hepatology and cell therapy. Eric Halioua is the Chief Executive Officer and co-founder of Promethera Biosciences. March 21, 2012, Promethera Biosciences completed a 23.6 million Euros B-round of funding.