BioLineRx: 'Bench to Bedside to Partner' - Bridging the gap between academia and pharma




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Video title: BioLineRx: 'Bench to Bedside to Partner' - Bridging the gap between academia and pharma
Released on: May 25, 2012. © PharmaTelevision Ltd
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  • Summary
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In this episode of PharmaTelevision News Review, filmed in Amsterdam at BioEurope Spring 2012, Fintan Walton talks to David Malek, Vice Preident of Business Development of BioLineRx.
Business operations and functions of BioLineRx Ltd
Fintan Walton:
Hello and welcome to PharmaTelevision News Review. On this show I have David Malek, who is Vice President of Business Development at a company called BioLineRx , welcome.
David Malek:
Thank you very much Fintan, it's a pleasure to be here.
Fintan Walton:
Good, your company that's actually based in Jerusalem, in Israel?
David Malek:
That's correct, yes.
Fintan Walton:
An Israelian company, your company is also listed it's a publicly quoted company and one of the intriguing things is how does a company like BioLineRx evolve and give us the history and how it's formed and how got to be a publically listed company?
David Malek:
Absolutely, and be happy to. We're actually listed in two places, we've been listed in the Israel-US Exchange in Tel Aviv as of 2007 we have fairly recently in about July of last year 2011 have been listed in NASDAQ as well. The company was founded in 2003 in Israel and really the underlying need that was at the basis in the core of founding this company was really understanding the gap that we saw that we wanted to bridge and the gap there was that we found there was a lot of very innovative cutting edge relevant basic research value and primarily in academic institutions in Israel, but that level of research did not really reach a maturity level that would then interest the larger players in the pharmaceutical and biotech industry in the world. And what BioLineRx was aiming and still is aiming to do is really bridge that gap, so basically the way we work is we do not have a discovery arm of our own, our discovery arm is basically the research letting a lot of mainly the academic institutions, it started in Israel but evolved later to other parts of the world and today we have assets coming from the US, and Canada, and France and other places, but basically we license in those compounds typically in a preclinical stage, we go and go ahead and develop them pre-clinically prepare the IND package et cetera, bring them into clinical development and typically up until our proof of concept in humans and at that point we would usually look for a partner or typically a larger pharmaceutical or biotechnology company to license those compounds to the typically Phase III and notice that developing and then commercialize them, we do not have a commercial operation nor do we have intentions of having such an operation in the near future and I think this unique value proposition of really being able to find great opportunities coming from academic institutions great science with a commercial applicability the ability to turn that concept into a product, a drug in clinical development and then basically represent that opportunity to larger pharmaceutical companies, I think that attracted the investors right from the get go and allowed us to list on both the Israeli and the stock exchange in the NASDAQ and provide us the funding that we require to do this in a fairly large scale.
Product portofolio and pipeline
Fintan Walton:
Right and of course it is expensive to do these things. So then, okay that's good what sort of products have you developed then? Where are you with these products?
David Malek:
So we currently have 18 compounds in our portfolio which is quite a lot for a company of little over 50 employees. We have five compounds in clinical development, one of which has already been licensed out it's BL-1040 was licensed out to a company called Ikaria, based in New Jersey for acute MI [PharmaDeals ID = 33597], so we have other than that four other compounds in development by us in the clinical stage and then 13 compounds in preclinical development. Our most advanced compound is probably BL-1020 which was developed for Schizophrenia in particular we believe will be the first-in-class compound to show improvement in cognition in Schizophrenia patient which is a true large unmet medical need. We typically in-license about, I am gonna say about six compounds a year, we try to really terminate the projects as quickly as we can, we try to terminate most of our projects in the first year or year and a half, because we have other great opportunities we want to invest in.
Fintan Walton:
Right. So it's a triage you have to get, you've got to weed out look for good things but weed out the better things?
David Malek:
Exactly that, we are actually very proud at our ability to terminate, I think the business model because these are not things that have been discovered in our company for 8, 10-years allows us a lot more objectivity in looking in these compounds saying okay this is the promise lets put them to a test that we think is relevant, very quickly in the game if they pass the test great then we can go on and invest a large amounts of money that they require and advance them but if they don't then you know we've tried and didn't work out, we didn't invest large amounts of money in. The other thing that allows us to do this is that we have quite a unique funding arrangement we are the only I guess a life sciences or biotech incubator in Israel that is actually funded also by the Chief Scientist [PharmaDeals ID = 18568] and that allows the best we get government funding of up to about 80% on our pre-clinical program.
Fintan Walton:
So Chief Scientisthas been the Chief Scientist at the government level?
David Malek:
Yes, the Chief Scientist's officer.
Fintan Walton:
Equivalence to researcher in general whatever in the United States?
David Malek:
Pretty well exactly and they have obviously funds that they invest in biotech and pharmaceutical companies in Israel and again BioLineRx was chosen to be really the only so far incubator that they are supporting in the life sciences area and that allows us to really hold a very large preclinical portfolio of today a 13 compounds investing them develop them further and then typically try to advance about a compound into the clinical about every 12 to 18 months, so that's pretty much how about pharma eventually works out.
Therapeutic opportunities and partnership strategy
Fintan Walton:
Right, and in terms of therapeutic focus what's your strategy there you're just happy to take any product in any therapeutic area?
David Malek:
We are quite opportunistic, so for us the way our model is built we are looking for great science and a great commercial potential and based on those criteria we pretty much are open to almost any opportunity, I would say the only thing we will not consider are things that would require very large clinical studies very early in the game. We also we are very flexible in terms of the underlying technology so in our pipeline today we have small molecules some oral, some topical, we have peptides, we have proteins, some antibodies, some non-antibodies we gonna have one oligonucleotide, so we are quite open also in terms of and we were able to develop them almost regardless of the underlying type of molecule if you like.
Fintan Walton:
Right, so within that model then obviously a critical is this balance between equity financing and then getting money from actually doing deals, so you've described how successful you are in licensing these products, how you triage those, how you make sure that the best ones are getting through into the clinic, How you doing in terms of externalizing those back to the industry, back to pharma companies to take them forward?
David Malek:
It's a good question. So again as you've mentioned today we are quite well funded, we have actually quite recently less than a month ago went to around of fund raising through basically through NASDAQ and raised another $15 million through US based investors, but we are still very much keen on creating basically a revenue stream if you like or a cash flow stream from out-licensing deals which is obviously the purpose of our existence, so as I mentioned we have one deal in place right now, we have received several milestones on those and we are eligible for additional development and then hopefully eventually sales milestone and royalties on that compound from our partners in Ikaria [PharmaDeals ID = 33597]. We have actually out-licensed another compound, we have actually in the past out-licensed BL-1020 that's Schizophrenia so to Cypress well [PharmaDeals ID = 36504] when Cypress was actually bought out by Royalty Pharma [PharmaDeals ID = 43821] we eventually got the rights and the compounds back. So basically now we are looking into basically the next generation if you'd like of out-licensing opportunities I think the most ripe if you like opportunities would be BL-1020 again that's a compound that's beyond the Phase II proof of concept. We also have BL-7040 which is developed for inflammatory bowel disease and we have announced that we will just began a Phase II study actually next month in ulcerative colitis which is a that's an oligonucleotide TLR-9 and another two compounds we have in clinical development are BL-5010 which is a compound for the removal of skin lesions , Actinic Keratosis or Seborrheic Keratosis another lesions and BL-1021 which is a small molecule developed for the treatment of neuropathic pain which we have successfully completed the Phase I with just about two or three months ago.
Fintan Walton:
Okay, so these are getting, you are getting these partner ready basically?
David Malek:
Yes, those have been even today here at the conference is quite a lot of interest in those which we are happy to hear and I think those if we find good partners and good arrangements for them we would definitely be opened for partnering deals, there are also a couple of compounds in our preclinical development that also creates some interest, some of them are for example are Hepatitis C compounds obviously that field is very active, so even compounds in preclinical stage have interests. Another example would be we have a compound called BL-7010 for celiac disease which is as you probably know a very high unmet medical need the very growing and fortuned market but also one that does not really have a lot to offer both definitely not in the market but also not in the pipeline and we think we have a very interesting and unique innovative solution to see the patients in that also creating a lot of interest even though it's in a late stage pre-clinical.
Business model and future development plans
Fintan Walton:
Okay, now you've said you've had 50 people it's a virtual are you operate on a virtual company basis or how much you know for running I am interested in you know running a company like BioLineRx with that number of programs with obviously some of that works done out through CRO's and so forth, so what sort of size organization do you need? What sort of critical mass do you need in order to be efficient in doing the type of thing you are doing?
David Malek:
That's a great question. I mean our company is not virtual in the sense that we have 50 some what people coming to the same office everyday and there we think it's very important the accessibility I get is the core of a business person to the scientist the ability to be in meetings like this and have discussions with eventually our potential customers and understand what's really need there then just turn around go back go to the office with a sign and signal say this is what we need to be and let's build the program that really fills that need either we make it or we don't, but that's what we need to approve I think is really invaluable, where we do use a lot of external help is we have a very, very large developed area of consultance on the clinical side, on the pre-clinical side, on the commercial side because we are spread over quite a large amount of indications we don't presume to become the expert in all of these indications so we will reach out quite extensively, we try to understand the market need, the opportunities, the reimbursement issues and then going back into what are the clinical studies that we require, who is competing with us in this field, what's the right preclinical development et cetera. In addition we do all of our in vivo studies externally, we do not run them inside again we feel those require a lot of specialty in certain areas, certain indications what we do is we will choose the best labs that we would find for any particular indication, we would go there and run our studies there. So we really try to find the areas were there is a lot of specialization required, we do those with the specialists and where we come to play is building our portfolio running through the right steps and really always understanding what is going to be the end goal eventually. What is going to be the required pack, the required package in the end of this process by a company that would eventually license this compound from us.
Fintan Walton:
And finally then just the future of this business, where do you see this business going?
David Malek:
I mean, I think we have in the past year or so we had some great developments, we've been able to in-license a lot of really interesting compounds, I think we really took our pipeline up and large by going into, for example areas like Hepatitis C where we've in-licensed two assets from really prominent scientists with innovative mechanism of action by licensing compounds for example like BL-7040 which we mentioned that is really a cutting edge innovative unique compound already in the clinic. So I think we're gonna continue to increase the quality, the uniqueness of the compounds that we bring in. I am pretty confident that we will be able the near-term to commercialize or we should say out-license at least one or two of our clinical stage compounds and may be some others. We think we are gonna be able to bring into to the clinic probably about two-compounds in the next year or so, one of them in HCV. So I think all of these aspects are really gonna make sure that we have a robust not just in terms of numbers which we still are willing and able to maintain but also in terms of the quality, the value proposition we bring in each and any of the projects that we have in the company.
Fintan Walton:
David Malek, thank you very much indeed for coming on the show.
David Malek:
Thank you very much, I appreciate that you having me here.
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).
David Malek
Vice President
At the time of recording this PTV interview David Malek serves as Vice President of Business Development of BioLineRx Ltd. David Malek was appointed as Vice President of Business Development in October 2011. Prior to joining BioLineRx , since 2006, Mr. Malek served at Sanofi in a number of management positions in the US and France, including Marketing, Finance and Business Development. Most recently Mr. Malek served as Director of Oncology - New Products and Business Development. Mr. Malek has an MBA from the Tuck Business School at Dartmouth College and also holds a BA in Statistics and Political Science from the University of Haifa.
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.
BioLineRx Ltd
BioLineRx Ltd is a publicly-traded biopharmaceutical development company. It is dedicated to building a portfolio of products for unmet medical needs or with advantages over currently available therapies. BioLineRx 's current portfolio consists of five clinical stage candidates: BL-1020 for Schizophrenia has commenced a Phase 2/3 study; BL-1040, for prevention of pathological cardiac remodeling following a myocardial infarction , which has been out-licensed to Ikaria Inc, is currently undergoing a pivotal CE-Mark registration trial; BL-5010 for non-surgical removal of skin lesions has completed a Phase 1/2 study; BL-1021 for neuropathic pain is in Phase 1 development and BL-7040for treating Inflammatory Bowel Disease (IBD) is commencing Phase 2. In addition, BioLineRx has 11 products in various preclinical development stages for a variety of indications, including central nervous system diseases , infectious diseases , cardiovascular and autoimmune diseases . BioLineRx 's business model is based on acquiring molecules mainly from biotechnological incubators and academic institutions. The Company performs feasibility assessment studies and development through pre-clinical and clinical stages, with partial funding from the Israeli Government's Office of the Chief Scientist (OCS). The final stage includes partnering with medium and large pharmaceutical companies for advanced clinical development (Phase 3) and commercialization.