Aicuris: Prof. Helga Rübsamen-Schaef . Clear Focus on Anti-Infective Cures.




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Video title: Aicuris: Prof. Helga Rübsamen-Schaef . Clear Focus on Anti-Infective Cures.
Released on: April 17, 2013. © PharmaTelevision Ltd
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In this episode of PharmaTelevision News Review, filmed at BioEurope Spring 2013, in Barcelona, Spain, Fintan Walton talks to Prof. Helga Rübsamen-Schaef , CEO at Aicuris.
Focus on anti infectives
Fintan Walton:
Hello and welcome to PharmaTelevision News Review here at BioEurope Spring, in Barcelona, in 2013. On this show I have Professor Helga R"bsamen Schaeff, who works at AiCuris, in fact she is the CEO of AiCuris, welcome.
Helga Rubsamen Schaeff:
Welcome, hello.
Fintan Walton:
Well Helga thanks for coming along and obviously AiCuris is a German company, it's spun out of Bayer back in 2006 and you are focused on anti-infectives, so tell us the story about AiCuris.
Helga Rubsamen Schaeff:
Well as you mentioned our roots are in Bayer and Bayer made the decision that they didn't want to continue infectious disease work and we were convinced that worlds, like today's world, needs of course new drugs against bad bugs.
Fintan Walton:
Yes exactly.
Helga Rubsamen Schaeff:
And so we decided to continue this work and found investors who formed the new company with us and we named it AiCuris for anti-infective cures and where we say cures, we mean it, so we really want to make drugs that make a difference.
Fintan Walton:
Okay, now obviously as you said rightly the anti-infective story is not over, there is a continual fight to kill off infectious diseases obviously both at the bacterial and viral level, what were you bringing with you from Bayer that gave confidence to investors to back it?
Helga Rubsamen Schaeff:
Yes, well Bayer at that time gave us all the young projects that we had been working at Bayer, so these were a total of 13 compounds that had not seen the human being yet, so they were preclinical or even only in research, but at least we had a large pool of compounds to draw from and to develop further and then to see where their gold nuggets would be.
Fundings and Investors
Fintan Walton:
Okay, so you've got your investors, what type of investors did you get in board, these were typical VC's?
Helga Rubsamen Schaeff:
No, these are private people, but they knew something about the pharmaceutical industry because they had, one of their major generics business in Germany called Hexal, and around the year when we were founded they've sold that to Novartis and were looking for new investments options and decided at least to put part of their money into innovative drugs.
Fintan Walton:
Okay and have they, and since then have you raised more money from other investors?
Helga Rubsamen Schaeff:
No, we are still with the same investors, in fact our investors have bought Bayer shares in 2011 and we had two additional financing rounds, one was 55 million Euros and one was 25 and this was done by our first investors and adding some of their friends and family as minority investors.
Lead compounds and science
Fintan Walton:
Okay, excellent. So obviously you've got some good funding, you have to make sure you use that money wisely obviously going forward?
Helga Rubsamen Schaeff:
Of course.
Fintan Walton:
So, how have you been using that money? What are your lead compounds now, where are they?
Helga Rubsamen Schaeff:
Well as I said and we've got, when we started we had 13 projects, four of them were for the human cytomegalovirus, one herpes drug, one drug against hepatitis B, there was a HIV project, hepatitis C projects and antibiotics. Right now we had, last year our first deal as a company where we sold our portfolio of drugs against the human cytomegalovirus, the cousin of herpes widespread in the human population, and today our lead drug is a drug against herpes, herpes simplex, the classical quote on quote herpes, causing labial and genital herpes and that also has very nice Phase II data and is now being prepared for Phase III. So in this year or early next year we want to find a partner for that drug, that's our major asset right now. In addition we have an interesting but still quite young antibiotic which is a gram negative resistance breaking antibiotic which is rather broadly active and that will start Phase I next year, but already now we can talk to some companies about it, because there is lots of interest in this area and again it's an area of very high unmet medical need.
Fintan Walton:
Right, when you take you know products out of a company like Bayer you have to bring with it obviously the products themselves, but you have to bring the expertise, the science as well, and obviously the founding science to some of these products has to be there, have you managed to retain that, and how much are you exploiting that still to that engine in order to keep your product line active?
Helga Rubsamen Schaeff:
Yes, I think that was one of the very important things that Bayer said to me at that time, that I would not only be allowed to take the projects but also people who had been working on them, and so I was really able to select the best biologists from that team at that time, so many who went with me are now seeing their own projects grow overtime and became in the new company the champion for the respective project, and I think this is really part of the reason why we are so successful and why we relatively short time could move so many projects to where they are today.
Fintan Walton:
Right.
Helga Rubsamen Schaeff:
But, just to answer another question that you implied, yes we do our own research, so this biology team is still doing research and this new antibiotic I was telling you about is already discovered outside Bayer, so that's our own discovery and was not started at Bayer yet.
Programs
Fintan Walton:
Okay, now just on the antibacterial, the gram negative antibiotic, what approach have you taken there? What is novel about the approach that you've taken there in relation to other antibiotics?
Helga Rubsamen Schaeff:
Well generally as I said that we want to make a difference so most of our drugs really come with totally novel chemistry and address novel targets in the bacteria or viruses, in this case we have done something different, we have taken an existing compound class but have modified the chemistry in order to bring it a broader, get it reach a broader resistance breaking potential.
Fintan Walton:
Okay and how, I mean anti-infectives obviously they relate because these are foreign bodies that come into us, but how, what is the relationship between the two, between a program that's focused towards bacteria versus a program that's focused against viruses?
Helga Rubsamen Schaeff:
A virus, well I think the main difference is that when you make an antiviral, a classical antiviral, you are targeting one virus, let's say herpes or HIV, when you today make an antibiotic what people expect you to do is target a number of different bacteria, so you always want to have something a broad spectrum, the reason is that if someone comes into the hospital, is very sick, the doctor doesn't know exactly which bug he has, but he has to treat immediately there because many of these conditions are life threatening, so people normally want a broad spectrum, things will change I think over time where there are specific diagnostic tests available in the future and then you can make more narrow spectrum drugs, but that's I think not here now, so we are still working on broad spectrum drugs but that of course makes this more difficult to come up with them.
Fintan Walton:
Yes, indeed and but also.
Helga Rubsamen Schaeff:
Because you have to hit a whole number of different.
Fintan Walton:
Exactly, but they also used prophylactically as well, so you try to hit off as many a potential infection as possible?
Helga Rubsamen Schaeff:
That's something you can do as well, but of course antibiotics normally are not being used prophylactically, because people are afraid of creating a lot of resistance.
Licensing deal with Merck Sharp & Dohme
Fintan Walton:
Yes sure. and so just you mentioned that you disposed off the cytomegalovirus program, who did you sell that to?
Helga Rubsamen Schaeff:
And this was a license that we gave last year in 2012 to Merck Sharp & Dohme [PharmaDeals ID = 49075] and so they have the whole portfolio of drugs with the front runner letermovir, which had a successful Phase II where we saw a very nice a dose dependent inhibition of the virus in the transplant setting, so that deal was struck last year. It was for us a very nice deal with an upfront of 110 million Euros and milestone payments of over 300 million Euros, these are milestones in terms of regulatory achievements but also in terms of clinical achievements, and then of course royalties and we also kept for us in some European countries an option for co-promoting drugs.
Fintan Walton:
Okay, so you must be pretty proud of what you've been able to achieve considering the effort that you needed to take to get that program out of Bayer?
Helga Rubsamen Schaeff:
Absolutely, I think what these seven-years have shown to us that the group that started as researchers has learned to develop drugs and to forecast markets et cetera, and that was quite some way that done not only myself but everyone who went with me from Bayer that we were going, but I think it was a way that was a lot of fun, was a challenge, but at the same time a very rewarding I think and for a small company like we are on having not just this program that we licensed last year but a second drug with the successful Phase II done and preparing for Phase III is quite something, so we are very happy about it.
Partnering strategies
Fintan Walton:
Right, and obviously now with the herpes simplex product that is now at the stage where you are looking to find a partner?
Helga Rubsamen Schaeff:
Yes so we're, again want to find a partner who would take over to do Phase III and the marketing for it and then the primary indication for that drug will be genital herpes, because that's the more severe condition, but the drug is also equally effectively for labial herpes, so I think it also makes sense to develop it for this indication, because who wants to have herpes on their face.
Fintan Walton:
Yes indeed.
Helga Rubsamen Schaeff:
And so maybe it's even two different partners, because it's very different indications that this drug could be used for, but I think it's a very unusual drug so it's first in class molecule again, it's addressing a new target compared to what's in the market and the nice thing is the drugs in the market need to be activated in order to work, and for this activation they need viral enzymes so they can only be active in the cell that's already infected. Our drug works right away, so it will protect uninfected cells and it has a long half life, so it means it stays in the body for, half life is 80 hours, for prolonged periods of time and that means that you know for an episode you can give one pill in treating the episode and for suppression when you want to suppress the virus long-term it's probably sufficient to give it once a week.
Fintan Walton:
Excellent. Helga, thank you very much indeed for coming on the show.
Helga Rubsamen Schaeff:
You are most welcome.
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).
Helga Rubsamen Schaeff
CEO
At the time of recording this PTV interview Helga Rubsamen-Schaeff serves as at AiCuris. Helga Rubsamen-Schaeff served as Post-doctoral researcher at Cornell University Ithaca (USA) and University of Gieben, Group leader at the University of Cologne, two Sabbaticals at Harvard University (USA) and Head of the Department of Immune Therapy followed by 7 years as Scientific and Managing Director of the Chemotherapeutic Research Institute Georg-Speyer-Haus in Frankfurt (Germany) and Professor of Biochemistry and Virology at the University of Frankfurt. Her Industrial experiences include Director of Antiviral Research, Bayer until 2001 and Senior Vice President and Global Head of Anti-Infective Research at Bayer HealthCare(Germany) until 2006.
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.
AiCuris
AiCuris GmbH & Co KG (name derived from Anti-Infective Cures) was founded in 2006 as a spin-off from Bayer Healthcare AG. With its deep roots in Bayer's long history of successful anti-infectives drug research and development, AiCuris is focused exclusively on the discovery, research and development of novel, resistance breaking antiviral and antibacterial agents for the treatment of severe and potentially life-threatening infectious diseases. Majority investors are Drs. Str"ngmann, founders and former owners of the pharmaceutical company Hexal. Besides the HCMV program, AiCuris is pursuing several other candidates in various stages of clinical development including a novel anti herpes simplex compound ready for Phase III clinical testing.