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Vivagel.Durex
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22 March 2010 (hope the timeline is a little sooner than she indicates here.. 2-3 MORE years is a long time).
Vaginal Gel to Meet Urgent Medical Need -For what is a global medical problem prevention is better than cure when lovers share more than their passion
Contact: Dr Jackie Fairley, CEO
Starpharma Pty Ltd
Baker Building, 75 Commercial Road
Melbourne, VIC 3000
International Telephone: +61 3 8532 2715
Email: jackie.fairley@starpharma.com
Website: http://www.starpharma.com
TRANSCRIPT:
DESLEY BLANCH : Every day nearly one million people acquire a new sexually transmitted infection (STI) with up to 80 per cent of curable STIs occurring in the developing world with adolescents and young adults accounting for the highest rates of infection. HIV/AIDS was virtually unknown 20 years ago, but a closer look at the rate of HIV spread reveals that it has infected more than 60 million people with approximately 14,000 new infections occurring daily. Over 90 per cent of people living with HIV/AIDS are in low and middle-income countries, with the disease now the leading cause of death in sub-Saharan Africa. It's the fourth biggest killer globally and it's the leading cause of death and disease in young women.
An Australian biotechnology company, Starpharma is leading the field in developing new technologies to address the global STI epidemic through prevention. Their lead product is VivaGel, a vaginal gel that women can apply to protect themselves against HIV and genital herpes.
The gel is a microbicide, a class of product which has been lauded by many including Barack Obama, Bill Clinton and Bill and Melinda Gates as the answer to HIV prevention. Dr Jackie Fairley is CEO of Starpharma and she's here in the studio.
Jackie, VivaGel is said to be one of the most advanced microbicides currently in development, and it's received more than 20-million dollars in funding from the National Institutes of Health, plus it's been granted 'fast-track' status by the United States Food and Drug Administration. So how close is it to market?
DR JACKIE FAIRLEY, CEO OF STARPHARMA : VivaGel taking consideration of the various elements, such as funding and regulatory requirements to satisfy for a product such as this, we expect that the product would be available in its various forms probably within the next two to three years.
DESLEY BLANCH : Well despite education campaigns that are designed to promote safe sex messages and practices, and despite best efforts to develop vaccines for these diseases with limited or no success, and so a new approach is needed to control the spread of HIV/AIDS and genital herpes, and this is where VivaGel comes in. So how's the gel intended to be used by an individual?
DR JACKIE FAIRLEY : The intention with this product is that the gel which is a water-based gel in a vaginal applicator is used by the woman prior to sexual intercourse and instilled in the vagina and there the gel resides ready to inactivate any viral elements that it comes in contact with.
DESLEY BLANCH : And how long does protection last?
DR JACKIE FAIRLEY : In our human studies we've shown that we have a very high level of protection, in fact complete protection at three hours, and in fact even as far out as 12 to 24 hours, a very good level of protection. We expect that the product will be recommended to be used within approximately two hours of intercourse.
DESLEY BLANCH : So what is a microbicide and how does VivaGel work?
DR JACKIE FAIRLEY : A microbicide is simply a product which contains a substance which is able to inactivate or kill a particular infectious agent, in this case a virus, the HIV virus and the genital herpes virus, and within that gel it contains a unique substance, in this case it's a dendrimer, our proprietary product, which binds to the virus and basically renders it incapable of infecting humans.
DESLEY BLANCH : So what's its potential as a contraceptive?
DR JACKIE FAIRLEY : Well in fact we have shown in animal studies that VivaGel does have a contraceptive activity. It's not an application of the gel product which we are pursuing, however, related to that we have signed a very important commercial deal for the company applying this anti-viral substance to the surface of a condom, in this case the deal is with the owners of the Durex brand of condoms, the world leading brand, and that is as an anti-viral coating.
DESLEY BLANCH : So what's the likelihood of women using a suitable microbicide?
DR JACKIE FAIRLEY : Well when you look at studies that have been conducted around the world, the rates of usage differ and in fact they often will track the severity or importance of sexually transmitted infections and the severities of those infections. In Africa, surveys tell us that in excess of 90 per cent of women surveyed would buy and use a topical microbicide, whereas in a country like the US in university students, surveys would suggest anywhere between say 40 and 70 per cent of women surveyed would buy and use a microbicide.
DESLEY BLANCH : So where is the biggest impact of VivaGel likely to be felt?
DR JACKIE FAIRLEY : I guess that in answering that question it depends on the sort of impact that you're looking at. There's no question that HIV is a massive problem globally, and in the developing world to have a product which enables women to prevent themselves becoming infected with that disease will have a huge impact on those communities and obviously the lives of those women.
However there's also an equally important opportunity, and in fact commercially a more significant opportunity in size in both the US and in Europe, where genital herpes, a different sexually transmitted infection, that is highly prevalent in those markets -- they're very common in those markets and a product there would be aimed more at the prevention of genital herpes as opposed to the prevention of HIV.
In both cases those diseases have very substantial health outcomes in terms of morbidity and mortality and really affecting people's lives enormously. So it depends a little bit on what disease you're talking about, but I would say in the developing world HIV, in the developed world genital herpes.
DESLEY BLANCH : What would you say to those women whose sexual health is often oppressed in cultures where condoms are stigmatised because of their association with infidelity?
DR JACKIE FAIRLEY : Well I guess that's one of the very attractive features of this category of product is for the first time women in these cultures will have access to a product which will enable them to be in control of and able to independently initiate the protection of themselves against these diseases.
And that's an important element, it's an important element probably in terms of preventing the spread of these diseases, because condom usage remains very low, even in countries where HIV rates are extraordinarily high for some of these cultural reasons you've referred to. So I think that this category of product and VivaGel will provide an opportunity for women to be more in control of their own health.
DESLEY BLANCH : What clinical trials are you running or about to run on VivaGel?
DR JACKIE FAIRLEY : So we have a range of clinical trials running and planned, and they include phase two trials for the VivaGel product that we're completing at the moment in the HIV and herpes program, and also a new program which we're about to kick off in the next few months, which is a different application of the product -- for the world's most common vaginal infection, bacterial vaginosis, which is an imbalance between the normal flora bacteria and pathogenic or bad bacteria, and those trials -- phase two trials for bacterial vaginosis we expect to be commencing in the next few months.
DESLEY BLANCH : How does your company make profits when the gel will be used mostly by people in the developing world who are unlikely to be able to pay for the product?
DR JACKIE FAIRLEY : Well firstly I should say that the company's activities are not restricted to VivaGel alone and there are a number of other commercial applications we're pursuing. But apart from that, there's no question that the HIV issue is a major issue globally to deal with, however the application of the product and I guess the returns of the VivaGel product we expect to be in large part coming from the developed world, not the developing world.
We expect in the developing world the distribution of the product would be probably through something like the WHO or an NGO like that. But in fact it's the prevention of diseases like genital herpes in the US and in Europe where obviously the pricing structures are quite different and the distribution arrangements are different, which we expect to be the greatest contributors.
DESLEY BLANCH : The product itself though is an anti-viral gel and it uses highly defined nano-particles, and these are called dendrimers, which you've mentioned, and these zero in on a target. So tell us more about dendrimers, which are a relatively new science and they really are your company's speciality aren't they?
DR JACKIE FAIRLEY : They are, in fact Starpharma is recognised around the world as having an extremely strong position across the board for a whole range of applications of dendrimers. Dendrimers, in simple terms are a kind of polymer, which are made up of many sub-units. Unlike other polymers that you might see in other kinds of products, this case it's a precisely defined as you say nano-particle, so quite a large particle compared with a drug for instance. You can make it in a very reproducible manner and it's chemically synthesized, so easy to synthesize. And if you think of it as - it's approximately a spherical agent made up of many sub-units in layers.
DESLEY BLANCH : So where are dendrimers going to take the company?
DR JACKIE FAIRLEY : Well dendrimers like polymers have a very broad range of potential applications, and at the moment we're really only at the very beginning of commercially exploiting those.
Dendrimers as drugs, an example of that is obviously the active ingredient in VivaGel itself, but some of the other very exciting applications of dendrimers include the use of the dendrimer not as the drug itself, but actually as a scaffold to which you can attach existing drugs, be they either typical drugs like something like aspirin for instance would be a typical drug, or in fact a protein, something like insulin, which you could attach to a dendrimer. And when you do that it changes the way that those drugs behave in the body. It changes the distribution of them and how long they last in the body, and in addition to that it offers the owners of those drugs an ability to get additional patent protection, and that is obviously commercially very attractive to them. So drug delivery is one obvious application. And we have a deal with Eli Lilly, the very large global pharmaceutical company, GSK, another pharmaceutical company and in animal health a company called Elanco.
And also in diagnostics, we have a commercial arrangement with Siemens Healthcare, where some of our dendrimers are used today in marketed products, which are used in emergency rooms right now to improve the performance of assays, which they use to determine if people have had heart attacks or not. So they're just a couple of the examples of applications, there are others: in water remediation and in agriculture, but there's a vast array of potential commercial applications for them.
DESLEY BLANCH : Well Jackie you joined Starpharma in 2005, you're a mother yourself. But what brought you to the company, what attracted you?
DR JACKIE FAIRLEY : I think it's really a combination of several factors as it always is. Starpharma's technology as I've described is really very broad, and has a whole array of very exciting opportunities which can be pursued in parallel through partnerships, and we have a very highly developed partnering strategy, and I've mentioned a couple of our partners already. But I think it was the combination of having a platform technology that had an array of exciting potential product opportunities, as well as the ability to be involved with a development program of a product such as VivaGel, which clearly has the ability to make such a huge impact globally, not only in the developing world in HIV, but also genital herpes, which is a massive problem in the US affecting approximately half of the female African American population already. And I think having a product which can enable women to take greater control of health outcomes can only be a good thing.
DESLEY BLANCH : Well in a climate which has seen many bio-techs fall over during the credit crisis, the GFC, what's your philosophy or strategy for avoiding the pitfalls and growing the company?
DR JACKIE FAIRLEY : Look I think a very important component of a sustainable and growing company in this sector is to have a range of opportunities that you explore in parallel, and also to not assume that you can commercialise or do everything yourselves. Holding onto the rights to a product for too long without forming a partnership with a leading company in that market in my view is not something which is wise, and it relates to I guess the fact that we're a technology platform company and we can't possibly be an expert in women's health products as well as condoms as well as water remediation, it's simply not possible.
So I believe that having an excellent technology that's well covered by intellectual property, but to commercially exploit that, not to seek to do it entirely yourself but through leading companies which have established marketing presences in those markets and know those markets is an important factor, and to have a number of those. So you create optionality and you know that if one program stalls or does not proceed for some reason you have a whole raft of other ones that are in your kit bag that will take over and generate revenues and build shareholder value.
DESLEY BLANCH : So where do you see the company positioned in five years?
DR JACKIE FAIRLEY : Well I think we think it's a very exciting time, that we're on the cusp of really pushing into the drug delivery applications of our dendrimers having signed these recent deals with Eli Lilly and GSK as I said. I expect that we will have not only obviously the VivaGel product in the market in various forms, the VivaGel-coated condom marketed by Durex, the world's leading brand of condoms from SSL, the UK based company, but in addition to that a range of other commercial deals in drug delivery with companies such as Eli Lilly and others, and some of these other applications in diagnostics, and potentially applications such as water remediation, which of course is such an important issue for us now.
DESLEY BLANCH : Dr Jackie Fairley, CEO of biotechnology company, Starpharma.
http://www.abc.net.au/ra/innovations/stories/s2836733.htm
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Interview w Dr. Fairley of Starpharma
