Biotica’s Balancing Act




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Video title: Biotica’s Balancing Act
Released on: April 21, 2009. © PharmaVentures Ltd
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Since 1996, when Biotica was spun out of Cambridge University, the company has been developing a pipeline of lead optimised polyketides focused on unmet clinical needs. In January 2009 they announced a deal with GlaxoSmithKline, an upfront cash payment and equity investment that has left the company in a strong position for the coming year. As Melanie McCullagh, Director of Business Development, explains in this interview the company’s broad range of different opportunities means they have to carefully balance their internal expertise with external demand.
The origin of Biotica and its pipeline.
Fintan Walton:
Hello and welcome to PharmaVentures Business review here at BioTrinity in Oxford. On this show I've Melanie McCullagh who is Director of Business Development in a company called Biotica based in Cambridge. Welcome to the show.
Melanie McCullagh:
Thank you.
Fintan Walton:
Melanie McCullagh, Biotica is a company that has a history that goes back into the mid 1990%27s. It's a business that's probably spun out of the University of Cambridge. It specializes in molecules that are derived from bacteria, which are of potential therapeutic use. Just tell us a little bit about the history and how Biotica came about?
Melanie McCullagh:
The Biotica was founded by two Cambridge academics, Professors Peter Leadlay and Jim Staunton. Peter Leadlay is still at the company as a Non-Executive Director. They had a lot of expertise in the Biochemistry and Molecular Biology of polyketides, as you mentioned which are very naturally bio active molecules. So they founded the company in '96. It went on to grow as joint venture Capital funding and we've expanded the company into building a pipeline of lead optimized polyketidestherapeutics.
Biotica's Polyketide technology and products.
Fintan Walton:
So it's this, polyketide technology or the molecules which are intrinsic and important part of the business?
Melanie McCullagh:
That's right. Our technology is around optimizing the basic polyketide . It's naturally produced by the molecule to make it more appropriate as a drug substance it does in therapeutics. So there are number of polyketides already approved on the markets such as Rapamycin, Doxorubicin is a polyketides recently approved ixapebilone BMS for example. Our technology involves genetically modifying the bacteria that produce the polyketide to make a better version or we can decision if we can use in definite indications.
Fintan Walton:
Okay, and is that done by a sort of like a Random Mutation or is it done through Molecular Biology and genetic engineering?
Melanie McCullagh:
It's very different from the Random Mutation. The genome sequence that is responsible for producing the polyketide Synthase that produces the polyketide is very structured, has very modular format. What we were able to do is to select specific modules to swap or to change within the polyketide synthase that results in very specific changes in the polyketide type that's produced very predictable molecule and so we can make these specific changes combine them together to make a targeted library of polyketide compounds with the range of different activities.
Fintan Walton:
So polyketides obviously have a therapeutic use. What is " what's the range, what can you do with the polyketide molecule?
Melanie McCullagh:
There is actually a huge range of different uses that have been put to. A number of major immune-suppressants are polyketides, also a range of cancer products and many of the most widely used Antibacterial compounds are based on the polyketides such as Erythromicins, the Tetracyclines are also polyketides and a number of others.
GSK deal with Biotica.
Fintan Walton:
Right, now the other key thing that's happened recently is you've done, I think it was last January in 2009 you did a deal with GSK [PharmaDeals ID = 32160], what was the basis of that? What - what, what's this GSK got for Biotica?
Melanie McCullagh:
So we announced that deal in January as you said and what we're doing there is restarting with the Rifamycins as our lead molecule. Rifamycins of course this is a well known Anti-bacterial compounds, but it and some of it's analogs have shown activity in anti- inflammatory indications. What Biotica is doing is we using our technology to reduce the Anti-bacterial activity and focus on the anti- inflammatory activity. So the new compounds will be able to address a wide range of anti- inflammatory very high level of unmet need there of course, so we are bringing a new class of molecules to those very important indications.
Fintan Walton:
Right, the other thing of course Biotica is not a public recorded company, it's a private company, you've got investors on board present presumably?
Melanie McCullagh:
Yes that's right, so our main investors are Biotechnology Value Fund Lp in San Francisco. They are very active on the board as well.
Fintan Walton:
Okay. So the deal with GSK was an important milestone for you because it brings in cash into the company. Does that deal mean if you -- you don't have a requirement to go forward to raise further " further capital?
Melanie McCullagh:
Yes, that's right. The deal as you say brought in a cash up front under an equity investment from GSK. We are not looking to raise further money in the markets at the moment; we have the money to invest in our internal projects as well as working on the GSK deal. So we think we are in a very good position to develop the company into the future.
Biotica internal developments and products available for partnering.
Fintan Walton:
Okay. So clearly you've done this deal with - with GSK. That's an important part of your portfolio of opportunities you can offer pharmaceutical companies. So what's left within the Biotica Company that could be partnered?
Melanie McCullagh:
So the GSK deal was a non-core program that we worked developing a strong lead internally. Our main portfolio for internal development we have a range of compounds in a range of different indications. The lead one is developing analogs of an immune-suppressant to tacrolimus which we are developing in the Asthma indication. What we are doing there is very typical of Biotica 's strategy because tacrolimus has shown activity in Asthma in clinical studies but it's not been developed further. Now we know that it's a very toxic molecule and the toxicity is actually target related. What biotech is doing is changing the molecule so that it's less systemically bio available. When we give it locally to the lungs you get the immune suppression activity at the site of inflammation but you don't get the Systemic Toxicity because the molecule is not being distributed. So this kind of taking a clinically validated compound, seeing the unmet need, so where Asthmaof course is a very important indication in these days and optimizing the molecule specifically for that need is very typical of Biotica's strategy.
Fintan Walton:
So where about some in clinical phase is that? Has that entered into clinical phase?
Melanie McCullagh:
It's not in the clinic yet now we are in the lead optimization stages of that program still.
Fintan Walton:
Okay, so that's all funded by yourself at this stage you haven't entered into collaboration presumably?
Melanie McCullagh:
No we haven't.
Fintan Walton:
So what is the strategy around that?
Melanie McCullagh:
So we would be looking to partner that sub-program at the time when we have pre-clinical proof of concept. Biotica has a company doesn't have the expertise to take these compounds through the biology parts of the pre-clinical development and so we will be looking for someone with inhalation respiratory expertise to develop and commercialize the program.
Fintan Walton:
Right. So again that's a " that's a very specific program and you are going forward with that. Again we look back at your platform if I can call it that.
Melanie McCullagh:
Yes.
Additional opportunities from polyketide platforms and balancing the business.
Fintan Walton:
What additional opportunities can arise from that platform?
Melanie McCullagh:
So that's a good question. There are around 5 to 10,000 known Bio-active polyketides. About 40 of those have been approved so far. We've got this huge pool of potential new opportunities and as we see it some of the really exciting novel mechanisms of action might be for example in cancer many polyketideto known to be active in cancer and we have an exploratory program going on looking for both validated and un-validated targets for projects that we can take forward into optimization.
Fintan Walton:
So how is the company like Biotica then balance, because you got such a broad range of potential therapeutic targets, how do you balance what is required from an internal resource growth perspective versus specialized growth against external collaborations?
Melanie McCullagh:
Well, that's an important part of our strategy actually. All of our internal expertise is around the lead optimization, so we have natural product chemistry, fermentation microbiology and the molecular biology required to manipulate the organisms. But when we start a therapeutic program we recruit expertise externally. So we look to industry, to academic groups, really Thought leaders in the therapeutic areas in which we are developing the compounds and we use them to develop a target product profile and development plan for every therapeutic program that we undertake.
Next big thing to come out of Biotica
Fintan Walton:
Right, so if we look at Biotica today and then look into the future in a next couple of years, what's " what headlines do we expect to see coming from Biotica?
Melanie McCullagh:
That's a very good question. So what Biotica is planning over the " the next few years is hopefully we'll be able to move some programs into the clinic, with our partners obviously we have the internal Asthma program which we will be looking to partner once we have proof of principal and we are also looking at other strategic deals in the earlier stages with a range of pharmaceutical companies. So we are expecting good news as well over the next few years.
Fintan Walton:
Well Melanie McCullagh, thank you very much indeed for coming on the show.
Melanie McCullagh:
Thank you.
Melanie McCullagh
Business Development Director
Melanie McCullagh joined Biotica as Business Development Director in April 2008. She was previously at Antisoma where she was instrumental in the 2007 licensing of Melanie McCullagh, Director of Business Development of Biotica, expects a good news to be come out from Biotica in next few years ASA-404 to Novartis in a deal worth $890m, and was involved in establishing the Roche collaboration in 2002. She was also responsible for bringing new investigational cancer drugs into the company through in-licensing and collaborations, and for company strategic analysis. Prior to Antisoma, Melanie McCullagh led the Strategy Analysis group in Datamonitor Healthcare, providing insight to leading pharmaceutical and biotechnology clients into areas such as forecasting, licensing, M&A and portfolio management. Melanie McCullagh has an MA from Cambridge University, a DPhil from Oxford University and an MBA from London Business School.
Biotica
Biotica, is a development stage drug discovery company with a broad pipeline of therapeutic programmes, all based on their proprietary polyketide bio-engineering technology. Biotica's distinctive drug discovery platform generates improved derivatives of important drugs that are inaccessible by medicinal chemistry. In particular, the Company rationally engineers the class of natural products known as polyketides. Many clinically and commercially valuable pharmaceuticals are polyketides, including the anti- cholesterol drugs Mevacor, Pravachol and Zocor, the anti- cancer drugs Torisel and Ixempra, and the immunosuppressants Rapamune and Prograf. In addition to using this technology to build an internal pipeline, Biotica is also open to technology collaborations with partners to generate analogues of their polyketide compounds. They can optimize a natural product lead to reduce toxicity, improve PK or expand IP protection. At the other end of the lifecycle, they can generate new, differentiated follow-ups to commercially successful drugs to expand a franchise into new therapeutic areas or post-patent expiry.