PolyTherics Ltd: PEGylation and the Polytherics Business Model

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Video title: PolyTherics Ltd: PEGylation and the Polytherics Business Model
Released on: May 26, 2010. © PharmaVentures Ltd
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In this episode of PharmaTelevision News Review, Fintan Walton talks with Sally Waterman, Chief Operating Officer at PolyTherics Ltd. Filmed at BioTrinity 2010 in Newbury, UK, they discuss:

• Origins and PEGylation technologies of PolyTherics

• Whats unique about PEGylation methodology?

• The importance of reduction of cost of goods for the types of proteins of therapeutic use

• PEGylation vs non PEGylation technologies

• Business model and collaborations -

• Future goals
Origins and PEGylation technologies of PolyTherics
Fintan Walton:
Hello and welcome to PharmaTelevision News Review here at BioTrinity in Newbury, Berkshire in the United Kingdom. On this show I have Sally Waterman, who is the Chief Operating Officer for a company called PolyTherics based in London, welcome. Tell me a little bit more about PolyTherics , what is the company and what is its unique proposition?
Sally Waterman:
PolyTherics was founded with technology from the London School of Pharmacy and grant funding from the Wellcome Trust and it was formed in 2002 it's received its first investors money in 2007, 2.3 million provided by Imperial Innovations, Longbow Capital and The Capital Fund and that same syndicate of investors invested another 3 million earlier this year and that money is being used to develop three very particular site-specific PEGylation technologies and between those technologies the company can PEGylate almost any protein or peptide of any type.
Whats unique about PEGylation methodology?
Fintan Walton:
So PEGylation has been around for sometime there are lots of companies out there who have developed PEGylation in fact have their products in the market so what is different what's unique about your PEGylation methodology?
Sally Waterman:
You are absolutely right there were nine PEGylated products on the market eight of which are proteins and that means it is a proven technology for extending a half life of drugs most of the existing products have random PEGylation so the products that are produced are heterogeneous and that means that they are more complex to purify you dont always get exactly the same product each time you make them, so the benefit of site-specific PEGylation is we are putting the PEG molecule on the particular part of the protein that allows you to try to avoid the active site of the protein which can help you maintain activity, it also simplifies the purification process which should lead to a lower cost of goods. Now there are quite a number of site-specific PEGylation technologies but PolyTherics technologies use very, very controlled chemistries and are extremely efficient. Often times the PEG itself is a large part of the cost of a PEGylated protein, with our technologies you can reduce the amount of PEG to protein ratio that by again contributing to the lower cost of goods and facilitating a well controlled process that produces the same product time and time again.
The importance of reduction of cost of goods for the types of proteins of therapeutic use
Fintan Walton:
So it is all about process and one of the key words that you used in your answer is cost of goods now how important is the reduction of cost of goods for the types of proteins of therapeutic use?
Sally Waterman:
It's really more about cost of treatment I think and obviously the whole purpose of PEGylation is to extend the half life and therefore the duration of action of the drug, so that you can give it less frequently and as we all know protein medicines are extremely expensive relative to small molecules. So it is important as there lot of pressure to get the cost of goods down. So the PEGylation process not only can reduce the frequency of dosing, reducing the cost to the patient but also with their very specific site specific PEGylation that we do we can actually get the manufacturing cost down as well, both of those things can contribute to a lower cost of treatment and that's what everybody is aspiring to globally.
PEGylation vs non PEGylation technologies
Fintan Walton:
Right, now the other thing of course with PEGylation as you've already mentioned there are products on the market, so when the company is considering that on their valuable proteins coming through clinical development and they are making a choice aren't they more likely to go for a technology that's already proven on the market than to one which is yet to be proven?
Sally Waterman:
Well PEGylation itself is proven, now a lots of other non-PEGylation half life extension technologies out there that really are not proven yet, PEGylation is proven but I think regulatory agencies are looking for more and more reduction of risks and obviously if you could have heterogeneous product that makes a PEGylated isomers could potentially have different immunogenicities, different safety profiles even different efficacy profiles so there is much of a move to get a homogenous product, so there is a real driver I think for site-specific PEGylation and a need for site-specific PEGylation.
Business model and collaborations
Fintan Walton:
Okay, so the business model for you is it are you there to develop your own products put them into a clinic or are you out there looking to do collaborations with specific companies?
Sally Waterman:
Both ways and we've been very successful in getting grant funding, we've had a number of Technology Strategy Board grants that have allowed us to do collaborative work with companies such as a VC or Glycoform [PharmaDeals ID = 29650], Isogenica and we've announced today another Technology Strategy Board [PharmaDeals ID = 35646] to expand our technology into a new area where we are trying to infuse two very different proteins together chemically to produce a whole range of new molecules. And so we've collaborated with other companies and the idea is there that the companies if they like what we give them we take a license to our technology for particular application but in addition to that we are developing our own biobetter proteins and there the known proteins obviously they are biobetters so we've got a PEGylated interferon which we've used our highPEG technology which is where we PEGylate on a histidine added to the protein, we are taking that forward into development this year. Our intent is to take one or two potential biobetter proteins through to proof of concept prior to the clinic and then partner out license them.
Fintan Walton:
Right, so who would what sort of company would be interested in that ultimately is it a genericcompany or do you expect one of the existing players in the field to take a product?
Sally Waterman:
Well both generic companies and a lot of the big pharma companies of course have said they are interested in biobetters. As more and more people realize that it's going to cost a lot of money to get a biosimilar product to market there is much more focus on trying to make something that's actually better that you know we pay charged at a premium price and so I think big pharma who are into biobetters and also the generic companies who are into biopharmaceuticals could be interested.
Future goals
Fintan Walton:
Right, so what can we expect from PolyTherics going forward? Are we going to see more you know deals being done with major pharmaceutical companies, what can we except Sally from PolyTherics over the next few years?
Sally Waterman:
Well we've got a number of collaborations already, we announced earlier this year our second collaboration with Celtic Pharma [PharmaDeals ID = 29730] where we are PEGylating a blood factor for them. And we are about to announce actually another collaboration which is top ten pharma [PharmaDeals ID = 35837] for a product of commercial interest to them, so we can certainly hope to see more commercial deals, options deals where we use our PEGylation technology with other people's proteins and peptides. The company is particularly interested in using the technology to PEGylate peptides and proteins at very early stage of development even some of the new scaffolds perhaps where those products would not actually be successful without some technology to extend their half life and that's our ultimate goal.
Fintan Walton:
Sally Waterman, thank you very much for coming on the show.
Sally Waterman:
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).
Sally Waterman
Dr. Sally Waterman Chief Operating Officer; her previous responsibilities include Director of Research & Development at Protherics (now part of BTG), global drug development and a polymer research group in Salt Lake City and with KS Biomedix (acquired by Xenova), and also on non-clinical development at Vernalis.
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.
PolyTherics Ltd
PolyTherics is a company dedicated to using biomedical polymers to optimize pharmaceuticals, in particular biopharmaceuticals, for the treatment and cure of the world's most important diseases. PolyTherics 's most advanced programmes are designed to exploit TheraPEG technology, an innovative, patent protected approach to the PEGylation of therapeutic proteins and antibody fragments. Through the targeted attachment of PEG via naturally occurring disulfide bonds within proteins, biochemical and biophysical properties can be altered without compromising biological activity. Beyond targeted PEGylation, PolyTherics has developed proprietary polymer-based technologies for application to both small molecules and large proteins, to create a broad portfolio of improved medicines.