PharmaTelevision - How SkyePharma Makes Good Drugs Better

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Video title: How SkyePharma Makes Good Drugs Better

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One important role of drug delivery companies is to improve or reposition existing drugs by the application of their own technologies. Christopher de Souza, VP Business Development, explains the technologies that SkyePharma is developing and how they will fit into current clinical needs. He discusses the changes that the company and drug delivery industry have gone through recently with a focus on inhalation products and the extent to which they will be used in the future.

SkyePharma's technology platform from a drug delivery perspective

Fintan Walton:

Hello and welcome to Pharmaventures business review here in Mannheim, Germany. On this show I have Christopher de Souza who is Vice President of Business Development at SkyePharma and you're based in Cambridge, Massachusetts. Welcome to the show.

Christopher de Souza:

Thank you.

Fintan Walton:

Christopher, SkyePharma is a company that has been around for several years now over since the early 1990's. It's a company that has clearly made it's mark in the area of drug delivery. I know that in it's journey it's acquired a number of companies and products in that journey, it also at one stage considered itself more as a specialty pharmaceutical company but today it still is a drug delivery company?

Christopher de Souza:

That's right, that's right.

Fintan Walton:

Yeah, so remind us then of what SkyePharma is in terms of it's technologies? What is your technology platform from a drug delivery perspective?

Christopher de Souza:

So you can put our technology into two spaces oral and inhalation and from inhalation perspective we have developed several products into the market that support an MDI which is a Metered-Dose-Inhaler, which is a Gas Propelled inhaler and a Dry-Powder-Inhaler along with lot of expedient related IP in that space and that's " it's a very specialized space you don't have the lot of players over there. In the Oral we have a Geoclock which continues to be a very robust and very productive platform for us which can deliver profiles that are variable single drugs, combinations of drugs and in the solubilization technology.

Fintan Walton:

Okay.

Christopher de Souza:

That enhances by availability.

Fintan Walton:

Just going to the Geoclock technology because that is controlled release? Specialized controlled release?

Christopher de Souza:

It's, yes it's controlled released but it's versatile in that you can do both in immediate release and a controlled release of the same drug. You can take a combination of drugs and do immediate release of one with controlled release of the other. So it's quite versatile. So to say it's controlled release is perhaps under mining the potential of that particular platform yeah.

Drug delivery and it's functional role in taking drugs that exist today.

Fintan Walton:

Right. drug delivery has been around now for nearly 30-years that was back in 1969 when (indiscernable) was formed Elan [PharmaDeals ID = 8465]was once originally a drug delivery company and even a company called Ciba produced a patch and way back in the late 60's and drug delivery has always played a role had a functional role in taking drugs that exist today and making them better, perform better, is that still the case?

Christopher de Souza:

Yep, that's our tag line making good drugs better in the sense that there is always the challenge as new drugs come about to improve them from a clinical perspective or to what the new term today is reposition them to take existing drugs and find new opportunities for them because after all it is tremendous amount of money invested in every single drug and why not then leverage that particular asset into other areas.

SkyePharma's competitive advantage over other drug delivery companies.

Fintan Walton:

Right. Now because drug delivery has developed itself there are lots of different technologies out there some of which is patent protected and some of it's not. So how does a company like SkyePharma position itself in relation to these other drug delivery companies? what is it about your firm your company that allows you to have a competitive advantage over other drug delivery companies?

Christopher de Souza:

So using Geoclock in IDD we've been very successful in taking 10 products to market for our partners. So in the process we have continued to generate new IP around the technology but the value that we bring to our partners is to take their technology, their compound and generate additional IP around their compound in that specific formulated and delivery mechanism either repositioning in into a different disease area or meeting or circumventing certain clinical issues associated with their current drug. So that allows them to have new IP and extend the life cycle of their drug or transfer it into a whole different area.

Fintan Walton:

Right, so the key thing here obviously with " with drug delivery is that you have some sort of level of control, you can change the properties basically or -- and obviously then has an impact on the Pharmacokinetics or the availability of a product?

Christopher de Souza:

Or the time when the drug is available.

Fintan Walton:

Right.

Christopher de Souza:

Especially night time drug delivery, you don't have a patient waking up at 2 o'clock in the morning to take their tablet. But with Geoclock and what we call Geoclock the patient can take their drug their tablet at 9 o' clock at night and we can specify or predetermine when that drug is released into circulation.

Fintan Walton:

Right.

Christopher de Souza:

So for things like sleep maintenance for rheumatoid arthritis these are important factors that were not addressed in the past.

SkyePharma's business model and the licensing of technology.

Fintan Walton:

Right, now the business model that you have is that you will work with a partner company could be a pharmaceutical company, could be a biotech or a start up type company. What is the reward basis? You are licensing your technology on to on to the pharma company or the partnering company? Do you work on a fee for service basis or do you work on royalty milestone royalty basis?

Christopher de Souza:

On the later. So we will work with the partner and develop their product for them applying our technology and extending our technology to cover their compound in it's new formulation and that allows us then to get milestones and a small royalty. The royalty obviously depends upon how much money we invest versus how much the partner invest. We've always shown situations taken concepts that we've generated, demonstrated that we can deliver what we have conceptualized and then obviously we get a slightly higher return on that investment or in some situations we've taken it all the way through a fairly late stage in clinical development and got a higher rate of return on that investment.

Selection of compounds and products

Fintan Walton:

Right, so that's clearly important because what you are doing then is a drug delivery company you are not just simply saying look we've got technology you can have a you can play with it or use it and we help you develop it. You are prepared to take on that risk yourself around your own technologies?

Christopher de Souza:

Yes.

Fintan Walton:

How do you select the compounds and the products to take all the way through?

Christopher de Souza:

That's always a challenge it generally we will start up with an unmet medical need. We see that there is a compound or a combination of compound that could serve a clinical benefit, there are issues with it right now perhaps adverse events that we can alleviate through controlling the release or putting the two drugs together to get a synergistic effect not just convenience in the today's world conveniences not reimbursable but to get a synergistic effect that has a clinical benefit. So we are constantly looking at the landscape and trying to find opportunities and we have a few in the past and we continue to put some more in.

Fintan Walton:

Is it from your experience as a company that has taken products through from " into P Phase II and then even into Phase III is it actually worth taking a product into Phase III to partner? do you actually get that additional inflection point in terms of value?

Christopher de Souza:

I think in the inhalation yes we've taken Flutiform all the way through to Phase III the beginning of Phase III before we license it out to kos [PharmaDeals ID = 24163] which now is a part of Abbott Respiratory [PharmaDeals ID = 25720] very good returns, we are very happy with that. We licensed it out to Mundipharma [PharmaDeals ID = 25213] in the U.S. cure and but that also requires a healthy amount of investment. What we've done in the much later program we took a concept and we licensed that concept out with it's IP to a VC they put a company around it and we continued to work with them in the area of sleep maintenance. So we've done both ends of the spectrum.

Manufacturing facilities of the company.

Fintan Walton:

But the key thing here is at the -in the current business model is it your drug delivery company not specialty pharmaceutical company?

Christopher de Souza:

That is correct, that is correct.

Fintan Walton:

And then that is " is you know lot of other drug delivery companies have taken away their name drug delivery and called them specialty pharma themselves with specialty pharmaceutical companies. Wasn't that a temptation for SkyePharma or isn't that a temptation for SkyePharma?

Christopher de Souza:

So let me clarify. How do you define a specialty pharma?

Fintan Walton:

Well a specialty pharmaceutical companies saying that they will take products to market, they will take it all the way through not just taking through, taking the clinical risk up to a certain point where they partnered it out but actually saying look we are gonna actually build our own portfolio products?

Christopher de Souza:

Yeah, so I'm not sure if that was discussed in the past but in it's present form for the last several years now we are strictly a business-to-business. We are not going to develop a commercial arm. We find that our competence is in drug delivery and we would rather partner with companies that have strong sales force and really specialized in that area just as we specialize in drug delivery.

Challenges in inhalation therapeutic area

Fintan Walton:

Right, the other component that SkyePharma has is it's manufacturing facilities?

Christopher de Souza:

That's true.

Fintan Walton:

What is that bring to the table when you -- when you're talking to potential partners?

Christopher de Souza:

Yeah, so Geomatrix is not a run of the mill manufacturing it it's not very difficult to do but it does require special manufacturing line, in some situations with the larger companies we've transferred the technology over to them with PAXIL-CR for example for GSK [PharmaDeals ID = 2260] and they've manufactured but for some of our small partners who don't have manufacturing we are strictly marketing organizations. We give them that added service so that we help them with their development, we help them with the clinical and regulatory and we continue to manufacture for them. So they can just focus on the marketing for themselves.

Fintan Walton:

Right, and then is that done on a fee for service basis or is a still part of the milestone royalty package?

Christopher de Souza:

It's a fee for service. Yeah.

Fintan Walton:

Right, so that is added to

Christopher de Souza:

That's added value, yes.

Fintan Walton:

Added value to the package. So we talked about you know the skill sets in inhalation and also the Geomatrix but also solubilization side of the business. In the inhalation area is there we've the industry has looked at inhalation a number of -- a number of traditional ways obviously asthma is a very classic way of delivering products through the lung. Is there from your perspective looking at the inhalation market still any potential for drugs to be delivered other than the traditional therapeutics areas?

Christopher de Souza:

Well asthma and COPD, especially COPD remain a very significant unmet medical need and that will continue to go on. I think what is challenging in inhalation is that it's not as easy to get approval as you would with an oral drug taking and existing drug so several of the drugs that are on the market today in Advair , Symbicort and Flutiform are existing drugs that have been around for a while but every time you put it into a new device or you try to deliver it into lungs the regulatory challenges a quite " quite stiff and it's almost always a 505(b)(2) at the minimum. So the investment stake are quite high for lot of peoples, so keeps lot of people out but also it's very specialized technology and unlike in the oral area where you have a lot of drug delivery companies doing formulation you really don't have a lot of companies, players in the inhalation area the large pharma's have their in-house inhalation but not all of them do, just say AstraZeneca [PharmaDeals ID = 9625] and GSK [PharmaDeals ID = 15070]. So this, the other companies that have a one off or a two off program have to find a competent partner to help them with drug delivery inhalation.

Fintan Walton:

Right.

Christopher de Souza:

And that's where the field is windling [Ph]. we have seen >Novartis [PharmaDeals ID = 14763] SkyePharma and Novartis] just acquired > Nektar [PharmaDeals ID = 31465] so that's one, that's one best player in the inhalation field and we've " we continue to build that area for ourselves.

SkyePharma's technologies in solubilization

Fintan Walton:

Right, right. Now the other area that you, you mentioned we talked about Geomatrix the old part of your technology but you've also got solubilization?

Christopher de Souza:

That's true.

Fintan Walton:

Technologies, solubilization is clearly an area that many companies have tried to crack through in their own broad range of different technologies or what is unique about your technology that would attract the company to come and use your technology?

Christopher de Souza:

It's true. So you're absolutely right. There is a broad range of technologies in solubilization and not one technology fits all projects, all needs and not all needs are managed by one particular technology. What we bring is -- is an array of solubilization technologies within our solubilisation platform that we will run a program through and then choose the best one. So in that sense we can solubilize all the way down to the nano area and having done it several times we've been able to alleviate the food effect increase viability, but that said you're absolutely right there are other companies they can do it. It's just a question of figuring out which is the right solubilization technology for the problem that a specific compound is facing and that depends upon the physical, chemical properties of the compound the solubility etc.

The next big news from SkyePharma.

Fintan Walton:

So when we look at SkyePharma and we look at the products that are in development in partnership with other companies what's the next big news that's is gonna come out of SkyePharma?

Christopher de Souza:

The next big news is the approval of Flutiform the clinical development has been completed in the U.S. we are on track to file an NDA with our partners in the U.S. for the first quarter of 2009 with our partners here in Europe and Mundipharma [PharmaDeals ID = 25178] end of 2009. So that's a highly visible and much tracked program. It's been a huge investment on our part and we are very excited about that opportunity. We have just recently licensed the sleep maintenance program to Somnus [PharmaDeals ID = 27547] that's moving along really well, that's going to take an existing drug and reposition it and set up a whole new indication of sleep maintenance versus just sleep inducement and we will be developing more projects on to into our pipeline that will be home grown, that we will continue to bring and make available to our partners.

Fintan Walton:

Okay. Well Christopher , we look forward to hearing about all these new break throughs over the next few years. Thank you very much indeed for coming on the show.

Christopher de Souza:

My pleasure. Thank you.

Fintan Walton:

Thank you.

Christopher de Souza

VP Business Development

Dr.Christopher de Souzanot only holds the position of VP Business Development at SkyePharma, but is also a Consultant at MOITI, the Massachusetts Office of International Trade & Investment and a Co-Chair of Business Development Committee at the Massachusetts Biotech Council. Before joining SkyePharma, Christopher de Souza was both a Consultant at Biopharmaceutical Business Development and a Director, Strategic Alliances at Novartis. Dr. de Souzastudied at Rutgers, The State University of New Jersey, the Louisiana State University and the Agricultural and Mechanical College at the University of Mumbai.

SkyePharma

SkyePharmais a specialist drug delivery company developing oral and inhalation products. They partner with a wide variety of companies from big pharmaceuticals, such as GlaxoSmithKline, Novartis, sanofi-aventis, AstraZeneca, Roche and Abbott Laboratories to a range of smaller specialty pharmaceutical companies. Whilst continuing to benefit from existing approved products, the Group aims to enhance it's product pipeline by identifying additional candidate products through it's own research as well as collaborations with partner companies. SkyePharma'sGeoclock and Geoclock technologies enable controlled- or timed-release versions of immediate-release products to be developed providing advantages to both partner companies and patients.