Speedel’s Renin Inhibitor Success Story




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Video title: Speedel’s Renin Inhibitor Success Story
Released on: February 01, 2008. © PharmaVentures Ltd
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Over a year on from their last discussion, Fintan Walton talks to Alice Huxley, CEO of the Swiss biopharmaceutical company Speedel. They look back at the company’s successes during 2007, in particular the launch of its renin inhibitor Tekturna® (aliskiren, SPP100) in the US and Europe. This is not only a first-in-class product, but the first of Speedel’s compounds to reach the market. The company’s plans to develop Tekturna further and to expand within the renin inhibitor field through its other drug candidates are also discussed. Alice goes on to offer an insight into the company’s strategy going forward in terms of whether it plans to in-license products or grow organically, and also talks about what 2008 may hold for Speedel.
Speedel's successes during 2007.
Fintan Walton:
Welcome to PharmaVentures Business Review brought to you by PharmaTelevision the world's first on demand pharmaceutical television channel. We are here in San Francisco recording a series of interviews at the Annual JP Morgan conference. This conference was originally run by the famous Hambrecht and Quist Bank and it's one of the oldest events in biotechnology. Today thousands descend from around the USbut also from around the world into San Francisco to do financial deals and recently it's also become an important partnering event. I hope you enjoy the series of interviews we've done from some of the key companies attending this conference. Hello and welcome to PharmaVentures Business Review here in San Francisco. On this show I have Dr Alice Huxley, who is CEO of Speedel which is based in Basel in Switzerland, welcome to the show.
Alice Huxley:
Thank you very much Fintan. Good afternoon.
Fintan Walton:
Good afternoon to you. Now Alice Huxley you've been on our show before just over a year ago now I think so lot has happened in 2007 we are now in 2008 but 2007 was a pivotal year for you, your lead product was launched both in the US and in Europe and you've managed to pick up a Gold Award from the Wall Street Journal as well, you happy?
Alice Huxley:
Yes. Yes we are very happy. I am happy and my collaborators are happy as well. Indeed 2007 was very, very important you remember that Speedel is working in the area of cardiovascular and metabolic diseases and you may remember from our previous interview that we managed to get to this our partner Novartis to bring the latest innovation in the area of cardiovascularand metabolic diseases in a form of a renin-inhibitorto the market.
Fintan Walton:
Okay. Well so I mean when we did do the interview before you were hoping to successfully conclude all your clinical trials get registration approvals so there you where in the on the brink of getting registration and so it in a way now things have changed for Speedel because before over a year ago you were a company that didn't have a product in the market now you have through your collaborator Novartis [PharmaDeals ID = 8957] a product on the market does that change things for Speedel ?
Alice Huxley:
Of course it did. Speedel is now one of the very few biotech's in Europe and actually worldwide that has a product on the market and this is the bigger goal of every and each young biotech company, so we are there it is our first product and that's something really very important.
Alice Huxley's advice on success for entrepreneurs.
Fintan Walton:
Right because we remember you are the founder of this company to get out of the original merger between Ciba-Geigy and Sandoz [PharmaDeals ID = 218] at the time you were determined to set up Speedel and take this compound which was going to be dropped originally if I am correct"
Alice Huxley:
Yes.
Fintan Walton:
And take it forward, so now you've got your dream as more or less come true whats for all those other entrepreneurs that are out there trying to think of similar things what things when you look back would you like to advice them on? What things would you say to them now you should get right?
Alice Huxley:
Well I do not have a perfect recipe for every and each success, what I think I can summarize in a nutshell is good innovation, good ideas, good people and never give up.
Fintan Walton:
Right.
Alice Huxley:
That would be if you will the short summary of my guidance to everybody else. Of course we had a unique start based on a product which indeed was no longer in the development pipeline of a newly created Novartis but it was based on more than 10-years of our research activities at Ciba-Geigy. So we knew that we have a potential blockbuster in our hand, we understood the technology as I said it's a renin-inhibitor and of course we are very, very happy that after 12-years it took the whole industry 12-years to bring to the patient something new innovative that we managed.
Speedel 's plans on further development of Tekturna.
Fintan Walton:
Right. Now we've looked at the success of your lead compound but you've also got other compounds in development in fact with your lead compound there are many multiple ways in which you can treat patients with that particular medication?
Alice Huxley:
Indeed, indeed the primary indication for this renin-inhibitorSPP100 or Tekturna that's a trade name here in United States and Rasilez in Europe, the main primary indication for which there is a registration in place in United States and in Europe is essential hypertension, so for this is a drug for treatment of elevated blood pressure. But we are already looking at the next era of the use of Tekturna still in clinical development but this goes beyond blood pressure, this goes into the area which one can call end organ protection and this is the next big step that Tekturna has to achieve.
Fintan Walton:
So part of the strategy clearly is to expand the breadth of indications to which this use?
Alice Huxley:
Definitely, definitely.
Fintan Walton:
And obviously that opens up the markets and so forth, behind Tekturna is a series of other compounds making the way through clinical trials, could you give us an update on what's happening there?
Alice Huxley:
Gladly. Tekturna is the first renin-inhibitor for ever will be the pioneer of this new mode of action but you know traditionally the history teaches us that there are usually several other drugs of the same mode of action with slightly different properties that will get to the market and help specific patients so we are working in this area of renin inhibition on next generation renin-inhibitors and we have already three of them which we have developed in our research in clinical development. Eventually we wanted to partner them with different big pharmas and it would be our big dream that one company Speedel to get it with its partners could bring to the patient more than one renin-inhibitor.
Fintan Walton:
Sure.
Alice Huxley:
So that's the area of renin inhibition. Apart of that we are working also in the area of endothelin-receptor blockade with our product coded SPP301 it's in development for diabetic kidney disease and very soon in March, on March 31st we have our R&D day, we are planning to disclose to the public yet another mode of action within cardiovascular franchise that we are working at.
Speedel 's strategy going forward in terms of in-licensing products and partnering.
Fintan Walton:
Okay. So clearly you are still focusing on your own compounds taking those forward. You've been successful with one of the compounds taking it through to the marketplace, our pharmaceutical industry is a risk game you are not always going to be successful, we do like to hope that you are successful every product that you take through, but there will be failures inevitably as it can be within the pharmaceutical industry. So in terms of additional compounds how you move forward for a company like Speedel capitalizing based on the success you got so far? Is your strategy to look for new compounds to broaden Speedel looking at potential acquisitions may be now that you've got some successes behind you?
Alice Huxley:
Well we are always looking around for jewels if you will or diamonds in the rough such as SPP100 was couple of years ago, it is getting increasingly difficult to in license attractive assets and albeit we are screening the whole biotech and pharma out licensing pipeline it is not easy to find something that fits our quality and other parameter, so primarily we plan to grow from inside we have our own research unit called Speedel Experimenta and as I have mentioned already three molecules out of our own research are in clinical development, so that's the primary source of clinical development candidates.
Fintan Walton:
And in terms of commercial development and taking molecules yourselves to market you've mentioned already that you are looking for partners for your existing compounds , is there a point in the near future where you would want to take the compounds all the way through to into the market yourselves without sponsorship from another partner company or you know are you always going to take continue to take the strategy of partnering?
Alice Huxley:
Fintan Walton, I believe we do whatever is best for the individual drug candidate. Whenever we are dealing with the drugs products that need large sales forces marketing huge Phase III program we will go for partnering. Whenever we have a product in our hands for a niche indication or a specialist indication where we could on our own master the Phase III and then there after marketing and sales forces then I think we will seriously consider that as well but whatever we do should be the best for the product to get it as expeditiously and as successfully to the patient as possible.
Financing and revenue streams of Speedel .
Fintan Walton:
Right. The other thing of course having a product on the market now with Novartis and still early days you know how you are going to grow, how that market is gonna actually grow and so forth, but from that obviously you are going to get revenue streams coming through that's the form of financing for your company, you are listed on the Swiss Stock Exchange?
Alice Huxley:
Yes.
Fintan Walton:
Does a company like yours depend purely on it's financing from it's royalty streams for it's existing products or are you going to look for additional funding to help develop some of the compounds you've got already?
Alice Huxley:
Everything depends on our cash needs in the next couple of years the more attractive our pipeline is the more money we would need and that's basically good. As a company with a permanent stream of revenues now recurring stream of revenues we are of course in another league than we used to be when we were just purely loss making company just with hope and dreams if you will so the situation has changed and we will do as in the past whatever is the best for the company and our shareholders.
Fintan Walton:
Did you ever think when you look back when you started Speedel that you'd ultimately create a company with a market cap of excess of a billion dollars?
Alice Huxley:
Not at all, not at all. In those early days you know we had only one motivation and one driver and that is to make the almost impossible possible to be the first company that will manage to bring a renin-inhibitor forward. You know the history of renin inhibition is a very, very strange one. All the big pharmas worked in that area and none of them managed and then you know there was this young at the beginning unknown biotech in Basel called Speedel which has started in the attic of my private house in Basel to get it this to other people and our only goal was to make it a success, all the financial or monitory or other aspects where non-present we just had a strong desire to make it.
Key events coming up for Speedel in the future.
Fintan Walton:
Okay. Now you've had a good 2007 what are we going to expect from Speedel in 2008? What do you see as key events coming up in 2008 year?
Alice Huxley:
The key events with regard to product and molecules that are dear to our heart of course are additional clinical trials from SPP100, Tekturna, Rasilez in the area of end organ protection. We are waiting anxiously now for the third result of the series of end organ protection clinical trials and then we are waiting for yet another approval of SPP100 in a combination, fixed combination with a diuretic that would be the second approval. So these are very important results. Further on we are waiting for results from Phase I and Phase II with our own renin-inhibitorand we are starting an important Phase IIb clinical trial with our endothelin-receptor blockade in diabetic kidney disease, plenty of things to do on our agenda definitely.
Fintan Walton:
Excellent, well thanks a lot Alice for coming on to PharmaVentures Business Review and learning more about Speedel . Thank you very much indeed.
Alice Huxley:
Thank you Fintan Walton, thanks for your interest.
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).
Alice Huxley
CEO
Dr. Alice Huxley is CEO, President and co-founder of Speedel . Before the birth of Speedel in 1998, she was Global Project Manager at Novartis Pharma and has extensive experience in research and drug development process in a matrix-type pharmaceutical R&D organization. She has led several global multidisciplinary teams that have successfully brought innovative drugs to market.
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.
Speedel
Speedel is a biopharmaceutical company that develops innovative therapies for cardiovascular and metabolic diseases. It was founded in 1998 through the merger of Ciba-Geigy and Sandoz, and has a focus in renin inhibition, a promising new approach with significant potential for treating cardiovascular diseases.In addition to SPP100Tekturna, now approved for use in hypertension, but still under development for other indications, the company's clinical pipeline includes two other renin-inhibitors (SPP635 in Phase II and SPP1148 in Phase I), an endothelin-A-receptor-antagonist (SPP301, in Phase II), and a direct-thrombin-inhibitor (SPP200, in Phase II).There are also several preclinical projects with other renin-inhibitors.Tekturna is partnered with Novartis.