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Questioning Market Leaders For Long Term Investors |
JAN TUREK - BIOLEX INC DOCUMENT # NAC621 JAN TUREK, President and Chief Executive Officer, Member of Board of Directors of Biolex. Mr. Turek has over 25 years experience in the pharmaceutical industry. Prior to joining Biolex, he was Senior Vice- President and General Manager for the Biological Products Business Unit of Bayer Corporation, a unit dedicated to therapeutic proteins. He has extensive experience in directing research, development, manufacturing and marketing of therapeutic proteins and small molecules. His previous experience was with Bristol Myers and Sandoz, where he held various positions of increasing responsibility. He has extensive international experience, having worked in Canada and Germany. Mr. Turek received his Bachelor of Science degree in Biochemistry from McGill University in Montreal Canada. Sector: biotechnology TWST: Could we start out with a quick overview of Biolex as you see it today? Mr. Turek: Biolex is a company that was founded in 1997 focusing on developing the next generation of patented recombinant protein production technologies in a plant-based system. We selected Lemna ' what we call duckweed plant ' as this system. Duckweed is one of the world's smallest flowering plants, has the fastest growth rate of all higher plants, and is a staple food of waterfowl, fish and so on. Our company turns this plant, Lemna, into a powerful production platform for biopharmaceuticals. With the Lemna System_, we can make recombinant proteins secreted from Lemna. Lemna has some very exciting characteristics that make it very suitable for this technology. It can produce a wide variety of proteins. We've already shown that by making eight different proteins with our Lemna System_. It also has some unique characteristics; it's a clonal plant, which means that it's asexual, reproducing by cloning itself. This eliminates the cross-pollination issues that can happen with some of the other plant production systems. Lemna has a very fast growth rate, doubling itself every one and one- half days, which allows for a very fast scale-up and a very large part of the plant is protein. 25%-35% of Lemna's biomass is actually protein and this allows for not only fast scale-up but also makes an abundant amount of protein available through our Lemna System_. The plant itself has some great characteristics, and it also can be grown in buffer solution, which makes it very economical. It can also be grown in enclosed systems such as those you would see at an FDA compliant facility. Lemna allows itself, very easily, to be scaled up efficiently, at low cost, and in an FDA regulatory environment. It can be managed very efficiently in that system. TWST: Why use a plant? Mr. Turek: Our plant-based approach, using the Lemna System_ is more cost-effective, producing higher yields than current systems. There are a number of other systems that are available, right now, for generating proteins. There are fermentation and self-culture systems; those are currently the only means of commercially producing pharmaceuticals. What is happening right now is, the capacity for producing proteins is becoming tighter and tighter. Worldwide capacity is at a maximum. In fact, some protein therapeutics such as Enbrel from Wyeth-Ayerst and Factor VIII from a number of other companies are actually in short supply. The actual capacity for manufacturing these types of proteins are very tight, and with over 700 proteins in research and development right now, the expectation is that the capacity requirements will increase between five- and sixfold in the future. With all of that as backdrop, more and more pharmaceutical companies and biotech companies are looking for alternative methods for scaling up their proteins in a fast, cost-effective manner. That's where Biolex, and our Lemna System_, fits perfectly, providing low-cost, efficient scale-up for these therapeutic proteins that are, of course, very much required by patients on a worldwide basis. TWST: What are you producing now? Mr. Turek: Right now, we have actually expressed and purified alpha- interferon, which is known by the trade name INTRON'-A. We have been able to make INTRON'-A at approximately the same levels as one would find from the current systems available in the marketplace. The protein we've produced has been shown to be comparable to the INTRON'-A on the marketplace, but we can produce it, by our estimations, at as little as one-tenth the cost of producing the INTRON'-A currently on the market. Now we have not, of course, brought this product to the marketplace; it's still in development. However, it is our expectation that our version of the protein will be produced at that kind of cost savings and scale-up advantage. We've been able to use alpha-interferon as the proof that the low-cost, fast scale-up benefits of the Lemna System_ can be realized. TWST: What do you have to do to get from where you are today to commercialization? Mr. Turek: Our goals are very simple. We want, as much as possible, to partner with other pharmaceutical and biotech companies to further prove the Lemna System_. They can work with us at further developing the system with the proteins we have, proteins such as alpha-interferon, or human growth hormone, and with proteins that they may have in their own pipeline. We would also be open to outlicensing our technology to various biotech and pharmaceutical companies to allow them to use that technology to develop these proteins for themselves. Finally, Biolex's long-term goal, or strategic vision is to become a premiere protein company, and to develop our own proprietary proteins for the marketplace, through collaborations with universities, or in cooperation with other companies. TWST: To fulfill that vision, what steps must be taken? Mr. Turek: We'd really like to enter into partnerships with a number of pharmaceutical companies to help us develop our proteins. We have made significant progress already toward commercialization, including developing greenhouse facilities to allow us to scale-up the proteins. However, we really need to take our development to the next phase: getting our greenhouses in place to allow us to produce the proteins, and then having them enter into the rigorous regulatory environment that any protein has to negotiate. TWST: Meaning FDA approval? Mr. Turek: Absolutely. TWST: What kind of time frame might you be looking at? Mr. Turek: As you know, the normal time frame for bringing any protein or any drug to market, depending on the drug's stage of development, can range anywhere from 8-10 years. Our goal, of course, is to work with the partners that we have to shorten that time frame as much as possible, because part of the reason it takes so long is the investment required by the manufacturing facilities. Those investments can range from $200- $400 million, and the construction of those facilities can take up to seven years. With our scale-up advantages, and the lower-cost facilities that we would be able to offer, we believe Biolex's advantages are cost savings and also time savings during the drug development process. TWST: What's been the response of potential partners? Mr. Turek: Being a new company, we've just begun, in the last 18 months, to make contacts with companies. Our first goal was insuring the achievement of our research and development milestones. We've really set those in place to make sure that when we did discuss cooperation with pharmaceutical companies, we could show them proof positive that this system actually works. We've done that, expressing eight proteins at this point. We're now able to show that our alpha-interferon is comparable to the one currently on the market, and have, again, begun our scale-up and development of the necessary manufacturing facilities and so on. We've spent the majority of the last two years focusing on those things. Now we've begun to make contacts with biotech and pharmaceutical companies and the response has been very positive. Companies with proteins like Enbrel and Factor VIII on the market today are experiencing the crunch of not having enough capacity for those proteins, and these companies are very receptive because they're living that pain right now. You may or may not know, but for every $100 million in a protein's unfulfilled capacity, that can cost a company about $1 billion in market value. That's the significance of not being able to fulfill that need for capacity. These companies are very interested in Biolex as an alternative to the fermentation and cell culture systems that exist today. Then there are the biotech companies that are still in the process of choosing a system for their proteins in development. These companies are very interested in alternative methodologies for bringing proteins to market, because they want to turn their proteins into those that not only treat patients effectively but, also, can offer cost savings advantages to those patients and to the healthcare systems in which those patients participate. TWST: How did you gather the expertise behind Biolex? Mr. Turek: The company was founded by Anne-Marie Stomp, PhD from the Lemna System_ technology developed by Dr. Stomp at North Carolina State University. She is a leading expert in the field of plant biology and in addition to her current position as Founder and Chief Scientific Officer at Biolex, she is an Associate Professor in the Forestry Department at North Carolina State University. Dr. Stomp previously held teaching posts at Harvey Mudd College, and the University of Connecticut. She's had significant experience and it was her patent that was the foundation of Biolex's core technology, the Lemna System_. The whole process is patented and we have a very strong patent position. The Lemna System_, again, combines the actual benefits that the plant offers; the clonal nature; doubling itself in one and a half days; the ability to reproduce in a contained environment; the low cost of scaling up due to the proliferation rate; and the large protein mass. With our very strong patent position, this should give us a very strong foothold in the worldwide marketplace going forward. The advantages of the plant, combined with the intellectual property position, makes us unique in the biotech business. TWST: Is anyone else working on similar technology? Mr. Turek: There are a number of companies that are looking at transgenic plants. Most of those companies are looking at the crop plants like corn and tobacco, but those types of systems can be fraught with challenges. They have some of the similar advantages that we have, being plant-based, in terms of scale-up and cost savings, but there are some significant drawbacks surrounding the long-term requirements for crop plants to get the kilogram quantities necessary. We can get the kilogram quantities of our proteins, through the Lemna System_, in about one year, whereas crop plants can take over three years because they have to go through the growing cycle, then get seeds, etc. There are, of course, issues surrounding growing transgenic crop plants out in the open. You've heard some of the concerns about the use of transgenic feed corn. Some transgenic feed corn was recently discovered in taco shells. That's a challenge that we would not face at Biolex, because Lemna is not a crop plant. TWST: What's the competition like? Mr. Turek: The systems that exist today have many things that make them less attractive for continued use. These existing systems will get a diminishing role. You've got the existing microbial systems that use e.coli or yeast for example; they have difficulty in making the full, functional complex human proteins, and this is well-known in the literature. Complicated, complex proteins cannot be made easily in the microbial systems, but they can be made readily by Biolex's Lemna System_. If you look at mammalian systems, such as the CHO cell systems, they're really the ones that most of the companies are using. Although these systems can make a greater diversity of these complex proteins, they have some real disadvantages in the capital costs. It's extremely expensive to build these facilities, somewhere in the neighborhood of $400 million, and they can also have low protein yields, that makes these systems less attractive as well. TWST: What milestones have you set for Biolex? Mr. Turek: For us, clearly, there are a few, and you can really put them into two areas. From a technology standpoint, we want to continue advancing our technology very aggressively, and the way we will do that is to continue to demonstrate the versatility of the Lemna System_, showing that we can produce a wide variety of proteins. We'd like to do that in cooperation with other pharmaceutical or biotech companies. We also want to continue our scale-up activities, utilizing our manufacturing greenhouse facilities, and we will do that, of course, to FDA standards. As I mentioned, the advantages surrounding our system will allow us complete compliance with FDA standards. These are our main goals. And then, of course, from a business standpoint, we want to take those technical milestones and make sure that we have partnership milestones that allow us to advance other companies' proteins as well as our own through the Lemna System_. TWST: What are the risks? Mr. Turek: The risks surrounding this system are behind us, for the most part. The risk we worried about was whether we would be able to express proteins in the system, on a consistent basis, and we've already demonstrated that continuously. Every protein we have put through the Lemna System_ we have expressed, and expressed at good and, in some cases, extremely high levels. I think that was one of the biggest risks that we clearly overcame. As we go forward, the risks will center on our ability to engage in cooperation with pharmaceutical companies and together, bring their proteins through our system. Do I believe that's a big risk? I don't. I see it as something that is more time-related than risk-related. It's a matter of time before we have those relationships with pharmaceutical and other biotech companies. TWST: Do you have the cash to get from here to signing some of those agreements? Mr. Turek: Yes, we are right now going out to raise our next round of funding. We expect this round to be somewhere in the range of $10-$20 million. We have made substantial progress since our last round. At this stage of our discussions with a number of top-tier pharmaceutical companies and feedback from current investors, we're very confident that we will raise that round. That round, of course, will be mainly used to help us continue developing our system in cooperation with those other companies. TWST: Thank you. (TM) JAN TUREK President & CEO Biolex, Inc. 158 Credle Street Pittsboro, NC 27312 (919) 542-9901 (919) 542-9910 - FAX www.biolex.com e-mail: jturek@biolex.com Each Executive who is the featured subject of a TWST Interview is offered the opportunity to include an Investors Brief or other highlight material to be provided and sponsored by and for the company. This Interview with Jan Turek, President & CEO of Biolex, Inc., is accompanied by an Investors Brief containing corporate information. Copyright 2001 The Wall Street Transcript Corporation All Rights Reserved The Wall Street Transcript (TWST) interviews are published verbatim, and TWST does not in any way endorse or guarantee the accuracy of any information or opinions expressed herein and all opinions are subject to change without notice. Nothing herein constitutes a solicitation to buy or sell any securities. TWST interviews with CEOs may include include "forward-looking statements", which are based on factors that involve risks and uncertainties. Actual results may differ materially from those expressed or implied. TWST shall have no liability whatsoever for any trading losses arising out of use of this information. Copyright 1999 Wall Street Transcript Corporation. All Rights Reserved. |