April 28, 2014 Issue
The Most Powerful Name In Corporate News and Information
Plant-Based Manufacturing Platform for Critical Illnesses
About PlantForm Corp
Dr. Stewart served as Director Research of Cangene
Corporation. At Cangene, Canada’s largest biopharmaceutical company, he
gained broad experience leading programs to develop biosimilar and
innovative antibody and protein drugs. Dr. Stewart studied biochemistry and
cell biology and graduated with a PhD from the University of London,
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – April 28, 2014
CEOCFO: Mr. Stewart, last year we spoke and you told us “PlantForm is focused on providing affordable healthcare solutions specifically generating high value, high cost biological drugs at lower cost to the consumer. “How have you advanced that over this past year?
Mr. Stewart: We have concentrated on that vision since we last spoke and we have received financing to advance our biosimilar Herceptin® (trastuzumab) project. We have engaged in a joint venture with a company in Brazil, which will advance a second bio-similar candidate. We are also assessing new biosimilar candidates that are in the orphan drug regime.
CEOCFO: Why did you decide to look at the orphan drug arena?
Mr. Stewart: We have interest in our large-market biosimilars. The area is competitive. It may be that our best approach is to go into secondary markets first and concentrate on areas where there is less competition. There is more opportunity for a company like ours to create an impact for the patient by concentrating on the areas where there are smaller opportunities in terms of number of patients served, but a bigger impact on those people.
CEOCFO: Are biosimilars becoming more acceptable?
Mr. Stewart: I was at a conference last week in New Jersey; there are a large number of conferences on biosimilars and the speakers tend to be very much the same. New biosimilars have come into the market; however, in terms of a thinking process, there is not much development and that is partly because of the continuing lack of issued guidelines by FDA. In terms of acceptance of drugs, the biosimilars definitely are more accepted in Europe. The biosimilar drugs in the European markets are enjoying increased sales compared to other markets so there have been significant advances in market penetration. In general there is wider acceptance but still a degree of caution.
CEOCFO: Would you tell us about biosimilars in general?
Mr. Stewart: A biosimilar is a similar version of a large-molecule drug. The term generic is used for small molecule drugs: exact copies are brought into the market when the patents on the name-brand originators expire. The regulatory agencies have come up with different terminology for large molecule drugs: biosimilar or follow-on biologic and a few others which describe a different path to approval to the market. A generic drug requires a complete characterization of the molecule as well as safety studies in animals and also a Phase 1 study in man. That gives you the path to approval for a generic drug. However, for a biosimilar drug because less is known about them, there is an additional requirement for clinical trials that typically can be an abbreviated Phase III study on one of the indications for the innovative drug.
CEOCFO: You recently added a VP of drug development to your team. How will he enhance the team and why is this the time?
Mr. Stewart: We are excited to have Craig Binnie on board as VP of Drug Development. He is an experienced pharmaceutical guy in the biologics area. He worked for Pfizer in the UK, Cangene Corporation in Canada as well as YM Biosciences which was successfully sold for over half a billion dollars last year. PlantForm has advanced from being a company doing research both on the production platform and on the early-stage developments of products to now bringing products through the development path to IND submission and clinical trials. Craig is the person who is going to lead that new initiative for the company where we have gone beyond being an early-stage research/development company to a company with a concentration on bringing our trastuzumab biosimilar through the clinical trial pathway towards market approval.
CEOCFO: How far will your current funding take PlantForm?
Mr. Stewart: Currently we are funded for about twelve months. We are engaged in a number of initiatives to seek additional funding focused on financing our Phase 1 clinical trials. We are excited about the possibilities that there seems to be a greater appetite for early-stage life sciences funding now that there was twelve or eighteen months ago.
CEOCFO: Would you tell us about the contract with PharmaPraxis in Brazil?
Mr. Stewart: We have an exciting relationship with a company called PharmaPraxis. It is part of the Axis Pharmaceutical Group based in Rio. They are a group with experience in the number of areas in provision of health care, including marketing and selling drugs as well as early-stage drug development and hospital and clinic management. Our relationship with them is being developed right now but we have announced that we formed a joint venture agreement. In the next couple of months we will be in a position to provide information on how that will be funded. We have had positive developments on that for the partnership.
CEOCFO: Was going into Latin America part of your strategy?
Mr. Stewart: It was opportunistic but also it reflects PlantForm’s business plan and also the PharmaPraxis business plan. Our objective at PlantForm is to develop distribution and marketing relationships with companies who have expertise on a regional basis. These could be large pharma companies who have great expertise in many of the markets or could be smaller companies who have expertise in a particular area and PharmaPraxis and their partners have expertise in the South American markets. Brazil is the seventh largest pharmaceutical market in the world and we anticipate it to become the fourth largest one in the coming few years. For us, Brazil is an important target. There is an understanding of biosimilar drugs in that domain and it fits with our strategic direction. With PharmaPraxis they are engaged in the business of bringing biosimilars at low cost into the market and have been exploring opportunities to work with a plant-based manufacturing system. We have advanced to a variety of sources for financing.
CEOCFO: Will you look internationally and do you see that as a better opportunity than the US?
Mr. Stewart: The U.S. is huge market and very important. The patents on many of the biosimilar drugs expire later in the USA than they do in other international markets. We have decided to focus on international markets at this time to bring drugs into the market and then use those files to advance drugs in the U.S.
CEOCFO: What is PlantForm working on today and what might you work on a year from now?
Mr. Stewart: Our major focus is on our biosimilar trastuzumab project and we are advancing our biosimilars program with a second candidate. We have completed a contract with the U.S. Defense Advanced Research Projects Agency (DARPA) on butyrylcholinesterase and that project and another project related to bioterrorism are being funded jointly between ourselves and the university that we spun the technology out of, which is the University of Guelph. This funding will be coming from Defense Canada. In addition, we have a strong relationship through a Canadian program called CHTD, which is funded jointly by the Bill and Melinda Gates Foundation and the Government of Canada. Under this program we have secured the second round of financing to advance the development of anti-inhibitory HIV/AIDS drug candidate. We have a number of things in development. We feel it is important to have different candidates at different stages of development. A year from now we hope to have our biosimilar Herceptin more advanced for clinical trials and further developments including evaluation of potential new biosimilar candidates at the early stage in our lab.
CEOCFO: Last October PlantForm won an Excellence in Writing award. Would you tell us about that?
Mr. Stewart: We are excited about these types of opportunities. The Excellence in Writing award is recognition of scientific writing. We just received an award related to partnering with a community college and recognition of PlantForm’s efforts to support the college and provide opportunities for their students and to learn about biotechnology. The relationship has benefitted us by a number of their students coming to work with us as full-time staff and also on the shorter-term contract placements.
CEOCFO: How do you focus your time as CEO?
Mr. Stewart: I spend much of my time on investments and investor issues. It is important to me that our current investors are properly informed. I am also spending time meeting with new potential investors and financial institutions that can support us now that we are in the second wave of development of our biosimilar Herceptin. This type of drug development is an area that I am quite familiar and although Dr. Binnie is looking after that project, we are both engaged in the decision-making process. I bundle my time between finance probably 70% and 15% of the time on our key projects and 15% on general activities.
CEOCFO: You have over 20 years experience in biotech; why are you sure about PlantForm?
Mr. Stewart: I like the blend that we have--a unique and interesting technology that helps the unmet medical need. It is important for us as a society to bring medication at low-cost to people in need. What excites me about PlantForm is that we have the opportunity to do this and it is based on solid science and based around an expanded team of experts.
CEOCFO: Final thoughts?
I am excited about the opportunity for PlantForm and the biotechnology
industry moving forward. I think the appetite for financing both from
government and venture is making money more available in more areas and
there are many opportunities that have been built upon over the last couple
of years and there will be an opportunity to advance them in the next couple
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