Dr. Dixey: Phytopharm is a small drug discovery and development company. Our mission statement is to be a world-class pharmaceutical company by developing three first-in-class therapeutics in areas of higher unmet medical need. Now, that mission statement is an extremely ambitious one and is normally associated with companies that have a very large cash burn because to be in a position to develop first-in-class therapeutics in difficult to understand and treat diseases requires very long and difficult work, and it is consequently associated with long research times. Phytopharm, however, is unusual in that it has been able to operate in this difficult sector on a low cash burn because we have developed medicines from medicinal plants. Now, medicinal plants have been a rich source of pharmaceuticals ever since the dawn of medicine, and one of the attractions of using medicinal plants as a drug discovery source is that you don’t have to ‘develop’ your discoveries; you ‘discover’ your discoveries. Consequently, a lot of the cash burn that is expended in discovering first-in-class therapeutics is not necessary if you discover them from natural sources. Phytopharm has been able to do this because we persuaded the regulatory authorities to allow us to conduct initial clinical trials on plant extracts. Such extracts, manufactured to pharmaceutical standards, are called botanicals by the FDA, and we achieved the world’s first INDA approval for botanicals in 1997. Now, botanicals allow you to build upon anecdotes – these are clinical reports given to us by clinicians – of traditional plant medicine that appear to work and directly conduct clinical trials on such medicines without having to screen them initially for activity. If the clinical data that emerges is exciting, one can then base drug discovery programs on that clinical data by doing pharmacology in the patients and by developing screens based on that pharmacology and using those screens to isolate active compounds. Where we have done those things, we have what we call a platform. Platforms contain the initial medicinal plants and extracts of them, the drug discovery screens based on the activity of those plants in man, and the the active compounds, which are patented, which have been isolated using those screens. They also involve semi-synthetic derivatives of those active compounds that are also active in the same screens as the originally naturally occurring active compounds. So, you end up with a library of active compounds and screens that have been discovered from a particular medicinal application, and which can then be applied in drug development programs both to this application and to related disease areas. We have four such platforms within the company, and nine development programs that have arisen out of these four platforms. We give these programs ‘P’ numbers. So, for example, in our metabolic disease platform, we have two programs: Program P–57, which is licensed to Pfizer; and program P–64, which is still in-house with Phytopharm. Program P–57 is the patented use of three medicinal plants and extracts and isolated active compounds thereof, all for the treatment of obesity and diabetes (protected by 6 patents). P-64, on the other hand, is a new library of compounds that we have developed in-house at Phytopharm based upon screening work and our understanding of how the plant extract works in man. To give another example, the neuro-degeneration platform within Phytopharm has about 60 compounds within it and all of the programs that have emerged from that platform use synthetic compounds developed from the naturally occurring forms. Program P-58 is a program for Alzheimer’s disease. Program P-59 is a program for motor neurone disease and P-63 is a program for Parkinson’s disease. We have licensed part of that platform to Yamanouchi. The third platform is for inflammatory disease where we have two programs: Program P-54, which uses the plant extracts primarily for canine arthritis in the veterinary market; and program P-61, which has taken the library of compounds that we have developed based upon the mode of action of the natural material and developed them as treatments for either asthma or irritable bowel syndrome. Finally, we have a dermatology platform where again there are two programs that have emerged out of it: Program P-7, which is a veterinary product for canine dermatitis; and program P-55, which is again a library of synthetic compounds for the treatment of dermatitis in man. So, Phytopharm has a broad range; there are four platforms in unrelated areas with a large number of compounds within those platforms that we can apply to major diseases. Furthermore, two of the platforms are indeed first-in-class: The programs P-57 and P-64, which are coming out of the metabolic disease platform, are first-in-class – the compounds are the world’s first orally available appetite suppressants ever discovered, and they works in a totally unique way by mimicking the effects of glucose on the glucose sensitive neurons in the mid brain and stopping eating behaviour. Similarly, the programs for motor neuron disease (P-58), Alzheimer’s (P-59) and Parkinson’s (P-63), which are coming out of the neurodegeneration platform are also first-in-class. These compounds are both neuro-regenerative and neuro-protective agents, and have the ability to restore levels of proteins that are altered in the ageing brain, returning them to levels seen in the young, causing beneficial outgrowth and branching of neurites and restoring the levels of dopinergic and muscarinic receptors. These compounds thereby offer the potential of disease modification in poorly treated but prevalent neurodegenerative conditions such as Alzheimer’s and Parkinson’s disease. If you look at why Phytopharm is able to do this on low cash burn, it’s not only because we don’t have to develop our discoveries, we can discover them in nature; it’s also because by having such a high degree of originality within the portfolio, we can reduce cash burn using other techniques. One is, of course, that we can license early and get good looking licensing deals. Secondly, and this is a unique feature of plant medicines, it is possible to take plant extracts which have activity in man but whose activity is not striking enough to justify full pharmaceutical development and market them in companion animals as veterinary foodstuffs. You will notice the program P-54v and program P-7v fit this bill. For various reasons neither program had the outstanding profile necessary to justify for pharmaceutical development in man, but they were of interest. So we are able to recoup some of the investment that we made in those programs by preparing them for launch into the companion animal market.
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