In the distant past, medicine relied on plant extracts of a simple kind. But these days, new botanical drugs are in demand. Coming up with them is an important scientific challenge. We introduce two Israeli biotech companies who are successfully meeting that challenge with cutting-edge development efforts.<\/strong><\/p>\n\n\n\n
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In Israel\u2019s Arava region, a company called Algatech<\/strong> is tapping microscopic algae for a powerful antioxidant called astaxanthin. More than half way across the country, in Yavne, a company called MediWound<\/strong> is extracting enzymes from pineapple stems to make unique products that can treat burns and chronic wounds. What do the two companies have in common?<\/p>\n\n\n\n
Both are groundbreaking Israeli biotech companies that successfully develop and manufacture original drugs from plant life and market them worldwide \u2013 all with the assistance of the Israel Innovation Authority.<\/p>\n\n\n\n
Dr. Zeev Even-Chen<\/strong>, a member of the Authority\u2019s array of professional evaluators, explains: \u201cUnlike conventional drugs, the medications we call \u2018botanical drugs\u2019 are usually a mix of substances. Some of the substances are plant extracts, but not all of them are. The elements typically act in synergy \u2013 that is, in combination \u2013 to make the active ingredients more effective.\u201d<\/p>\n\n\n\n
Today in the western world, stringent regulations require manufactured drugs to show no significant variation over time in their characteristics or their effect. Additionally, the manufacturing process must meet the pharmaceutical industry\u2019s accepted standards as codified in the guidelines of the FDA (the American Food and Drug Administration). And just like synthetic drugs, plant-extracted drugs also need to be proven effective against a particular disease.<\/p>\n\n\n\n
Supplement versus Drug: What’s the Difference?<\/h2>\n\n\n\n
Traditional medicine passed down verbally from generation to generation through centuries of history, uses plant-based substances to treat wounds, pain, and disease. But our ancestors didn\u2019t understand the scientific complexities involved. They didn\u2019t know what quality or ingredients the plant possessed that cured the patient of what ailed them, or how it happened. If a particular plant was found to relieve a headache or stomach ache, for example, people just used it.<\/p>\n\n\n\n
The situation nowadays is entirely different. Developing a botanical drug based on traditional medicine, or based on a particular plant material that is known to contain a family of beneficial substances, requires attention to many details. A company has to know how to formulate the drug correctly, <\/em><\/strong>dispense it accurately, and keep it stable. Not to mention patenting it, respecting regulations, and being economically realistic.<\/p>\n\n\n\n
Plant-sourced substances can be used to promote human health in three different ways:<\/p>\n\n\n\n
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As part of our nourishment (a health food)<\/li>\n\n\n\n
As a food supplement<\/li>\n\n\n\n
As a drug<\/li>\n<\/ul>\n\n\n\n
For each category, the supervision is distinct in both scope and regulations.<\/p>\n\n\n\n
While health foods are relatively simple to understand, the difference between supplements and drugs can be more complicated. When plant products are marketed as dietary supplements, they come with no specific medical guidelines. They claim only to be \u201cbeneficial to health\u201d in a general sense, and like any other food, they simply need to provide proof that they aren\u2019t toxic. Dietary supplements do not, and must not, come with a promise to heal any illness or disease.<\/p>\n\n\n\n
On the other hand, if a product is approved as a botanical drug, it comes with clear medical guidelines for use just as any other approved drug does.<\/p>\n\n\n\n
Regulation lays down absolute restrictions for botanical drugs: Firstly, since such drugs are a mix of substances, each lot must be tested for compliance with specifications. And there must be a sort of \u2018fingerprint\u2019 showing which lot each purchased dosage belongs to.<\/p>\n\n\n\n
Also, the FDA requires controlled growing conditions \u2014kept stable artificially \u2014 because as seasons change and growing conditions vary, the same plant may not always yield an identical drug. If left to nature, the plant won\u2019t always have the same content and concentration of active and inactive substances.<\/p>\n\n\n\n
These two demands can place a burden on researchers and entrepreneurs who develop botanical drugs. According to Dr. Even-Chen, the number of FDA-approved botanical drugs is small; as well as the number of botanical drugs approved for use in Israel. Israeli regulations have adopted principles of the Food and Drug Administration, and of its European equivalent the European Medicines Agency. As winning approval for botanical drugs remains so difficult, most researchers and entrepreneurs focus on developing and manufacturing food supplements instead. Endorsement for dietary supplements is immeasurably easier to obtain.<\/p>\n\n\n\n
As a result, today\u2019s pharmacy shelves are filled with long rows of products containing active substances \u2013 substances such as lycopene or antioxidant polyphenols \u2013 but the products are sold as dietary supplements, not drugs.<\/p>\n\n\n\n
Another example, turmeric, has long been recognized as an active agent against non-bacterial inflammations. Several companies sell capsules of turmeric extract as a food supplement. Garlic and onion pills are also sold as dietary supplements. There are various types of algae from which all sorts of active materials are extracted and sold as food supplements.<\/p>\n\n\n\n
\u201cOccasionally it happens that from a botanical source, they isolate an active substance that can be used as a drug. Then its chemical structure can be analyzed and then researchers need to find how to obtain an identical but synthetic substance, in case the botanical material it isn\u2019t always available \u2014 or merely to work more naturally and comfortably under regulation,\u201d explains Dr. Even-Chen.<\/p>\n\n\n\n
For example, the drug Taxol, which is used in chemotherapy for breast cancer, was first discovered in the bark of the Pacific yew tree. To extract enough of that substance, someone would have to plant yew forests across the Amazon. Instead, they identified the molecular structure of the active agent, and today the drug is chemically synthesized without the yew trees.<\/p>\n\n\n\n
\u201cThe industry in Israel is very creative, and it turns out many studies,\u201d Dr. Even-Chen says in conclusion, \u201cwhether the goal is producing \u2018botanical foods\u2019 that are spiked with active substances or whether it\u2019s new technologies in the life sciences from the Technion and other institutes.\u201d<\/p>\n\n\n\n
Algae \u2013 An Oasis in the Desert<\/h2>\n\n\n\n
Algatech, a biotech firm established in 1998, develops and manufactures active substances from microscopic algae. The microalgae are grown in a closed, sustainable, environmentally friendly system that harnesses the nourishment of desert sunlight.<\/p>\n\n\n\n
Algatech is a global leader in the manufacture and supply of one of the most powerful antioxidants in existence \u2013 astaxanthin, a natural substance based on a one-celled species of microalgae called Haematococcus Pluvialis. The material is marketed under the brand name AstaPure.<\/p>\n\n\n\n
Microalgae are extremely adaptable microorganisms that grow in a variety of locations and are naturally rich in a wide range of healthy and beneficial substances. To date, scientists have identified some thirty thousand different species of microscopic algae that produce unique and potentially useful chemicals. Products based on micro algae have a broad variety of unique applications in the food industry as nutritional supplements, as drugs, and in cosmetics. However, not very many species are being used for practical and commercial purposes due to practical concerns. Commercial growers of microalgae need to find a delicate balance between the necessary growing technology, the available growing location, and the desired final product. The task demands time, capital, and versatility. <\/p>\n\n\n\n