products. In fact, several products have been formulated and have also undergone extensive studies. These novel formulations can be used as :

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Dwight Sharp
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1 Enzymes A Ray of Hope! By Shilpa Risbud, Sr Technical Manager R&D and Dr. Anita Joshi, Biotechnology Consultant For Advanced Enzyme Technologies Ltd., Thane. Published by Pharmainfo.net in Nov 2007 In the World of Today, the spectrum of information is expanding with a galloping speed in almost every field and in particular in Biotechnology. To keep up pace with advances in this ever changing and challenging field, one has to keep a vigilant glance on new developments and current research for need-based upgradation of products and services to tackle existing lacunae in the market. Today s tremendously changed life styles have led to drastically changed eating habits. Due to convenience, good traditional eating habits have been replaced by high consumption of fast food and low consumption of fruits and vegetables. Adding fuel to fire, we have increased stress levels resulting from the fast pace of life. We also have increased environmental toxins to combat. Consequently the disease pattern responsible for morbidity and mortality has shifted from communicable infections to lifestyle diseases. In spite of this, unfortunately, the load of illnesses in a developing nation like India is enormous. In case of infectious diseases the overuse and misuse of antibiotics has escalated drug resistance patterns to an alarming level. Doctors fear that if the use of antibiotics is not curtailed we may soon approach a day when untreatable infections will rule the roost. Morbidity and mortality is also markedly increased by the patients poor compliance to the prescribed regimen of drugs. Nowadays, the trend is to look out for alternative medicines due to toxicities and side effects associated with conventional therapies. For instance, Nonsteroidal anti-inflammatory drugs (NSAIDs: COX-1 and COX-2 inhibitors), 1

2 which are the most widely prescribed drugs in the treatment of pain and inflammation in many chronic conditions including osteoarthritis and rheumatoid arthritis, have several known side effects. To counteract these lacunae, trends have changed from Disease Management to Health Management or prevention therapy and several organizations are working towards this. Pharmaceutical and Nutraceutical R&D at Advanced Enzyme Technologies Ltd., Thane, too is working on similar lines by providing unique non toxic solutions through natural products such as enzymes and probiotic supplements for several lifestyle as well as communicable diseases such as obesity, cancer, cardiovascular health, Tuberculosis, Leprosy etc. Enzymes function in the normal physiological range. They are indispensable constituents of all living creatures. In fact, enzymes have aptly been called the Fountains of Life. They are biological catalysts that are ubiquitously found in nature and are responsible for the myriad reactions taking place in our bodies. Not only do they orchestrate the break down of complex molecules into simple molecules useful to our body, but they also regulate and control each and every process that keeps the body functioning harmoniously. Enzyme action is highly specific and is well known and well characterized. Each enzyme has its own specific role and activity and has typical biochemical properties. Healthy tissues and cells have natural mechanisms protecting them from enzyme action. The human body consists of checks and balances in the form of inhibitors, which enable them to function properly without deactivation. Enzyme Therapy has been practiced for a long time both in India and abroad. They are regarded to be completely safe as oral or systemic enzyme supplements. Therapeutic enzymes have been used primarily as digestive aids, as anti inflammatory agents and also as thrombolytics. These supplements are singly used and are either from animal origin or of plant origin. 2

3 New Trends in Modern Day Systemic Multi-Enzyme Therapy involves orally administering high doses of mixtures of enzymes from plant, animal and microbial origin, which have been blended together in predetermined proportions to develop Polyenzyme Formulations. These formulations are enteric coated so as to be suitable for oral administration and can with stand the acidic ph of the stomach. The long-term safety of these systemic enzyme supplements has been explored in great details. The result is that enzymes are generally found to be highly safe without any toxic effects, irrespective of the dosage. On the contrary, the deficiency of enzymes in the human body may lead to clinical problems. No known toxicity at any level of enzyme dosage in animal/ human studies has been recorded. There are several players in the market for Industrial Enzymes. On the domestic scenario, we have Biocon enzymes now with Novozymes (Rs. 85 crores), Novozyme (originally at Rs. 83 crores), Advanced Enzyme Technologies (Rs. 56 crores), Rossari Biotech (Rs crores) and Maps India (Rs. 15 crores) in the year and boasts of a 17% growth rate. The total size of the Industrial Enzyme sector in India is about Rs 375 crores (BioSpectrum June and July 2006). The global leaders are Danisco and Novozymes and the global market is estimated to be at 1.6 to 2.0 billion $, which includes enzymes used in food and beverages, animal feed, textile, leather, detergents, paper and pulp and specialty enzymes etc. Specialty enzymes are the enzymes used in Pharmaceuticals, diagnostics, Biotechnology applications. Globally, the market for enzymes in general is increasing and is estimated to reach 5.1 billion dollars by 2009 (Market Analyst Freedonia). Enzymes have always been an integral part of many a reaction required by the Pharmaceutical industry. The major example of such a process is the manufacture of the β-lactam antibiotics like penicillin. Modern concepts in Biotechnology have further extended these roles of enzymes to newer 3

4 applications including Biotherapeutics. The use of enzymes such as Streptokinase and urokinase for dissolving clots in patients with cardiovascular diseases is well documented and is a common practice. Similarly, trypsin and chymotrypsin are used for patients with pancreatitis. Serratiopeptidase is an enzyme known for its anti-inflammatory properties. Drugs in which it is given in conjunction with other drugs such as Nimesulide are available in the market. The key players in the Indian Pharmaceutical enzyme sector are Advanced Enzyme Technologies Ltd., Thane with approximately a 60% share and Biocon, Bangalore with approximately a 40% share and the major global players are Danisco, Nagase and Novozymes. The Pharmaceutical enzyme industry in India is estimated to be around 70 crores and globally it is around 1500 crores. Of these, Advanced Enzyme Technologies Ltd. Thane (AETL) has recently forayed into the area of Polyenzyme Formulations and thus is currently the only player in this area. The concept of polyenzyme formulations is not new to the European and American markets and they are available across the counter under the brand name Wobenzyme and Disperzyme developed by Mucos Pharma in Germany. The sister concern of AETL, Specialty Enzymes and Biochemicals based in Chino, CA has also been manufacturing and marketing SEB kinase and EXCLzyme EN which are polyenzyme formulations. They are well accepted in these markets and are tried and tested products serving as a replacement to conventional medicines. Some of these supplements are also available in the Indian markets, but the concept of polyenzyme formulations is yet to take roots in India. Currently, AETL is striving hard not only to just introduce these novel polyenzyme products into the Indian Markets and generate awareness about their manifold utilities but also to manufacture them as nutraceuticals which have no side-effects and which are completely natural products. They are products that can boast greater efficacy than the enzyme blended allopathic 4

5 products. In fact, several products have been formulated and have also undergone extensive studies. These novel formulations can be used as : New antimicrobial or conjunction with currently used antibiotics, Immunomodulators Alternative to NSAIDs for alleviating pain in arthritis and other chronic inflammatory diseases Replacement to Aspirin Blood thinners cardiovascular and hypertension medications In conjunction with currently used cancer treatment Wound healing agents As fibrinolytic agents As mucolytic agents When used in conjunction with currently used therapy they act as potentiators. These formulations will help reduce the dosage in turn help in subsiding the side effects and toxicities of currently used medicines. Surely, a ray of hope for a healthy life? 5

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