B plan


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B plan

  1. 1. Venture Name : GLYCOPHARMA. Category : Life Sciences, Health Care. Project stage : Prototype testing. Underway. Grant : BIG, Department Of Biotechnology. Contact Person: A.R.Muralidharan Incubatee, Indian Institute of Crop Processing Technology Tanjore. E-mail – naratturmurali@rediffmail.com Mobile – 8754483776, 9445666317.
  2. 2. World’s only glycosylated Banana juice with Pharmaconutritive potential using a novel Glycotechnology tool. Prevention based health care product for gut dysfunction. Executive Summary We have produced a novel nutraceutical from one variety of indigenous banana using enzyme Glycotechnology, a new field of Biotechnology. The fruit has been modified at molecular level to make available two therapeutic forms namely Bioactives and Glycocores to be used in preventing intestinal infections and inflammation. This Bioactive state is unavailable in a normal banana fruit. The Bioactives deactivates four enteropathogens namely Shigella Flexineri, E.Coli, Salmonella spp, Klebsiella pneumonia and cleanse intestine from infections. The unique Glycocores (sugar cores) strengthen the intestinal walls by specific complex sugar bonds. This is a preventive based Health Care product and safeguards the intestine against plethora of gut disorders like Ulcerative Colitis, Crohn’s disease, Celiac disease, infections and inflammation. Presently there is no product targeted at preventing intestinal infection and inflammation as against the secondary Gut health care products addressing flatulence, acidity, indigestion etc. Our product draws a direct correlation between consumption and disease prevention. The startup is presently undergoing rigorous prototype testing and semi-commercial run. We have been successful in initiating initial marketing contacts. The product will carve its own market owing to non availability of similar product in the respective category. The product has a global market and it can sustain competition owing to the exclusive IPR rights obtained from the invention. The startup capital requirement including the working capital comes to around 100 lakhs and the breakeven will be achieved in a year.
  3. 3. BUSINESS CONCEPT Prevention based health care Banana pulp/ fruit Enzymatic Glycosylation Banana juice Food meets Biomolecular modification – Value addition Pharma Complex functional beverage/nutraceutical  Presently no technology for making banana juice. Ours is the only product *.  Product and process patentable  Value addition of the juice to mucosal health protectant – a highly complex neutraceutical to treat gut dysfunction, only one of its kind **.  Final product contains Bioactives and Glycocores.  Bio actives inactivate enteropathogenic organisms through compound mediated innate immunity, acting as a powerful anti inflammatory factor.  Glycocores complement in strengthening the damaged intestinal lining.  Scientific evidence available for FDA, USA, endorsement under “Qualified claims“ category ***.  Organising for “Authorised claims” from FDA‟s centre for biologics evaluation -----------------------------------------------------------------------------------------------------------------------------* Bananas aren’t the easiest thing to put in a bottle.’- Mr. Dave Bober of Daily Juice Products, America’s # 1 selling family of non-alcoholic frozen blended cocktail mixes, juices and new products. * According to Nuclear Agriculture and Biotechnology Division, Baba Atomic Research Center (BARC) – unlike other fruits, juice cannot be extracted from banana by any simple means such as crushing, grinding or squeezing. If an appropriate technology is developed to extract juice from banana, a highly marketable product could be produced. They have developed a product called Banana nectar which is only 30-40% banana juice unlike our technology (100% banana juice).
  4. 4. ** Prof. Bruce Watkins, Functional foods, Purdue University, on the role of mucosal protectants – “we are not as developed in this area as pertains to creating functional foods that deliver health protectants. So we need research to further describe, characterize and discover the roles of these health protectants.” th ** Prof Martin Wikham during an international event on functional food 29-30 Sep 2011 on Innovative Health – Promoting Food – Gastro – Intestinal performance expressed key considerations - To deliver success in the Gut health market, industry and consumers demand innovation. How can science deliver this innovation? – Leatherheed Food Research. *** “Qualified claims” endorsement from FDA requires less scientific evidence whereas “Authorised claims” requires very strong scientific evidence. TECHNOLOGY STEPS Glycoprotein (ethnic banana) Removing N-glycans Deglycosylated Banana 1 Removing less specific O- linkages Deglycosylated Banana 2 Removing enzyme specific O-linked glycans Unmet gut health care need Banana juice (With Bioactives and Glycocores) We have engineered a novel nutraceutical beverage from ethnic banana using enzyme technology from its pulp, enabling bioactives and complex sugar cores. The former deactivates four enteropathogens preventing intestinal infections. The latter prevents
  5. 5. inflammation by the formation of specific complex sugar bonds, unique to the intestine. We have utilized the unique signaling channels of this banana, whose cycle lasts for less than 12 hrs post harvest stage Description of technology In scientific terms, eating a raw banana vis a vis banana juice has a marked difference in the quality of available bio active components for our health. Moreover bananas are difficult to convert in to juice owing to internal shielding effect. Our banana juice processing invention (the only one of its kind) using novel glycobiology principles is a breakthrough not only in banana juice processing but also engineering bio active banana state. The principle involves the use of a novel enzyme with distinct specificity to act on the reducing end of sugar bonds (attached to select protein terminal) to produce natural juice. The enzyme used here is a novel one whose specificity for bond breaking is unmatched except with a recently discovered metabolic enzyme. Even the cloned metabolic enzymes have not been up to the mark. Premise for the innovation 1. The complex carbohydrates of this ethnic banana match with that of the complex carbohydrates present in the intestinal layer. This banana is highly specific for OGalNAc sugars. The intestine is extensively and more so exclusively packed on the surface with the above specific complex sugars. This complex sugar coats are truncated or reduced (short) in diseased conditions. 2. Plants undergo extensive glycosylation especially during stress and periods of infection. A novel glycosylating enzyme in this pathway has been isolated and used in the molecular modification of this ethnic banana. There is no enzyme presently which can be used with this specificity, to modify the substrate. This extent of glycosylation that we have brought about is unique and patentable. This level of glycosylation will be difficult to achieve even with presently available process namely hydrazinolysis and enzyme digestion (Ref: sigma glyco files). The bio active
  6. 6. component has shown activity with four enteropathogenic organisms displaying multi glycosylation sites and will be effective to immune regulate the intestine for effective gut defence. Then there are carefully carved glycocores to strengthen the complex sugar ratios in intestinal layer. The technology requires some crucial studies to highlight its therapeutic role in a larger perspective. This will help us to organize ourselves for the much needed scientific evidence towards clinching the „Authorized claims‟ status from the CBER ( center for biologics evaluation and research), FDA. This will have a phenomenal impact in marketing our product. Already we have scientific evidence to obtain the „Qualified claims‟ status from the FDA. The „Authorized claims‟ status solicits a high degree of scientific evidence as against the‟Qualified claims‟ status. Benefits / Solution for the problem area 1. More than 3-5 bn people are affected with intestinal infections every year and in US alone, it is more than 300 mn. Acute secretory diarrhea causes approximately 8,00,000 child deaths each year especially in developing and under developed countries. Average cost of treatment is US $ 6256/patient. More than 4mn people are affected with intestinal inflammation (1mn Americans) every year on a global basis. Total health care cost is US$ 140 bn and economic impact evaluated at US$ 6.3 bn annually. Despite advancement in Medical Technology, procedures are expensive and are partially effective. They do not address healing injuries and infection relapses. The ORS (Oral rehydration therapy), a simple sugar and salt solution with zinc supplement and electrolytes don‟t appear to work. Our product is to be used in the prevention of intestinal disorders like Ulcerative Colitis, Crohn‟s disease, Celiac disease, enteropathogenic infections, inflammations and related gut dysfunction. This product aims at lowering the economic burden of huge health care costs of individuals through Preventive based health care treatment. According to „NIH-2004 report‟, the healthcare costs of digestive disorders were
  7. 7. staggering $97.8 bn on direct medical costs and $44 bn on indirect costs in US alone and are increasing. 2. This technology provides a breakthrough in the post harvest fruit processing sector. As much as 40% of India‟s banana crop is lost to wastage which equals 10.5 million thus, more than the total crop in Philippines. There is an imperative need for new technology in the banana processing sector to boost the economy. Lack of technology in banana fruit juice processing is a severe constraint on its global trade. More over transportation costs of banana are expensive as their refrigeration requires special provisions to improve their shelf life. Raw Banana and Banana juice (Deglycosylated) Raw banana is nutritious while the Banana juice is Pharmaco nutritive. The innovative product has all the nutritional contents of banana as specified by WHO standards as well as the unique components made bio available for preventing a disease. Enzymatic digestion of banana Stage I Stage II Stage III
  8. 8. Antibacterial activity of Bioactives with enteropathogens Klebsiella Pneumonia Shigella Flexineri E.Coli Salmonella Market Analysis  Global market for Gut health nutraceuticals is US $ 60bn annually - 10% of global health and wellness industry.  India‟s Digestive market Rs. 15.1bn in 2010, to grow by 66% in 2015 . Competitors Host of pharma companies and Health & Wellness products manufacturing firms including Nestle, BASF nutrition, Abott Nutrition, Danone etc.
  9. 9. Product Positioning Functional foods / beverages Digestive health ingredients 1. prebiotics 2. probiotics 3. enzymes 4. protectants (our product) Competitive advantage: In the first year of successful commercial run, we plan to comply conditions and research trials laid down by FDA for its approval. We already have sufficient evidence to obtain the lesser valued „qualified claim‟ status endorsed by FDA of USA. Our claim for preventive health care prospects of the products is materially different from lesser claims as envisaged by our competitors‟ namely aiding digestion, good for heart, upset stomach etc. We will organize and propose our technical inputs to get the ” Authorized claims “status from FDA to have a phenomenal impact in marketing. However it is interesting to note that there are no players who have been in the foray of producing complex functional foods for gut/intestinal related problems including high level players like Nestle, Danone, Yakult, Beneo etc. Again prebiotics and probiotics products available in the market, although healthy, have not been specific in their functional target. They have also been hit hard by the new regulatory process and have been rejected due to insufficient characterization of approved gut health ingredients. Since our digestive system is highly complex with intervening multiple biochemical signaling pathways, the design of a complex nutraceutical and its non availability in the present juncture adds value to our product.
  10. 10. Competitive Analysis OUR PRODUCT COMPETITORS First Mucosal Health Protectant No advanced Nutraceutical available Nestle Health Science Product for primary gut disorder secondary gut disorders. eg. Flatulence, indigestion, acidity etc. Scientific evidence already for “Qualified Hit hard by regulatory authorities claims” from FDA, seeking for “ Authorised claim” status. Market- Growth rate and trends Due to exceptional growth of the Indian economy and higher purchasing power parity (PPP) of the consumers in the last decade, consumers are moving towards specific functional foods. Although this is a new concept in our country and the market is still in infancy, the demand for functional foods would continue to increase due to their specific health benefits and Government‟s plan to invest $ 21.5 billion in food processing industry in next five years. Industry analysts such as Frost & Sullivan and Netscribes (India) Pvt. Ltd. also predict a continued growth of the sector in the future. Apart from this, functional foods can be an opportunity for economic growth of our country as India is endowed with rich biodiversity and traditional knowledge of the health effects of certain indigenous plant species. According to the George Morris centre for the 20052010 review period, the digestive sector alone in the functional food category has been valued as US$63.2bn for 32 markets combined.
  11. 11. Apart from the functional food sector, the natural health products category which includes 100% fresh juices is also growing at a rapid pace. As our product cuts across both the segments the start up is all set to have a niche market. Global imports of fresh bananas have followed a long-term upward trend, reaching 16.3mmt in 2009. In the near future, a number of large banana producers (notably India, and possibly Brazil, which together grow almost double the volume of bananas currently traded worldwide) could emerge as major banana exporters(source-Index mundi.com) . Banana juice thus has a huge potential and will open up the market in a big way. The major impediment in increasing banana global trade has been the lack of technology in juice processing and our breakthrough technology will create waves in global banana trade. Marketing We have begun talks with „Nutrasorb‟ a nutraceutical company at New Jersey. The company is backed by reputed R & D scientists Dr.llya Raskin, Professor, Rutgers state university of New Jersey and Dr. Mary Ann Lila, Director, Plants for Human Health Institute, North Carolina State University. The company will help us in obtaining the required “claims” status from FDA for our nutraceutical beverage. Also they will leverage on their marketing network for selling our products. We are also opening another channel through Boots centre for innovation. Our major targets are Walgreen and Alliance boots in US and UK respectively which comprises of around 8000 outlets. We are about to initiate talks with Boots Center of Innovation before which we are working on the presentation of technical details and specifically addressing the functionality of the product. On successful screening we will have access to their international outlets. The product can also be sold in our brand name. In India we are looking for an exclusive pharma marketing company to market our product. The Indian Pharmacy retail outlets are also taking new shapes and will focus on Health & Wellness products. The retail chains through which we plan to sell our product include:
  12. 12.  Apollo Pharmacy retail chain – 230 outlets.  Health & Glow – 65 operational stores.  Religare Wellness – pan India world class retail network of health stores –1000.  Med plus – 800 pharmacy stores.  Himalaya Health care  Trust Chemists & Druggists – 80 stores.  Zydus wellness – A cadila group.  Reliance Wellness.  Global Healthline – pharmacy retail chain with international presence.  Hetero pharmacy – A Indian pahrma company with 2000 crores as revenue. We plan to market our product through an exclusive pharma marketing driven company. The firm has a strong field force of 250 medical representatives who will highlight the product to 65,000 doctors to generate prescription and sell the product. The company has a dealer distribution network of 3, 00,000 chemist stores. We are also meeting potential customers through Bio-partnering meets. A nutraceutical company, Oriental yeast co Ltd, has evinced interest in our product and we are meeting them in Bombay at Cphi‟2013, a pharma sourcing event during December. Business System Description The prototype has already been developed. We are incubating at The Indian Institute of Crop Processing Technology, Tanjore. Rigorous testing of prototype is on the anvil. The optimum recovery of Bioactive elements along with quality control is being assessed. We are scaling up the production volume from 1ltr to 10 ltrs and then to 100 ltrs per batch production. The final produce is a freeze dried powder with active forms. We plan to obtain certification from the Food Safety and Standards Authority of India (FSSAI), an autonomous statutory body, under the aegis of the health ministry,
  13. 13. which ensures food safety, regulate foods for special purposes as well as nutritional uses. Raw materials are available in plenty in the region. MILESTONE 2013 Nov 1. 2. Dec 2014 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Rigorous Prototype Testing Assays Health care 3. Qualified Claims 4. 5. 6. 7. Authorised Claims Patenting Test market 1 Test market 2 8. Commercial run Financial Analysis The budget estimate for the startup has been pegged at Rs 100 lakhs, with equipment and machinery alone costing Rs 80 lakhs. As we are planning to utilize the incubation facilities of IICPT, Tanjore, the rental costs would be calculated in the working capital. Our average cost of sales will take in to account the cost of enzyme, raw materials and elements involved in the processing module including the packaging costs. In determining the costs of inputs, we have inflated the costs by 15% to 20% to take care of the market risks. The working capital requirement for 3 months period is Rs 20 lakhs. The sales price of 100 gms of banana mucosal health protectant has been fixed at Rs.5000 after buffering sales commission as high as 30% which can be reduced by 10% or more in the market place. This price fixation is nevertheless less compared to those fixed for functional food products globally, often with less scientific evidence than our product to be used in preventive health care.
  14. 14. Cash Flow Year year 1 year 2 year 3 year 4 year 5 cash inflow cash on hand sales working capital loan Total 10,00,000 5,85,03,845 12,62,57,690 19,40,11,535 33,03,83,225 123750000 13,50,00,000 13,50,00,000 27,00,00,000 27,00,00,000 20,00,000 13,80,00,000 19,35,03,845 26,12,57,690 46,40,11,535 60,03,83,225 Cash flow Enzyme 1,80,00,000 1,80,00,000 1,80,00,000 3,60,00,000 3,60,00,000 Raw material 12,00,000 12,00,000 12,00,000 24,00,000 24,00,000 Water 12,00,000 12,00,000 12,00,000 24,00,000 24,00,000 Misc.Labour 12,00,000 12,00,000 12,00,000 24,00,000 24,00,000 Packaging &cans 12,00,000 12,00,000 12,00,000 24,00,000 24,00,000 Professional fees 1,50,000 1,50,000 1,50,000 3,00,000 3,00,000 2,29,50,000 2,29,50,000 2,29,50,000 4,59,00,000 4,59,00,000 12,00,000 12,00,000 12,00,000 24,00,000 24,00,000 60000 60000 60000 120000 120000 Advertising 2,40,000 2,40,000 2,40,000 4,80,000 4,80,000 Transportation 2,40,000 2,40,000 2,40,000 4,80,000 4,80,000 Accounts&legal 300000 300000 300000 600000 600000 2,40,000 2,40,000 2,40,000 4,80,000 4,80,000 60000 60000 60000 120000 120000 Electricity 4,80,000 4,80,000 4,80,000 9,60,000 9,60,000 Solvents 24,00,000 24,00,000 24,00,000 48,00,000 48,00,000 120000 120000 120000 240000 240000 60000 60000 60000 120000 120000 51,92,308 51,92,308 51,92,308 1,03,84,616 1,03,84,616 Interest (10%) 3,00,000 3,00,000 3,00,000 6,00,000 6,00,000 Depreciation 1,50,000 1,50,000 1,50,000 3,00,000 3,00,000 3,11,53,847 3,11,53,847 3,11,53,847 6,23,07,694 6,23,07,694 21,00,000 21,00,000 21,00,000 42,00,000 42,00,000 Total 6,72,46,155 6,72,46,155 Net profit 5,85,03,845 12,62,57,690 19,40,11,535 33,03,83,225 46,67,54,915 Total cost of sales Expenses Salary Repair &maintenance Rent Telephone water Insurance Taxes (5%) Sales commission (25%) Freight 6,72,46,155 13,36,28,310 13,36,28,310
  15. 15. PROFIT & LOSS Year Total revenue (sales) Cost of sales Enzyme year 1 year 2 year 3 year 4 year 5 135,000,000 135,000,000 270,000,000 270,000,000 123,750,000 18,000,000 18,000,000 18,000,000 36,000,000 36,000,000 Raw materials 1,200,000 1,200,000 1,200,000 2,400,000 2,400,000 Misc. Labour 1,200,000 1,200,000 1,200,000 2,400,000 2,400,000 Packaging & cans 1,200,000 1,200,000 1,200,000 2,400,000 2,400,000 Water sales commission (25%) 1,200,000 31,153,847 1,200,000 31,153,847 1,200,000 31,153,847 2,400,000 2,400,000 62,307,694 62,307,694 Professional fees 150,000 150,000 150,000 300,000 300,000 54,103,847 69,646,153 54,103,847 80,896,153 1,200,000 1,200,000 1,200,000 2,400,000 2,400,000 60000 60000 60000 120000 120000 Advertising 240,000 240,000 240,000 480,000 480,000 Transportation 240,000 240,000 240,000 480,000 480,000 Accounts & legal 300000 300000 300000 600000 600000 Rent 240,000 240,000 240,000 480,000 480,000 60000 60000 60000 120000 120000 Electricity bill 480,000 480,000 480,000 960,000 960,000 Water 120000 120000 120000 240000 240000 60000 60000 60000 120000 120000 5,192,308 5,192,308 5,192,308 10,384,616 10,384,616 Interest ( 10%) 300,000 300,000 300,000 600,000 600,000 Depreciation Equipment Solvents 150,000 150,000 150,000 300,000 300,000 8,000,000 2,400,000 2,400,000 2,400,000 4,800,000 4,800,000 Freight 2,100,000 2,100,000 2,100,000 4,200,000 4,200,000 Total expenses 75,246,155 75,246,155 75,246,155 180,392,310 180,392,310 Net profit 48,503,845 59,753,845 59,753,845 Total cost of sales Gross profit Expenses salary Repair & maintenance Telephone Insurance Taxes (5%) 54,103,847 108,207,694 108,207,694 80,896,153 170,515,388 170,515,388 89,607,690 89,607,690
  16. 16. Exit strategy We have plans to strengthen this start up in to a fully fledged R&D driven Agri Food Biotechnology Company. Our future plans include the development of processing technologies for other varieties of banana, jackfruit and other tropical fruits to exploit the versatility of tropical fruits. TEAM A.R.Muralidharan, B.Sc Incubatee, IICPT, Biotechnology Ignition Grant, DBT More than 12 years of experience in Food Biotechnology industry. First to introduce high temperature Button mushroom isolates in south India along with a researcher at Horticultural research institute, wellesborne. Owner of this invention along with another team member. A.Pallavi, M.Sc Biochemistry Glycobiology researcher 7 years of experience in Biotechnology A.M.Sripriya, Bsc. Biochem, PGDMLT Glycobiology researcher 8 years experience in Biochemistry .