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B plan
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. 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. 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. ** 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. 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. 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. 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. 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. 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. 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. 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.
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. 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.
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
.