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Hived off as a separate business unit from a Group in Dietary Supplements and Contract Research since 1994.  Clinically proven proprietary formulas for.

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Presentation on theme: "Hived off as a separate business unit from a Group in Dietary Supplements and Contract Research since 1994.  Clinically proven proprietary formulas for."— Presentation transcript:

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2 Hived off as a separate business unit from a Group in Dietary Supplements and Contract Research since  Clinically proven proprietary formulas for efficacy and safety  Regulatory compliant across geographies and categories  Standardized Phyto ingredients meeting Pharma benchmarks  Laboratory proven consistent quality of active constituents  Patented Intellectual property for best commercial prospects.  Strong Market Positioning Support

3 WE ARE A “FOUR IN ONE” GROUP

4  Serving the Nutraceutical, Pharmaceutical, Cosmetics and agricultural industry since 1994 ISO 9001:2008, Organic & Kosher Certified

5 PHARMACOPOEAL EXTRACTS Ipecac Extract ( Tincture, liquid, and Soft Extract) Belladonna Extract (Dry and Soft) PHYTOCHEMICALS Thiocolchicoside Capsaicin 95% USP Reserpine Berberine HCl Piperine 95% Quinine Bisulphate Yohimbine HCl

6  Largest and Oldest Full Service Contract Research Organization (CRO) for Natural Products  Provides Regulatory, Preclinical and Clinical services  Completed over 300 preclinical studies (GLP and non-GLP)  Completed over 45 Clinical studies across the globe including US, Canada, Germany, Netherlands, France, Hong Kong  4 papers published in International journals, 5 submitted

7  Full Service Contract Research Organization (CRO) for Pharma  Operations in India with presence in US and Business partners worldwide  Supports Phase II - IV, BA-BE studies, IND, ANDA, NDA, 505(b)(2) submissions & clinical trials  Wide therapeutic expertise & Business partners worldwide  Medical Advisory Board of Eminent Industry experts

8 Jayesh Chaudhary Founder Director  Qualified in Pharmacy and Microbial Engineering from University of Minnesota  Co-founded &managed several companies in the Phyto-pharmaceuticals and Contract Research space.  involved in product development and international business since 2 decades  Responsible for the Biocatalyst and Natural Products technical support and national sales at Boehringer Mannheim India at the beginning of his career. Latha Chaudhary Co-founder & President  Masters in Pharmacy from the top Pharmacy School in India - the University Dept of Chemical Technology, Mumbai.  Proven track record of building profitable businesses in Nutraceuticals, Phytochemicals and Organic Agriculture Inputs.  R&D experience in one of India’s leading drug companies  Bringing Pharma expertise to the Product and Business Development in Nutraceuticals, Phytochemicals & Organic Agriculture realms.

9 Dr.Arun Nanivadekar – Medical director Dr. Nanivadekar served for several years as Medical Director with Pfizer & Wyeth and as member of several Ethics Committees and editorial boards such as the British Medical Journal, Journal of Association of Physicians of India, and Indian Journal of Pharmacology. Dr. Nanivadekar’s mission of simplifying drug development drives the mission of the Company to develop safer and effective healthcare solutions. He has been honored with a Lifetime Achievement Award by the Indian Society of Clinical Research in 2008 Dr. C.I. Jolly - Research Advisor Dr. Chungath Jolly has more than 36 years of teaching experience in a pharmacy and guided more than 50 students in research and doctorate over his career span. He has over 150 National & International published papers, 2 patent to his credit and is a member of American Society of Pharmacognosy. Dr. Jolly has also been associated with Indian Herbal Pharmacopoeia. Dr. Jolly has a PhD in Pharmacognosy and Phytochemistry and Enovate’s guiding force in early stage product development and standardization.

10 Dr.Richard Rosenbloom – Senior scientific associate & consultant Medical Researcher with extensive experience in developing pioneering therapies for the treatment of Cancer, Diabetes & Central nervous system disorders. Medical degree with a Ph.D. in Nutrition Science with specialization in Nutraceuticals gives him expertise to identify, research and develop safe therapies from whole plant-based sources. Secured more than 40 domestic and International Patents and authored many publications including botanical drugs and medical foods Nova care - USA manufacturing location GMP compliant facility that uses state-of-the-art manufacturing and packaging equipment. Global Fulfillment & Logistics capability that handles drop ship fulfillment services direct to consumers across the globe.

11 P HARMACOGNOSTIC TAXONOMICAL MORPHOLOGICAL PHARMACOLOGICAL / THERAPEUTIC CHEMICAL/ BIOGENETIC P HYTOCHEMICAL EXTRACTIVE VALUE CHEMICAL PROFILING TLC FINGERPRINTING MARKERS BIOACTIVE BIOLOGICAL CHEMICAL HPTLC/HPLC BASED QUANTIFICATION P HYSICOCHEMICAL ASH VALUE pH OPTICAL ROTATION SPECIFIC GRAVITY HARDNESS FRIABILITY DISINTEGRATION DISSOLUTION ELEMENTAL COMPOSITION P URITY PROFILE HEAVY METALS PESTICIDES/FUMIGANTS/FUNGICIDES PATHOGENS RADIOACTIVES HERBAL DRUGS STANDARDIZATION PARAMETERS FOUR P PROTOCOL 0.

12 Researching the market for unmet medical needs.Feasibility study on the product design & formulation.Regulatory check for ingredients of formulation.Clinical study design and protocol.Clinical research, result and paper publication. Product of western standards ready to market.

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14  Dedicated clinical trial company to conduct international standard clinical trials for efficacy and safety

15  Option of India and USA manufactured finished products

16 Clinical trials published in American Journal of Therapeutics and the Journal of Alternative and Complementary Medicine

17  Established Agri products business to facilitate understanding from cultivation to finished product

18  Option of customized co-development as per market needs. Joint development project structure

19  Extensive international experience of sourcing and supplying plant extracts, Phytochemicals and plants API

20  Proven expertise of handling international business partnerships

21  20+ years of business track record with confident investor group

22 Market Size Osteoarthritis increases aggregate health care expenditures by $186 billion annually. Unmet Medical Need Short lasting effect Questionable efficacy Market Drivers: Estimated 50 million adults in the USA have arthritis. By 2030, an estimated 67 million American adults projected to have doctor- diagnosed arthritis. Targeted market: Sufferers of joint pain, inflammation and stiffness, Sports persons. Main Competitors: NSAIDS, Glucosamine, Chondroitin, Omega Fatty Acids. Stage of Development Competitive Advantage: Rapid pain & stiffness reduction Sustained efficacy after discontinued of treatment Effective on various arthritic conditions other than OA Randomized, Triple Blind, Placebo Controlled, Multicenter, ICH GCP Compliant trial, Registered with Clinical Trial Registry of India Treatment Duration: 84 days & Observation Period: 46 Days (After discontinuations of treatment) Research Highlight: Management of metabolic processes leading to joint pain & stiffness Research paper published in American Journal of Therapeutics

23 MARKET POSITIONING SUSTAINED RELIEF THAT HELPS TO ENJOY “TREATMENT HOLIDAYS” PREVENTS FURTHER DEGENARATIVE CHANGES DOUBLE PAIN RELIEF – For the dull aching pain + intense intermittent pain PATIENT FRIENDLY 12 WEEKS TAKE, 6 WEEKS BREAK REGIMEN ADDS POWER TO PHYSIOTHERAPY, YOGA AND OTHER PHYSICAL THERAPIES

24 Management of metabolic process of Male Sexual health US Patent Applied, Research paper published in American Journal of Therapeutics Market Size >$3 billion globally and $1.5 billion in USA. Forecast at U.S.$6.6 billion by 2012 Unmet Medical Need Sustained and maintained effect of treatment Questionable efficacy for lack of research & trials. Market Drivers: Estimated One in 10 men across the world & nearly 30 million men in USA have erectile dysfunction. Urologists expect the number of men seeking solution to double in the coming years. No Insurance cover for ED Targeted market: Sufferers of erectile, ejaculatory dysfunction & loss of libido. Main Competitors: Viagra, Cialis (Sildenafil, Tadalafil) Stage of Development Competitive Advantage: 67% improvement in erectile concerns 63% improvement in ejaculatory concerns 58% improvement in sexual desire 70% improvement in self satisfaction index & 82% improvement in partner satisfaction index Non-spiked, non-hormonal natural product Double Blind, Placebo Controlled, Multicenter, ICH GCP Compliant trial Registered with Clinical Trial Registry of India Treatment Duration: 60 days on 140 patients. Research Highlight:

25 MARKET POSITIONING SIMPLIFY THE TREATMENT FOR PREMATURE EJACULATION AND ASSOCIATED ERECTILE DYSFUNCTION TACKLES ASSOCIATED ANXIETY AND PROMOTES FEELING OF WELL BEING WELL SUITED FOR PEOPL E WHO ARE TAKING NITRATES OR ALPHA BLOCKER DRUGS PROVEN BENEFITS ACROSS MALE ADULT AGE GROUPS ( 21 – 60 YEARS)

26 Novel Botanical for Management of Nasal Congestion & Respiratory Health Market Size Global respiratory market valued at $44.0bn Annual drug market for allergic rhinitis is $10bn & for asthma is $12bn. Unmet Medical Need Proven and safe product for long term Complicated physiology to target multiple concerns. Market Drivers: Approximately 40 million people in the USA alone. Typical therapy is short-term and long term therapy is associated with lot of side effects. Targeted market: Moderate, severe, chronic or recurrent, non-infective nasal congestion with-or-without rhinorrhea Competitors: Anti-histamines (Loratidine), immune boosters, NSAIDs, nasal steroids. Stage of Development Competitive Advantage: Symptom-specific essential nutrients to restore the normal processes associated with nasal discharge & congestion Non-sedating, natural formula for safe long term use. Double-blind, dose-finding, time-effect defining study for 16 weeks on 55 subjects Extended follow-up phase of 36 weeks (Total 52 weeks) duration Research Highlight: India Patent Application No: 3298/MUM/2011

27 MARKET POSITIONING ANNUAL PROTECTION FROM UNPREDICTABLY CHANGING SEASONS AND RESULTANT RUNNING NOSE, NASAL CONGESTION AND SNEEZING DOUBLE BENEFIT OF ANTI-INFLAMMATORY AND IMMUNITY BUILDER RELIEF WITHIN 48 HOURS NO HANGOVER AND SAFE FOR REGULAR LONG TERM USE

28 A Novel Botanical for Management of Sleep Related Concerns Market Size About 200 million people affected worldwide Total USA market to hit $759 mn by 2013 & global market to reach $3.5 bn. Unmet Medical Need An option that can be used safely across a broader patient population. Significantly improve quality of sleep while eliminating the side effect of daytime impairment. Risk reduction of over dosage. Market Drivers: 50% Americans surveyed experience at least 1 symptom of insomnia & mn adults in the US are affected. Only 10% of the estimated population from 150 mn use prescribed pharma products for insomnia. Targeted market: Moderate, severe, chronic or recurrent Insomnia. Non restorative & poor-quality sleep, difficulty in falling or maintaining sound sleep. Competitors: Orexin receptor antagonists, Ambien (Sanofi-Aventis, 87% market share), Somaxon, Merck & Glaxo Stage of Development Competitive Advantage: Symptom-specific essential nutrients to restore the normal processes associated with sleep deprivation Non-habit forming, no hangover, natural formula for safe long term use. Exploratory, open label study for 6 weeks on 20 patients. Evaluation of efficacy (immediate and sustained) and safety of the product. Research Highlight:

29 MARKET POSITIONING ENHANCED SENSORY PERCEPTION UPON WAKING UP IN THE MORNING NORMALIZES SLEEP ARCHITECHTURE TO SUPPORT UNDISTURBED SLEEP HELPS TO AVOID MID-AFTERNOON “SLUMP” SPECIALLY SUITED FOR “NIGHT OWLS”, “GRAVEYARD SHIFT WORKERS” & “NEW MOTHERS POST LACTATION” TO ENHANCE SLEEP QUALITY

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31 Develop products complying to maximum Geographies and Regulatory Segments Substantiate Various Claims through High Quality Proprietary Studies Use softer claims for Food Supplement Market. Use higher level technology for Medical Foods. Offer Phase II product to BioPharm.

32 ISO 9001:2008 Organic Certificate Kosher Certificate

33 Drive Growth with our Branded Ingredients  Product Innovation  Efficient Supply Chain  Managing price risk  Consistent product quality

34  Full spectrum, naturally occurring B-Complex derived from Wheat germ  Provides broad matrix of Natural Vitamins with superior bioavailability  Suitable for fortified functional foods and beverages as natural source of vitamins Enrich your Functional food products with Food sourced Vitamins like never before

35  Extracted from Botanical matrix of Terminalia arjuna  Standardized vegetable source of calcium  Provides significant cardio-protection along with Natural Calcium Let your Heart beat with Bio-available Natural Calcium

36  Standardized for 1% Charantin and 20% Bitters  Tested by HPLC Nutraceutical ingredient for your metabolic health supplements

37  Standardized for 1.5% Nitrate  100% water soluble making it suitable for ready to drink premixes  Improves heart health, helps maintain healthy blood pressure levels, enhances exercise performance and boost stamina and endurance. Ideal Ingredient to boost power of your performance enhancing sports supplements

38  GreeNite is standardized for 1% Nitrate Flex your Muscles with Popeye’s Favorite

39  Natural actives in little shapes like moon, star, heart works like magic in your products  Customized Solubility rates ideal for use in active water systems

40 Enovate Biolife LLC 552, Shorebird Circle, Unit # 1101 Redwood Shores, CA , USA Exotic Naturals 203, Morya Landmark 1 Andheri (West) Mumbai , India


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