OMARIA™for the     and     of Malaria
OMARIA™Malaria- epidemiological overview               2
GLOBAL PREVALENCE OF MALARIA                                                  •   Prevalence of malaria depends on climati...
MALARIA IN INDIA                         Malaria in India           Category    Country’s      Total     P.falciparum   De...
MALARIA IN INDIA    -AFFECTS BOTH URBAN AND RURAL AREAS                        Malaria in India       Malaria Treatment De...
OMARIA™Product Overview        6
OMARIA™ – AN INDIGENOUS BREAKTHROUGH    WIDELY NOTICED     •    OMARIA™ holds out a new promise when malaria continues una...
OMARIA™ – A NOVEL ANTI-MALARIAL                          OMARIATM                                                         ...
OMARIA™PRODUCT PORTFOLIO FOR MARKETING                             OMARIA™  OMARIA-P ™                             OMARIA-...
OMARIA™ – BOTANICAL SOURCE•   OMARIA™ is derived from the dried rind of the fruit Punica granatum, commonly known as Pomeg...
OMARIA™ – MODE OF ACTION ( EXO-ERYTHROCYTIC + ERYTHROCYTIC + GAMETOCIDAL)                                                 ...
OMARIA™    EFFECTIVELY CLEARS THE MALARIAL PARASITE, TREATS    CEREBRAL MALARIA AND PROVIDES PROPHYLAXIS                  ...
OMARIA™    SHOWS COMPREHENSIVE TREATMENT OF P.falciparum    MALARIA WITH MARKED OVERALL IMPROVEMENT                 Recove...
OMARIA™ -CLINICAL DATA & EXPERIENCE      Tests           Relevence                               Comments                 ...
OMARIA™ -CLINICAL DATA & EXPERIENCE            Tests                    Relevence                   Comments              ...
OMARIA™ – DOSAGE & ADMINISTRATION   PROPHYLACTIC                                                          • Hard gelatin C...
OMARIA™ – MILESTONES IN DEVELOPMENT                        OMARIATM efficacy proven in resistant strains of P.falciparum i...
OMARIA™How it all started… Dr. Deepak Bhattacharyya, Inventor-formulator of OMARIATM                       The Koraput mod...
The Koraput model   REQUEST BY KORAPUT DISTRICT ADMINISTRATION                 (ODISHA STATE)Invitation by The Collectorat...
The Koraput model  FIELD TRIALS HANDLED BY RED CROSS (IRCS)Terms and Conditions•Free OMARIATM supplies.•Free superintenden...
OMARIA™                           The Koraput modelDEMONSTRATED HIGH CLINICAL EFFICACY INKORAPUT DISTRICT HQ IRCS DISPENSA...
OMARIA™                            The Koraput modelTHERAPEUTIC EFFICACY IN HQ DISPENSARY LED TOPROPHYLACTIC USE ON A WIDE...
OMARIA™                            The Koraput modelPROPHYLACTIC USE ADOPTED AT THE BLOCK LEVELPROVIDING SUCCOR TO UNDERPR...
OMARIA™                           The Koraput model PROPHYLACTIC USE ADOPTED BY GOVT. OF ODISHA EVIDENCE BASED AT ITS BEST...
OMARIA™                              The Koraput model PERSONIFYING A NOBLE PPP INITIATIVE(PUBLIC PRIVATE PARTNERSHIP)Comm...
OMARIA™ GOT NOTICED INTERNATIONALLY AND GOTVALIDATED IN EUROPEAN LABS                     26
OMARIA™ HAS BEEN PROVEN TO BE EFFECTIVE ININDIAN AS WELL AS AFRICAN RESISTANT STRAINS                      27
ANTIMALARIAL RESISTANCE IS GOING UPALARMINGLY AS PER CLINICAL EXPERIENCE !!!                        •High treatment failur...
OMARIA™HAS BEEN APPROVED FOR MARKETING                                   CURRENT STATUS              Patent               ...
LET US COLLABORATE TO FIGHT AGAINST MALARIA                                  Contact us :Jitendu Roy                     +...
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Omaria a novel antimalarial

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OMARIA is a new generation,patented antimalarial from India, validated in Europe and benefitting 15,000 people over 15 years

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Omaria a novel antimalarial

  1. 1. OMARIA™for the and of Malaria
  2. 2. OMARIA™Malaria- epidemiological overview 2
  3. 3. GLOBAL PREVALENCE OF MALARIA • Prevalence of malaria depends on climatic factors such Malaria Prevalence as: temperature, humidity and rainfall • Malaria is caused generally due to 4 plasmodium species –P.vivax, P.falciparum, P.malariae and P.ovale • Malaria is transmitted in tropical and subtropical areas, where Anopheles mosquitoes can survive and multiply. • Temperature is particularly critical, e.g. at temperatures below 20 C, Plasmodium falciparum cannot complete its cycle and therefore, cannot be transmitted. • In warmer regions closer to the equator, transmission is more intense and incidences of malaria take place perennially. • The highest transmission is found in Africa, South of the Sahara and in parts of Oceania such as Papua NewIndia also has a high endemicity of malaria GuineaSource: CDC 3
  4. 4. MALARIA IN INDIA Malaria in India Category Country’s Total P.falciparum Death Population Malaria incidence (%) (%) incidence (%) (%) High Malaria 41 67 77 43 endemic states North Eastern 4 13 18 46 states Others 55 20 5 11 P.Vivax and P.falciparum account for 80% of malaria incidence in India • High endemic areas contribute 80% of burden of disease in the country. The high endemic states are:  Orissa, Andhra Pradesh, Jharkhand, Chattisgarh, Madhya Pradesh, Gujarat, Maharashtra and Rajasthan  High incidences are also seen in the North-Eastern statesSource: WHO, India Country Profile 4
  5. 5. MALARIA IN INDIA -AFFECTS BOTH URBAN AND RURAL AREAS Malaria in India Malaria Treatment Delivery in India Thousands 3,000 2,388 2,500 2,085 2,023 2,059 2,154 1,842 1,869 1,915 1,874 2,000 58 242 622 825 550 1,500 1,000 2,085 1,842 1,869 1,915 1,816 1,781 1,509 1,532 1,563 500 0 2001 2002 2003 2004 2005 2006 2007 2008 2009 No. of No. of ACT courses fi rst-line treatment Malaria accounts for significant morbidity and mortality despite large scale delivery of treatments Malaria Mortality in India 2,000 1,708 Malaria is not a “Rural” disease. At 1,500 1,311 1,061 1,133 892 1,015 973 1,006 949 963 present, Urban Malaria Scheme is 1,000 protecting 11.07million people affected 500 with malaria as well as from other 0 mosquito borne diseases in 131 towns 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 in 19 States and Union Territories Mortality/100,000 populationSource: WHO, India Country Profile 5
  6. 6. OMARIA™Product Overview 6
  7. 7. OMARIA™ – AN INDIGENOUS BREAKTHROUGH WIDELY NOTICED • OMARIA™ holds out a new promise when malaria continues unabated despite availability of various antimalarial therapeutic interventionsSource: WHO, India Country Profile 7
  8. 8. OMARIA™ – A NOVEL ANTI-MALARIAL OMARIATM CO-Rx PROPHYLACTIC (Potentiates the action of some conventional anti-malarials) THERAPEUTIC Molecule Effect Chloroquine Synergistic Mefloquine Synergistic Artesunate Synergistic P.vivax P.falciparum Simple / uncomplicated Severe / Complicated malaria malaria 8
  9. 9. OMARIA™PRODUCT PORTFOLIO FOR MARKETING OMARIA™ OMARIA-P ™ OMARIA-T ™ Prophylactic preparation Therapeutic preparation Given the OTC treatment Classical pharma with heavy media coverage marketing through field and point of purchase force marketing. The distribution channel will be heavily dependent on Retail chemist 9
  10. 10. OMARIA™ – BOTANICAL SOURCE• OMARIA™ is derived from the dried rind of the fruit Punica granatum, commonly known as Pomegranate.• OMARIA™ does not contain alkaloids• OMARIATM has active antiplasmodium activity due to a mixture of:  Ellagic acid and its glycoside ,  Punicalagins, and Punicalins-C34H22O22 Punicalagins-C48H28O30  Punicalins Punica Grantum Collectively called Ellagitannins Ellagic Acid- C14H6O8 OMARIATM is classified as a Herbal (Botanical) drug Substance 10
  11. 11. OMARIA™ – MODE OF ACTION ( EXO-ERYTHROCYTIC + ERYTHROCYTIC + GAMETOCIDAL) OMARIA™ attacks malaria at multiple stages of its cycle OMARIATM acts on Exo-erythrocytic phase OMARIATM acts on Erythrocytic phase OMARIA acts on Gametocytes, blocking transmission too !!!Source: Antimicrobial Agents Chemother, Mar. 2009, p. 1100–1106; Asian Pacific Journal of Tropical Disease (2011)142-149 11
  12. 12. OMARIA™ EFFECTIVELY CLEARS THE MALARIAL PARASITE, TREATS CEREBRAL MALARIA AND PROVIDES PROPHYLAXIS Activity against P.falciparum and P.vivax • The constituent of OMARIA™ are Ellagic acid (1/3 rd) and Ellagitannins (2/3 rd) possessing strong plasmocidal activity.  Studies show high activity of ellagic acid against all Plasmodium falciparum strains, irrespective of their levels of chloroquine and mefloquine resistance • Upon initiation of treatment with OMARIA™, blood slides indicate complete parasite clearance within 36 hours. • Repeat slide films after 7 days and in subsequent months indicate nil deviation of blood picture from normal. • Once clinically cleared, most of the cases thwart re-infestation for a period ranging from 6 months to 4 years • Gametocytes of either sex get killed by OMARIA™ in 24-36 hours resulting in effective prevention of transmission 12Source: Antimicrobial Agents Chemother, Mar. 2009, p. 1100–1106; Asian Pacific Journal of Tropical Disease (2011)142-149
  13. 13. OMARIA™ SHOWS COMPREHENSIVE TREATMENT OF P.falciparum MALARIA WITH MARKED OVERALL IMPROVEMENT Recovery from Malaria • OMARIA™ results in complete parasite clearance within 36 hours and repeat slides after 7 days and in subsequent months indicate no deviation of blood picture from normal. Myalgia • No relapse observed • There is unfailing smooth, rapid clearance and recovery along- Parasitemia with wane of myalgia • Return of appetite, smooth bowel and GIT function are reported within 24 hours including clearance in known resistant cases who Fever previously had P. falciparum infection between 4 – 6 times / yr. even after full and complete Chloroquine – Mefloquine - antibiotic, and other combination, or MDT therapy during each episode . • With OMARIA™, hematological and biochemical parameters The fig. presents the recovery improve, raised blood differential count is noted to take a down- schedule at constant dose intake of turn towards normalcy. OMARIA™ by adults (without • Under treatment with OMARIA™, it is observed in patients that Paracetamol). N = 300. that blood pressure stabilizes, liver function improves even in known alcohol induced hepatic diseases and jaundice, which are Myalgia indicates a consistent down frequent among the tribal populations. regulation immediate post 1st dose of OMARIA™. This is due to its anti- • Complete recovery of P. vivax is also reported inflammatory, anti-oxidant and ultra wide/stable process scavenging activitySource: Asian Pacific Journal of Tropical Disease (2011)142-149; 9thProceedings of The Orissa Science Congress, 12-12- 2005, Indian ScienceCongress Association : Bhubaneswar pp. 76 – 84 13
  14. 14. OMARIA™ -CLINICAL DATA & EXPERIENCE Tests Relevence Comments Year long continuous exposure test of OMARIA on albino mice at a dose of 200 mg/kg/day indicated nil toxicityToxicity To determine safety Cytotoxic tests were done using human dermal fibroblasts (European Collection Cultures-UK) = indicated nil toxicity Lower the Haemolgobin Hemoglobin Degradation Assay done degradation, better the activity of active compounds through SDS -PAGEEfficacy In-vitro Drug Susceptibility Assay done To check the efficacy of OMARIA in resistant as well as susceptible strains In-vivo anti-plasmodial efficacy evaluation done in Europe Helps in productFormula Weight standardisation Identification of product characteristics 14
  15. 15. OMARIA™ -CLINICAL DATA & EXPERIENCE Tests Relevence Comments Helps in product Identified throughStructure of active ingredients standardisation Chromatography techniques Falciparum malaria OMARIA shows anti-oxidativeAnti-oxidant Assay has high incidence of role in vivo contributing to down systemic inflammation regulation of myalgiaMMP-9 expression/ promoter Hemozoin phagocytosisactivity and Gene expression stimulates MMP-9,activating TNF- Use in Falciparum alpha which degrades basal malariaAssay of NF-kB (role & effect) lamina and matrix proteins in brain vasculature To establish Ellagic Intestinal microflora formUrolithin pathway Acid as one of the Urolithins from Ellagic acid active compoundsNo evidence of OMARIA Experimental observation in fieldmoieties passing Placental and Safety trialsBlood Brain Barrier 15
  16. 16. OMARIA™ – DOSAGE & ADMINISTRATION PROPHYLACTIC • Hard gelatin Capsules of 500 mg each (OMARIA-P) 1 Cap per week(specific day of the week) for 8 weeks.Prophylaxis In areas with high endemicity,2 capsules per week for To be administered orally 8 weeks THERAPEUTIC (OMARIA-T) P. falciparum 1 Cap x 3 times daily (tid) x 4 days = 12 Capsules To be administered orally (uncomplicated) To be mixed with water and 6gm OMARIA™ powder (12 capsules) every 3 P. falciparum administered through a Ryle’s tube hours for 12 to 24 hours depending upon the (Complicated / Severe) after a gastric lavage. patient’s morbidity and clinical state Patient to be kept in inclined position. P. vivax 1 Cap x 2 times daily x 12 days = 24 Capsules To be administered orally Children who cannot swallow the capsules: for oral administration, OMARIA™ powder may be taken out and administered with water and / or honey 16
  17. 17. OMARIA™ – MILESTONES IN DEVELOPMENT OMARIATM efficacy proven in resistant strains of P.falciparum in Africa. Results of clinical trials published in International Journal of Clinical Medicine 2012 International attention on OMARIATM: Studies published in international Journals 2010-11 such as Malaria Journal and Asian Pacific Journal of Tropical Diseases . Manufacturing licence under GMP and Marketing permission 2004-09 OMARIA™ has been used successfully in over 15,000 patients over 13 years 2004 Jointly researched in Italy- Milan & Camerino University - Results published in Jour-Of-Ethno 2003 Data on OMARIA™ was accepted by the ASTMH (Am Soc of Trop Med Hyg) and was presented at 2004 Congress 2000 In Orissa, the Koraput District Collectorate adopts 3 villages for Comprehensive Whole Village Malaria Prevention Program using only OMARIA™. After 6 months, it was seen that prevention of by affliction (specially drug resistant strain) was almost complete BBC and Economic Times of India reported it as a Global News .1994-97 The innovator, Deepak Bhattacharya develops a new anti-malarial from a phytosource that demonstrates activity against malarial parasite and shows grip over malaria. OMARIA™ is being used continuously since 1997 and distributed from Indian Red Cross Societys dispensary with outstanding results,17 notably against P. falciparum
  18. 18. OMARIA™How it all started… Dr. Deepak Bhattacharyya, Inventor-formulator of OMARIATM The Koraput model 18
  19. 19. The Koraput model REQUEST BY KORAPUT DISTRICT ADMINISTRATION (ODISHA STATE)Invitation by The Collectorate – Koraput in face of unrelenting incidence of falciparumMalaria• 949/IX- 4195 dt. 15-7-98 {invitation}Perusal by The Collectorate :• 1060 dt. 26-11-2007 { Extension request }• 593 dt. 01-07-2009 { Extension request} 19
  20. 20. The Koraput model FIELD TRIALS HANDLED BY RED CROSS (IRCS)Terms and Conditions•Free OMARIATM supplies.•Free superintendence.•Capsules sent to Secretary – IRCS.•Technical Liability – Inventor’s.•Blood test was done by the Pathologist –Dist hospital.•All Case Record Forms cum InformedConsent Forms– submitted to Inventor.•Administration provided all logistics.•Each his Own Cost. 20
  21. 21. OMARIA™ The Koraput modelDEMONSTRATED HIGH CLINICAL EFFICACY INKORAPUT DISTRICT HQ IRCS DISPENSARY OMARIA™ therapeutic use summary 1998-2002 IRCS Clinic at District HQ went on to treat more than 16,000 cases till 31-04-2011. Observed Results No No of feed backs 531 Cases having history of < 5 episodes/yr 176 Cases having history of > 5 Episodes / yr 355 Cases Switched from Allopathy 115 Cases Reported Contradiction 00 Cases Reported Side Effects 00 Re-affliction within 1 yr of OMARIA™ 76 100 % Compliant 512 Pre & Post Treatment Blood Slides 150 Infants below 5 yrs of age 42 Child between the age of 5 and 15 yrs 90 Geriatric stage afflictions (above 60 yrs ) 71 Cases with confounding therapy 32 Not Pregnant & lactating mothers noted The table shows the summary of cases treated with OMARIA™, which includes acute, chronic, child, youth, middle aged, geriatric, adult, lactating and pregnant mothersSource: Asian Pacific Journal of Tropical Disease (2011)142-149 21
  22. 22. OMARIA™ The Koraput modelTHERAPEUTIC EFFICACY IN HQ DISPENSARY LED TOPROPHYLACTIC USE ON A WIDER GEOGRAPHICAL AREAWhole Village Comprehensive Prevention Programme with a followup for 1 year Total Total Village homes inhabitant Infant Child Adult Old Malaria Measles C. Pox Badamput 35 173 6 40 117 10 5 - 3 Gunthaguda 26 119 26 21 66 6 - 3 - Mundaguda 27 119 18 25 56 10 - - - Total 88 411 50 86 239 26 5* 3 3 5 cases did not avail OMARIA – P as they were floating population ( non use group )Mundaguda Gunthaguda 22
  23. 23. OMARIA™ The Koraput modelPROPHYLACTIC USE ADOPTED AT THE BLOCK LEVELPROVIDING SUCCOR TO UNDERPREVILIGED STUDENTS1152 students benefitted from Malaria Prophylaxis with a followup for 9 months Total Average No., of times Day Total Total No. of OMARIA caps. Malaria Affliction Residential Scholars Boarders School* # (Boys & Received & Consumed per head Pre- Post- (Boys & Girls) Consumed OMARIA OMARIA Girls) Dandabadi 33 370 3080 08 05 Nil Palaput 48 190 2370 12 04 Nil Kumbhari 51 190 2370 12 06 Nil Podapodar 80 190 2370 12 07 Nil 4 Res. Schools 212 940 10190 Avg = 11 Avg. = 5·5 Nil 23
  24. 24. OMARIA™ The Koraput model PROPHYLACTIC USE ADOPTED BY GOVT. OF ODISHA EVIDENCE BASED AT ITS BEST3100+ students benefitted from Malaria Prophylaxis resulting in better attendance Shri Balamukund Bhuyan,OAS (I), Presently DPC,SSA-RTE,Koraput District, took this initiative, ably supported by: •WEO,Narayanpatna block •Dr.P.K.Pradhan,IRCS,KoraputDr.Bhattacharyya, WEO-Mr.Samal, Dr.PK Pradhan, Redcross Dispensary, Koraputalongwith others 24
  25. 25. OMARIA™ The Koraput model PERSONIFYING A NOBLE PPP INITIATIVE(PUBLIC PRIVATE PARTNERSHIP)Committed individuals who have created a paradigm shift in healthcare… Shri Balamukund Bhuyan OAS (I) DPC,SSA-RTE, Koraput District, Odisha stateShri Sachin R Jadhav, IASDM & Collector, KoraputDistrict, Odisha state 25
  26. 26. OMARIA™ GOT NOTICED INTERNATIONALLY AND GOTVALIDATED IN EUROPEAN LABS 26
  27. 27. OMARIA™ HAS BEEN PROVEN TO BE EFFECTIVE ININDIAN AS WELL AS AFRICAN RESISTANT STRAINS 27
  28. 28. ANTIMALARIAL RESISTANCE IS GOING UPALARMINGLY AS PER CLINICAL EXPERIENCE !!! •High treatment failure to chloroquine has been detected in 300 PHCs of 92 districts spread over 20 states in the country. 28
  29. 29. OMARIA™HAS BEEN APPROVED FOR MARKETING CURRENT STATUS Patent Patent applied for in Aug 2008 Trade Mark Registered Manufacturing License (GMP) Granted Marketing Authorization Obtained Packaging and Label Designs Ready Pricing Decided INCAM Life Sciences Pvt. Ltd. Sri Radhakrishna, Kedar Gouri Road, Manufactured by Plot No. 232, Holding No. 14 (1) P. O. Old Town, Bhubaneshwar – 751002, Orissa 29
  30. 30. LET US COLLABORATE TO FIGHT AGAINST MALARIA Contact us :Jitendu Roy +91-9810712738 jitenduroy@yahoo.comShubhendu Dash +91-9030739849 skdash@strategm.com Watch OMARIATM video at Youtube.com INCAM Life Sciences Pvt. Ltd. 2E Caxton House, Jhandewalan Extn., New Delhi - 51 http://youtu.be/hDCUO1q62yY We invite Expression of Interest for partnering with us for India, SAARC countries, South-East Asia and African countries. 30

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