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OMARIA™




for the     and     of Malaria
OMARIA™




Malaria- epidemiological overview




               2
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 New
India also has a high endemicity of malaria           Guinea




Source: CDC                                   3
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 states
Source: WHO, India Country Profile                        4
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 population




Source: WHO, India Country Profile                      5
OMARIA™




Product Overview




        6
OMARIA™ – AN INDIGENOUS BREAKTHROUGH
    WIDELY NOTICED
     •    OMARIA™ holds out a new promise when malaria continues unabated despite availability
          of various antimalarial therapeutic interventions




Source: WHO, India Country Profile                7
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
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
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
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
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


                                                                                             12
Source: Antimicrobial Agents Chemother, Mar. 2009, p. 1100–1106; Asian Pacific Journal of Tropical Disease (2011)142-149
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 activity
Source: Asian Pacific Journal of Tropical Disease (2011)142-149; 9th
Proceedings of The Orissa Science Congress, 12-12- 2005, Indian Science
Congress Association : Bhubaneswar pp. 76 – 84                                        13
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 toxicity
Toxicity         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 -PAGE

Efficacy                                          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 product
Formula Weight   standardisation
                                                  Identification of product characteristics


                                            14
OMARIA™ -CLINICAL DATA & EXPERIENCE


            Tests                    Relevence                   Comments
                                  Helps in product       Identified through
Structure of active ingredients
                                  standardisation        Chromatography techniques
                                  Falciparum malaria    OMARIA shows anti-oxidative
Anti-oxidant Assay                has high incidence of role in vivo contributing to down
                                  systemic inflammation regulation of myalgia
MMP-9 expression/ promoter                               Hemozoin phagocytosis
activity and Gene expression                             stimulates MMP-9,activating TNF-
                                  Use in Falciparum
                                                         alpha which degrades basal
                                  malaria
Assay of NF-kB (role & effect)                           lamina and matrix proteins in
                                                         brain vasculature
                                  To establish Ellagic
                                                         Intestinal microflora form
Urolithin pathway                 Acid as one of the
                                                         Urolithins from Ellagic acid
                                  active compounds
No evidence of OMARIA
                                                         Experimental observation in field
moieties passing Placental and Safety
                                                         trials
Blood Brain Barrier                           15
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
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
                    Society's dispensary with outstanding results,17
                                                                   notably against P. falciparum
OMARIA™
How it all started…


 Dr. Deepak
 Bhattacharyya,
 Inventor-formulator
 of OMARIATM




                       The Koraput model
                             18
The Koraput model
   REQUEST BY KORAPUT DISTRICT ADMINISTRATION
                 (ODISHA STATE)
Invitation by The Collectorate – Koraput in face of unrelenting incidence of falciparum
Malaria
• 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
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 Informed
Consent Forms– submitted to Inventor.
•Administration provided all logistics.
•Each his Own Cost.



                                            20
OMARIA™                           The Koraput model

DEMONSTRATED HIGH CLINICAL EFFICACY IN
KORAPUT 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 mothers
Source: Asian Pacific Journal of Tropical Disease (2011)142-149         21
OMARIA™                            The Koraput model

THERAPEUTIC EFFICACY IN HQ DISPENSARY LED TO
PROPHYLACTIC USE ON A WIDER GEOGRAPHICAL AREA
Whole 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
OMARIA™                            The Koraput model

PROPHYLACTIC USE ADOPTED AT THE BLOCK LEVEL
PROVIDING SUCCOR TO UNDERPREVILIGED STUDENTS
1152 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
OMARIA™                           The Koraput model

 PROPHYLACTIC USE ADOPTED BY GOVT. OF ODISHA
 EVIDENCE BASED AT ITS BEST
3100+ 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,Koraput




Dr.Bhattacharyya, WEO-Mr.Samal, Dr.PK Pradhan, Redcross Dispensary, Koraput
alongwith others
                                            24
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 state




Shri Sachin R Jadhav, IAS
DM & Collector, Koraput
District, Odisha state



                                         25
OMARIA™ GOT NOTICED INTERNATIONALLY AND GOT
VALIDATED IN EUROPEAN LABS




                     26
OMARIA™ HAS BEEN PROVEN TO BE EFFECTIVE IN
INDIAN AS WELL AS AFRICAN RESISTANT STRAINS




                      27
ANTIMALARIAL RESISTANCE IS GOING UP
ALARMINGLY 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
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
LET US COLLABORATE TO FIGHT AGAINST MALARIA


                                  Contact us :

Jitendu Roy                     +91-9810712738           jitenduroy@yahoo.com
Shubhendu 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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Omaria a novel antimalarial

  • 1. OMARIA™ for the and of Malaria
  • 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 New India also has a high endemicity of malaria Guinea Source: CDC 3
  • 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 states Source: WHO, India Country Profile 4
  • 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 population Source: WHO, India Country Profile 5
  • 7. OMARIA™ – AN INDIGENOUS BREAKTHROUGH WIDELY NOTICED • OMARIA™ holds out a new promise when malaria continues unabated despite availability of various antimalarial therapeutic interventions Source: WHO, India Country Profile 7
  • 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. 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. 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. 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. 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 12 Source: Antimicrobial Agents Chemother, Mar. 2009, p. 1100–1106; Asian Pacific Journal of Tropical Disease (2011)142-149
  • 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 activity Source: Asian Pacific Journal of Tropical Disease (2011)142-149; 9th Proceedings of The Orissa Science Congress, 12-12- 2005, Indian Science Congress Association : Bhubaneswar pp. 76 – 84 13
  • 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 toxicity Toxicity 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 -PAGE Efficacy 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 product Formula Weight standardisation Identification of product characteristics 14
  • 15. OMARIA™ -CLINICAL DATA & EXPERIENCE Tests Relevence Comments Helps in product Identified through Structure of active ingredients standardisation Chromatography techniques Falciparum malaria OMARIA shows anti-oxidative Anti-oxidant Assay has high incidence of role in vivo contributing to down systemic inflammation regulation of myalgia MMP-9 expression/ promoter Hemozoin phagocytosis activity and Gene expression stimulates MMP-9,activating TNF- Use in Falciparum alpha which degrades basal malaria Assay of NF-kB (role & effect) lamina and matrix proteins in brain vasculature To establish Ellagic Intestinal microflora form Urolithin pathway Acid as one of the Urolithins from Ellagic acid active compounds No evidence of OMARIA Experimental observation in field moieties passing Placental and Safety trials Blood Brain Barrier 15
  • 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. 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 Society's dispensary with outstanding results,17 notably against P. falciparum
  • 18. OMARIA™ How it all started… Dr. Deepak Bhattacharyya, Inventor-formulator of OMARIATM The Koraput model 18
  • 19. The Koraput model REQUEST BY KORAPUT DISTRICT ADMINISTRATION (ODISHA STATE) Invitation by The Collectorate – Koraput in face of unrelenting incidence of falciparum Malaria • 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. 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 Informed Consent Forms– submitted to Inventor. •Administration provided all logistics. •Each his Own Cost. 20
  • 21. OMARIA™ The Koraput model DEMONSTRATED HIGH CLINICAL EFFICACY IN KORAPUT 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 mothers Source: Asian Pacific Journal of Tropical Disease (2011)142-149 21
  • 22. OMARIA™ The Koraput model THERAPEUTIC EFFICACY IN HQ DISPENSARY LED TO PROPHYLACTIC USE ON A WIDER GEOGRAPHICAL AREA Whole 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. OMARIA™ The Koraput model PROPHYLACTIC USE ADOPTED AT THE BLOCK LEVEL PROVIDING SUCCOR TO UNDERPREVILIGED STUDENTS 1152 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. OMARIA™ The Koraput model PROPHYLACTIC USE ADOPTED BY GOVT. OF ODISHA EVIDENCE BASED AT ITS BEST 3100+ 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,Koraput Dr.Bhattacharyya, WEO-Mr.Samal, Dr.PK Pradhan, Redcross Dispensary, Koraput alongwith others 24
  • 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 state Shri Sachin R Jadhav, IAS DM & Collector, Koraput District, Odisha state 25
  • 26. OMARIA™ GOT NOTICED INTERNATIONALLY AND GOT VALIDATED IN EUROPEAN LABS 26
  • 27. OMARIA™ HAS BEEN PROVEN TO BE EFFECTIVE IN INDIAN AS WELL AS AFRICAN RESISTANT STRAINS 27
  • 28. ANTIMALARIAL RESISTANCE IS GOING UP ALARMINGLY 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. 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. LET US COLLABORATE TO FIGHT AGAINST MALARIA Contact us : Jitendu Roy +91-9810712738 jitenduroy@yahoo.com Shubhendu 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