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
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