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BRAND PLAN FOR
CURCUMIN NANO PARTICLE
Natural Supplement for healthier life
MANAS RANJAN BHUYAN
B-PHARMA,MBA,MMM
Phone :9819316456 ,e-mail manas_bhuyan2001@yahoo.com
Brand Plan for
Curcumin Nano Particle
 Product Description
 IBD & its current management
 Business Objective
 Strategy
 STP
 Major Marketing Activities
 Financials (P&l)
Proposed Brand Name
CurcuMed
Micronised Curcumin 500mg vegetarian capsules
Curcumin Market Size to grow at over 9.5%
CAGR to reach $99.3mn by 2024
 India & China are the major supplier of Curcumin , The turnover of Curcumin could reach USD
94.32 million in 2022
 India contributes 80% of world production and roughly 60% of export
 Indian Curcumin market size accounted for over 81% of the overall Asia pacific revenue
most of these as a food coloring agent
 Though Curcumin is currently used majorly as a cosmetic but the market may witness a growth of
10% over last year ,majorly driven by its role as a dietary supplements (as a immunity booster
& anticancer drugs)
Cont… next slide
Curcumin Market Size to grow at over 9.5%
CAGR to reach $99.3mn by 2024
 UK Curcumin Pharmaceutical applications were valued at over USD 700000 in 2015
 EFSA has approved the standard that is acceptable daily intake per person is 3mg
Since the there is more understanding of Curcumin in medical & food industry the sales of
Curcumin were rising as well
 Curcumin market size has expands in over 17% CAGR from 2015 to 2022
 Export of turmeric and its products is around Rs120-170 cores
# European Food Safety Authority (EFSA)
Chemical Composition of Curcumin
PRODUCT DESCRIPTION:
Chemical Formula:1, 7-bis (4-hydroxy-3-methoxyphenyl) -1, 6-heptadiene-3, 5- dione
 Curcumin is the main active ingredient in turmeric it contains Bioactive Compounds with Powerful
Medicinal Properties these compounds are called curcuminoids ,It has powerful anti-inflammatory
effects and is a very strong antioxidant as indicated by over 6,000 citations.
 In addition, over one hundred clinical studies have been carried out with curcumin and another
100+ currently ongoing as per clinicaltrials.gov
 Turmeric contains Curcumin along with other constituents known as “Curcuminoids”
 Primary indication: Turmeric extracts can play a role in improving IBS symptoms and health-related
quality of life
 Insoluble in water & ether
TURMERIC
 Turmeric contains very low level of
curcuminoids , it’s around 3%, by weight.
 Most of the studies on this herb are using
turmeric extracts that contain mostly curcumin
itself, with dosages usually exceeding 1GM
per day(360mg TID to QID)
 Unfortunately, curcumin is poorly absorbed
into the bloodstream. It helps to consume
black pepper with it, which
contains piperine… that enhances the
absorption of curcumin by 2000%
CURCUMIN
 It is a patented extract of the rhizome of
Curcuma longa, standardised to provide 95
% of natural mixed curcuminoids and
sesquiterpenoids (with bioperine (another
name for piperine)
 Turmeric extracts that are standardized to
include large amounts of curcumin.Mainly
curcumin (Diferuloyl methane),
Demethoxycurcumin and
Bisdemethoxycurcmin.
 Enhanced bioavailability allows for less
frequent dosing.
 Highly soluble thus final dosage form will be
in a small vegetable capsule.
CURCUMIN Vs. TURMERIC
Three main curcuminoids
Were isolated from turmeric
Medical Properties of Curcumin
Diarypeptanoids ( Yellow Pigments) known as Curcumin has numerous medicinal properties, According to
the national institutes of Health, 61 clinical trials are completed or underway to study the use of dietary
curcumin for a variety of clinical disorders
Anti-Inflammatory Action
Unique Anti-Inflammatory
The laboratory studies have identified a number of
different molecules involved in inflammation that
are inhibited by curcumin including
 Phospholipase,
 Lipooxygenase,
 Cyclooxygenase 2,
 Leukotrienes,
 Thromboxane,
 Prostaglandins,
 Nitric oxide,
 Collagenase,
 Elastase,
 Hyaluronidase,
 Monocyte Chemoattractant Protein-1(MCP-1),
Interferon-inducible protein,
 Tumor necrosis factor (TNF), and
 Interleukin-12 (IL-12).
Beneficial effects of Curcumin on Human body Mechanism of Action
Curcumin is a Natural Anti-Inflammatory Compound Curcumin can inhibit many molecules known to play major roles in
inflammation.TNF-a ,COX etc.
Turmeric Dramatically Increases The Antioxidant Capacity of The
Body
Curcumin has powerful antioxidant effects. It neutralizes free radicals
on its own, then stimulates the body’s own antioxidant enzymes.
Curcumin Boosts Brain-Derived Neurotrophic Factor, Linked to
Improved Brain Function and a Lower Risk of Brain Diseases
Curcumin boosts levels of the brain hormone BDNF, which increases
the growth of new neurons and fights various degenerative processes
in the brain
Curcumin Leads to Various Improvements That Should Lower
Your Risk of Heart Disease
Curcumin has beneficial effects on several factors known to play a
role in heart disease. It improves the function of the endothelium and
is a potent anti-inflammatory agent and antioxidant
Turmeric Can Help Prevent (And Perhaps Even Treat) Cancer Curcumin leads to several changes on the molecular level that may
help prevent and perhaps even treat cancer.
Unique MOA of Curcumin
Beneficial effects of Curcumin on Human body Mechanism of Action
Curcumin May be Useful in Preventing and Treating Alzheimer’s
Disease
Curcumin can cross the blood-brain barrier and has been shown to
lead to various improvements in the pathological process of
Alzheimer’s disease
Arthritis Patients Respond Very Well to Curcumin Supplementation Arthritis is a common disorder characterized by joint inflammation.
Many studies show that curcumin can help treat symptoms of arthritis
and is in some cases more effective than anti-inflammatory drugs
Studies Show That Curcumin Has Incredible Benefits Against
Depression
A study in 60 depressed patients showed that curcumin was as
effective as prozac in alleviating the symptoms of depression
Curcumin May Help Delay Aging and Fight Age-Related Chronic
Diseases
Curcumin has a antioxidant property on skin
Unique MOA of Curcumin
 Antioxidant Activity
Curcumin protects biomembranes against peroxidative cell membrane damage ,
Scavenging of the reactive free radicals involved in peroxidation
 Anti-Inflammatory effect
Curcumin is most likely mediated through its ability to inhibit COX-2 ,Lipoxygenase &
inducible nitric oxide synthase (iNOS)
 Glutathione Synthesis
Curcumin can increase cellular glutathione levels( An important intracellular antioxidant)
By enhancing the transcription of genes that encode Glutamate Cysteine Ligase (SCL),
This feature of Curcumin is useful in liver related disorders
Major benefits of Curcumin
in Human body
 Once absorbed ,curcumin is subjected to sulfation and glucuronidation at various tissues sites
(majorly hepatocytes)
 Major biliary metabolites : Glucuronides of tetrahydrocurcumin (THC) & Hexa hydro curcumin (HHC)
 Orally administrated curcumin is absorbed from the alimentary tract and present in the general
blood circulation after largely being metabolized to the form of glucuronide /Sulfate conjugates
 There is no clear understanding on whether curcumin metabolites are as active as curcumin
Metabolism of Curcumin
 Curcumin is unstable at neutral and basic PH & is degraded to Ferulic acid & ferubyl methane
 More than 90% of the curcumin decomposes rapidly in buffer systems at neutral basic PH & this
degradation occurs due to oxidative mechanism
 Curcumin is also unstable in phosphate buffer at PH 7.4
 Curcumin is expected to be stable in stomach and small intestines ,since the PH is between
1 to 6 & the degradation is really slow in these condition
 The poor absorption from the intestine ,coupled with high degree of metabolism of curcumin in the
liver and its rapid elimination in the bile makes it unlikely that high concentrations of the substance
would be found in the body long periods of time after ingestion
 Piperin has been found to increase the bioavailability & Absorption of curcumin in both rats &
humans with no adverse effects
 Upon oral administration of curcumin with piperin ,curcumin could be found in blood even up to 8
days the extent of absorption of Curcumin when taken with piperine was 78% compared to 63.5%
when taken without piperine
Stability of Curcumin
 Many studies recommend 400mg of turmeric three times per day in capsules or
tablets form turmeric as a spice can also be incorporated into the diet as a way to
promote health
 A dose up to 3g is safe
Dosage
Side Effects
 Curcumin may cause Hypoglycemia , Anti coagulant , Sometimes may cause menstruation and
stimulate uterus
 In Pregnancy & Lactation there has been no studies on Pregnant women
 Curcumin is contraindicated in patients who are on blood thinning medications like Warfarin ,Aspirin
 People who are on nonsteroidal anti-inflammatory drugs like indomethacin ,Ibuprofen e etc.
 People who are on the hypotension drug like reserpine
Human Clinical Trials
with Curcumin
Curcumin in Combination With Mesalamine
 Design: a multicenter randomized, placebo-controlled, double-blind study
 Patients: 50 mesalamine-treated patients with active mild-to-moderate UC
who did not respond to an additional 2 weeks of the maximum dose of
mesalamine oral and topical therapy.
Patients were
divided in 2
groups
Curcumin capsules (3 g/day) (n 26) for 1 month with
continued mesalamine
Placebo (n 24) for 1 month with continued mesalamine
Clinical Gastroenterology and Hepatology 2015;13:1444–1449
Clinical response and remission rate at study end
point at week 4.
Endoscopic response and remission rate at study end
point at week 4.
Curcumin as add-on therapy with optimized mesalamine is superior to optimized mesalamine alone
in inducing clinical remission in patients with active mild-to-moderate UC.
Curcumin in Combination with Mesalamine
Curcumin Therapy in Inflammatory Bowel Disease
 Design: A pure curcumin preparation was administered in an open label study to
five patients with ulcerative proctitis and five with Crohn’s disease.
Patient profile at study entry
One CD patient was later discontinued
Patients were treated with
550 mg of curcumin twice
daily for 1 month and then
550 mg three times daily for
another month.
EFFECTS OF CURCUMIN ADMINISTRATION IN ULCERATIVE PROCTITIS PATIENTS
Numbers
represent
semi-
quantitative
scores
ranging from
1 to 3. The
higher the
score, the
worse the
status.
EFFECTS OF CURCUMIN ADMINISTRATION IN CROHN’S DISEASE PATIENTS
Curcumin Therapy in Inflammatory Bowel
Disease (cntd…)
Digestive Diseases and Sciences, Vol. 50, No. 11 (November 2005),
pp. 2191–2193
Conclusion:
 All five subjects with proctitis improved by the end of the study as judged
by a global score (P < 0.02).
 Two subjects eliminated their pre-study 5ASA medications, two subjects
reduced their medications (including termination of the prednisone therapy in
one subject).
 The CDAI scores for all completed subjects fell, with a mean reduction of 55
points.
 Curcumin appears to have reduced the inflammatory response in four of
five ulcerative colitis patients and four of five Crohn’s disease patients.
Curcumin Therapy in Inflammatory Bowel
Disease (cntd…)
Curcumin Maintenance Therapy for
Ulcerative Colitis
 Design: Randomized, double-blind, multicenter trial in Japan.
Patients were
divided in 2
groups
43 patients received curcumin, 1g after breakfast and 1g
after the evening meal, plus sulfasalazine (SZ: 1.0 –3.0
g/day) or mesalamine (MS: 1.5 –3.0 g/day)
39 patients received placebo plus SZ or mesalamine
Treatment Duration: 06 months
 Clinical activity index (CAI) and endoscopic index (EI) were determined at entry,
2, 4 & at 6 months.
Results:
 The mean Clinical Activity Index (CAI) in the curcumin group was improved from
1.3±1.1 at baseline to 1.0±2.0 at 6 months (P=0.038).
 In contrast, CAI in the placebo + SZ/MS group showed significant deterioration.
Curcumin Maintenance Therapy for Ulcerative
Colitis cntd…
0
5
10
15
20
25
Curcumin+SZ/MSPlacebo+SZ/MS
No. of patients
% with recurrence
• Only 2 of 43 patients treated with curcumin in combination
with SZ or mesalamine relapsed during the 6 months of therapy.
• Whereas 8 of 39 patients who received placebo with SZ or
mesalamine relapsed.
Recurrence Status at 6 Months
SZ: Sulfasalazine
MS: Mesalamine
CLINICAL GASTROENTEROLOGY AND HEPATOLOGY 2006;4:1502–1506
Curcumin, is potentially a promising medication for the treatment of IBD & is both
effective and safe in maintaining UC remission.
Major global Clinical Trials Status of
curcumin
Need of Nano-sized Particles of curcumin
 Curcumin is known to suppress inflammation via multiple pathways, like inhibiting
the production of pro-inflammatory cytokines i.e., TNF-a.
 The pleiotropic effects of curcumin are counterbalanced by its poor water
solubility and low oral bioavailability.
 The encapsulation of curcumin in pH-sensitive nano particles (NPs) results in a
significant permeability enhancement emphasizing the potential of these NPs
also toward increasing curcumin oral bioavailability.
 Nano-sized particles are taken up by an increased number of immune-related
cells in active inflammation.
International Journal of Pharmaceutics 473 (2014) 203–212
Benefits of nano sized curcumin
 Nano-sized drug delivery systems to target the inflamed mucosa are a promising
strategy in IBD treatment.
 Reducing the particle size of drug delivery systems is believed to increase
colonic residence time but can also provide additional benefits for IBD
therapy, such as a selective accumulation in inflamed tissues.
 The pH-sensitive release profile of curcumin from pH-sensitive nanoparticles
shows curcumin release at pH above 7.2 making them suitable for colonic
drug delivery.
 (More than 90 % release in alkaline medium)
International Journal of Pharmaceutics 473 (2014) 203–212
In-Vitro Confirmatory study of nano sized
curcumin & its anti-TNF action
 The anti-inflammatory efficacy of curcumin-loaded nano particles
was evaluated in vitro in Lipo-polysaccharide-(LPS) activated
macrophages and in vivo in a murine DSS-induced colitis model.
 In vitro, curcumin-nano particles significantly reduced TNF-a
secretion by LPS-activated macrophages (p < 0.01)
International Journal of Pharmaceutics 473 (2014) 203–212
4. Antioxidant effect of curcumin in tropical
pancreatitis
 Design: Twenty consecutive
patients with tropical pancreatitis
were randomised to receive 500
mg of curcumin with 5mg of
piperine, or placebo for three
times a day for 6 wk in a single
blind, randomized and placebo-
controlled trial.
 The effects on the pattern of
pain, and on red blood cell levels
of malonyldialdehyde (MDA) and
glutathione (GSH) were assessed. 0
2
4
6
8
10
12
14
16
Placebo Curcumin Placebo Curcumin
Baseline
6 Wk
MDAGSH
Significant reduction in the erythrocyte MDA level (P< 0.01) in the curcumin group compared to the
placebo group. Also increase in the GSH levels in curcumin group reported (non-significant). There was
no corresponding improvement in pain.
Results:
Oral curcumin with piperine reversed lipid peroxidation in patients with tropical pancreatitis.
P< 0.01
Indian J Med Res 122, October 2005, pp 315-318
Human Clinical Trial
in colorectal cancer
 In a phase I clinical trial ,curcumin extracts (containing 36 -180mg of curcumin) to 15
patients with refractory colorectal cancer.
 The curcuma extracts were well tolerated orally and no dosage limiting toxicity was
observed
 The disease was stable when observed radiologically during 2-4 months of treatment
 The study showed that curcuma extract can be safely administrated in dosage of up to
2.2g/d(180mg of curcumin) has low oral bioavailability in humans and may undergo
intestinal metabolism
Human Clinical Trial
in Cancer
In been examining that the anticancer effect of turmeric /curcumin reported a study of
25patients with one of five high-risk conditions: recently resected bladder cancer, arsenic bowen’s
disease of the skin , and intestinal metaplasia of the stomach
Curcumin was administrated orally for three months with doses ranging from 500 to
1200mg/day , curcumin was found to be non-toxic in doses of up to 8000mg/day orally for
three months
The results also showed that one of two patients with bladder cancer ,two of seven patients with
Leucoplakia , One of six patients with intestinal metaplasia , and two of six patients with bowen’s
disease developed frank malignancies in spite of treatment with Curcumin. But the remaining
patients in all categories were stable.
Human Clinical Trial
in HIV
 In a follow-up to pharmacological research on the effects of curcumin on HIV Cell
replication ,18 HIV positive patients were given an average dose curcumin of 2g/d for
127days
 There was a significant increse in CD4 and CD8 lymphocytes counts . The subsequent
phase I/II study using doses of 2.7-4.8g/d of curcumin failed to show any benefits on viral
loads of CD4 counts in HIV positive individuals
 It was suggested that the poor bioavailability of Curcumin could be a factor in these
negative results
Key benefits of Curcumin
 Natural and safe alternative, therefore devoid of side effects shown by existing
medications used in IBD management such as steroids, immuno suppressants.
 Curcumin inhibits key pro-inflammatory mediators such as TNF a, NfkB, and
interleukins.
 Clinical trials have shown that curcumin exhibits comparatively greater
remission of clinical improvement than existing 5ASA drugs.
 pH sensitive nano particles of curcumin selectively releases drug above pH
7.2 thereby increasing colonic residence time and selective accumulation in
inflamed tissues.
Proposed Formulation
Each capsule contains:
 pH sensitive nano-particles of curcumin…..500 mg
Indications:
 Management of IBD (UC and CD)
Dosage and Administration:
 One capsule twice daily for 6 months
BNIFICIAL EFFECTS
BNIFICIAL EFFECT
INFLAMMATORY BOWEL DISEASE (IBD)
INFLAMMATORY BOWEL DISEASE (IBD)
Normal Colon
Inflamed Colon
Normal Colon
 Inflammatory bowel disease IBD : A group of chronic intestinal diseases characterized
by inflammation of the bowel - the large or small intestine.
 The most common types of inflammatory bowel disease (IBD) are ulcerative
colitis and Crohn disease
Epidemiology
 Prevalence of ulcerative colitis (UC) of approximately 42 per 100,000 persons
 In a population based study in Punjab incidence of 6.02 per 100,000 persons
 The incidence of UC in Asian countries ranges from 0.4 to 2.1 per 100,000 population
 Prevalence is highest in India as compared to China and Malaysia
 The peak age of onset of UC is between 15-30 years & a second peak occurs between the ages of
60-80 years
 Seen equally in both males and females and appears to run in families4
Gut. 2003 Nov;52(11):1587-90 Indian J Gastroenterol (November–December 2012) 31(6):299–306 Lancet 2012; 380: 1606–1619
SEVERITY OF ULCERATIVE COLITIS
>30>30< 30ESR
Transfusion required<75% of normalNormalHemoglobin
>90>90NormalPulse
>37.5> 37.5NormalTemperature (C)
ContinuousFrequentIntermittentBlood in Stool
>10>6 - <10<4
Stools (per day)
ESR :Erythrocyte sedimentation rate
MODERATE
>4
Intermittent
Normal
Normal
Normal
< 30
SEVERE FULMINANTMILD
IBD Treatment Approach
 The 2 goals of therapy are the achievement of remission (induction) and the prevention of
disease flares (maintenance). Note that a top-down approach, with earlier introduction of
biologics and immunomodulators , is frequently advocated to forestall complications.
 Two approaches to treatment: "step-up," which starts with milder drugs first, versus "top-down,"
which gives people stronger drugs earlier in the treatment process.
 The goal of inflammatory bowel disease treatment is to reduce the inflammation that triggers
your signs and symptoms
Anti-inflammatory drugs
Anti-inflammatory drugs are often the first step in the treatment of inflammatory bowel disease.
 Aminosalicylates. Sulfasalazine (Azulfidine), Mesalazine
 Corticosteroids. (prednisone and hydrocortisone)
Immune system suppressors
 Azathioprine and mercaptopurine
 Cyclosporine
 Infliximab , adalimumab and golimumab .
 Methotrexate (Rheumatrex).
 Natalizumab (Tysabri) and vedolizumab (Entyvio).
 Ustekinumab
Pharmacotherapy for IBD
Antibiotics
 Metronidazole
 Ciprofloxacin
 Rifaximin
 Other medications
Anti-diarrheal medications.
 Pain relievers
 Iron supplements
 Vitamin B-12 shots.
 Calcium and vitamin D supplements.
 Nutrition
 Surgery
Surgery for ulcerative colitis.
Surgery for Crohn's disease
Pharmacotherapy for IBD
Management algorithm of IBD recommends the use of a comprehensive treatment plan
aiming optimum coverage for inflammatory mediators with minimum side effects
MOA
Mesalazine
Mesalazine is an amino salicylate anti
inflammatory drug , it alleviates pain by
counteracting the Cyclooxygenase (COX)
enzyme & Prostaglandins creating
inflammation.
Curcumin
Inhibits Arachidonate 5-lipoxygenase,
potential inhibitor of up-regulation of
TNF-alpha and IL-6
Side-effects
Mesalazine
Long-term use of NSAIDs can cause gastric
erosions, which can become stomach
ulcers and in extreme cases can cause severe
haemorrhage, The risk increases almost
twentyfold for those over 75.Other dangers
of NSAIDs are exacerbating asthma and
causing kidney damage.
Curcumin is safe when taken by mouth
or applied to the skin appropriately for up
to 24 months.
Mesalazine Vs. Curcumin
Montreal classification of IBD
Marketing Plan
CurcuMedMicronised Curcumin 500mg vegetarian capsules
Launch Rational
 Launch of Curcumed in Suprakare may further reinforce our vision for a Gastro focus
Business unit
 Launch of Curcumed may improve our relation with Gastro ,Surg & CP as these
three specialties are equally important for our key growth drivers like Dompan Gr,EvaQ,
Livrite
 IBD is an immerging market & Curcumed may spearhead a IBD franchise under
Suprakare banner with the launch of other molecules currently used for IBD management
 Growing number of clinical studies with Curcumin in IBD would add to its awareness
CurcuMed
Micronised Curcumin 500mg vegetarian capsules
IBD Market at a Glance CurcuMed
Micronised Curcumin 500mg vegetarian capsules
Total 200cr INR with 20% VAL Gr
 Total Scope in Units : 295 lakhs strips
 Mesalazine is the biggest value contributor estimated 75cr INR followed by Sulfasalazine
 Total sales in Unit for Mesalazine : 85 lakh
Mesalazine Market
at a Glance
CurcuMed
Micronised Curcumin 500mg vegetarian capsules
 Mesalazine is the biggest value contributor estimated 75cr INR followed by Sulfasalazine
 Total sales in Unit for Mesalazine : 85 lakh
 All brands showing good growth
C P R 170 0.08
GASTRO 47 1.05
ORTHO 31 0.84
NEURO 71 0.22
CARDIO 113 0.14
CONS PHY 131 0.14
DIABETO 102 0.08
GEN SURG 144 0.08
NEPHRO 88 0.08
PSYCHIA 76 0.04
CHEST 142 0.04
GEN PHY 197 0.02
For Each Specialty Rx Reach Based On Unique Rx
RANK: indicates preference of this category in
respective specialty
Rx REACH by SPECIALTY
MESALAZINE / SULFASALAZINE
Period: JUL-OCT 2016
Specialty
RANK
Rx%
Gastro are the
Major contributors
C MARC :CPR (India) MESALAZINE/SULPHA SALAZINE
Specialist :: GASTRO Rx Response(Share) Trend Four Monthly
Category Molecule
JULY-
OCT'15
NOV-
FEB'16
MAR-
JUN'16
JULY-
OCT'16
M-J'16 J-O'15
92 103 109 102 -6 11
MESALAZINE / SULFASALAZINE =100.0 =100.0 =100.0 =100.0
MESALAZINE / MESALAMINE 87.0 86.4 85.3 91.2 0 16
SULPHASALAZINE 10.9 12.6 12.8 8.8 -36 -10
%+/- In July -Oct'2016
Over
Mesalazine has a stronger acceptance at Gastro
IBD Prescription
Preference at Gastro
CurcuMed
Micronised Curcumin 500mg vegetarian capsules
C MARC :CPR (India) MESALAZINE/SULPHA SALAZINE
Specialist :: GASTRO Rx Response (Share) Trend Four Monthly
MOLECULE / BRAND
JULY-
OCT'15
NOV-
FEB'16
MAR-
JUN'16
JULY-
OCT'16
M-J'16 J-O'15
80 89 93 93
MESALAZINE / MESALAMINE =100.0 =100.0 =100.0 =100.0 0 16
MESACOL TAB [SPIL-SYGNUS ] 48.8 43.8 46.2 28.0 -40 -33
PENTASA TAB [FERRING Ph. ] 8.8 15.7 3.2 20.4 533 171
VEGAZ-OD TAB [DRL-RECURA ] 8.8 13.5 12.9 18.3 42 143
MESACOL SUPPOSITORIES [SPIL-SYGNUS ]13.8 5.6 8.6 14.0 63 18
MESACOL OD TAB [SPIL-SYGNUS ] 12.5 7.9 19.4 14.0 -28 30
10 13 14 9
SULPHASALAZINE =100.0 =100.0 =100.0 =100.0 -36 -10
SAZO-EN TAB / SAZO TAB [WALLACE-LIFE]80.0 61.5 71.4 55.6 -50 -38
SAAZ TAB [Ipca-ACTIVA ] 15.4 21.4 22.2 -33
SALAZOPYRIN TAB [WALLACE-D ] 20.0 7.7 0.0 22.2 0
%+/- In July -Oct'2016
Over
40
12
5 4
1
3
1
3
32
12
21
12
7
42
1 0
1
4
0
5
10
15
20
25
30
35
40
45
GEN
PHY
CONS
PHY
GEN
SURG
CARDIO GASTRO ORTHO NEURO CHEST OTHERS
CPR : Rxer%
MESALAZINE / MESALAMINE
 Good scope in gastro , CP & Surg
MESALAZINE(S) Prescription
Distribution across specialties
CurcuMed
Micronised Curcumin 500mg vegetarian capsules
40
12
5 4
1
3
1
3
32
11
20
3
8
2
47
4
1
5
0
5
10
15
20
25
30
35
40
45
50
GEN PHY CONS
PHY
GEN
SURG
CARDIO GASTRO ORTHO NEURO CHEST OTHERS
CPR : Rxer%
SULPHASALAZINE
: Rx ( %) Distribution Across Specialty
Sulphasalazine(S) Prescription
Distribution across specialties
CurcuMed
Micronised Curcumin 500mg vegetarian capsules
INFERENCES
 IBD market is estimated at 200cr growing at 20%
 Mesalazine is the largest prescribed contributing 35% to the market
 Unit wise there is a business of 295 lakhs strips out of which Mesalazine sales up to 85 lakh strips
with a growth of 11%
 In IBD Mesalazine has strong acceptance at Gastro followed by Surg. & CP
 Though Sulfasalazine is also indicated in IBD but its primary acceptance is in Arthritis , so it
acceptance is very high among Ortho (Rx contribution is up to 47%)
 Co-prescription data shows approximately 13% of Mesalazine prescription is with another anti-
inflammatory drug (Rifaximin)
CurcuMed
Micronised Curcumin 500mg vegetarian capsules
Market Sizing CurcuMed
Micronised Curcumin 500mg vegetarian capsules
 Target Market : Mesalazine market
 Total sales of Mesalazine : 85 lakhs strips per annum
Current sales of Mesalazine
8500000 Strips
5%
Scope for Co-Rx
425000
Strips
1st Year
 MRP-100/Strip of 10s
 NRV- Approximately Rs.72
 Desired PCPM- 100
1. Mesacol 800mg----137
2. Vegaz 1.2gm------223
3. Pentasa SR- 500mg----256
4. Coolgut1.2gm-----220
 Average price of Mesalazine ranging from 140 to 256 for 10s
Particular /Year 1st Year 2nd Year 3rd Year
Exp. Sales in Units 277200 396000 594000
Exp. Sales Value @ 72
with Gr @10%
200 285 428
3 year projection CurcuMed
Micronised Curcumin 500mg vegetarian capsules
Challenges for Curcumed
 Limited Clinical Data & user
experience among the Indian
Gastroenterologists.
 Curcumin is yet to find a place
in International IBD protocol.
 Curcumin is not US-FDA
approved.
 Use of Curcumin is so common in
India , it will be a herculean
task to change patients
perception to accept it in a new
dosage form.
 Product may demand high
promo budget as establishing
Curcumin in IBD management
may need high amount of
scientific efforts(CME ,RTD ,
Indian Publications).
Strategy
 Identify mesalazine prescribers
,establish Curcumin as an ideal
add on that ensures better
treatment outcome and minimum
relapse
Action Plan
 More thrust on Scientific
Promotion using reprints &
literatures
 Regular CME involving Gastro ,
Surg , CP
 Patient registry activity with
Gastro (PMS),through IBD
detection camps
 Social marketing to establish
the power of naturopathy in
IBD management .
Strategy & Action Plan CurcuMed
Micronised Curcumin 500mg vegetarian capsules
Co-Rx with Mesalazine
 Segmentation:
 The whole market is
segmented based on the
Mesalazine prescribers &
Mesalazine non prescribers
(RCPA to Segment)
Preferred Specialties
 Gastro
 Surg
 Top Consultant Physicians
 Targeting:
 20 Doctors/TM
 All India 7000 doctors
 Gastro :5 (All), Surg :10(All
based on their preference
for mesalazine) ,CP :10 (All
based on their preference
for mesalazine)
Positioning:
 Curcumed, is potentially a
promising medication for the
treatment of IBD & is both
effective and safe in
maintaining UC remission , A
Powerful yet safe Co-Rx that
ensure better outcome in IBD
Major indication :
• IDB (Ulcerative
colitis and Crohn disease)
• Co-Rx with Mesalazine &
Sulfasalazine
STP CurcuMed
Micronised Curcumin 500mg vegetarian capsules
Pay Off Line:
A natural yet effective & safe co-prescription for IBD
65
 Pathophysiology of IBD is complex & often involved multiple inflammatory mediators depends upon
the severity , age and other comorbidities , In this scenario initiating a treatment plan with multiple
drugs that covers different inflammatory mediators without escalating the side effects can proven
more beneficial than with mono therapy
Rationale for the Co-Rx CurcuMed
Micronised Curcumin 500mg vegetarian capsules
 Mesalazine alleviates pain by
counteracting
the Cyclooxygenase (COX) enzyme
& Prostaglandins creating
inflammation
 Curcumin is known to suppress
inflammation via multiple
pathways, like inhibiting the
production of pro-inflammatory
cytokines i.e., TNF-a.
 Curcumin is safe in long run
Zenith Nutrition , MRP of 90 capsules :Rs 1599
INLIFE Curcumin ,MRP of 60 capsules : Rs639
Himalaya Haridra , MRP of 60 capsules :Rs 110 (400mg)
Boswellia Turmeric , MRP of 60 capsules :Rs873
Price ranging fro 2/capsule to 18 / capsule
Available pricing CurcuMed
Micronised Curcumin 500mg vegetarian capsules
MRP (incl. of all taxes),10s 100
RP 79.20
NRV 72.00
 MRP-100/Strip of 10s
 NRV- Approximately Rs.72
 Desired PCPM- 100
1. Mesacol 800mg----137
2. Vegaz 1.2gm------223
3. Pentasa SR- 500mg----256
4. Coolgut1.2gm-----220
 Average price of Mesalazine ranging from 140 to 256 for 10s
Particular /Year 1st Year 2nd Year 3rd Year
Exp. Sales in Units 277200 396000 594000
Exp. Sales Value @ 72
with Gr @10%
200 285 428
3 year projection CurcuMed
Micronised Curcumin 500mg vegetarian capsules
Communication
Objectives
 No matter ,whether your treatment plan is Top Down or Bottom up , Add Curcumin to improve
treatment outcomes in IBD
 CurcuMed is India’s 1st micronized Curcumin that ensure better bioavailability
 Curcumin known to suppress inflammation via multiple pathways like inhibits key pro-
inflammatory mediators such as TNF a, NfkB, and interleukins.
 Mesalazine alleviates pain by counteracting the Cyclooxygenase (COX) enzyme &
Prostaglandins creating inflammation
 Curcumin as add-on therapy with mesalazine is superior to high dose mesalazine alone in
inducing clinical remission in patients with active mild-to-moderate UC.
 Clinical trials have shown that curcumin exhibits comparatively greater remission of clinical
improvement than existing 5ASA drugs.
CurcuMed
Micronised Curcumin 500mg vegetarian capsules
6
9
Total Sales Value (A)
Net COG (Rs. L)(B)
Cross Margin (Rs.L)(A-B)=(C )
Brand Promotion Expenses (Rs L)
[ PS + gifts + bonus + Product incentive + LBL + Spl.
Activity +V .aid + advert]
Other Marketing Exp (Rs.L) (D)
Selling Exp (Rs.L) (E)
(Field Staff Exp + Field Staff Salary + Misc Exp
Distribution Exp (L) @ 3.75%
Overheads Exp(L)@7%
Total Exp
PBT (C-(D+E)
PROFIT PLAN SUMMARY CurcuMed
Micronised Curcumin 500mg vegetarian capsules
Curcumin brand plan. 1st cut

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Curcumin brand plan. 1st cut

  • 1. BRAND PLAN FOR CURCUMIN NANO PARTICLE Natural Supplement for healthier life MANAS RANJAN BHUYAN B-PHARMA,MBA,MMM Phone :9819316456 ,e-mail manas_bhuyan2001@yahoo.com
  • 2. Brand Plan for Curcumin Nano Particle  Product Description  IBD & its current management  Business Objective  Strategy  STP  Major Marketing Activities  Financials (P&l)
  • 3. Proposed Brand Name CurcuMed Micronised Curcumin 500mg vegetarian capsules
  • 4. Curcumin Market Size to grow at over 9.5% CAGR to reach $99.3mn by 2024  India & China are the major supplier of Curcumin , The turnover of Curcumin could reach USD 94.32 million in 2022  India contributes 80% of world production and roughly 60% of export  Indian Curcumin market size accounted for over 81% of the overall Asia pacific revenue most of these as a food coloring agent  Though Curcumin is currently used majorly as a cosmetic but the market may witness a growth of 10% over last year ,majorly driven by its role as a dietary supplements (as a immunity booster & anticancer drugs) Cont… next slide
  • 5. Curcumin Market Size to grow at over 9.5% CAGR to reach $99.3mn by 2024  UK Curcumin Pharmaceutical applications were valued at over USD 700000 in 2015  EFSA has approved the standard that is acceptable daily intake per person is 3mg Since the there is more understanding of Curcumin in medical & food industry the sales of Curcumin were rising as well  Curcumin market size has expands in over 17% CAGR from 2015 to 2022  Export of turmeric and its products is around Rs120-170 cores # European Food Safety Authority (EFSA)
  • 6. Chemical Composition of Curcumin PRODUCT DESCRIPTION: Chemical Formula:1, 7-bis (4-hydroxy-3-methoxyphenyl) -1, 6-heptadiene-3, 5- dione  Curcumin is the main active ingredient in turmeric it contains Bioactive Compounds with Powerful Medicinal Properties these compounds are called curcuminoids ,It has powerful anti-inflammatory effects and is a very strong antioxidant as indicated by over 6,000 citations.  In addition, over one hundred clinical studies have been carried out with curcumin and another 100+ currently ongoing as per clinicaltrials.gov  Turmeric contains Curcumin along with other constituents known as “Curcuminoids”  Primary indication: Turmeric extracts can play a role in improving IBS symptoms and health-related quality of life  Insoluble in water & ether
  • 7. TURMERIC  Turmeric contains very low level of curcuminoids , it’s around 3%, by weight.  Most of the studies on this herb are using turmeric extracts that contain mostly curcumin itself, with dosages usually exceeding 1GM per day(360mg TID to QID)  Unfortunately, curcumin is poorly absorbed into the bloodstream. It helps to consume black pepper with it, which contains piperine… that enhances the absorption of curcumin by 2000% CURCUMIN  It is a patented extract of the rhizome of Curcuma longa, standardised to provide 95 % of natural mixed curcuminoids and sesquiterpenoids (with bioperine (another name for piperine)  Turmeric extracts that are standardized to include large amounts of curcumin.Mainly curcumin (Diferuloyl methane), Demethoxycurcumin and Bisdemethoxycurcmin.  Enhanced bioavailability allows for less frequent dosing.  Highly soluble thus final dosage form will be in a small vegetable capsule. CURCUMIN Vs. TURMERIC
  • 8. Three main curcuminoids Were isolated from turmeric
  • 9. Medical Properties of Curcumin Diarypeptanoids ( Yellow Pigments) known as Curcumin has numerous medicinal properties, According to the national institutes of Health, 61 clinical trials are completed or underway to study the use of dietary curcumin for a variety of clinical disorders
  • 10. Anti-Inflammatory Action Unique Anti-Inflammatory The laboratory studies have identified a number of different molecules involved in inflammation that are inhibited by curcumin including  Phospholipase,  Lipooxygenase,  Cyclooxygenase 2,  Leukotrienes,  Thromboxane,  Prostaglandins,  Nitric oxide,  Collagenase,  Elastase,  Hyaluronidase,  Monocyte Chemoattractant Protein-1(MCP-1), Interferon-inducible protein,  Tumor necrosis factor (TNF), and  Interleukin-12 (IL-12).
  • 11. Beneficial effects of Curcumin on Human body Mechanism of Action Curcumin is a Natural Anti-Inflammatory Compound Curcumin can inhibit many molecules known to play major roles in inflammation.TNF-a ,COX etc. Turmeric Dramatically Increases The Antioxidant Capacity of The Body Curcumin has powerful antioxidant effects. It neutralizes free radicals on its own, then stimulates the body’s own antioxidant enzymes. Curcumin Boosts Brain-Derived Neurotrophic Factor, Linked to Improved Brain Function and a Lower Risk of Brain Diseases Curcumin boosts levels of the brain hormone BDNF, which increases the growth of new neurons and fights various degenerative processes in the brain Curcumin Leads to Various Improvements That Should Lower Your Risk of Heart Disease Curcumin has beneficial effects on several factors known to play a role in heart disease. It improves the function of the endothelium and is a potent anti-inflammatory agent and antioxidant Turmeric Can Help Prevent (And Perhaps Even Treat) Cancer Curcumin leads to several changes on the molecular level that may help prevent and perhaps even treat cancer. Unique MOA of Curcumin
  • 12. Beneficial effects of Curcumin on Human body Mechanism of Action Curcumin May be Useful in Preventing and Treating Alzheimer’s Disease Curcumin can cross the blood-brain barrier and has been shown to lead to various improvements in the pathological process of Alzheimer’s disease Arthritis Patients Respond Very Well to Curcumin Supplementation Arthritis is a common disorder characterized by joint inflammation. Many studies show that curcumin can help treat symptoms of arthritis and is in some cases more effective than anti-inflammatory drugs Studies Show That Curcumin Has Incredible Benefits Against Depression A study in 60 depressed patients showed that curcumin was as effective as prozac in alleviating the symptoms of depression Curcumin May Help Delay Aging and Fight Age-Related Chronic Diseases Curcumin has a antioxidant property on skin Unique MOA of Curcumin
  • 13.  Antioxidant Activity Curcumin protects biomembranes against peroxidative cell membrane damage , Scavenging of the reactive free radicals involved in peroxidation  Anti-Inflammatory effect Curcumin is most likely mediated through its ability to inhibit COX-2 ,Lipoxygenase & inducible nitric oxide synthase (iNOS)  Glutathione Synthesis Curcumin can increase cellular glutathione levels( An important intracellular antioxidant) By enhancing the transcription of genes that encode Glutamate Cysteine Ligase (SCL), This feature of Curcumin is useful in liver related disorders Major benefits of Curcumin in Human body
  • 14.  Once absorbed ,curcumin is subjected to sulfation and glucuronidation at various tissues sites (majorly hepatocytes)  Major biliary metabolites : Glucuronides of tetrahydrocurcumin (THC) & Hexa hydro curcumin (HHC)  Orally administrated curcumin is absorbed from the alimentary tract and present in the general blood circulation after largely being metabolized to the form of glucuronide /Sulfate conjugates  There is no clear understanding on whether curcumin metabolites are as active as curcumin Metabolism of Curcumin
  • 15.  Curcumin is unstable at neutral and basic PH & is degraded to Ferulic acid & ferubyl methane  More than 90% of the curcumin decomposes rapidly in buffer systems at neutral basic PH & this degradation occurs due to oxidative mechanism  Curcumin is also unstable in phosphate buffer at PH 7.4  Curcumin is expected to be stable in stomach and small intestines ,since the PH is between 1 to 6 & the degradation is really slow in these condition  The poor absorption from the intestine ,coupled with high degree of metabolism of curcumin in the liver and its rapid elimination in the bile makes it unlikely that high concentrations of the substance would be found in the body long periods of time after ingestion  Piperin has been found to increase the bioavailability & Absorption of curcumin in both rats & humans with no adverse effects  Upon oral administration of curcumin with piperin ,curcumin could be found in blood even up to 8 days the extent of absorption of Curcumin when taken with piperine was 78% compared to 63.5% when taken without piperine Stability of Curcumin
  • 16.  Many studies recommend 400mg of turmeric three times per day in capsules or tablets form turmeric as a spice can also be incorporated into the diet as a way to promote health  A dose up to 3g is safe Dosage
  • 17. Side Effects  Curcumin may cause Hypoglycemia , Anti coagulant , Sometimes may cause menstruation and stimulate uterus  In Pregnancy & Lactation there has been no studies on Pregnant women  Curcumin is contraindicated in patients who are on blood thinning medications like Warfarin ,Aspirin  People who are on nonsteroidal anti-inflammatory drugs like indomethacin ,Ibuprofen e etc.  People who are on the hypotension drug like reserpine
  • 19. Curcumin in Combination With Mesalamine  Design: a multicenter randomized, placebo-controlled, double-blind study  Patients: 50 mesalamine-treated patients with active mild-to-moderate UC who did not respond to an additional 2 weeks of the maximum dose of mesalamine oral and topical therapy. Patients were divided in 2 groups Curcumin capsules (3 g/day) (n 26) for 1 month with continued mesalamine Placebo (n 24) for 1 month with continued mesalamine Clinical Gastroenterology and Hepatology 2015;13:1444–1449
  • 20. Clinical response and remission rate at study end point at week 4. Endoscopic response and remission rate at study end point at week 4. Curcumin as add-on therapy with optimized mesalamine is superior to optimized mesalamine alone in inducing clinical remission in patients with active mild-to-moderate UC. Curcumin in Combination with Mesalamine
  • 21. Curcumin Therapy in Inflammatory Bowel Disease  Design: A pure curcumin preparation was administered in an open label study to five patients with ulcerative proctitis and five with Crohn’s disease. Patient profile at study entry One CD patient was later discontinued Patients were treated with 550 mg of curcumin twice daily for 1 month and then 550 mg three times daily for another month.
  • 22. EFFECTS OF CURCUMIN ADMINISTRATION IN ULCERATIVE PROCTITIS PATIENTS Numbers represent semi- quantitative scores ranging from 1 to 3. The higher the score, the worse the status. EFFECTS OF CURCUMIN ADMINISTRATION IN CROHN’S DISEASE PATIENTS Curcumin Therapy in Inflammatory Bowel Disease (cntd…) Digestive Diseases and Sciences, Vol. 50, No. 11 (November 2005), pp. 2191–2193
  • 23. Conclusion:  All five subjects with proctitis improved by the end of the study as judged by a global score (P < 0.02).  Two subjects eliminated their pre-study 5ASA medications, two subjects reduced their medications (including termination of the prednisone therapy in one subject).  The CDAI scores for all completed subjects fell, with a mean reduction of 55 points.  Curcumin appears to have reduced the inflammatory response in four of five ulcerative colitis patients and four of five Crohn’s disease patients. Curcumin Therapy in Inflammatory Bowel Disease (cntd…)
  • 24. Curcumin Maintenance Therapy for Ulcerative Colitis  Design: Randomized, double-blind, multicenter trial in Japan. Patients were divided in 2 groups 43 patients received curcumin, 1g after breakfast and 1g after the evening meal, plus sulfasalazine (SZ: 1.0 –3.0 g/day) or mesalamine (MS: 1.5 –3.0 g/day) 39 patients received placebo plus SZ or mesalamine Treatment Duration: 06 months  Clinical activity index (CAI) and endoscopic index (EI) were determined at entry, 2, 4 & at 6 months.
  • 25. Results:  The mean Clinical Activity Index (CAI) in the curcumin group was improved from 1.3±1.1 at baseline to 1.0±2.0 at 6 months (P=0.038).  In contrast, CAI in the placebo + SZ/MS group showed significant deterioration. Curcumin Maintenance Therapy for Ulcerative Colitis cntd… 0 5 10 15 20 25 Curcumin+SZ/MSPlacebo+SZ/MS No. of patients % with recurrence • Only 2 of 43 patients treated with curcumin in combination with SZ or mesalamine relapsed during the 6 months of therapy. • Whereas 8 of 39 patients who received placebo with SZ or mesalamine relapsed. Recurrence Status at 6 Months SZ: Sulfasalazine MS: Mesalamine CLINICAL GASTROENTEROLOGY AND HEPATOLOGY 2006;4:1502–1506 Curcumin, is potentially a promising medication for the treatment of IBD & is both effective and safe in maintaining UC remission.
  • 26. Major global Clinical Trials Status of curcumin
  • 27. Need of Nano-sized Particles of curcumin  Curcumin is known to suppress inflammation via multiple pathways, like inhibiting the production of pro-inflammatory cytokines i.e., TNF-a.  The pleiotropic effects of curcumin are counterbalanced by its poor water solubility and low oral bioavailability.  The encapsulation of curcumin in pH-sensitive nano particles (NPs) results in a significant permeability enhancement emphasizing the potential of these NPs also toward increasing curcumin oral bioavailability.  Nano-sized particles are taken up by an increased number of immune-related cells in active inflammation. International Journal of Pharmaceutics 473 (2014) 203–212
  • 28. Benefits of nano sized curcumin  Nano-sized drug delivery systems to target the inflamed mucosa are a promising strategy in IBD treatment.  Reducing the particle size of drug delivery systems is believed to increase colonic residence time but can also provide additional benefits for IBD therapy, such as a selective accumulation in inflamed tissues.  The pH-sensitive release profile of curcumin from pH-sensitive nanoparticles shows curcumin release at pH above 7.2 making them suitable for colonic drug delivery.  (More than 90 % release in alkaline medium) International Journal of Pharmaceutics 473 (2014) 203–212
  • 29. In-Vitro Confirmatory study of nano sized curcumin & its anti-TNF action  The anti-inflammatory efficacy of curcumin-loaded nano particles was evaluated in vitro in Lipo-polysaccharide-(LPS) activated macrophages and in vivo in a murine DSS-induced colitis model.  In vitro, curcumin-nano particles significantly reduced TNF-a secretion by LPS-activated macrophages (p < 0.01) International Journal of Pharmaceutics 473 (2014) 203–212
  • 30. 4. Antioxidant effect of curcumin in tropical pancreatitis  Design: Twenty consecutive patients with tropical pancreatitis were randomised to receive 500 mg of curcumin with 5mg of piperine, or placebo for three times a day for 6 wk in a single blind, randomized and placebo- controlled trial.  The effects on the pattern of pain, and on red blood cell levels of malonyldialdehyde (MDA) and glutathione (GSH) were assessed. 0 2 4 6 8 10 12 14 16 Placebo Curcumin Placebo Curcumin Baseline 6 Wk MDAGSH Significant reduction in the erythrocyte MDA level (P< 0.01) in the curcumin group compared to the placebo group. Also increase in the GSH levels in curcumin group reported (non-significant). There was no corresponding improvement in pain. Results: Oral curcumin with piperine reversed lipid peroxidation in patients with tropical pancreatitis. P< 0.01 Indian J Med Res 122, October 2005, pp 315-318
  • 31. Human Clinical Trial in colorectal cancer  In a phase I clinical trial ,curcumin extracts (containing 36 -180mg of curcumin) to 15 patients with refractory colorectal cancer.  The curcuma extracts were well tolerated orally and no dosage limiting toxicity was observed  The disease was stable when observed radiologically during 2-4 months of treatment  The study showed that curcuma extract can be safely administrated in dosage of up to 2.2g/d(180mg of curcumin) has low oral bioavailability in humans and may undergo intestinal metabolism
  • 32. Human Clinical Trial in Cancer In been examining that the anticancer effect of turmeric /curcumin reported a study of 25patients with one of five high-risk conditions: recently resected bladder cancer, arsenic bowen’s disease of the skin , and intestinal metaplasia of the stomach Curcumin was administrated orally for three months with doses ranging from 500 to 1200mg/day , curcumin was found to be non-toxic in doses of up to 8000mg/day orally for three months The results also showed that one of two patients with bladder cancer ,two of seven patients with Leucoplakia , One of six patients with intestinal metaplasia , and two of six patients with bowen’s disease developed frank malignancies in spite of treatment with Curcumin. But the remaining patients in all categories were stable.
  • 33. Human Clinical Trial in HIV  In a follow-up to pharmacological research on the effects of curcumin on HIV Cell replication ,18 HIV positive patients were given an average dose curcumin of 2g/d for 127days  There was a significant increse in CD4 and CD8 lymphocytes counts . The subsequent phase I/II study using doses of 2.7-4.8g/d of curcumin failed to show any benefits on viral loads of CD4 counts in HIV positive individuals  It was suggested that the poor bioavailability of Curcumin could be a factor in these negative results
  • 34. Key benefits of Curcumin  Natural and safe alternative, therefore devoid of side effects shown by existing medications used in IBD management such as steroids, immuno suppressants.  Curcumin inhibits key pro-inflammatory mediators such as TNF a, NfkB, and interleukins.  Clinical trials have shown that curcumin exhibits comparatively greater remission of clinical improvement than existing 5ASA drugs.  pH sensitive nano particles of curcumin selectively releases drug above pH 7.2 thereby increasing colonic residence time and selective accumulation in inflamed tissues.
  • 35. Proposed Formulation Each capsule contains:  pH sensitive nano-particles of curcumin…..500 mg Indications:  Management of IBD (UC and CD) Dosage and Administration:  One capsule twice daily for 6 months
  • 39. INFLAMMATORY BOWEL DISEASE (IBD) Normal Colon Inflamed Colon Normal Colon  Inflammatory bowel disease IBD : A group of chronic intestinal diseases characterized by inflammation of the bowel - the large or small intestine.  The most common types of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn disease
  • 40. Epidemiology  Prevalence of ulcerative colitis (UC) of approximately 42 per 100,000 persons  In a population based study in Punjab incidence of 6.02 per 100,000 persons  The incidence of UC in Asian countries ranges from 0.4 to 2.1 per 100,000 population  Prevalence is highest in India as compared to China and Malaysia  The peak age of onset of UC is between 15-30 years & a second peak occurs between the ages of 60-80 years  Seen equally in both males and females and appears to run in families4 Gut. 2003 Nov;52(11):1587-90 Indian J Gastroenterol (November–December 2012) 31(6):299–306 Lancet 2012; 380: 1606–1619
  • 41. SEVERITY OF ULCERATIVE COLITIS >30>30< 30ESR Transfusion required<75% of normalNormalHemoglobin >90>90NormalPulse >37.5> 37.5NormalTemperature (C) ContinuousFrequentIntermittentBlood in Stool >10>6 - <10<4 Stools (per day) ESR :Erythrocyte sedimentation rate MODERATE >4 Intermittent Normal Normal Normal < 30 SEVERE FULMINANTMILD
  • 42. IBD Treatment Approach  The 2 goals of therapy are the achievement of remission (induction) and the prevention of disease flares (maintenance). Note that a top-down approach, with earlier introduction of biologics and immunomodulators , is frequently advocated to forestall complications.  Two approaches to treatment: "step-up," which starts with milder drugs first, versus "top-down," which gives people stronger drugs earlier in the treatment process.  The goal of inflammatory bowel disease treatment is to reduce the inflammation that triggers your signs and symptoms
  • 43. Anti-inflammatory drugs Anti-inflammatory drugs are often the first step in the treatment of inflammatory bowel disease.  Aminosalicylates. Sulfasalazine (Azulfidine), Mesalazine  Corticosteroids. (prednisone and hydrocortisone) Immune system suppressors  Azathioprine and mercaptopurine  Cyclosporine  Infliximab , adalimumab and golimumab .  Methotrexate (Rheumatrex).  Natalizumab (Tysabri) and vedolizumab (Entyvio).  Ustekinumab Pharmacotherapy for IBD
  • 44. Antibiotics  Metronidazole  Ciprofloxacin  Rifaximin  Other medications Anti-diarrheal medications.  Pain relievers  Iron supplements  Vitamin B-12 shots.  Calcium and vitamin D supplements.  Nutrition  Surgery Surgery for ulcerative colitis. Surgery for Crohn's disease Pharmacotherapy for IBD Management algorithm of IBD recommends the use of a comprehensive treatment plan aiming optimum coverage for inflammatory mediators with minimum side effects
  • 45. MOA Mesalazine Mesalazine is an amino salicylate anti inflammatory drug , it alleviates pain by counteracting the Cyclooxygenase (COX) enzyme & Prostaglandins creating inflammation. Curcumin Inhibits Arachidonate 5-lipoxygenase, potential inhibitor of up-regulation of TNF-alpha and IL-6 Side-effects Mesalazine Long-term use of NSAIDs can cause gastric erosions, which can become stomach ulcers and in extreme cases can cause severe haemorrhage, The risk increases almost twentyfold for those over 75.Other dangers of NSAIDs are exacerbating asthma and causing kidney damage. Curcumin is safe when taken by mouth or applied to the skin appropriately for up to 24 months. Mesalazine Vs. Curcumin
  • 47. Marketing Plan CurcuMedMicronised Curcumin 500mg vegetarian capsules
  • 48. Launch Rational  Launch of Curcumed in Suprakare may further reinforce our vision for a Gastro focus Business unit  Launch of Curcumed may improve our relation with Gastro ,Surg & CP as these three specialties are equally important for our key growth drivers like Dompan Gr,EvaQ, Livrite  IBD is an immerging market & Curcumed may spearhead a IBD franchise under Suprakare banner with the launch of other molecules currently used for IBD management  Growing number of clinical studies with Curcumin in IBD would add to its awareness CurcuMed Micronised Curcumin 500mg vegetarian capsules
  • 49. IBD Market at a Glance CurcuMed Micronised Curcumin 500mg vegetarian capsules Total 200cr INR with 20% VAL Gr  Total Scope in Units : 295 lakhs strips  Mesalazine is the biggest value contributor estimated 75cr INR followed by Sulfasalazine  Total sales in Unit for Mesalazine : 85 lakh
  • 50. Mesalazine Market at a Glance CurcuMed Micronised Curcumin 500mg vegetarian capsules  Mesalazine is the biggest value contributor estimated 75cr INR followed by Sulfasalazine  Total sales in Unit for Mesalazine : 85 lakh  All brands showing good growth
  • 51. C P R 170 0.08 GASTRO 47 1.05 ORTHO 31 0.84 NEURO 71 0.22 CARDIO 113 0.14 CONS PHY 131 0.14 DIABETO 102 0.08 GEN SURG 144 0.08 NEPHRO 88 0.08 PSYCHIA 76 0.04 CHEST 142 0.04 GEN PHY 197 0.02 For Each Specialty Rx Reach Based On Unique Rx RANK: indicates preference of this category in respective specialty Rx REACH by SPECIALTY MESALAZINE / SULFASALAZINE Period: JUL-OCT 2016 Specialty RANK Rx% Gastro are the Major contributors
  • 52. C MARC :CPR (India) MESALAZINE/SULPHA SALAZINE Specialist :: GASTRO Rx Response(Share) Trend Four Monthly Category Molecule JULY- OCT'15 NOV- FEB'16 MAR- JUN'16 JULY- OCT'16 M-J'16 J-O'15 92 103 109 102 -6 11 MESALAZINE / SULFASALAZINE =100.0 =100.0 =100.0 =100.0 MESALAZINE / MESALAMINE 87.0 86.4 85.3 91.2 0 16 SULPHASALAZINE 10.9 12.6 12.8 8.8 -36 -10 %+/- In July -Oct'2016 Over Mesalazine has a stronger acceptance at Gastro IBD Prescription Preference at Gastro CurcuMed Micronised Curcumin 500mg vegetarian capsules
  • 53. C MARC :CPR (India) MESALAZINE/SULPHA SALAZINE Specialist :: GASTRO Rx Response (Share) Trend Four Monthly MOLECULE / BRAND JULY- OCT'15 NOV- FEB'16 MAR- JUN'16 JULY- OCT'16 M-J'16 J-O'15 80 89 93 93 MESALAZINE / MESALAMINE =100.0 =100.0 =100.0 =100.0 0 16 MESACOL TAB [SPIL-SYGNUS ] 48.8 43.8 46.2 28.0 -40 -33 PENTASA TAB [FERRING Ph. ] 8.8 15.7 3.2 20.4 533 171 VEGAZ-OD TAB [DRL-RECURA ] 8.8 13.5 12.9 18.3 42 143 MESACOL SUPPOSITORIES [SPIL-SYGNUS ]13.8 5.6 8.6 14.0 63 18 MESACOL OD TAB [SPIL-SYGNUS ] 12.5 7.9 19.4 14.0 -28 30 10 13 14 9 SULPHASALAZINE =100.0 =100.0 =100.0 =100.0 -36 -10 SAZO-EN TAB / SAZO TAB [WALLACE-LIFE]80.0 61.5 71.4 55.6 -50 -38 SAAZ TAB [Ipca-ACTIVA ] 15.4 21.4 22.2 -33 SALAZOPYRIN TAB [WALLACE-D ] 20.0 7.7 0.0 22.2 0 %+/- In July -Oct'2016 Over
  • 54. 40 12 5 4 1 3 1 3 32 12 21 12 7 42 1 0 1 4 0 5 10 15 20 25 30 35 40 45 GEN PHY CONS PHY GEN SURG CARDIO GASTRO ORTHO NEURO CHEST OTHERS CPR : Rxer% MESALAZINE / MESALAMINE  Good scope in gastro , CP & Surg MESALAZINE(S) Prescription Distribution across specialties CurcuMed Micronised Curcumin 500mg vegetarian capsules
  • 55. 40 12 5 4 1 3 1 3 32 11 20 3 8 2 47 4 1 5 0 5 10 15 20 25 30 35 40 45 50 GEN PHY CONS PHY GEN SURG CARDIO GASTRO ORTHO NEURO CHEST OTHERS CPR : Rxer% SULPHASALAZINE : Rx ( %) Distribution Across Specialty Sulphasalazine(S) Prescription Distribution across specialties CurcuMed Micronised Curcumin 500mg vegetarian capsules
  • 56. INFERENCES  IBD market is estimated at 200cr growing at 20%  Mesalazine is the largest prescribed contributing 35% to the market  Unit wise there is a business of 295 lakhs strips out of which Mesalazine sales up to 85 lakh strips with a growth of 11%  In IBD Mesalazine has strong acceptance at Gastro followed by Surg. & CP  Though Sulfasalazine is also indicated in IBD but its primary acceptance is in Arthritis , so it acceptance is very high among Ortho (Rx contribution is up to 47%)  Co-prescription data shows approximately 13% of Mesalazine prescription is with another anti- inflammatory drug (Rifaximin) CurcuMed Micronised Curcumin 500mg vegetarian capsules
  • 57. Market Sizing CurcuMed Micronised Curcumin 500mg vegetarian capsules  Target Market : Mesalazine market  Total sales of Mesalazine : 85 lakhs strips per annum Current sales of Mesalazine 8500000 Strips 5% Scope for Co-Rx 425000 Strips 1st Year
  • 58.  MRP-100/Strip of 10s  NRV- Approximately Rs.72  Desired PCPM- 100 1. Mesacol 800mg----137 2. Vegaz 1.2gm------223 3. Pentasa SR- 500mg----256 4. Coolgut1.2gm-----220  Average price of Mesalazine ranging from 140 to 256 for 10s Particular /Year 1st Year 2nd Year 3rd Year Exp. Sales in Units 277200 396000 594000 Exp. Sales Value @ 72 with Gr @10% 200 285 428 3 year projection CurcuMed Micronised Curcumin 500mg vegetarian capsules
  • 59. Challenges for Curcumed  Limited Clinical Data & user experience among the Indian Gastroenterologists.  Curcumin is yet to find a place in International IBD protocol.  Curcumin is not US-FDA approved.  Use of Curcumin is so common in India , it will be a herculean task to change patients perception to accept it in a new dosage form.  Product may demand high promo budget as establishing Curcumin in IBD management may need high amount of scientific efforts(CME ,RTD , Indian Publications). Strategy  Identify mesalazine prescribers ,establish Curcumin as an ideal add on that ensures better treatment outcome and minimum relapse Action Plan  More thrust on Scientific Promotion using reprints & literatures  Regular CME involving Gastro , Surg , CP  Patient registry activity with Gastro (PMS),through IBD detection camps  Social marketing to establish the power of naturopathy in IBD management . Strategy & Action Plan CurcuMed Micronised Curcumin 500mg vegetarian capsules Co-Rx with Mesalazine
  • 60.  Segmentation:  The whole market is segmented based on the Mesalazine prescribers & Mesalazine non prescribers (RCPA to Segment) Preferred Specialties  Gastro  Surg  Top Consultant Physicians  Targeting:  20 Doctors/TM  All India 7000 doctors  Gastro :5 (All), Surg :10(All based on their preference for mesalazine) ,CP :10 (All based on their preference for mesalazine) Positioning:  Curcumed, is potentially a promising medication for the treatment of IBD & is both effective and safe in maintaining UC remission , A Powerful yet safe Co-Rx that ensure better outcome in IBD Major indication : • IDB (Ulcerative colitis and Crohn disease) • Co-Rx with Mesalazine & Sulfasalazine STP CurcuMed Micronised Curcumin 500mg vegetarian capsules Pay Off Line: A natural yet effective & safe co-prescription for IBD
  • 61. 65  Pathophysiology of IBD is complex & often involved multiple inflammatory mediators depends upon the severity , age and other comorbidities , In this scenario initiating a treatment plan with multiple drugs that covers different inflammatory mediators without escalating the side effects can proven more beneficial than with mono therapy Rationale for the Co-Rx CurcuMed Micronised Curcumin 500mg vegetarian capsules  Mesalazine alleviates pain by counteracting the Cyclooxygenase (COX) enzyme & Prostaglandins creating inflammation  Curcumin is known to suppress inflammation via multiple pathways, like inhibiting the production of pro-inflammatory cytokines i.e., TNF-a.  Curcumin is safe in long run
  • 62. Zenith Nutrition , MRP of 90 capsules :Rs 1599 INLIFE Curcumin ,MRP of 60 capsules : Rs639 Himalaya Haridra , MRP of 60 capsules :Rs 110 (400mg) Boswellia Turmeric , MRP of 60 capsules :Rs873 Price ranging fro 2/capsule to 18 / capsule Available pricing CurcuMed Micronised Curcumin 500mg vegetarian capsules MRP (incl. of all taxes),10s 100 RP 79.20 NRV 72.00
  • 63.  MRP-100/Strip of 10s  NRV- Approximately Rs.72  Desired PCPM- 100 1. Mesacol 800mg----137 2. Vegaz 1.2gm------223 3. Pentasa SR- 500mg----256 4. Coolgut1.2gm-----220  Average price of Mesalazine ranging from 140 to 256 for 10s Particular /Year 1st Year 2nd Year 3rd Year Exp. Sales in Units 277200 396000 594000 Exp. Sales Value @ 72 with Gr @10% 200 285 428 3 year projection CurcuMed Micronised Curcumin 500mg vegetarian capsules
  • 64. Communication Objectives  No matter ,whether your treatment plan is Top Down or Bottom up , Add Curcumin to improve treatment outcomes in IBD  CurcuMed is India’s 1st micronized Curcumin that ensure better bioavailability  Curcumin known to suppress inflammation via multiple pathways like inhibits key pro- inflammatory mediators such as TNF a, NfkB, and interleukins.  Mesalazine alleviates pain by counteracting the Cyclooxygenase (COX) enzyme & Prostaglandins creating inflammation  Curcumin as add-on therapy with mesalazine is superior to high dose mesalazine alone in inducing clinical remission in patients with active mild-to-moderate UC.  Clinical trials have shown that curcumin exhibits comparatively greater remission of clinical improvement than existing 5ASA drugs. CurcuMed Micronised Curcumin 500mg vegetarian capsules
  • 65. 6 9 Total Sales Value (A) Net COG (Rs. L)(B) Cross Margin (Rs.L)(A-B)=(C ) Brand Promotion Expenses (Rs L) [ PS + gifts + bonus + Product incentive + LBL + Spl. Activity +V .aid + advert] Other Marketing Exp (Rs.L) (D) Selling Exp (Rs.L) (E) (Field Staff Exp + Field Staff Salary + Misc Exp Distribution Exp (L) @ 3.75% Overheads Exp(L)@7% Total Exp PBT (C-(D+E) PROFIT PLAN SUMMARY CurcuMed Micronised Curcumin 500mg vegetarian capsules