Curcumin brand plan. 1st cut

66
BRAND PLAN FOR CURCUMIN NANO PARTICLE Natural Supplement for healthier life MANAS RANJAN BHUYAN B-PHARMA,MBA,MMM Phone :9819316456 ,e-mail [email protected]

Transcript of Curcumin brand plan. 1st cut

Page 1: Curcumin brand plan. 1st cut

BRAND PLAN FOR

CURCUMIN NANO PARTICLE

Natural Supplement for healthier life

MANAS RANJAN BHUYAN

B-PHARMA,MBA,MMM

Phone :9819316456 ,e-mail [email protected]

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Brand Plan for

Curcumin Nano Particle

Product Description

IBD & its current management

Business Objective

Strategy

STP

Major Marketing Activities

Financials (P&l)

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Proposed Brand Name

CurcuMed Micronised Curcumin 500mg vegetarian capsules

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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

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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)

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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

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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

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Three main curcuminoids

Were isolated from turmeric

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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

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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).

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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

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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

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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

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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

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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

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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

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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

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Human Clinical Trials

with Curcumin

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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

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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

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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.

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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

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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…)

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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.

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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.

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Major global Clinical Trials Status of

curcumin

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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

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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

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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

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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

MDA GSH

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

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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

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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.

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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

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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.

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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

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BNIFICIAL EFFECTS

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BNIFICIAL EFFECT

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INFLAMMATORY BOWEL DISEASE (IBD)

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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

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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

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SEVERITY OF ULCERATIVE COLITIS

>30 >30 < 30 ESR

Transfusion required <75% of normal Normal Hemoglobin

>90 >90 Normal Pulse

>37.5 > 37.5 Normal Temperature (C)

Continuous Frequent Intermittent Blood in Stool

>10 >6 - <10 <4 Stools (per day)

ESR :Erythrocyte sedimentation rate

MODERATE

>4

Intermittent

Normal

Normal

Normal

< 30

SEVERE FULMINANT MILD

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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

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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

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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

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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

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Montreal classification of IBD

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Marketing Plan

CurcuMed Micronised Curcumin 500mg vegetarian capsules

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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

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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

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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

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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 / SULFASALAZINEPeriod: JUL-OCT 2016

Specialty

RA

NK

Rx%

Gastro are the

Major contributors

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C MARC :CPR (India) MESALAZINE/SULPHA SALAZINE

Specialist :: GASTRO Rx Response(Share) Trend Four Monthly

Category MoleculeJULY-

OCT'15

NOV-

FEB'16

MAR-

JUN'16

JULY-

OCT'16

M-J'16 J-O'15

92 103 109 102 -6 11MESALAZINE / 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

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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 93MESALAZINE / 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 9SULPHASALAZINE =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

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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

GENPHY

CONSPHY

GENSURG

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

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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 CONSPHY

GENSURG

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

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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

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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

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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

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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

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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

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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

Page 62: Curcumin brand plan. 1st cut

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

Page 63: Curcumin brand plan. 1st cut

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

Page 64: Curcumin brand plan. 1st cut

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

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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

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