1. 1.DRUG CLASS AND MECHANISM: Esomeprazole is in a class of drugs called proton pump
inhibitors (PPIs) which block the production of acid by the stomach. Other drugs in the same class
include omeprazole (Prilosec),lansoprazole (Prevacid), rabeprazole (Aciphex)
and pantoprazole(Protonix). Chemically, esomeprazole is very similar to omeprazole. Proton pump
inhibitors are used for the treatment of conditions such as stomach and duodenal
ulcers, gastroesophageal refluxdisease (GERD) and the Zollinger-Ellison syndrome which all are
caused by stomach acid. Esomeprazole, like other proton-pump inhibitors, blocks the enzyme in the
wall of the stomach that produces acid. By blocking the enzyme, the production of acid is decreased,
and this allows the stomach and esophagus to heal. Esomeprazole was approved by the FDA in
February 2001.
1. 2. In chemistry, isomers (/ˈaɪsəmərz/; from Greek ἰσομερής, isomerès; isos = "equal",
méros = "part") are molecules with the same chemical formula but different chemical
structures. That is, isomers contain the same number of atoms of each element, but
have different arrangements of their atoms in space. In chemistry, isomers (/ˈaɪsəmərz/;
from Greek ἰσομερής, isomerès; isos = "equal", méros = "part") are molecules with the
same chemical formula but different chemical structures. That is, isomers contain the same number
of atoms of each element, but have different arrangements of their atoms in space.[1][2]
Isomers do
not necessarily share similar properties, unless they also have the same functional groups. There
are many different classes of isomers, like positional isomers, cis-trans isomers and enantiomers,
etc. (see chart below). There are two main forms of isomerism: structural
isomerism and stereoisomerism (spatial isomerism).
2. http://upload.wikimedia.org/wikipedia/commons/thumb/0/04/Isomerism.svg/883px-
Isomerism.svg.png
3. Bioavailabilty of all-trans and cisismers of lycopene
4.
Effect of esomeprazole 40 mg vs omeprazole 40 mg on 24-hour
intragastric pH in patients with symptoms of gastroesophageal
reflux disease
Omeprazole and esomeprazoleLokesh patil (22) Madhura jagtap (10)
Animesh Amal (01) Vishal mehta (16) Khushbu Mascarenhas (13)
2. Executive Summary Brand name is Esoz 20 Molecule - Esomeprazole Tablet – 20
mg tablet Target Doctors - CP, GP, Gastro, Sur, Gynaec Total market for Esomeprazole
is Rs 102.23 cr Market growth – 23.14%
3. Disease & Market definition 1. Gastro esophageal refluxdisease: ( GERD) • It is a chronic
symptom of mucosal damage caused by stomach acid coming up from the stomach into the
esophagus tube. 2. Heart burn: • It is a painful burning feeling in the chest or throat. It
happens when stomach acid backs up into esophagus tube that carries food from mouth to
stomach. 3. Dyspepsia: • Means indigestion
4. Epidemiology Trigger factors: 1. Age- Most of the studies have included population
above the age of 18 years or older who is affecting from this disease. 2. Dietary Factors-
spicy, fried or food prepared outside the home contributed insignificantly to worsening of
symptoms. 3. NSAIDs- same drugs like aspirin ( increase acid secretions) 4. Helicobacter
Pylori infection: (Responsible for ulcer) • It is a gram negative bacterium found in stomach. •
present in patients with chronic gastritis and gastric ulcers, conditions.
5. Esomeprazole Profile 1. Indication: GERD Healing of Erosive Esophagitis
Maintenance of Erosive Esophagitis Peptic Ulcer disease Risk reduction of NSAID-
Associated Gastic Ulcers Acid Peptic Disorders
2. 6. Mechanism of Acid Secretion Proton pump is a catalytic enzyme. Present in the parietal
cells. Histamine, Acetylcholine and Gastrin are the three important stimuli for acid secretion.
Final step in acid production in activation of proton pump.
7. Mechanism of Action- PPI inhibitors Acetylcholine, gastrin and histamine can increase the
acid production with increasing the activity of proton pump. PPI blocks the final step of acid
production. Therefore reduce the acidity of the stomach contents leaking into the esophagus,
which reduces the incidence of heartburn.
8. Dosage and Administration Indication Dose (mg) Duration Healing of erosive esophagitis
20-40 4-8 Weeks Symptomatic relief of GERD 20 4 Weeks To prevent replace of GERD 20
For eradication of H.pylori infection 40 Once daily for up to 6 months Once daily for up to 10
months
9. Esomeprazole Profile Side effect: • • • • Headache Flatulence (gas) Nausea Dry mouth/
Diarrhoea Precautions: • Efficacy and safety in pediatric patents and in pregnant women
and nursing mother have not been established
10. SWOT Analysis STRENGTHS AND WEAKNESSES • Management of multiple
indications • Fixed dose combination • Company with well trained workforce • Late entrance.
• Can’t be given in pregnancy & Lactating females • Issue in paediatric patients (use only in
above 12 yr age) OPPORTUNITIES AND THREATS • Growing therapeutic segment. •
Increase patients • High market value (102 cr) • High competitors. • New combinations for
indications.
11. Key issues • contraindicated in patients with known hypersensitivity to any component of
the formulation or to substituted benzimidazoles. • contraindicated in patients with a known
hypersensitivity to any macrolide antibiotic. • should be taken at least one hour before meals.
• serious side effects, including: symptoms of a low magnesium blood level
12. Market analysis 11/1/2013 12
13. Competitive Analysis 1) In Terms of Molecules / All PPI: • PH maintaining Time period
Median PH>4 Time period (Hrs) Esomeprazole 16.7 hrs Lansoprazole Rabeprazole
Pnatorazole Omeprazole 12.7 hrs 10.8 hrs 10.5 hrs 10.4 hrs
14. Competitive Analysis 2) In Terms of Market: • • Indian Pharmaceutical Market: 72.760
Crs Growing at Rate: 10.5% • Value of Gastro Intestinal market is 7613Crs. • Gastro is on
3rd position in terms of value. • Growth is 7.3% annually. • Total Esomeprazole market is
growing with 23.14% annually. • Esomeprazole-20 mg market is growing with 13.85%
annually.
15. Competitive Analysis • Major players in Esomeprazole Market: COMPANIES TORRENT
ASTRAZENECA SUN PHARMACEUTICAL RANBAXY LABORATORIES CIPLA MICRO
LABS ALKEM ABBOTT HEALTHCARE M.S. 34.4 26.2 15.2 9.5 2.0 1.1 1.0 0.1 • Major
players in Esomeprazole 20mg Tab Market: Companies M.S. TORRENT 33.93
ASTRAZENECA 21.03 SUN PHARMACEUTICAL 13.68 RANBAXY LABORATORIES 8.57
Alkem 4.67
16. Esomeprazole 5C’s insights customer • Doctors & chemists are over crowded by large
no. of drugs and diff. prices. • Doctors knows importantance of PPI • MR focus on chemist
concurrently with launch consumer Target to special class, special cases because of its
feature. There are some old established brands which sticks to the patient mind. patients
need effective solutions competition Weekly feedback collection compound Most effective
Safe Sales/ MS to be measured each quarter, then monthly 2013. Analyze competitor
activity and market Higher availability Immediate acting PPI Highest healing rate 94.1%
channels Distributors play a major role in the availability. Shortage can affect sales
negatively. Bonus strategy. MR rewarding system.
17. Vision & values To emerge as a leading integrated research – based global
pharmaceutical compan Achievement We value achievement of objectives and consistently
strive towards our Vision, with perseverance. Respect We respect all our stakeholders.
Knowledge We value knowledge such that it empowers our people to find innovative
solutions to manage change
3. 18. Division It is a multi-specialty division. Its focus areas encompass internal medicine‚
pediatrics, orthopedics and surgeons. Product Lists Cough Management Anti-Infectives
Stomatologicals Prokinetic / Anti-Nauseants Anti-Ulcerants Anti-Protozoal Pain Management
Mucolytic Nutraceuticals Peripheral Arterial Diseases Esomeprazole
19. Critical Success Factor • Glenmark is ranked among the Top 5 Fastest Growing
Generics Companies in the world. • Huge customer base. • Cost Efficiencies to result into
optimum prices to the customers and better margin. • Understanding the Competition. •
Duration of action.
20. Key Performance Indicators • • • • 11/1/2013 Target market coverage. Market share. No.
of new prescriptions. Conversion rate. 21
21. BRAND STRATEGY 11/1/2013 22
22. Brand Name Glenmark pharma present….. Esoz 20 Esomeprazole magnesium 20 mg
Tabs with Buffer
23. Objective: Short Term And Long Term Short term Long term • To achieve 2.5 Cr in the
year of launch with 1.5% market share. To be a Top brand in the PPI market by 2020
24. Indication Gastro esophageal reflux disease: ( GERD) Heart burn:
25. Market Segmentation: Pan India Metro Cities: Class 1 Cities Target customers (GP) CP
GAST Class 2 Cities SUR GYN
26. Prescription Analysis AS PER MAT JAN 2013 DATA RX/D/M 50 GP, 45 45 40 CP, 35 35
GAST, 30 30 25 GYN, 20 20 SUR, 15 15 10 5 0 GP CP GAST SUR GYN DOCTORS GP CP
GAST SUR GYN RX/D/D 45 35 30 15 20
27. DOCTOR CLASSIFICATIO Total Doctor- 150/MR Total no. of MR 400 Brack-up Dr by
Specialty GP SUR GYN GAST Physician Dr/MR 90 10 15 5 30 Class "A" 50 5 10 5 20 Class
"B" 40 5 5 0 10 TOTAL 150 90 60
28. Field Force Planning Sales Force Planning Assumptions Total MR’S MR Working Days
Call/Day Call /Month 1 400 24 24 10 10 240 96000 Dr Classification Class A Class B Dr/MR
90 60 Call to Dr/Month Calls to Dr/Month Dr Total/month 2 1 180 60 72000 24000 Total Dr
by Specialty GP SUR GYN GAST Physician 150 Dr/MR 90 10 15 5 30 240 96000 Calls to
Dr/Month Dr Total Class A 50 5 10 5 20 class B 40 5 5 0 10 100 10 20 10 40 40 5 5 0 10 140
15 25 10 50 = 240/MR 11/1/2013 29
29. PRICING Rs. For 20 mg Tab Price calculation Product out of Price control MRP 25.15
VAT (6%) -1.5 ED (6% + 3%) -1.54 22.11 Discount to Retailer -4.42 Price to Retailer (-ED &
VAT) 17.69 Discount to Stockist 10% 1.76 Price to Stockist (NRV) NRV 15.93 Company
Margin (60%) 11/1/2013 20% Non-schedule 9.55 Basic Cost 6.38 30
30. Sales Forecasting 130000 160000 140000 120000 100000 80000 60000 40000 20000 0
125000 120000 115000 110000 105000 100000 95000 M1 25% M2 35% M3 40% 130000
Q1 Q3 125000 M1 30% Q2 Q4 120000 115000 110000 105000 100000 M1 35% M2 35%
M3 30% M- month Q- Quarter M3 35% 160000 140000 120000 100000 80000 60000 40000
20000 0 M1 40% 95000 M2 35% M2 35% M3 25%
31. Q1 Month 1 Month 2 Month 3 Total Q2 Month 1 Month 2 Month 3 Total % 25% 35% 40%
20mg(Unit) 98,437.5 1,37,812.5 1,57,500 3,93,750 15,68,109.37 21,91,218.75 25,08,975
62,68,303.12 30% 35% 35% 1,18,125 1,37,812.5 1,37,812.5 3,93,750 18,81,731.25
21,95,353.12 21,95,353.12 62,72,437.49 Q3 Month 1 Month 2 Month 3 Total Q4 Month 1
Month 2 Month 3 Total % 35% 35% 30% 1,37,812.5 1,37,812.5 1,18,125 3,93,750
21,95,353.12 21,95,353.12 18,81,731.25 62,72,437.49 1,57,500 1,37,812.5 98,437.5
25,08,975 21,91,218.75 15,68,109.37 62,68,303.12 11/1/2013 40% 35% 25% Value(Rs)
3,93,750 15,75,000*15.93 = 32 2,50,81,481.22
32. Promotional expenses QUARTER WISE INPUT PLAN Total Promotional Expense: Rs.
30 lakhs Q1 (Rs.) Q2 (Rs.) Q3 (Rs.) Q4 (Rs.) Samples 4,20,000 4,20,000 4,20,000 4,20,000
Visual Aid 52,000 52,000 52,000 52,000 Brand reminders 2,25,000 2,25,000 2,25,000
2,25,000 Clinical Posters/LBL 1,20,000 1,20,000 1,20,000 1,20,000 4,50,000 Pen &
prescription pad 1,20,500 1,20,500 1,20,500 1,20,500 1,50,000 Total 9,37,500 9,37,500
9,37,500 9,37,500 Promotional expense 30,00,000 cost as calculated sampling 25.00%
4. 7,50,000 gift 20.00% 6,00,000 campaign 15.00% 4,50,000 print 4.00% 1,20,000 training
10.00% 3,00,000 meeting 6.00% 1,80,000 crm 15.00% incentives 5.00% 30,00,000
33. Rs. 20 mg Sales (Rs.) Cost Of Goods (COGS) (40%) Units X NRV* 15,75,000*15.93 =
2.5 cr 0.0 1cr 0.0 1.5 cr 0.0 30 Lakh 0.0 6 Lakh 0.0 30 Lakh 7 Gross Margin (Rs.) Less Advt
& Promo (A&P) (20% of sales) Less Selling Expenses (4% of sales) Less Marketing
expenses (20% of sales) Less Distribution Expenses (5% of sales) 0.0 7.5 Lakh 8 Gross
Profit Before Tax (PBT) 0.0 76,74,933 Lakh Brand P&L 1 Less 2 3 4 5 6 9 Total
34. COMMUNICATION STRATEGY • • • • • 11/1/2013 Quality Brand at affordable price Most
preferred drug in DERD, Heartburn case Quick Action in shorter duration of time Longer half-
life Most beneficial effect and most effective PPI 35
35. When acid strikes Esoz 20 Esomeprazole magnesium 20 mg Tabs with Buffer The 60 x
24 PPI Controls heartburn within a minute One tab irrespective of meals Attains PH >6
within 60 seconds for immediate control of Heartburn Maintains PH >4 for 22.5 hrs – Total
24 hrs protection * Co-Rx with NSAIDs Ref: sherman et al. Am j Gastroenterology
2009;104:1278-95 Mint flavor Escoz
36. Offering comprehensive Solution for Esomeprazole Treatment provides significantly
greater gastric acid suppression than lansoprazole or pantoprazole Mean % of time during
that gastric PH was > 4.0 Esomeprazole Pantoprazole Lansoprazole 74.20% GERD
HEARTBURN Rx Esoz 20 Esomeprazole magnesium 20 mg Tabs with Buffer One Tablet /
day Prize: 3.50 Rs / Tab 60.80% 66.50% Esoz 20
37. Esoz 20 Esomeprazole 20 mg Tabs with Buffer 7 Tablets Esoz 20
38. Prelaunch plan 1) One week surveys: • PPI drugs usage? Which? why? better if? Cost
benefit concept? Which cases? Competitor perception? • “NEXPRO” brand problems? • VIP
Doctors ( 30/MR ) sample • 5 min paper-less questioner + chemist feedback 2) S.W.O.T
Analysis: • Rx Weight (ims) • Chemist availability, self stock • Distribution channel analysis
39. Positioning messages plan Hammering strategy: Easy to use 3-4 sequential visits /Dr.
Messages related gimmicks, LBL. Promotional tools 1st choice Positioning Message plan
Product samples every visit in first month. Annual (4 differentiating positioning msg)
Branding, competitor management campaigns. Higher bioavaila bility safest
40. Direct to customer tactics 1) Doctor activity: - Event: group meeting, round tables
meeting - KOL conference, OR education camps - FDA approved badge ( as a promotional
tool ) - 3D demo CD ( how “Esoz 20 ” is the best) - VIP visit ( 3 visit/Month) 2) Field force
activity: - Monthly meeting - Team campaigns - Attractive incentive plan 3) Chemist activity: -
Bonus plan - Our Product Stand
41. Direct to customer tactics 4) Patient activity: - Awareness materials - CD”s in clinic’s
waiting rooms - you tube classy real situations ads
42. Promotional Input Launching gift Promotional inputs
43. Promotional Input Educational material