Swapnil Waichale

Project Outline
Secondary Research Primary Research
Findings &
Recommendations
Objective of Secondary Research:
1) To find out indications in which the molecule Rosuvastatin is used
2) To find out what other substitute molecules can be used under same
indications
3) To find out competitive brands in the market, their shares and growth rates,
size and growth rate of the market
4) To Understand the types of doctors involved
5) To understand current Cipla strategy for Rosulip
6) To understand the way it is implemented in the field
Sources of Information:
1) www.CiplaMed.com 2) Online Journals 3) Rosulip ORG Data
4) Vitalis PPT 5) Rosulip PMT, Mr. Vishal Kucheriya 6) SM/BM Vitalis
Project Outline
Secondary Research Primary Research
Findings &
Recommendations
References Used:
1) http://ciplamed.com/articles/dyslipidemia-essence-series-0?spec=1
2) http://ciplamed.com/slide-library/diabetic-dyslipidemia?spec=1
3) http://ciplamed.com/articles/atherogenic-dyslipidemia-questions-and-
answers-dr-abhimanyu-garg-usa?spec=1
4) http://www.apiindia.org/pdf/medicine_update_2010/diabetology_25.pdf
5) http://www.ijem.in/article.asp?issn=2230-
8210;year=2012;volume=16;issue=2;spage=240;epage=245;aulast=Dalal
6) http://www.who.int/gho/publications/world_health_statistics/EN_WHS2013
_Full.pdf
7) http://www.biomedscidirect.com/download/IJBMRF2011208/13/obesity_and_
dyslipidemia
Project Outline
Secondary Research Primary Research
Findings &
Recommendations
References Used:
1) http://www.ncbi.nlm.nih.gov/pubmed/23644555
2) http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3582048/
3) http://www.ncbi.nlm.nih.gov/pubmed/22360820
4) http://www.ncbi.nlm.nih.gov/pubmed/21498906
5) http://www.mdpi.com/2072-6643/5/7/2708
6) http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2656667/
7) http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2681027/

Findings of the Secondary Research
NCEP Guidelines: All adults over the age 20 should have a
12 hour fasting lipid profile once in 5 years
Overall prevalence of dyslipidemia in India ranges from 10-
73% (Dibetology Medicine update 2010, API India)
Prevalence of Hypercholesterolemia: 28% in Urban
subjects and 22% in Rural subjects
ADA Guidelines Targets

Lipid Target
Triglyceride (TG) < 150 mg/dl
LDL Cholesterol < 100 mg/dl
HDL Cholesterol > 40 mg/dl
Findings of the Secondary Research
In urban New Delhi, Prevalence of Hypertriglyceridemia
was 61% in non-obese subjects, and 73% in obese subjects
24% of urban population of north India had low levels of
HDL Cholesterol
Population based studies:
High triglycerides in upper SEC due to high fat intake
High triglycerides in lower SEC due to high carb intake
Type-2 Diabetes pattern Dyslipdemia (Parikh et al)
High LDL, Low HDL
High LDL in males, Low HDL in females as bigger threat
Findings of the Secondary Research
Types of Dyslipisemia







Manifestations of Dyslipidemia
No Symptoms
May be diagnosed after a myocardial infarction or stroke
Xanthomas : intra- and extra-cellular deposition of cholesterol


Type Causes
Primary Several monogenetic disorders
Secondary Non-genetic
Hypothyroidism, Obstructive Liver Disease, Nephrotic
Syndrome, etc. (Hypercholesterolemia)
Obesity, Diabetes, Pregnancy, Chronic Renal failure, Alcohol,
etc. (Hypertriglyceridemia)
Type-2 Diabetes mellitus, Rheumatoid arthritis, Malnutrition,
Obesity, Cigarette Smoking, etc. (Low HDL)
Findings of the Secondary Research
Consequences of Lipid Abnormalities
Coronary Heart Disease (CHD)
Stroke
Peripheral Artery Disease (PAD)
Management of Dyslipidemia
Therapeutic Lifestyle Changes (TLC)
Reduced intake of saturated fats (<7% of total calories) and cholesterol
(<200 mg/day)
Therapeutic options for enhancing LDL lowering such as plant stanols
sterols and increased viscous fiber
Weight reduction
Increased physical activity
Drug Therapy

Findings of Secondary research
Drugs affecting Lipoprotein Metabolism














Fibric Acid Brand: Fenolip
Combinations: Atorlip-F, Rosulip-F

Drug Class Effects
HMG-CoA Reductase
Inhibitors (Statins)
LDL Lower 18-55%
HDL Rise 5-15%
TG Lower 7-30%
Fibric acids (Fibrates) LDL Lower 5-20%
HDL Rise 10-20%
TG Lower 20-50 %
Nicotinic Acid (Niacin) LDL Lower 5-25%
HDL Rise 15-35%
TG Lower 20-50%
Cholesterol Absorption
Inhibitors (CAL)
LDL Lower 17%
HDL Minimal Change
TG Minimal Change
Bile Acid Sequestrants LDL Lower 15-30%
HDL Rise 3-5%
TG No change or Rise
Statins Cipla Brands
Simvastatin Simcard
Atorvastatin Atorlip
Rosuvastanin Rosulip
Lovastatin
Pravastatin
Fluvastatin
Secondary Research on Statins
Rosuvastatin is more effective compared to Atorvastatin in
reduction of sdLDL levels.
Most Effective LDL-C Reduction Doses


All three safe in muscular and hepatic functions
Renal Safety:
Atorvastatin > Rosuvastatin > Pravastatin
Rosuvastatin is most effective statin at reducing LDL-C,
Triglycerides, and total cholesterol at lowest dose of 10
mg.
Moreover, it reduces HDL-C the least, compared to other
statins

Rosuvastatin 10 Atorvastatin 40 Pravastatin 20
29.03% 22.8% 20.3%
Secondary Research on Statins
Patients with Acute Coronary Syndrome are recommended for early aggressive
low-density lipoprotein (LDL) cholesterol-lowering therapy.
LUNAR study: RSV40 more effectively decreased LDL cholesterol, increased HDL
cholesterol, and improved other blood lipid parameters than ATV80 in patients
with acute coronary syndrome.
Patrol Trial: The safety and efficacy of these 3 strong statins are equal. It is
suggested that the use of these 3 statins be completely dependent on physician
discretion based on patient background.
In patients with the metabolic syndrome, despite attainment of LDL cholesterol
goals, these patients may retain considerable residual coronary heart disease risk.
Patients with the metabolic syndrome may have relatively normal LDL cholesterol
when LDL particle concentration is elevated because these patients have a
preponderance of small, cholesterol-poor LDL particles.
Thus, LDL cholesterol may underestimate risk in patients with the metabolic
syndrome.
RSV was more effective than ATV in reducing LDL cholesterol (P < 0.001), LDL
particle concentration (P < 0.05), and non-HDL cholesterol (P < 0.01) after 6 and 12
weeks.
Secondary Research: Stroke & Statins
Large clinical trials have shown that statins reduce the incidence of
cerebrovascular events.
In addition to their cholesterol lowering properties, statins exert a
number of pleiotropic, vasculoprotective actions that include
improvement of endothelial function, increased nitric oxide (NO)
bioavailability, antioxidant properties, inhibition of inflammatory
responses, immunomodulatory actions, regulation of progenitor cells,
and stabilization of atherosclerotic plaques.
long-term statin treatment reduces stroke risk
Combined data from 9 trials including 70 070 patients indicated
relative and absolute risk reductions for stroke of 21% and 0.9%,
respectively, with statins
Rosuvastatin reduces by more than half (51%) the incidence of
ischemic stroke among men and women with low levels of LDL-C
levels who are at risk because of elevated levels of high-sensitivity C-
reactive protein.
Sources: Stroke, Journal of the American Heart Association 2004, 2010,
2103.
Project Outline
Secondary Research Primary Research
Findings &
Recommendations
Objectives of Primary Research:
1) To understand the level of awareness in public regarding Dyslipidemia
2) To understand the therapy choice of doctors
3) To understand affinity of doctors towards brands, and reasons behind them
4) To understand how Cipla can partner with Doctors, in order to enhance
timely detection of Dyslipidemia
5) To understand the purchasing and compliance behavior of patients
Methodologies to be used:
1) Public awareness survey 2) Patient Survey 3) Discussions with Doctors
4) Lipid Profile Check-up Camp Observation 5) Retail Survey
Interaction with Doctors in EASD
Webcast
Dr. Mahendra Wawhal, Asst. Professor, MGM




After 3 months, repeat lipid profiles are checked, and doses are
adjusted/titrated according to lipid levels and patient compatibility
(Side effects, etc.)
Percentage ratio in Practice: Atorvastatin : Rosuvastatin :: 60 : 40
Atorvastatin: Good Results
Rosuvastatin: Less Dose, better results
Concern area for Rosuvastatin: Safety in Elderly Patients

Indication Drug
Chronic Stable Angina Rosuvastatin 40 mg
Unstable Angina Rosuvastatin 40 mg
Triple Vessel Disease Rosuvastatin 40 mg
After Heart Operative Procedures Rosuvastatin 40 mg
Interaction with Doctors in EASD
Webcast
Dr. Amit Choradiya, Sr. Resident, MGM
Acute Coronary Syndrome: Rosuvastatin 40 mg or Atorvastatin 80 mg
Surgical Intervention: In Clinic (7-15 days) & 1 month, Rosuvastatin 40
mg or Atorvastatin 80 mg is prescribed.
After one month, lipid profiles are rechecked, and depending on results
and patient compatibility, further doses are decided.
Transient Ischemic Attack (TIA) & Cerebrovascular Accident (CVA):
10mg & 5 mg are preferred (Lower Doses)
Depending on TG levels, Fenofibrate Combination is prescribed.
When asked on selection between Atorvastatin and Rosuvastatin, he
says, Its like choosing between Maruti 800 and Swift. Both serve the
purpose.
Interaction with Doctors in EASD
Webcast
Dr. M. B. Pisolkar, Sr. Physican (Old Doctor)
Atorvastatin is molecule of choice, Rosuvastatin has more
side effects
Starting Dose he prescribes is Atorvastatin 80 mg.
Lipid Tests every month
Within 3-4 month, Patient comes to maintenance dose of
10 mg.
Conducted study on 200 patients, in which he started
statins. Statins he continued for 15 years. 90% of patients
did not suffer any problems, and he found their
angiography to be perfectly normal.
Interaction with Doctors in EASD
Webcast
Dr. R. Kharkar, Sr. Physician (Old Doctor)
Individualized Treatment plan for every patient, according
to lipid profiles
3 Month Repeat check-ups for further titration
Atorvastatin as molecule of choice
Rosuvastatin is unsafe due to renal and other Side-effects
Other Doctors:
Young Doctors preferred Rosuvastatin more compared to
old doctors, who preferred Atorvastatin
Interaction with Cardiologists
during calls
Dr. Magarkar Dr. Shirish
Deshmukh
Dr. Deodhar Dr. Kalbande
After procedures (Peripheral Coronary Intervention, Angioplasty, etc.),
A high dose of Atorvastatin 80 mg is used for a period of 7-30 days.
After further lipid tests, dosages are lowered to 20/40 mg as per patient
needs.
Lifelong maintenance dose: Atorvastatin/Rosuvastatin are used in
small dosages.
No one preferred Rosuvastatin 40 mg.
Dr. Magarkar, however mentioned that he is on shift to Rosuvastatin.
Interaction with Nephrologists
during calls
Dr. Borkar S. S., Kamal Nayan Bajaj Hospital
Low doses of Atorvastatin are prescribed in patients with CKD
Prefers monotherapy to combinations
Shifting focus on Rosuvastatin (Low dosages)
Does not need Atorvastatin 80 mg or Rosuvastatin 40 mg
Dr. Sudhir Kulkarni, MGM
Customized treatment according to lipid profiles
Atorvastatin 10/20/40 are used mostly.
Concerned about renal safety in Rosuvastatin usage
Synopsis of Insights from doctors
Physicians &
Diabetologists
Low shares of 40 mg Rosuvastatin
More shares of 5/10/20 mg
Young Doctors preferring Rosuvastatin
Cardiologists
Interventions: 40 mg rosuvastatin
Also 5/10/20 mg
Young Doctors preferring Rosuvastatin
Nephrologists
5/10 mg most common
Concerned about renal side effects
Competition is huge, and every company is offering Lipid Profile Test Coupons,
Expensive Gifts, Conferences Invitations, etc.
Doctors are not brand loyal. They prescribe as per the activities/expenditures
by companies on them.
Retail Survey of Chemists with
Neurologists and Neuro-Surgeons
SM Vitalis noticed potential for statins at a
neurologist, Dr. Ukadgaonkar
He has added him in MSL
However there is no focus on other neurologists and
neurosurgeons
In order to assess neuro-potential of statins and
competitive status, we are carrying out this Retail
survey
Results: Refer Next Slide
Neurologist Retailing Findings
Chemist Statin Monotherapy Combination
Shree Medical, Dr.
Majid
70 strips-Atorvastatin (10/20/40)
10 strips-Stator 80 mg
200 Strips-Coltro (Rosuvastatin)
30 Strips-Novastat 10
150 strips-Atorfit CV

Max Medical, Dr.
Devdatt Deshmukh
40 strips-Rosuvas 90 strips-Ecosprin 75/150

Bajaj Medical 30 strips-Tonact 10/20
30 strips-Tonact 80 mg
30 strips-Rosuvas
40 strips-Ecosprin 75/150

Dr. kanjalkar, Manik
Hospital
40 strips-Atorva 10/20
10 strips-Stator 10
40 strips-Rozavel 10/20
Sachin Medical, Dr.
Panse
20 strips-Atorvastatin 10/20
10 strips-Rosuvas 10
Dr, Anand Soni,
MGM Hospital
10 strips-Tonact 10/20 20 strips-Ecosprin 75
Brain Medical,
Dr. Ukadgaonkar
180 strips-Atorvastatin 10/20/40
20 strips-Rosuvas 10
Patient Awareness Survey
Conducted a survey among 50 OPD patients in Hedgevar Hospital
All patients more than 40 yrs age selected (Range: 40-72 yrs)
Findings:
29 people with no Lipid Profile Test (LPT) so far
12 people with Associated Risk factors (Family History, Obesity, etc.)
Among 21 who did LPT, 16 cases were recommended LPT by doctor when
they approached Doctor for
10 cases with Diabetes & Hypertention
6 cases with Unrelated ailments (Allergy, Foot Ache, Stone Operation, etc.)

Patient Age (Some Cases) First LPT
72 (Diabetes, Hypertention) After Angioplasty (At age of 56)
66 (Diabetes, Hypertention) Last Week! (At age of 66)
63 (Diabetes, Hypertention) 2 months back (At age of 63)
51 (Diabetes, Hypertention) 3 months back (At age of 51)
55 (Hypertention) 3 yrs back (At age of 52) Regular Since then
50 (Hypertention) 4 yrs back (At age of 46) Regular Since then
50 Female (Foot ache Visit: => LPT) At the age of 50
What is
the need
to do LPT?
When I am
absolutely
fine?
We do
not
know
such
things
Patient
Patient Segmentation
Urban
More Awareness in higher Income groups
Access to healthcare
Rural
Unaware mostly
Lack access to Healthcare, need to visit cities
Try to avoid Dr. visits due to economic troubles, unawareness, etc.
Unaware
At risk
In spite of family history, diagnosed diabetes/hypertention, obesity,
etc.
Lack of knowledge, Lack of access, etc.
Competitive Price Analysis
Strategic Pricing of DRL:
The 40 mg and 80 mg Doses are priced minimum
These are the doses, given first time to the patient
Atocor 80 mg comes in pack of 30 tablets, while Atorlip 80 comes in 3
strips of 7 tablets (21 tablets)(less value/Converted prescription)
The patient are then titrated to lower doses, which are priced higher
5 mg and 10 mg are lifelong maintenance doses
Acquire Patient at cheap price, maintain at higher price!
Low Pricing of Abbott
Showing great growth as compared to market
Atorvastatin 5 10 20 40 80 Share Growt Value Units
STORVAS Ranbaxy 6.29 9.792 18 24.7 29.4 17.31 2.95 1,15,64,70,155 1,05,84,511
ATORVA Zydus 3.652 10.45 19.85 25.35 36.95 11.35 11.99 75,82,51,099 80,36,016
AZTOR Sun 4.011 6.206 15.9 22.9 28.39 9.61 15.99 64,24,07,473 74,44,298
TONACT LUPIN. 6.615 12.9 21.51 17.64 27.37 9.01 14.69 60,18,91,549 52,48,818
LIPICURE Intas 4.4 7 17.33 21.4 27 6.57 -3.58 43,91,18,320 32,72,262
ATOCOR DRL 6.35 9.2 10.77 16.28 16 4.88 6.71 32,62,95,220 41,52,502
ATORLIP CPL 5.2 9.4 17.3 19.96 23 4.35 -0.91 29,08,10,923 31,95,744
STATOR Abbott 4.22 7.7 16.8 3.65 17 24,36,16,861 59,13,855
Lipikind Mankind 1.9 3.8 1.45 5.84 21,38,45,018 24,95,872
Atorvastatin Market 100 6.66 6,68,24,12,146 9,30,39,715
Share Eaters
Zydus Cadilla
Sun
Lupin
Dr. Reddys
Competitive Price Analysis
Strategic Pricing of DRL & USV
Both showing above market growth
Great Pricing strategy for foray into Rural market, which is as good as
White Field, due to very less competition
Converting City Doctors Vs. Acquiring Rural Doctors/ young PGs
Cipla CEO Vision: To develop a Reach as good as Hindustan
Unilever, to make avaiable medicines to everyone who needs them
Ciplas Differentiation: Field Force, Portfolio, Pipeline
Rosuvastatin 5 10 20 40 Share Growth Value Units
ROSUVAS RBY
6.83 9.50 26.54 39.90 22.64 18.65 65,40,79,646 63,05,564
ROZAVEL SPI
6.19 11.20 20.64 30.20 12.48 38.03 36,05,70,954 43,59,098
CRESTOR AZN
13.09 18.10 32.47 52.75 8.17 17.22 23,58,52,043 15,57,212
ROZUCOR TNT
5.95 11.80 22.40 30.00 7.71 47.34 22,26,60,512 24,60,918
ROSEDAY USV
3.59 5.99 11.99 7.38 54.39 21,32,60,165 51,01,614
NOVASTAT LU.
5.84 10.61 18.59 38.00 5.67 36.46 16,36,74,989 17,11,201
RAZEL GMK
6.60 13.20 23.70 35.00 5.08 46.73 14,67,77,754 16,16,897
ROZAT DRL
3.99 5.85 10.80 18.00 3.64 53.08 10,51,05,181 22,30,254
CREVAST ELS
5.50 10.00 21.60 32.50 2.84 36.02 8,20,99,063 10,94,525
ARVAST IN9
7.20 10.50 23.00 35.00 2.79 16.91 8,04,85,207 7,51,029
ROSULIP CPL 5.60 9.90 15.00 28.00 2.73 29.90 7,87,93,701 10,54,545
ROSAVE AMB
6.10 11.70 22.50 2.37 43.30 6,85,76,723 9,10,412
Rosuvastatin 100 31.23 2,88,84,77,298 3,68,30,682
MRP/Tablet
Share Eaters
Sun
Torrent
USV
Lupin
Glenmark
Dr. Reddys
Alembic
Competitive Strategies from Field
USV:
Doctors Choice Program: 5 top prescribing Doctors are chosen per TM, and they are
given a choice to choose from a list of 5 Gifts/Medical equipment etc.
Conferences: Either Travelling or Stay Costs of Doctors are born
Lipid Profile Camp Coupons
Piramal: (Old Strategy from Ex-Piramal Cipla person)
Their per tablet price was Rs. 3. So they created a buzz around the number 3. They gifted
Doctors everything that came in Rs. 3, like balms, pens, etc.
25%, 50%, 100% Lipid profile Test Coupons given to Doctors, depending on Doctor
profiling
Conferences, Expensive Gifts to select Doctors
LBLs, patient education materials, camps
Ranbaxy:
Lipid profile camps, Diabetic Camps, Multi-Speciality Camps
Talk about Legacy
Conferences, Expensive Gifts to select Doctors, CMEs, etc.
Everyone is doing the same things!
SWOT Analysis of Rosulip
Strengths
Descent Prices
Cipla Equity: Quality, Several Firsts
Camps, Activities: RED4U
Academic Inputs: CMEs, Conferences
Distribution & Field Force Reach


Weaknesses
Late Market Entry
Less Focus on Rural patients
Me too Brand Strategy: Camps,
Academics, Gifts
Neurologists: Neglected Segment
So far less focus on Patient Awareness
Opportunities
Patient Awareness: To enable & drive
patients for regular check-ups
Rural India: Awareness & Diagnosis
Pricing Tactics
Threats
Already established competitors
Threat from brand substitution
Highly competitive Market in Cities
Brand Shifting among Doctors


Strategy Recommendation
Urban: Fight It! Rural: Win It!
Current Strategy is Recommended
Additionally, More Focus required on
getting New patient Share through
Diagnosis Camps, & Direct Patient
Awareness
Know Number of new Cipla patients,
Number of old patients, their
purchasing frequency. Refer to Next
slide to know how!
More focus required on generating
relationships with new PGs (0-5 years of
practice)
More focus on Neurologists and
Neurosurgeons Segment required
Urban India: Highly competitive
Market! Fight It!

Align with Mr. Subhanu Saxenas
Vision: To have distribution reach as
good as Hindustan Unilever!
Really make the drugs required by them,
affordable! Reduce Prices if needed! (Ref.
DRL Pricing Strategy in previous Slide)
Create awareness in public regarding
health check-ups, healthy life-style
Attach with young PGs to do Diagnosis
Camps, Mobile Clinics in rural areas:
Provide access to Healthcare
Rural India: White Field Business
Opportunity! Win It!
Patient Loyalty: How to Measure
Chemist will handover Discount coupons for repurchase to the patients, in every
New Prescription.
These coupons will have a code written over them, which will tell us the number of
New patients.
To avail discount, the patient will give one coupon at every repurchase to the chemist.
Company will reimburse the discounted money to the chemist, when the chemist gives
these coupons to company. This will tell us number of times of their repurchases.
Business Sense: Discounts will keep people stuck to Cipla brand. In fact they will
insist Doctor, that some of my coupons are remaining, kindly do not change my brand!

Connect to patients through Coupons: Take their Contact numbers or ask them to
register online on a website, provide them information, services, advice.
Biocon provides 24 hrs facility and Diabetic Advisor reach to patient at home
within 2 hours of complaint from patient, especially for Insulin
Chemist Relation: Advice Chemist on getting these patients back to their counters
(Their contact numbers, home delivery options, etc.) Develop relationship with the
chemist, and enjoy it in Acute therapies OTC Sales!
Acquire & Retain your patients!
Thank You