PGP Dissertation Report Nirav Patel

Strategic Marketing Plan of Vildagliptin

Stevens Business School

PGP Dissertation


In Partial Fulfillment of the Requirements of Post Graduated Programme at


Prepared By

Nirav Patel

Under Supervision of

Dr. Raashid Saiyed

Professor




3. Certificate by faculty Guide



2. DECLARATION

I Mr. Nirav Patel hereby declare that the project work titled “Strategic

Marketing Plan of Vildagliptin” is the original work done by me and

submitted to the Stevens Business School Ahmedabad, in Partial

fulfillment of the requirements for the award of Post Graduated

Programme in area of Marketing and is a record of original work done

by me under the supervision of Dr. Raashid Saiyed of Stevens Business

School.

Date: 16th April, 2011.

Name: Nirav Patel

Roll No: PGP/MBA/09-11/025



3. Acknowledgement

“Expression of feelings by words makes them less significant when it comes to

make statement of gratitude”

During my PGP Dissertation Project Report I realized that ―Success is not

destination, but a journey‖. This may not have been so accurate and successful

without the help, guidance and support of certain people who acted as guides,

friends and torch bearers along the way. On the voyage of learning I came across

many hurdles but each hurdle was a good experience for me. At each step of

training my mentor gave me full support which helped me in carrying positive

attitude whenever I faced any problem.

I would also to thank Prof. Dr.Raashid Shaiyed for giving me their invaluable

guidance and suggestions regarding the project and helping me in each and every

aspect. The constant guidance and meaningful suggestions provided by him also

helped in making this project a relevant and a rich source of learning for me.

Further, I am thankful to all the respondents of our questionnaire who spared there

time from their busy schedule and obliged me by giving their co-operation and the

information I needed.

I would also like to thank my parents and friends who have directly or indirectly

helped me and gave full support during the project.

Nirav Patel




4. Preface

“Give a man a fish, he will eat it

Train a man to fish, he will feed his family”

The above saying highlights the importance of Practical knowledge. Practical

training is an important part of the theoretical studies. It is of an immense

importance in the field of management. It offers the student to explore the valuable

treasure of experience and an exposure to real work culture followed by the

industries and thereby helping the students to bridge gap between the theories

explained in the books and their practical implementations.

Research Project plays an important role in future building of an individual so that

he/she can better understand the real world in which he/she has to work in future.

The theory greatly enhances our knowledge and provides opportunities to blend

theoretical with the practical knowledge.



5. Executive Summary

Market information is key thing before launching new product. The accurate market information

results in to success of product performance. Market research is the systematic design, collection,

analysis and reporting of data relevant to a specific marketing situation facing an organization.

Strategic marketing include the drug information. It also includes threat to the drug in terms of

substitute drug.

The objective is to do this project are as follow:

1. To Know the Profile of molecule.

2. To know the Disease Profile.

3. To know the discovery profile of Molecule.

4. To know the market scenario of the selected molecule.

5. To know the research and development happening in area of selected molecule.

6. To make Strategic marketing plan.

By considering above things in mind I have selected personal interview method to find the above

information.

The project contains the future scenario of Vildagliptin drug. It also include the substitute drug

which are going to come in market. The future therapy of diabetes is also considered in this

project.



INDEX

Sl. No. Particular Page

No.

1 Certificate by faculty guide 2

2 Declaration by student 3

3 Acknowledgement 4

5 Preface 5

5 Executive summary 6

6 Molecule Profile 9

6.1 Chemical Structure 9

6.2 Pharmacokinetic data 9

6.3 Synthesis 10

6.4 Vildagliptin In diabetes 10

6.5 Indication 11

6.6 Side Effect 12

6.7 Drug Interaction 13

6.8 Contraindication 13

6.9 Precaution 13

6.10 Other Molecule in family 14

7 Disease Profile 15

7.1 Diabetes and its types 15

7.2 Diabetes Symptoms 18

7.3 Diabetes Treatment 19

7.4 Diabetes Prevention 19

7.5 Diabetes Management 21

8 Discovery Profile 24

8.1 Environment leading to discovery 24



8.1.1 Incretin mimetic and enhancers 24

8.1.2 Need of Dipeptidyl Peptidase (DPP)-IV Inhibitor 25

8.2 Novartis account 27

9 Market Scenario 28

9.1 Major Player and their Profile 28

9.2 Market Share of major player 30

9.3 Marketing Strategy 32

9.4 Financial Condition of players 32

10 R&D Scenario 33

10.1 Competing molecule being expected 33

10.2 Leader player and R&D strategy 35

10.3 Expected announcement date 35

11 Strategic Marketing Plan 36

11.1 Strategic Marketing Plan for Leader 36

11.2 Action Programs 37

11.3 Budget 40

11.4 Sales Month wise 41

11.5 Expenses 42

11.6 Profit 42

11.7 Strategies used by Companies 42

11.8 Communication Strategy 43

12 Conclusion 44

13 Recommendation 45

14 Limitation 46

15 Bibliography 47

16 Annexure 48

16.1 Research Proposal 48



6. Molecule Profile

Vildagliptin

6.1 Chemical Structure

IUPAC Name

(S)-1-[N-(3-hydroxy-1-

adamantyl)glycyl]pyrrolidine-2-carbonitrile

Formula C17H25N3O2

Mol. Mass 303.399 g/mol

Synonyms

(2S)-1-{2-[(3-hydroxy-1-

adamantyl)amino]acetyl}pyrrolidine-2-

carbonitrile

6.2 Pharmacokinetic Data

Bioavailability 85%

Protein binding 9.3%

Metabolism

Mainly hydrolysis to inactive metabolite;

CYP450 not appreciably involved

Half-life 2 to 3 hours

Excretion Renal

http://en.wikipedia.org/wiki/File:Vildagliptin_Structural_Formulae.png



6.3 Synthetic Chemistry

Galvus (Vildagliptin) tablets contain the active ingredient vildagliptin, used to treat type 2 or

non-insulin dependent diabetes (NIDDM). It works by increasing the amount of two incretin

hormones found in the body, called glucagon-like peptide-1 (GLP-1) and glucose-dependent

insulinotropic peptide (GIP). These hormones are normally produced naturally by the body in

response to food intake. Their function is to help control blood sugar (glucose) levels. Galvus is

used for people with type 2 diabetes whose blood sugar is not sufficiently controlled by other

antidiabetic medicines. It can be added to treatment with metformin; a sulphonylurea, for

example gliclazide; or another type of antidiabetic medicine known as a thiazolidinedione, for

example pioglitazone or rosiglitazone.

6.4 Vildagliptin in Diabetes

Administration of Galvus (Vildagliptin) to patients with type 2 diabetes suggests it is a safe and

effective treatment with the potential to achieve long-term glycaemic control, a recognised

deficiency of current oral anti-diabetic medications.

In phase II trials the addition of Vildagliptin 50mg/day to metformin, a standard treatment for

type 2 diabetes, resulted in improved glucose control in patients inadequately controlled on

metformin alone. Levels of hemoglobin A1c (HbA1c), fasting plasma glucose, mean prandial

glucose and peak prandial glucose were reduced to a significantly greater effect after 12 weeks

of additional treatment with Vildagliptin compared with continued therapy with metformin

alone.

Importantly, the results achieved at 12 weeks were sustained over a year, indicating that patients

treated with Vildagliptin can achieve good long-term glycaemic control. In patients maintained

on metformin alone, glycaemic control tended to deteriorate over time.

http://en.wikipedia.org/wiki/File:Vildagliptin_synth.png



Long-term treatment with Galvus (Vildagliptin) appears well tolerated as reflected by low rates

of study discontinuation for adverse events in clinical trials. In the phase II trials, drug-related

adverse events occurred in 4.8% of patients receiving Vildagliptin in addition to metformin

compared with 6.9% of those receiving metformin plus the placebo. Treatment with Vildagliptin

does not appear associated with weight gain, which is an important benefit for patients with type

2 diabetes.

In phase III trials Galvus (Vildagliptin) has been evaluated as both mono therapy and in

combination with other standard ant diabetic drugs.

Potential to preserve pancreatic beta cell function

Patients with type 2 diabetes experience the progressive loss of pancreatic beta cell function and

a concomitant loss of insulin secretion and glycaemic control. In preclinical studies, Galvus

(vildagliptin) was found to have a beneficial effect on insulin secretion by increasing beta cell

production and inhibiting programmed cell death (apoptosis).

Subsequent clinical studies, in which Vildagliptin was administered to patients with type 2

diabetes not previously treated with oral ant diabetic medications, showed that it increased the

active forms of GLP-1 and GIP when compared with the placebo. This translated into improved

beta cell function as measured by enhanced insulin secretion on glucose challenge.

The drug's ability to improve the functioning of insulin-producing cells in the pancreas, albeit in

studies with small numbers of patients, suggests it may have disease-modifying potential in the

treatment of type 2 diabetes.

6.5 Indication

Galvus is indicated to be used for people with type 2 diabetes diabetes (non-insulin dependent

diabetes whose blood sugar is not sufficiently controlled by other antidiabetic medicines.



6.6 Side Effects

The various reported side effects of the drug are:

Tremor (when used with metformin or a sulphonylurea).

Headache (when used with metformin or a sulphonylurea).

Dizziness (when used with metformin or a sulphonylurea).

Low blood sugar levels (when used with metformin or a sulphonylurea).

Nausea (when used with metformin).

Feeling weak (when used with a sulphonylurea).

Weight gain (when used with a glitazone).

Swelling of the legs and ankles due to excess fluid retention (when used with a glitazone).

Fatigue (when used with metformin).

Constipation (when used with a sulphonylurea).

Headache (when used with a glitazone).

Feeling weak (when used with a glitazone).

Serious Side Effects

Vildagliptin can also cause several serious side effects that may require immediate medical

attention. According to the consumer leaflet for Galvus, patients should inform their physicians

or go to the hospital immediately if they experience swelling of the face, lips, mouth, tongue or

throat. This may be an indicator of an allergic reaction known as anaphylactic shock, which may

result in complete airway obstruction if left unattended. Other serious reactions may include

sudden development of rash or hives. Liver and gastrointestinal dysfunction may also occur,

resulting in nausea, loss of appetite, light colored urine and the yellowing of the skin and eyes

due to bile displacement. Additionally, pancreatic reactions may occur, resulting in severe pain

in the upper abdominal area.



6.7 Drug Interaction

Medicines that increase blood sugar levels as a side effect may make this medicine, and other

antidiabetic medicines, less effective at controlling blood sugar. Medicines that can increase blood sugar

levels include the following:

Bronchodilators (beta agonists), eg salbutamol, terbutaline, salmeterol

Corticosteroids, eg prednisolone

Levothyroxine

Thiazide diuretics, eg bendroflumethiazide.

6.8 Contraindication

People over 75 years of age.

People with mild heart failure.

People taking ACE inhibitor medicines, eg captopril.

6.9 Precaution

Hypoglycemia (low blood glucose) has been commonly reported when this medicine is used in

combination with metformin or sulphonylurea medicines, eg glimepiride. Symptoms of

hypoglycaemia usually occur suddenly and may include cold sweats, cool pale skin, tremor,

anxious feeling, unusual tiredness or weakness, confusion, difficulty in concentration, excessive

hunger, temporary vision changes, headache, nausea and palpitations. The patient should talk to

the doctor or diabetes specialist about this and should make sure what to do if experiences any of

these symptoms.

The ability to concentrate or react may be reduced if the patient has low blood sugar, and this can

cause problems driving or operating machinery. Precautions to made when driving.

People with diabetes have a higher risk of developing foot ulcers and blistering of the skin. It is

therefore important to have a good foot care routine. The doctor should be properly consulted if

the patient gets any new blisters or ulcers while taking this medicine.

The patient should consult well before taking the medicine if the patient is Pregnant or is

breastfeeding.

This medicine is not recommended for people receiving dialysis or who have moderate to severe

kidney disease.

This medicine is not recommended for people with suffering from severe heart failure, Type 1

diabetes and Diabetic ketoacidosis.



This medicine is not recommended for children and adolescents under 18 years of age because it

has not been studied in this age group.

This medicine contains lactose and should not be taken by people with rare hereditary problems

of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform

your doctor or pharmacist if you have previously experienced such an allergy.

6.10 Other Molecule in Family

Sr.

No.

Drug Name Status

1 Sitagliptin FDA approved 2006, marketed

by Merck & Co. as Januvia

2 Vildagliptin marketed in the EU by Novartis as

Galvus

3 Saxagliptin (FDA approved in 2009, marketed as

Onglyza

http://en.wikipedia.org/wiki/Merck_%26_Co.

http://en.wikipedia.org/wiki/Novartis



7. Disease Profile

7.1 Diabetes and its types

Diabetes is a metabolic disorder where in human body does not produce or properly uses insulin,

a hormone that is required to convert sugar, starches, and other food into energy. Diabetes

mellitus is characterized by constant high levels of blood glucose (sugar). Human body has to

maintain the blood glucose level at a very narrow range, which is done with insulin and

glucagon. The function of glucagon is causing the liver to release glucose from its cells into the

blood, for the production of energy.

There are three main types of diabetes:

Type 1 diabetes

Type 2 diabetes

Gestational diabetes

Type 1 and Type 2 diabetes impede a person’s carefree life. When breakdown of glucose is

stopped completely, body uses fat and protein for producing the energy. Due to this mechanism

symptoms like polydipsia, polyuria, polyphegia, and excessive weight loss can be observed in a

diabetic. Desired blood sugar of human body should be between 70 mg/dl -110 mg/dl at fasting

state. If blood sugar is less than 70 mg/dl, it is termed as hypoglycemia and if more than 110 mg

/dl, it’s hyperglycemia.

Diabetes is the primary reason for adult blindness, end-stage renal disease (ESRD), gangrene and

amputations. Overweight, lack of exercise, family history and stress increase the likelihood of

diabetes. When blood sugar level is constantly high it leads to kidney failure, cardiovascular

problems and neuropathy. Patients with diabetes are 4 times more likely to have coronary heart

disease and stroke. In addition, Gestational diabetes is more dangerous for pregnant women and

their fetus.

Though, Diabetes mellitus is not completely curable but, it is controllable to a great extent. So,

you need to have thorough diabetes information to manage this it successfully. The control of

diabetes mostly depends on the patient and it is his/her responsibility to take care of their diet,

exercise and medication. Advances in diabetes research have led to better ways of controlling

diabetes and treating its complications. Hence they include:-

New improved Insulin and its therapy, (external and implantable insulin pumps)

have advanced well to manage elevated blood sugars without any allergic

reactions.

Oral hypoglycemic drug, controls diabetes type 2.

http://diabetesinformationhub.com/






New improved blood glucose monitor (new device for self blood glucose

monitoring), and hemoglobin A1c laboratory test to measure blood glucose

control during previous 3 months.

Effective availability of the treatments for affected body organs due to diabetes.

Better ways to manage mother and its fetus health during the gestational diabetes

phase.

What is Diabetes?

The diseases which are listed under Diabetes Mellitus are many with the most common

being Type-1 diabetes and Type-2 diabetes. These are diseases of the metabolic system

and involve the body's ability in metabolizing sugar using the hormone insulin. Insulin

helps the cells use the simple sugar glucose which is needed for repair, growth and

energy.

In Type-1 diabetes, the body produces little or no insulin so those with this type of

diabetes need to be on insulin therapy for their entire lives. Before 1924 Type-1 diabetes

usually ended with dead after a couple of years but with the advent of insulin those who

have this disease are now able to manage this chronic condition. Type-1 diabetes is also

known as juvenile diabetes because those who have this type of diabetes are usually

diagnosed with it between the ages of 9 and 15 years of age.

With Type-2 diabetes, the body produces plenty of insulin but cells are unable to use it.

This type of diabetes is the most common form of diabetes and although it used to

normally develop in older adults, Type 2 diabetes is now developing at all ages. Major

risk factors for Type-2 diabetes are unhealthy diets, little or no exercise and being

overweight or obese. There is currently a world wide epidemic of Type-2 diabetes which

researchers believe is being driven in many areas because of sedentary life styles

revolving around computers, video games, television and fast foods. Fast food restaurants

are now in every corner of our world.



Diabetes in the US

Currently in the United States 7.8% of the population or around 23.6 million people have

diabetes with 5.7 million being undiagnosed. Most of those diagnosed have Type-2

diabetes and are usually 45 years of age or older. But this snapshot is changing as more

children and adolescents are increasingly being diagnosed with this type of diabetes.

Studies show that the most common complication of Type-2 diabetes is cardiovascular

and it is also the most costly complication at a cost of approximately $7 billion of the $44

billion annual direct medical costs for diabetes. This figure is from 1997 and many

estimate that these figures could have doubled by now.

Diabetes in India

As of 2000 it was estimated that 171 million people globally suffered from diabetes or

2.8% of the population. Type-2 diabetes is the most common type worldwide.

Figures for the year 2010 show that the 5 countries with the largest amount of people

diagnosed with diabetes were India (40.9 million), China (38.9 million), US (19.2

million), Russia (9.6 million), and Germany (7.4 million).

Currently, India is the diabetes capital of the world. It is estimated that over 40 million of

those with diabetes are currently in India and that by 2025 that number will grow to 70

million. In other words, 1 in every 5 diabetics in the world will live in India. Diabetes is

the number one cause of kidney failure, is responsible for 5% of blindness in adults and 1

million limb amputations.

Because of the chronic nature of diabetes, the relentlessness of its complications and the

means required to control both diabetes and its complications; this disease is very costly,

not only for affected individuals and families but also for the healthcare systems. Studies

done in India estimate that for a low income family with an adult having diabetes, as

much as 25% of the family's income may need to be devoted to diabetes care.

Stress also seems to be a greater risk factor in India for diabetes. It is important to de-

stress according to each one's disposition - for example spending quality time with

friends and family, Yoga, breathing exercises, walking, meditation, aerobics and other

fitness regimen can ward off diabetes.

Preliminary findings of a recent study in India among school children in the higher socio-

economic group in Chennai showed child obesity is growing higher and girls were found

to be disproportionately "heavier" than boys.



Stopping the Epidemic

It is really fairly simple - medical professionals believe that turning off the TV and

computer and going outside to walk or exercise will go a long way to stopping this

epidemic. Other suggestions include cutting calories in diets, snacking on whole grain

and high-fiber foods, avoiding smoking and alcohol, exercising regularly and getting

stress levels under control are pro-active ways to keep this diabetic epidemic from

continuing to grow.

7.2 Diabetes Symptoms

Diabetes mellitus is a chronic disease which involves the amount of insulin in the blood system.

There are many types of diabetes mellitus but the two major types are Type 1 diabetes also referred

to as juvenile diabetes, and Type 2 diabetes which is the form of diabetes that is the most common.

Both forms of diabetes are basically metabolic disorders which affect the body's ability to process

and use sugar or metabolize glucose.

The symptoms of course do vary by type but some symptoms which are common with most

forms of diabetes mellitus are:

• Extreme thirst

• Fatigue

• Excessive urination

• Wounds which heal slowly

• Blurring of vision

• Weight loss

But there are those rare times when this disease is present but there are no symptoms. This shows

why it is important to get regular checkups throughout your life time.



7.3 Diabetes Treatment

The treatment of diabetes involves many areas. There is common standard of practice treatment

as well as herbal and alternative treatments. And there is currently a multitude of research being

conducted to find better medications and treatments as well as hopefully someday a cure for this

chronic disease.

Diabetes mellitus is a disease in which the body is not able to metabolize the glucose in the

blood. Type 1 diabetes is believed to happen because of the destruction of Beta islet cells in the

pancreas where insulin is secreted. People with Type-1 diabetes need to be on insulin therapy for

their their life. Type 2 diabetes is cause by the destruction of insulin receptors on cell surfaces

which causes the cells to be resistant to insulin. Type 2 diabetes can be managed with medication

and/or lifestyle changes.

Both Type 1 and Type 2 diabetes are treated differently but still both involve many of the same

aspects of self care. Self care is a responsibility which every diabetic patient must commit to in

order to best manage this life long chronic disease.

Besides current treatment, there is research being done on herbal treatments as well as alternative

substances. Herbs from Asia as well as the Amazon are currently being studied as well as the

substance in hot peppers which makes them hot. Another substance that is being studied is a

substance in cocoa. It is hoped that these substances can be made into new medications to treat

the symptoms of diabetes. Also there is research being done in the area of stem cells as well as

organ transplants in the hopes a cure can be found in these areas.

Because of the chronic nature of diabetes, it can become quite expensive to treat this long term

disease for an unknown period of time. Studies have been conducted on the impact of poverty on

treatment and the outcome of these treatments.

As well as diabetes mellitus treatment there is also information on diabetes insipidus which is

caused by problems with the kidney instead of the pancreas. There are many forms of diabetes

insipidus with a different treatment for each.

7.4 Diabetes Prevention

There are two classifications of diabetes - Mellitus and Insipidus. Mellitus is from the Latin word

for 'honey' referring to the taste of the urine which is sweet and is the type of diabetes that almost

everyone is familiar with. Insipidus means 'no taste' referring to the highly diluted urine in cases

of diabetes Insipidus which is mostly water. Diabetes Insipidus is extremely rare.

Diabetes Mellitus is the form of diabetes that involves insulin and the blood system. There are

several types of diabetes mellitus:

Type 1 Diabetes Mellitus - also known as juvenile diabetes, as well as 'insulin dependent'

diabetes - probably can't be prevented.

http://diabetes.co.in/diabetes-treatment/



Type 2 Diabetes Mellitus - also known as 'adult onset' diabetes as well as 'insulin resistant'

diabetes - can be prevented.

Gestational Diabetes Mellitus - happens during pregnancy - probably can be prevented.

Prediabetes Mellitus - not yet diabetes - can be prevented.

There are qualifiers of course with all of these forms of diabetes. It depends on other issues -

such as ethnic groups, age groups and many other risk factors.

Is your head spinning yet? Take a deep breath as there is more!

Central Diabetes Insipidus - also known as 'water' diabetes - probably can't be prevented but it

really depends on the cause.

Neurogenic Diabetes Insipidus - another form of 'water' diabetes - probably can't be prevented,

but yet, depending on the cause, in some cases, probably can.

Gestational Diabetes Insipidus - another form of 'water' diabetes - probably can't be prevented.

Dipsogenic Diabetes Insipidus - probably can't be prevented.

Diabetes Insipidus are very rare forms of diabetes and involve the inability to retain any water in

the body. Insipidus and mellitus only commonality is they both involve the frequencies of

urination and extreme thirst. Each type of diabetes has many other factors involved - some

factors can be prevented and others can't.

The really important question for any form of diabetes should be; can it be treated? But the

answers are not clear on that question either so we will leave that for another section.

This section on 'Diabetes Prevention' is to help explain the intricacies of the many different

forms of diabetes and why some forms can be prevented while others can't and still others are

really a 'maybe'.



7.5 Diabetes Management

The management of diabetes is so important for diabetics to understand. For a newly diagnosed

diabetic, any management plan can be overwhelming at first, but it is a vital means of controlling

this disease as well as preventing complications.

The main items that need to be managed are:

• Glucose level monitoring

• Diet

• Weight control

• Exercise

• Regular medications and insulin injections

• Foot care

• Skincare

• Teeth and mouth hygiene

• Regular visits to dentist

• Regular visits to eye doctor

• Regular checkups with primary doctor

• Lab work as ordered by primary doctor

This is when diabetics need to make a life time commitment to doing what is necessary to

control diabetes. All of these factors are interconnected. And in the case of Type 2 diabetes, it

can be totally controlled in some cases with diet and exercise.

Glucose monitoring

The home monitoring of glucose levels needs to be done frequently using a glucometer. This is

vital as this is the main way to know that your management plan is working.

Diet

The dietary requirements for both Type 1 and Type 2 diabetes are critical but for different

reasons for both types. For Type 1 diabetes diet is necessary to be able to regulate your dosage of

insulin therapy. For Type-2 diabetes diet is important to manage the blood glucose level as well

as weight control.

Weight Control

Weight is a risk factor for Type 2 diabetes, so managing the weight is a critical factor for

controlling blood glucose levels.

Exercise

Exercise is important in helping with weight control as well as helping any medication or insulin

therapy to work more effectively.

Managing of Medication and Insulin Therapy

Daily medications and insulin need to be taken as instructed by your physician.

Foot and skin care



This is important as dry skin or problems with the feet are prone to infections and need to be

monitored on a daily basis.

Tooth and Mouth Care

This is an important area to monitor as the mouth is a great place for infections. Daily a diabetic

needs to brush teeth at least twice a day and floss daily.

Dental Visits

Regular visits every 6 months to the dentist are very important.

Eye Visits

Regular visits to the eye doctor need to be made twice each year. This should be a

comprehensive exam including dilation of the eyes to check the blood vessels in the back of the

eye.

Lab Tests

Any lab tests ordered by your primary doctor should be followed up on so that he is able to

check on how well your management plan is working.

Checkups with Primary Doctor

It is important to have follow-up visits with your primary doctor so that he can determine how

well your management plan is working and to discuss any lab tests. A yearly physical exam

should be scheduled with this doctor as well so that he can check for any complications.

Managing all of these items is extremely important to keep up with. This section on "Diabetes

Management" will cover the management of diabetes in more detail.

Type 2 Diabetes

Type 2 diabetes is a disease of the metabolism involving the body's ability to use sugar to

provide energy to the cells of the body. Type 2 diabetes is the most common of the diseases of

diabetes mellitus. Type 2 diabetes usually occurs in adults but more and more young adolescents

are being diagnosed with this disease. It is believed to be caused by poor diet, little or no exercise

as well as being overweight or obese.

With Type 2 diabetes, the body's ability to use glucose is impaired. Insulin is a substance which

is used by the body to help facility the movement of glucose from the blood system into the cells

of the body. The insulin used in this process is produced in the pancreas and those with Type 2

diabetes either produce too little insulin or produce plenty of insulin but the cells are unable to

use it. This is known as "insulin resistant".

Because of this the level of glucose builds up in the body and is excreted from the body in urine.

This extreme urination often causes dehydration and the dehydration without replacing the fluids

can lead to a diabetic coma also known as hyperglycemic hyperosmolar nonketotic syndrome

The symptoms of this disease which usually leads a person to see their medical professional

includes extreme thirst as well as excessive urination. Occasionally diagnosis is made after the

person ends up in the hospital after suffering an episode such as diabetic coma.

High blood glucose levels overtime can damage the nerves, the small blood vessels in the eyes,

kidneys and the heart leaving the person predisposed to atherosclerosis (hardening) of the large

arteries that can cause heart attack and stroke as well as many other severe complications.



This condition is treated by medication, dietary changes and exercise and in some cases can be

treated with dietary changes and exercise alone. Those who are obese or overweight need to also

lose weight. The diabetic needs to daily monitor the level of blood glucose in the body using a

portable glucometer which can take the reading from a small drop of blood from the finger.

Both types of diabetes mellitus are conditions or diseases which have no cure and last a life time.

But with proper medication and other lifestyle changes Type 2 diabetes is a disease that can be

managed well but involves a life time commitment to regular professional as well as self care.



8. Discovery Profile

8.1 Environmental Leading to Discovery

8.1.1Incretin mimetic and enhancers

Drugs that work via the manipulation of incretin hormones GLP-1 (glucagon-like peptide) and

GIP (glucose-dependent insulinotropic peptide), that play an important role in diabetes, are set to

be the next blockbusters. “The hormones they target are secreted naturally in the gut in response

to food with the purpose of regulating activity of both the alpha and beta islet cells of the

pancreas,” explained Professor Bo Ahren, a researcher in clinical metabolism at Lund

University, Sweden. Normally alpha cells release glucagon to stimulate hepatic glucose

production between meals, when blood sugar is low, while beta cells produce insulin when it is

high, after eating. Incretin hormones modify the activity of both cell types as appropriate. In

diabetes, however, the normal incretin response is lost, GLP-1 secretion is reduced by around 25

per cent, beta cells are reduced in number and are under-active; insulin feedback to alpha cells is

diminished so these are persistently overactive. The healthy glucagon-insulin balance is lost

resulting in both fasting and postprandial hyperglycaemia.

There are two ways of attempting to restore the correct balance via the incretin response. Incretin

mimetics or GLP-1 analogs boost GLP-1 levels artificially to supra-physiological levels while

incretin-enhancers inhibit the dipeptidyl peptidase-4 (DPP-4) enzyme - which normally degrades

endogenously-produced GLP-1 within a few minutes - so as to prolong its activity. Both drug

types are effective in reducing HbA1c.The incretin mimetic Byetta (Exenatide, Lilly),

administered by injection, delays gastric emptying and increases satiety leading to weight loss of

around 4 to 5 kgs over two years. It reduces HbA1c by around 1%. “Incretin enhancers (DPP-4

inhibitors), administered orally, do not delay gastric emptying, but they boost insulin sensitivity

and may preserve beta cell function and increase beta cell mass, according to animal studies,”

noted Professor Ahren. Because their mode of action is more physiological and also regulates

glucagon as well as insulin, they are weight-neutral and, like the mimetics, do not carry the risk

of hypoglycaemic episodes associated with insulin and sulphonylureas.

The first incretin-mimetic, exenatide (Byetta, Lilly) was launched in the US last year and has

been enthusiastically received there with demand outstripping supply at one point. In Europe it

has received a positive opinion from the Committee for Medicinal Products for Human Use.

Byetta normally involves twice-daily injections and achieves satisfactory reductions in HbA1c

and weight, but is associated with a high incidence of nausea affecting up to 50 per cent of users.

“As time goes on you find people either love it or hate it”, noted Professor Edward Horton of the

Joslin Diabetes Center, Boston, US. “Sure, patients lose weight but the more you use it, the more

patients you notice developing GI side effects – nausea, vomiting and diarrhoea.”



Other incretin-mimetics are in development, including a long-acting once-weekly injection of

exenatide, using slow-release polymeric microspheres being developed by Lilly in collaboration

with Alkermes. In a phase II study, the long-acting version achieved reductions in HbA1c over

15 weeks of 1.4% with a 0.8mg dose, and 1.7% with a 2mg dose. Fasting plasma glucose

reductions of 2mmols/L, were observed, - better than those seen with the twice-daily injectable.

It also caused less nausea but produced a new problem of injection-site reactions.

8.1.2. Need of Dipeptidyl Peptidase (DPP)-IV Inhibitor

Type 2 diabetes is a progressive, metabolic disorder characterised by two fundamental defects:

insulin resistance at peripheral target tissues and pancreatic beta-cell dysfunction. Insulin

sensitivity declines as an individual moves from normal to impaired glucose

tolerance state. Pancreatic beta cells compensate by hyper-secretion of insulin in order to

maintain normoglycaemia. When pancreatic beta cells exhaust and the function of pancreatic

beta cells deteriorates progressively, an individual progresses from the state of impaired fasting

glucose or impaired glucose tolerance to frank diabetes.

Despite good compliance to treatment, the glycaemic control of type 2 diabetes deteriorates

progressively. Analysis from the United Kingdom Prospective Diabetes Study (UKPDS)

demonstrated that after 3 years of longitudinal follow up, only 50% of the initial cohort could

achieve the target haemoglobin A1c (HbA1c) control of <7% while the remaining 50% required

the addition of a second drug for diabetes control. By the time of nine years, 75% of patients

required multiple therapies to achieve the target HbA1c control3. Hence, new therapeutic agents

are continuously being developed to help our diabetes population. Recent studies have shown

that early intervention at prediabetes state4, 5 and beta cell protection with insulin sensitisers6

may improve the prognosis of diabetes.

Dipeptidyl peptidase (DPP)-IV inhibitors, which act via enhancing the incretins, represent

another new therapeutic approach to the treatment of type 2 diabetes. Glucagon-like peptide 1

(GLP-1) and glucose dependent insulinotropic peptide (GIP) account for the majority of incretin

action7. GLP-1 is a gut hormone that plays a key role in glucose homeostasis via its incretin

effect. GLP-1 is produced from the enteroendocrine L-cell of small intestine and is secreted in

response to meal and nutrients (Table 1). It stimulates insulin release from the pancreatic islets in

a glucose dependent manner. It restores the defective first and second phases of insulin response

to glucose in type 2 diabetes patients8,9. Moreover, GLP-1 suppresses post-prandial glucagon

release, delay gastric emptying and increase satiety10-12. In animal models, GLP-1 and its

analogs are shown to stimulate beta-cell proliferation and differentiation. These may help in

preserving the pancreatic beta cell mass and function, and thus have beneficial effect in the

prognosis of type 2 diabetes13,14. However, GLP-1 has a very short half-life. It is rapidly

degraded inside our body by the enzyme dipeptidyl peptidase (DPP)-IV. Therapeutic agents, that



can block the DPP-IV enzyme (DPP-IV inhibitor), can increase the endogeneous GLP-1 level

and thus enhances the incretin action. Sitagliptin is a potent and highly selective DPP-IV

inhibitor. It is the first from this novel class of oral antihyperglycaemic agent that has been

approved by the United States (US) FDA in October 2006 for the treatment of type 2 diabetes. It

can be used as a monotherapy or in combination with metformin or thiazolidinedione. Sitagliptin

is orally active and can be administrated once daily. A single oral dose of Sitagliptin 100mg can

inhibit plasma DPP-IV activity 80% over 24 hours of time15. By slowing incretin degradation,

Sitagliptin increases meal-stimulated active GLP-1 level to two to threefold, leading to increase

in insulin and C-peptide levels, reduction in plasma glucagon levels, reduction in post-prandial

glucose excursion and better glycaemic control in type 2 diabetes patients16. A 24-week

randomised, double-blinded, placebo-controlled study in type 2 diabetes patients demonstrated

that Sitagliptin 100mg daily monotherapy improved fasting and postprandial glycaemic control,

reduced HbA1c by 0.79% (p<0.001), improved beta-cell function, with neutral effect on body

weight, similar incidence of hypogycaemia, slightly higher overall gastrointestinal adverse

experiences when compared with placebo. Patients with baseline HbA1c 9% had greater

reductions in placebosubstracted HbA1c (-1.52%) than those with baseline HbA1c <9%17. DPP-

IV inhibitor had been shown to improve beta cell function in patients and animal models with

type 2 diabetes18-21. In animal models, DPP-IV inhibitor can lead to beta cell neogenesis and

survival22,23. Nonetheless, long term clinical studies are required to see whether similar beta

cell effects are found in patients with type 2 diabetes. Vildagliptin is another DPP-IV inhibitor

which acts via similar mechanism as Sitagliptin but has not yet been approved by US FDA.

In summary, DPP-IV inhibitors is a novel class of oral hypoglycaemic agent with potentials in

improving pancreatic beta cell function and the clinical course of type 2 diabetes. More clinical

trials are needed to explore their long-term clinical effects and their potential beneficial effects in

human beta cell neogenesis and survival.

Action of Glucagon-like peptide (GLP-1).

Action of GLP-1:

1. Stimulate insulin secretion in glucose-dependent manner.

2. Decrease glucagon secretion in glucose-dependent manner.

3. Delay gastric emptying.



4. Decrease appetite.

5. Increase pancreatic beta cell mass.

8.2 Novartis Financial Impact after launch of Galvus

Galvus is launched in 2008. After launch it takes the market rapidly. The effect is seen on the

financial statement of the company.

2007

(USDM) 2008

(USDM)

Net sale 38072 41459

Operating Income 6781 8964

% of net sale 17.80% 21.60%

Net Income 6540 8163

% of net sale 17.20% 19.70%

EPS (USD) 2.81 3.59

The EPS and net income is increased in spite of recession period.



9. Market Scenario

9.1 Major Player and their profile

a. Novartis

Novartis International AG is a multinational pharmaceutical company based in Basel,

Switzerland, ranking number three in sales among the world-wide industry. Company sales

totalled 36.173 billon US$ in 2008. Currently] Novartis is the sixth largest pharmaceutical

company in terms of revenue ($41.5 billion in 2009) with a profit margin of about 20%, which is

the same as its industry competitors. Novartis profits were down by 31% from 2007

levels.] Novartis manufactures such drugs

as clozapine (Clozaril), Diclofenac (Voltaren), carbamazepine (Tegretol), valsartan (Diovan), im

atinib mesylate and (Gleevec / Glivec). Additional agents include ciclosporin (Neoral /

Sandimmun), letrozole (Femara), methylphenidate (Ritalin), terbinafine(Lamisil), and others.

Renamed to Novartis following an acquisition by Ciba-Geigy, it owns Sandoz, a large

manufacturer of generic drugs. The company formerly owned the Gerber Products Company, a

major infant and baby products producer, but sold it to Nestlé on 1 September 2007.

Novartis is a full member of the European Federation of Pharmaceutical Industries and

Associations (EFPIA)[ and of the International Federation of Pharmaceutical Manufacturers and

Associations (IFPMA)

Novartis was created in 1996 from the merger of Ciba-Geigy and Sandoz Laboratories, both

Swiss companies with long histories. Ciba-Geigy was formed in 1970 by the merger of J. R.

Geigy Ltd (founded in Basel in 1758) and CIBA (founded in Basel in 1859). Combining the

histories of the merger partners, the company's effective history spans 250 years.

http://en.wikipedia.org/wiki/Novartis#cite_note-2

http://en.wikipedia.org/wiki/Clozapine

http://en.wikipedia.org/wiki/Diclofenac

http://en.wikipedia.org/wiki/Carbamazepine

http://en.wikipedia.org/wiki/Valsartan

http://en.wikipedia.org/wiki/Imatinib_mesylate

http://en.wikipedia.org/wiki/Imatinib_mesylate

http://en.wikipedia.org/wiki/Ciclosporin

http://en.wikipedia.org/wiki/Letrozole

http://en.wikipedia.org/wiki/Terbinafine



b. USV

We are a 49 year old leading healthcare company which began as a joint venture with USV&P

Inc. USA, a subsidiary of Revlon. Our product offering today includes Active Pharmaceutical

Ingredients (APIs), Peptides, Biosimilars, Injectables and Ophthalmics and Solid Orals. These

are manufactured in our cGMP compliant plants located in India.

We market our products globally to 57 countries. In the financial year 2009-10, our sales were

Rs. 10,211 million. Our Indian business contributed 67% to this and the rest was from export of

APIs and Finished Dosages.

In India we are recognized for our leadership in the Oral Anti-Diabetic market where we rank

No. 1 by Rx and Value. In the Cardiovascular diseases segment we are No. 1 by Rx and in the

top 10 by Value. We also have a significant presence in the areas of Gynaecology, Dermatology,

Gastroenterology and General Practice.

Our international business consists of:

A large portfolio of small molecule APIs. Of the 54 products in our portfolio, 21 APIs are

commercially available, with others in various stages of development. Our special skills

include production and characterization of polymorphs and particle sizing.

A portfolio of Finished Dosages. These include immediate release, modified release and

products with 'complex' characteristics which are promoted through ANDA filings and

Dossiers linked to supply.

Our spend of 7% of sales on R&D ensures that we are able to deliver on our research portfolio.

We have over 100,000 sq. ft. of laboratory space with excellent infrastructure. Our research is

driven by a team of 250 scientists including 3 doctors, 33 PhDs and 165 post-graduates, many of

whom have studied in universities in USA, Europe and Japan. Our intellectual property portfolio

consists of 83 patent filings of which 30 have been granted.

c. Piramal

Piramal Healthcare Ltd, a Piramal Group company, is a globally integrated healthcare company

that fulfills unmet medical needs across the world. It has a growth track record of above 29%

CAGR since 1988. Piramal Healthcare had consolidated revenues of US$ 656 million in

FY2009. PHL is currently ranked 4th in the Indian market with a diverse product portfolio

spanning several therapeutic areas. It is also one of the largest custom manufacturing companies

with a global footprint of assets across North America, Europe and Asia.

At Piramal Healthcare, our core values of Knowledge, Action and Care propel us to improve the

quality of lives by democratizing healthcare. We aim to attain leadership in market share,

innovation and profits by:



Partnering the medical fraternity

Building strong capabilities to deliver product and process innovations

Attracting and developing the best in class talent

We believe we can create value only if we care for the ones we serve, that our care will have an

impact only if it is followed by timely and bold action, and that we will take timely action if it is

backed by knowledge.

9.2 Market Share of major player

9.2.1 Anti diabetic market

2007 2008 2009 2010

Average 1 1.2 1.3 1.6

Count 1317 1335 1396 1462

Sum 1258.6 1624.8 1869.8 2318.5

9.2.2 Oral Anti Diabetic

2007 2008 2009 2010

Average 0.8 0.9 1 1.3

Count 1188 1211 1276 1331

Sum 909.9 1115.6 1304.5 1671.7

9.2.3 Vildagliptin

2009 2010

Average 2.6 19.3

Count 2 2

Sum 5.3 38.6

Galvus global sales

Year Sales (USD M) % Change

2009 180 117%

2010 391



9.2.4 Vildagliptin market share

Molecule_Desc PACK_DESC BRANDS MANUFACTURE 2008 2009 2010

EPALRESTAT ALDONIL FILM C.TABS 50 MG x 10

ALDONIL ZYDUS CADILA 0.0 1.0

EPALRESTAT ALRISTA FILM C.TABS 50 MG x 10 ALRISTA

MACLEODS PHARMA 0.4 1.2 0.5

EPALRESTAT ARISTAT FILM C.TABS 50 MG x 10

ARISTAT

MACLEODS PHARMA 0.2 0.0 0.0

EPALRESTAT EPAREL FILM C.TABS 50 MG x 10 EPAREL MICRO LABS 0.1

VILDAGLIPTIN GALVUS TABS 50 MG x 14 GALVUS NOVARTIS 3.9 21.9

VILDAGLIPTIN JALRA TABS 50 MG x 14 JALRA U S V 1.4 16.6

SITAGLIPTIN PHOSPHATE

JANUVIA FILM C.TABS 25 MG x 7

JANUVIA

MSD PHARMACEUTICAL 0.2 0.4



JANUVIA




JANUVIA


Brand Name Composition Company Packing MRP GALVUS tab Vildagliptin 50mg

NOVARTIS 14 270.00

GALVUS MET tab Vildagliptin 50mg, metformin 500mg NOVARTIS

10 N.A.


10 N.A.


10 N.A.

JALRA tab Vildagliptin 50mg USV

14 270.00

JALRA-M tab Vildagliptin 50mg, metformin 500mg USV

10 198.00

ZOMELIS tab Vildagliptin 50mg PIRAMAL

14 270.00

ZOMELIS MET tab Vildagliptin 50mg, metformin 500mg PIRAMAL

10 198.00

ZOMELIS MET tab Vildagliptin 50mg, metformin 1000mg PIRAMAL

10 N.A.



9.3 Marketing Strategy

a. Novartis

High Promotion Activity

Providing education to Doctor

Provide Journals of Diabetes

Latest information about the Vildagliptin

Arrangement of Seminar (Scientist)

b. USV

Education to doctor

Arrangement of group discussion for Doctors

Provide Research Paper

9.4 Financial Condition of player

Following is the present situation and future prospect of the companies. It looks healthy

company in terms of net profit.

Novartis USV

2011 2012 2011 2012

Revenue 57195M 58846M 61900M 64500M

EBIT 15519M 15584M

Net Profit 11747M 12359M 14108M 15010M

Share Price $54.89

$54.91



10. R&D Scenario 10.1 Competing molecule being expected

Following are the molecule which are being expected as competitor of Vildagliptin.

Sr.

No.

Drug Name Status

1 Linagliptin being developed by Boehringer

Ingelheim

2 Dutogliptin being developed by Phenomix

Corporation

3 Gemigliptin being developed by LG Life

Sciences,Korea

4 Alogliptin developed by Takeda Pharmaceutical

Company, whose FDA application for

the product is currently suspended as of

June 2009

1. Linagliptin

Linagliptin (BI-1356, expected trade name Ondero) is a DPP-4 inhibitor developed

by Boehringer Ingelheim undergoing research for type II diabetes.

Results from a Phase III clinical trial of linagliptin showed that the drug can effectively

reduce blood sugar.

Linagliptin is the most advanced investigational compound for the treatment of type 2 diabetes

within the Boehringer Ingelheim diabetes portfolio. It belongs to the class of dipeptidyl peptidase

(DPP)-4 inhibitors and is being developed as an oral once-daily tablet. In clinical studies to date,

linagliptin has been shown to:1-6

http://en.wikipedia.org/wiki/Boehringer_Ingelheim


http://en.wikipedia.org/w/index.php?title=Phenomix_Corporation&action=edit&redlink=1


http://en.wikipedia.org/w/index.php?title=LG_Life_Sciences,Korea&action=edit&redlink=1


http://en.wikipedia.org/wiki/Takeda_Pharmaceutical_Company




provide significant, sustained and clinically meaningful improvements in blood glucose control

have an excellent safety and tolerability profile, and low risk of hypoglycaemia

not cause weight gain

not require dose adjustment, irrespective of concomitant disease or co-medication, even in

patients with renal impairment (linagliptin has a primarily non-renal route of excretion)

have a once-daily dosing regimen as a convenient small tablet which can be taken time and food

independent

2. Dutogliptin Dutogliptin (PHX-1149T), being developed by Phenomix Corp, Forest Laboratories Inc and

Chiesi Farmaceutici SpA, is a small-molecule dipeptidyl peptidase-4 (DPP-4) inhibitor for the

potential oral treatment of type 2 diabetes mellitus (T2DM). DPP-4 quickly degrades the insulin

secretory hormones, glucose-dependent insulinotropic peptide and glucagon-like peptide-1; thus

inhibiting the degradation of these hormones is a viable treatment option for patients with

T2DM. In preclinical studies, dutogliptin potently inhibited DPP-4 and, in a model of T2DM,

treatment with dutogliptin improved glucose homeostasis. Pharmacokinetic analyses in animals,

healthy individuals and patients with T2DM demonstrated that drug exposure increased in a

dose-dependent manner. Results from phase II clinical trials indicated that once-daily

dutogliptin, in combination with other oral diabetes therapies, reduces postprandial blood

glucose and HbA1c levels, both indicators of successful diabetes management. In phase I and II

trials, dutogliptin was safe, well tolerated and associated with extremely low rates of

hypoglycemia. At the time of publication, phase III trials were underway and the results of these

will be imperative to determine the efficacy of dutogliptin compared with other small molecule

DPP-4 inhibitors, such as sitagliptin and vildagliptin.

3. Alogliptin



Alogliptin (codenamed SYR-322) is an investigational anti-diabetic drug in the DPP-4

inhibitor class, being developed by Takeda Pharmaceutical Company. In January 2008, Takeda

submitted a New Drug Application for alogliptin to the U.S. Food and Drug Administration,

after positive results from Phase III clinical trials. However, the FDA submission was suspended

or withdrawn in June 2009 needing more data.

10.2 Leader Player and R&D Strategy

1. Boehringer Ingelheim

Boehringer Ingelheim's successes in research & development continuously strengthen our

portfolio of medications and offer patients true therapeutic benefit. The drug discovery focuses

on six major research areas: Respiratory diseases, Cardiometabolic diseases, Oncology,

Neurological Diseases, Immunology and Infectious Diseases.

2. LG life science. Korea

LG Life Sciences R&D Park was established in 1979 as Lucky Research Institute. Since then,

they have been focused on biopharmaceuticals and new chemical drugs. Since the launch of

Intermax-gamma®in 1990 - Korea's first genetically engineered product - various kinds of

biopharmaceuticals were developed. In 2003, FACTIVE®was approved as a new chemical entity

by the FDA, and in 2007, Valtropin® was approved in EMEA as a biosimilar - both a first time

achievement in Korea.

10.3 Expected Announcement date

Sr.

No.

Drug Name Status Expected

Announcement

Date

1 Linagliptin Boehringer Ingelheim 2013

2 Dutogliptin Phenomix Corporation 2014

3 Gemigliptin LG Life Sciences,Korea 2014-2015

4 Alogliptin Takeda Pharmaceutical

Company

2013








11. Strategic Marketing Plan

11.1 Strategic Marketing plan for Leader

The market leader has to focus on the ahead for the new drug investigation and development.

Apart from finding the new drug company should also focus on the new combination of drugs

which are having better efficacy and pharmacological action.

Company should focus on the following strategy which helpful them for the better performance.

The market leader should keep the doctor updated and provide the latest information. So,

doctor can prescribe the Vildagliptin.

The activities should be carried out for the better performance of the drug.

The update from the authentic authority or institute should be published and provide

information to the doctor.

The promotional tools should be such that it motivates the doctor to prescribe the

medicines.

The seminar from the clinical research institute should be carried out for the education of

the doctor.

The company should come out with the new combination of the drugs. So, it will give

better edge over the competitor.

Segmentation:

Geographic:

Country: India

City/States: Gujarat, MP, UP, Delhi, Assam, Orissa, Rajasthan

Target Market:

Diabetologist and Cardiologist from different urban and rural area.

Positioning:

We would like to place our product in mine of doctor on basis of quality of

product. We would like to give as good quality of tablet as can be possible.



11.2 Action Programs

Price

We would like to keep our pricing as following

MRP 245

Retailer 196

Stockiest 176.4

Promotion Plan

Promotion is one of the important parameter for the success of product.

For Promotion we have decided following things to keep in mind.

1. Teaser

2. Visual Aid

3. Leave Behind

4. Calendar

5. Chemist Cards

6. Samples

7. Gifts

1. Teaser

Teaser is only given in one time at the time of introduction. We will give it

on 1st visit in January.



2. Visual Aid

Visual aid is given to Medical Representative to show or detailing of our

product. This will consist of four pages.

In first page we only display brand name and company name.

On the second page the function of natural progesterone will be listed.

On third page different indications in which the doctor prescribes

Progesterone is listed.

On fourth page package of the product will be display.

3. Leave Behind

Leave behind will be given in every 2 month.

Front side only one lady in natural environment will be shown. It also

includes indication of Progesterone.

On back side we will display package of product, brand logo and company

logo will be displayed.

4. Calendar

We will give calendar to doctor. It will be based on the gynecology theme.

5. Chemist Card

Chemist card will consist of only price of the product.

6. Samples

We will give samples to the doctors in every month. Sample consists of 2

capsules.



Yearly Calendar:

We would focus on following plan yearly.

Yearly calendar

Month Visit Detail Description

January

1 Treasure

2 Detailing + Sample

3 Detailing + Reminder Card

February

1 Detailing + Calendar


3 Detailing + Mailer

March

1 Detailing + Gift



April

1 Detailing



May

1 Detailing



June

1 Detailing + Gift



July

1 Detailing



August

1 Detailing



September

1 Detailing + Gift



Octomber

1 Detailing



November

1 Detailing



December

1 Detailing + Gift





11.3 Budget

State wise Medical Representative

State No. of MR

Gujarat 35

MP 30

UP 45

Delhi 20

Assam 30

Orissa 40

Rajasthan 25

Total 225



11.4 Sales month wise

YEAR

2011 2012 2013

Strips/BE/Month

Total Sale

Strips/BE/Month

Total Sale

Strips/BE/Month

Total Sale

January 20 4500 55 12375 115 25875

Quarter 1 February 10 2250 60 13500 120 27000

March 15 3375 65 14625 125 28125

Total 10125 40500 81000

April 25 5625 70 15750 130 29250

Quarter 2 May 30 6750 75 16875 135 30375

June 30 6750 80 18000 140 31500

Total 19125 50625 91125

July 35 7875 85 19125 145 32625

Quarter 3 August 35 7875 90 20250 150 33750

September 40 9000 95 21375 155 34875

Total 24750 60750 101250

October 45 10125 100 22500 160 36000

Quarter 4 November 45 10125 105 23625 165 37125

December 40 9000 110 24750 170 38250

Total 29250 70875 111375

Year

Total 83250 222750 384750

Value 146853

00 392931

00 678699

00



11.5 Expenses

Sr No.

Head Total BE Quantity per BE

Total Quantity

Price per head Total Cost

1 Teasure 225 30 6750 4 27000

2 Visual Aid 225 1 225 15 3375

3 Leave behind 225 30 40500 2 81000

4 Calender 225 30 6750 45 303750

5 Mailer 225 30 6750 3 20250

6 Produt Card 225 30 6750 2 13500

7 samples 225 30 6750 14 1134000

8 Gifts 225

0

0

a. High value 225 5 1125 175 196875

average

value 225 15 3375 75 253125

Total

2032875

11.6 Profit

Total Sales 14685300

Expenses 2032875

Gross Profit 12652425

11.7 Strategy used by Companies

Improving in clinic performance by strengthening Scientific communication

Expanding market by CME/RTM

Life Academia Programs for Doctors



11.8 Communication Strategy

The following Communication strategy should be used to influence the doctor.

Sr. No. Speciality Core Message Medical

Rationale

1 Diabetologist

Dual Benefit: Increase in Insulin Release, Decrease in Glucagon release Complete CV Protection

USFDA approval for CV

Protection & proven

renoprotection

2 Cardiologist Offer Complete protection with both Reno & CV Protection BP Reduction

Proven in trial by Littlejohn

released in ASH’09 & ESH’10

3 Nephrologists Powerful BP reduction with Renoprotection

Proven Renoprotection by reduction in

UAER



12. Conclusion

My conclusion on this project is as below

Vildagliptin is the drug of DPP4 inhibitor class. It is the latest therapy for the type 2

Diabetes. So, the future of this class is excellent. It has better advantage over other class

of therapy. But there are number of drugs in this class. Only 3 drugs are marketed till the

date. Other number of drugs is waiting for the approval. So, it will challenge the market

of Vildagliptin.

Diabetes is life style disease. The change in life style due to modernization. The disease

is spreading at the higher rate.

Novartis has launched Vildagliptin for European market for the first time. It got the

success there and after that it launched in other country. This has increased the share

price in spite of the recession. Thus the launches of the good drug increase the share price

and strengthen the financial condition of organization.

Novartis is the market leader in Vildagliptin market. The strategy being perused by the

Novartis is in the Introduction stage. The company more concentrates on the awareness

about Vildagliptin among the doctors.

There are number of drugs in the pipeline to come in the market. This will have the threat

for the Vildagliptin drug. The side effect of the Vildagliptin is very less compare to the

others. So, the Vildagliptin has competitive advantage over others drugs.

The reputed pharmaceutical companies have invested in R&D in DPP4 inhibition class.

This will give the signal of bright future of this class categories drugs. So, the share

prices of these companies are expected to increase at the time of announcement of drug

launch.



13. Recommendation

The companies should more focus on the educating the doctors. Because this is the new

therapy segment for the diabetic drugs.

The newer marketing strategy should be made. So the executive can show the benefits of

Vildagliptin over other molecule.

The indication in which Vildagliptin is prescribe should be stated properly.

The threat molecule should be taken in account. The marketing strategy should be

designed in such away that it induce the spreading of newer molecule.

The seminar and group discussion for doctors about the Vildagliptin molecule should be

done.



14 Limitations

Sample size was very small for making reliable decision.

As the survey is not been conducted in Vildagliptin makers companies,

results would not be specific.

As I have adopted face to face interview tool for data collection purpose,

deeper meanings resides in the respondents mind can not be acquire.

As I have used Qualitative and methods, which was very difficult to

generalize the result.

It was very difficult for me to make respondents understand question, as it

requires deeper sense and attention of respondents at very high level.

Some part of project is purely depending on the respondent answer and due

to small sample size it may not be generalized.



15. Bibliography

Research Methods for Business Students (3rd

Edition) by Mark Saunders, Philip Lewis

and Adrian Thornhill (2007), Dorling Kindersley (India) Pvt Ltd, New Delhi

Marketing: An Introduction (7th

Edition) by Armstrong and Philip Kotler (2005), Dorling

Kindersley (India) Pvt Ltd, New Delhi.

http://www.pharmaceutical-drug-manufacturers.com/pharmaceutical-industry/ (15th

July

2010)

http://business.mapsofindia.com/india-company/pharmaceutical.html (15th July 2010)

http://www.medicalnewstoday.com/articles/25348.php (15th July 2010)

http://www.prlog.org/10329431-top-10-pharmaceutical-companies-in-india-growth-

strategies-performance-swot-analyses.html (15th July 2010)

http://www.themedica.com/drug (15th July 2010)

http://bw.businessworld.in/PDF_upload/Indian_Pharma.pdf (17th July 2010)



16 Annexure

16.1 Research Proposal

Title:

“Research Proposal for PGP Dissertation on Vildagliptin Molecule.”

Research Objective:

1. To Know the Profile of molecule.

2. To know the Disease Profile.

3. To know the discovery profile of Molecule.

4. To know the market scenario of the selected molecule.

5. To know the research and development happening in area of selected molecule.

6. To make Strategic marketing plan

Research Method

Stages Data required Data Source Data collection

tool

1.

Molecule Profile

Family Details, Substitutes

Process Details, reaction,

Technology, Cost of Discovery,

IPR holder.

Administration Details,

Indications, Contraindication.

Secondary

Data

Literature

Review



2.

Disease Profile

Symptoms.

Casual and Precipitating Factors.

Details of occurrence and spread

trajectory.

Secondary

Data

Literature

Review

3.

Discovery Profile

Environmental Leading to

discovery, Companies in race, and

their profile.

Announcement date and its

impact on share prices.

Analysis of final accounts of the

IPR holder in the year of

announcement.

Secondary

Data

Literature

Review

4.

Market Scenario

Major Players and their profile.

Market shares, Marketing

Strategies being Pursued, Share

prices.

Analysis of final account of the

major players.

Secondary

Data

Literature

Review

5.

R&D Scenario

Competing Molecule being

expected.

Lead players and research

strategies being pursued.

Investment made in R&D,

expected announcement and its

impact on market shares,

Face to face

interview

Interview With

Industry

Executive



Profitability and share prices.

6.

Strategic Marketing Plan

For Leader/Challenger/Nicher

R&D strategy, Investment,

Capital Structure, Marketing

Strategy.

Projected Market Share,

Profitability and Share Prices.

Face to face

interview

Interview With

Industry

Executive

Sampling Design

Target population : Industry Executive

Sample Size : 2 – Industry Executive

Time scale

Sr.

No. Function Days

1 Molecule Profile

7th

jan,2011 to 14th

jan,2011

2 Disease Profile

15th jan,2011 to 20th

jan,2011

3 Discovery Profile

21st jan,2011 to 25

th

jan,2011

4 Market Scenario

26th

jan,2011 to 5th

feb,2011

5 R&D Scenario

6th

feb, 2011 to 15th

feb

2010

6 Strategic Marketing Plan

16th

feb,2011 to 5th

march, 2011



7 Submit Draft to guide and

await for feedback

6th

march,2011 to 10th

march,2011

8 Revise draft and format for

submission

11th

march,2011 to 15th

march,2011

9 Print and bind 18th

march,2011

10 Submission 21st march,2011

Resources

Transportation expenses for market survey for fill up of questionnaire and talk with

doctors and dealers.

Stationary expenses for printing of questionnaire and report and binding of report.

References

Research Methods for Business Students (3rd

Edition) by Mark Saunders, Philip Lewis

and Adrian Thorn hill (2007), Dorling Kindersley (India) Pvt Ltd, New Delhi

Marketing: An Introduction (7th

Edition) by Armstrong and Philip Kotler (2005), Dorling

Kindersley (India) Pvt Ltd, New Delhi.

Proposal Approved By

Academic Guide

Name : __________________________________________

Signature : __________________________________________

PGP Dissertation Report Nirav Patel

Documents

Transcript of PGP Dissertation Report Nirav Patel