Vildagliptin Study

1. Product Plan
Muhammad Nauman Khalid

2. Contents
Disease
About Compound
Disease Prevalence
Vision of Galvus
MarketAnalysis
Market Share
Action Plan
Muhammad Nauman Khalid

3. Diabetes Mellitus
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A disease in which the body’s ability to produce or
respond to the hormone insulin is impaired, resulting in
abnormal metabolism of carbohydrates and elevated
levels of glucose in the blood

4. Types Of Diabetes
Diabetes
Type 1 diabetes, once known as juvenile diabetes or
insulin- dependent diabetes, is a chronic condition in
which the pancreas produces little or no insulin.
Type 1 Diabetes
Type 2 Diabetes
Diabetes mellitus Type 2 is a long-term
metabolic disorder that is characterized by high
blood sugar
, insulin resistance
Gestational Diabetes
Gestational diabetes mellitus (GDM) is
defined as any degree of glucose
intolerance with onset or first
recognition during pregnancy Muhammad Nauman Khalid

5. Role of Pancreas
 Beta cells (β cell)
 Alpha cells (α cell)
 Delta cells
 PP cells
Pancreas
1 to 2 million Islets of Langerhans,
Diabetes
Muhammad Nauman Khalid

6. Decreases blood glucose
levels
Beta cells
High levels of blood
glucose
Low levels of blood
glucose
Released by
Action
Secreted in
response to
Secretion
inhibited by
Increases blood glucose
levels
Alpha cells
Low levels of blood
glucose
High levels of blood
glucose
Insulin Glucagon
The Pancreatic Islets
Hormones released
Diabetes
Muhammad Nauman Khalid

7. Released by
Action
PP cells
Somatostatin Pancreatic Polypeptide
Delta cells
Suppresses Insulin
and Glucagon
slows intestinal motility
Not Known
Diabetes
The Pancreatic Islets
Hormones released
Muhammad Nauman Khalid

8. Blood Glucose regulation, fasting state
Role of liver
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Glycogenolysis:
Conversion of
glycogen to glucose
Gluconeogenesis:
Conversion of fat to
glucose

9. Increase in glucose concentration
Liver performs 2 functions
After a meal
Function 1: Conversion of glucose to Glycogen : Glycogenesis
Blood Glucose regulation, fed state
Role of liver
Function 2: Conversion of glucose to triglycerides
Muhammad Nauman Khalid

10. Galvus
(Vildagliptin)
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Best in Class DPP4 Inhibitor,
Incretin Based Therapy with low Risk of
Hypoglycemia and Wait Gain

11. What are Incretins?
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 Hormones produced by the gastrointestinal tract in response to
incoming nutrients, and have important actions that contribute to
glucose homeostasis.
 Two hormones:
▶ - Gastric insulinotropic polypeptide (GIP)
▶ - Glucagon-like peptide-1 (GLP-1)

12. Half-Lives of GLP-1 and GIP
GLP-1
Muhammad Nauman Khalid
Inactive compounds
1 to 2 min
DPP-4
DPP-4
Inactive compounds
GIP
7 min

13. Incretin Hormones Regulate Insulin and Glucagon Levels
Adapted from Kieffer T.Endocrine Reviews. 1999;20:876–913. Drucker DJ. Diabetes Care. 2003;26:2929–2940. Nauck MAet al.
Diabetologia. 1993;36:741–744. Adapted with permission from Creutzfeldt W.Diabetologia. 1979;16:75–85. Copyright © 1979
Springer-Verlag.
Hormonal signals
• GLP-1
• GIP
Glucagon
(GLP-1)
Insulin
(GLP-1,GIP)
Neural signals
cells
cells Normoglycemia
Ingestion
of food
Incretin effect diminished in T2DM
Muhammad Nauman Khalid

14. Role of Galvus for Glycemic Control
Incretins
GIP&GLP1
Stimulate
insulin
release
Inhibit
Glucagon
Release
DPP-4
Enzyme
inactivates
Incretins
Lowering of
Blood
Glucose
Galvus Blocks
Muhammad Nauman Khalid

15. DPP-4=dipeptidyl peptidase-4; T2DM=type 2 diabetes mellitus
Adapted from Unger RH. Metabolism 1974; 23: 581-593. Ahrén B. Curr Enzyme Inhib 2005; 1: 65-73.
 Insulin
 Glucagon
Improved
glycemic control
Incretin
activity
prolonged
Improved islet
function
DPP-4 inhibitor
 Glucagon
Hyperglycemia
T2DM
Incretin
response
diminished
Further impaired
islet function
 Insulin
Blocking DPP-4 Can Improve IncretinActivity and Correct
the Insulin:Glucagon Ratio in T2DM
Muhammad Nauman Khalid

16. Pharmacology of Galvus
Mechanism ofAction
Vildagliptin a member of islet enhancer class, is a
potent and selective DPP-4 Inhibitor that improves
glycemic control. Galvus inhibit DPP-4 results in
increased fasting and postprandial endogenous levels
of incretin hormones GLP1 and GIP.
Pharmacodynamics
In patients with type 2 diabetes , administration of
Vildagliptin led to inhibition of DPP4 enzyme activity
for 24- period.
The enhanced insulin/glucagon ratio during
hyperglycemia due to increase incretin hormones
levels results in a decrease in fasting and
postprandial hepatic glucose production, leading to
reduce glycemic levels. Muhammad Nauman Khalid

17. Pharmacology of Galvus
Muhammad Nauman Khalid
Characteristics Details
Half life 2-3 Hours
Bioavailability 85%
Protein Binding 9.3%
Elimination Urine 85% Feces 15%
Peak Plasma Level 1.7 to 2.5 Hours

18. ♦Known hypersensitivity to vildagliptin or to
any of the excipients
♦ Patients with creatinine clearance <30 ml/min
♦ Congestive heart failure
♦Acute or chronic metabolic acidosis including
lactic acidosis or diabetic ketoacidosis with or
without coma
♦ Should be temporarily discontinued
in patients undergoing radiologic studies
involving intravascular administration of
iodinated contrast materials.
Contraindications
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19. Rare cases of angioedema. Rare cases of
hepatic dysfunction (including hepatitis)
Adverse reactions:
Muhammad Nauman Khalid
Common:
Dizziness
Uncommon:
Headache, Constipation, Edema peripheral.

20. Disease
Prevalence

21. Worldwide prevalence of diabetes is high and is expected to
increase to 592 million in approximately 20 years
www.idf.org/diabetesatlas/6e/
Number of people with diabetes 2013: 382 million
Estimated number of people with diabetes in 2035: 592 million (~55%)
24.1 38.5
LatAm
+60%
36.8 50.4
North
America
+109%
19.8 41.5
Africa
+37% +22%
+96%
34.6 67.9
Middle East &
NorthAfrica
+71%
72.1 123.0
South-East
Asia
Western
Pacific
+46%
138.2 201.8
56.3 68.9
Europe
Muhammad Nauman Khalid

22. Prevalence in Pakistan
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According to latest survey there is 35.3 Adults
are diabetic patients in our country.
IDF also confirmed there are more than 25%
adult population in Pakistan is Diabetic.

23. • Diabetes is a serious public health concern which places a great
burden on the individual, on the society and on the health
services.
• Number of people suffering from diabetes is increasing all over
the world.
• There are currently an estimated 143 Million people with
diabetes world wide.
• The figure is projected to rise to 300 Million by the year 2025.
• In Pakistan diabetes is on the rise.
Facts about Diabetes
Muhammad Nauman Khalid

24. • Diabetes is the fourth leading cause of death by disease
globally.
• In our country it is the most common cause of blindness and
end stage renal disease in adults.
Facts about Diabetes
Muhammad Nauman Khalid

25. Vision of Galvus
Our Vision is to Become the leader
in Anti Diabetic Market
Muhammad Nauman Khalid

26. Total Anti Diabetic Market Size 9 billion Rs
30%
45%
25%
Market Analysis
Sus DPP4 Others
Muhammad Nauman Khalid

27. DPP4 Market Analysis
18%
16%
15%
14%
DPP4 Market
Galvus SitaGlu Tagip Sita Met
Muhammad Nauman Khalid

28. Action Plan for Q2

29. Smart & Effective Customer List
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• Wise Customer Selection for targeted product.
• T1 to ST Conversion.
• Expand and Explore new Customers and
Institutions.
• Untapped Opportunities
• Sound Knowledge of Prescribers and non
Prescribers

30. Key Factors to Achieve Leadership in
Anti Diabetic Market
 Maintain our Leadership DPP4
Market
 SU’s Market Share
 Generics Share
Muhammad Nauman Khalid

31. Maintain our Leadership DPP4 Market
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• Continuous Chamber Excellence & Engagement with
Leading Diabetologist and Physicians.
• Focus on Early Treatment Intensification.
• Cross Territory or within territory KOL’s engagements
with quality participants “SLP”
• Strong follow-up of activities about to or executed.
• Family Physicians forum quality engagements.

32. SU’s Market Share / Generics Share
Muhammad Nauman Khalid
• GPAwareness program in each territory 2 to 3 “G & G”
Programs per Quarter. Speaker: Associate/Asst Prof,
Audience: GP’s
• Patient Screening Camps with Gp’s
• MO’s SMO’s PG’s and Registrars will be engaged in
program “One 2 One”
• Find SU’s prescribers and share studies on Galvus
accordingly.
• Field Force Trainings and Skill development.

33. Summary
The biggest activity and investment is
Chamber Presence, Performance and
Excellence.
Muhammad Nauman Khalid