global diabetes market revi

Global Diabetes Market Review 2008 & World Top Ten

Diabetes drugs

World Top Ten diabetic drug brands, market trends and top companies

2008

Actos and Lantus emerged as the top selling PPAR agonist and insulin analogue in 2008 with

sales of $4.2 billion and $3.3 billion followed by newer insulin analogues from Novo Nordisk.

Takeda was the market leader in diabetes market followed by Sanofi Aventis, Novo Nordisk

and Lilly. Januvia was the one of the latest approved diabetic drug to reach $1.3 billion sales

and the entry of Merck in the diabetic market. Lilly lost its insulin market dominance in 2008

to Novo Nordisk and Sanofi Aventis. The top ten products generated $21 billion sales and

global diabetic market was 24 billion in 2008.

Contents

Results and Discussion (Para 3)AcknowledgementsDiabetic Drug CategoriesTable 1. Top Selling Diabetic Medicine Brands 2006- 2008Diabetic Pathways for Development of New Drugs Copied from wikipedia under GNU Free Documentation

License GLP1, DPP4GLP1, DPP4 Glucagon...From Merck Data http://www.januvia.com/sitagliptin/januvia/hcp/janumet/efficacy/starting_therapy.jsp?WT.svl=5.1 From...Associations

FoundationsFDA Panel Votes to Restrict AvandiaMark it as your favorite knol Share and Comment Share |

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Under Creative Commons Attribution 3.0 License

Diabetic Map from International Diabetic Federation Neurons in action j0438727.jpg

Copied from office.microsoft.com Clip Art and Image Library

Results and Discussion (Para 3)


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The global antidiabetic market was $ 24 billion in 2008 with insulins and analogs at $ 12.5 billion and PPAR agonists

at $5.8 billion. Actos and Lantus emerged as the top selling PPAR agonist and insulin analogue in 2008 with sales of$4.2 billion and $3.3 billion followed by newer insulin analogues from Novo Nordisk. Takeda was the market leader indiabetes market followed by Sanofi Aventis, Novo Nordisk and Lilly. Novo Nordisk was still leading the insulin marketfollowed by Sanofi Aventis and Lilly. Thus Novo Nordisk, Lilly and Bayer lost their long held market dominance in2008 to new arrivals Takeda and Sanofi Aventis. GSK Avandia lost market shares and sales due to black box warnings

and FDA/EMEA regulatory action to restrict its use leaving Actos as the PPAR market leader. Many PPAR agonistsprojects in development and clinical trials continue despite concerns about class carcinogenicity and cardiotoxicity ofPPAR agonists and tougher regulatory criteria for approval.

Pfizer pulled out of production and marketing of Exubera® (inhaled insulin licensed from Nektar) due to poor salesand low patient compliance, difficulty of inhaler use and reduced lung function in some patients. Pfizer had invested

over $2 billion in licensing, production and marketing of Exubera. MannKind Afresa® (Technosphere insulin) a rapidlong acting inhaled insulin showed positive results in two Phase III studies and the company decided to continuedevelopment and file IND for FDA approval. Two other inhaled insulin projects in development were terminated.Novartis Starlix® (Nateglinide) was another new diabetic drug with poor sales.

Commercial success of Merck Januvia® (Sitagliptin) a dipeptidyl peptidase 4(DPP4) inhibitor, which enhancesendogenous glucagon like peptide 1(GLP1) action, will lead to success of other follow up DPP4 inhibitors in treatment

of type II diabetes by providing glycemic control without weight gain. Galvus® (Vidagliptin) from Novartis wasapproved by EMEA in 2007 and launched in 2008 in Europe. Onglyza® (Sexagliptin) from BMS licensed to AstraZeneca for Europe and Otsuka for Japan was filed for approval in July 2008 and awaiting approval in USA andEurope. Victoza® (liraglutide, Novo Nordisk) received a positive opinion from CPMP in Europe. The FDA advisory

committee was split about the safety of the drug Novo Nordisk drug Victoza® (liraglutide, Novo Nordisk) and theFDA is likely to ask for additional safety data. FDA approved only one new antidiabetic drug Welchol® (colesevelam)from Daiichi Sankyo in 2008. Bayer has failed to come up with newer diabetic medicines after patent expiry ofGlucophage® (Metformin) and Glucobay® ( Acarbose) and loss of sales to generic competition.

Byetta® (Exenatide) with sales of $900 million is a new antidiabetic class (incretin mimetics), is an analog of GLP1and is a synthetic analog of Extendin 4 a hormone discovered in the saliva of Gila monster. GLP1 is a regulator of

glucose metabolism and insulin secretion. Byetta was approved by FDA in 2005 and provided effective glycemiccontrol without weight gain with mild gastrointestinal and CNS adverse events in clinical trials. Six cases of acutepancreatitis with 2 deaths were received by FDA (November 2008) probably linked to the use of Byetta in diabeticpatients. Acute pancreatitis may be a class toxicity of all GLP 1 analogs. Additional long term studies to explore the

link and incidence of acute pancreatitis may delay the regulatory approval of other GLP1 analogs like Victoza®(Liraglutide, Novo Nordisk) and Taspoglutid (Roche, Ispen)

!4 November every year

Top Diabetic Countries by Numbers and % of population (Data from IDF)

Country Diabetics

millions Country

% of

diabetics


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India 41 Nauru 30.7

China 40 UnitedArabEmirates

19.5

USA 19 SaudiArabia

16.7

Russia 9.6 Bahrain 15.2

Germany 7.4 Kuwait 14.4

Comments and suggestions for improved forecasts are invited from pharmaceutical and biotechnology executives andmarketing professionals or Wall Street analysts. Reliable sales data from Japan and Europe is required for some ofthese listed products.


Nervous System j0438747.jpgCopied from office.microsoft.com Clip Art and Image Library


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Acknowledgements

Thanks are due to Mr. Jean-Antoine de Mandato (PDP, Geneva) for providing office facilities and administrativesupport.


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Author Image Collection


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Diabetic Drug Categories


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Drug Category Brands ®

EfficacyHbA1c <7%,

Glucose & LipidsControl

Weight loss, BP

Safety

SulphonylUrea

TolbutamideGlipizideGlimpiride

Glyburide

Weight gain, GItoxicity

MeglitinidesRepaglinideNateglinide

Weight gain, GItoxicity

BiguanidesMetformin

Phenformin

Effective and

cheaper

Diarrhea, GI

toxicity, Lacticacidosis

Alpha Glycosidase

InhibitorsAcarbose GI toxicity

PPAR AgonistsPioglitazone

Rosiglitazone

ClassCarcinogenicity, wt

gainClass cardiotoxicity

DPP4 InhibitorsSitagliptin

Vildagliptin

Class hepatotocicity,

wt gain

GLP1 AgonistsExtenatide

Liraglutide

Thyroid tumors?, wt

gain, nausea

Amylin analogs Pramlintide wt gain, nausea

Sodium GlucoseTransporter 2inhibitor

SGLT 2

Dapagliflozin BMS, AZ

Weight loss,increases Gl urinaryexcretion

YouTube Video


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18F-AV-133 human pancreas

PET image

Diabetes ImagingPDF

Imaging of insulin producing beta cells in the pancreas

http://www.avidrp.com/technology/Diabetes_Compound.jpg

Table 1. Top Selling Diabetic Medicine Brands 2006- 2008

Sales data for 2008 is based on actual 1-3Q2008 data as reported by companies and adding 4th quarter projections


10 of 18 1/6/2011 1:08 PM

based on sales growth of current 3Q2008 and change between 3 and 4 Q 2007. Exchange rates are average of theperiod 1-3Q2008 as reported and used by companies.

This projected data P will be regularly updated and replaced by actual results A as companies start reporting in 2009.

Actual (Projected) Sales

Generic Name Brands ® Companies Sales $ billion

2006 2007 2008

Pioglitazone Actos Takeda 2.88 3.65 3.86 (4.2)

Insulin

Lantus SanofiAventis

2.2 2.8 3.58 (3.3)

Insulin Analogs Novo Nordisk 1.7 2.74 3.4 (3.0)

Insulin Novulin Novo Nordisk 2.5 2.46 2.3 (2.5)

Rosiglitazone Avandia GSK 1.9 2.4 1.5 (1.6)

Insulin Humalog Lilly 1.3 1.47 1.5 (1.6)

Sitagliptin Januvia Merck 1.0 1.4 (1.3)

Insulin Humulin Lilly 0.92 0.98 0.98 (1.1)

Exenatide Byetta Lilly, Amylin 0.43 0.65 0.68 ( 0.9)

Acarbose Glucobay Bayer 0.45 0.50 0.52


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Goals of diabetic treatment

Lifestyle Changes : Exercise, dietary, weight loss

stabilize Glucose levels through A1c <7%

BP and weight within the normal range

Lipids, Cholesterol and triglycerides near normal levels

Diabetic Pathways for Development of New Drugs

Copied from wikipedia under GNU Free Documentation License

GLP1, DPP4


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Glucagon (Cys-Glu-Lys) http://en.wikipedia.org/wiki/Glucagon

http://en.wikipedia.org/wiki/Peroxisome_proliferator-activated_receptor

Glucagon (Cys-Glu-Lys) http://en.wikipedia.org/wiki/Glucagon

http://en.wikipedia.org/wiki/Peroxisome_proliferator-activated_receptor

http://en.wikipedia.org/wiki/Glucagon-like_peptide-1


Kai Ge Research Image: Organ Distribution of PPAR Receptor in Mouse

BAT/WAT Brown/White Adipose Tissue

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

www2.niddk.nih.gov ID


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From Merck Data http://www.januvia.com/sitagliptin/januvia/hcp/janumet/efficacy

/starting_therapy.jsp?WT.svl=5.1

A1C test study: Significant mean A1C reductions at 24 weeks (primary end point)

From Novartis

From Sanofi Aventis Lantus web site

LANTUS® Long-Acting Insulin: Effective Glycemic Control

LANTUS® long-acting (basal) insulin delivers effective glycemic control in diabetes patients as part of an overall diabetes treatment plan, which includes diet,

exercise and other diabetes medications.

An appropriate dose and proper titration are necessary for glycemic goal attainment.

From data on file.1,3,4


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Associated with a low rate of hypoglycemia1

Study designed to compare safety and efficacy of LANTUS®, long-acting (basal) insulin and NPH insulin3

In a 52-week study 570 patients with type 2 diabetes poorly controlled by oral diabetes medications (OADs) were randomized to either LANTUS® (n=289) or

NPH (n=281) at bedtime to reach a target blood glucose of 120 mg/dL. OADs were continued.

From LANTUS® Prescribing Information1 and data on file.

3

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Diabetes Knols

Type 1 Diabetes

By Anne Peters, MD, FACP, CDE

Type 2 DiabetesBy Anne Peters, MD, FACP, CDE

The biological diagnosis of the diabetesBy Salim Djelouat

The Diabetes Dictionary

Associations

International Diabetes Federation

American Diabetes Association


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http://pcde.wordpress.com/

Diabetes UK

Diabetes Australia

Diabetes New Zealand

Foundations

Juvenile Diabetes Research Foundation

Diabetes Research InstituteDiabetes Research Institute LogoThe Iacocca Foundation

Krishan Maggon Krishan Maggon Knols

FDA Panel Votes to Restrict Avandia New York Times - Gardiner Harris - 5 hours agoGAITHERSBURG, Md. - A federal medical advisory panel recommended Wednesday thatAvandia, a controversial diabetes drug, should either be withdrawn from the market or havesales severely restricted because it increases the risks of ...Video: GlaxoSmithKline Settles Avandia Lawsuit for $460 Million, Analysts See It As A Win(GSK) SmarTrend NewsFDA panel says Avandia should stay, but with restrictions Los Angeles Times


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David Roberts

Blood Glucost Testing

Thank you for your informative Knoll - do you have any data on Blood Glucose test strips?

Last edited Jan 8, 2009 1:02 AMReport abusive comment0 View/post replies (1) to this comment ▼

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