Life Cycle Strategic Plan

7/28/2019 Life Cycle Strategic Plan

1/78

Life Cycle Strategic Plan:

Insulin glargine (Lantus)

Company: Sanofi-Aventis

Resurreccion Alloza

Cecilia P. Mota

Tanya Stoyanova

Swati Toppo

Gilbert N. Atuga

7/7/2013 1Drug Discovery, Development &Commercialization 2013


2/78

Brief Introduction

Brand name: Lantus Generic name: Insulin glargine Company: Sanofi-aventis Regulatory approvals:

US - April, 2000

Europe- June, 2000 Lantus was first launched in Germany in May 2000. It

was introduced in the US in May 2001 and in the UK inAugust.

It is now the single largest basal insulin brand in the

German market. In the US, it is the No. 1 insulin in newly insulinized type

2 patients, and the most frequently prescribed basalinsulin in newly diagnosed type 1 patients.

7/7/2013Drug Discovery, Development &Commercialization 2013 2


3/78

Specific terminology:

NPH insulin: neutral protamineHagedorn (human insulin as isophaneinsulin suspension)

HbA1C: glycosylated haemoglobin FPG: fasting plasma glucose

FBG: fasting blood glucose



4/78

1. THE MARKET

Tanya Stoyanova



5/78

Medical Unmet Need Lantus - insulin glargine (rDNA origin) injection meets the following needs

combined:

- Long-acting insulin

- Once daily administration

- 24-hour glucose lowering effect

At launch the first and only insulin

Analog that offers 24-Hour, once-a-day treatment for diabetes.

Allows patients to go without an injection for 24 hours, contributing topatient comfort in cases of active lifestyle and nocturnal hypoclycaemia.

Lantus can be prescribed for all types of diabetes. However, it is mostcommonly prescribed to people with type 1 diabetes.

Lantus may be prescribed to people with type 2 diabetes for whom oralhypoglycemic agents have not shown to be sufficiently effective.

Longer acting than previously available Insulin Detemir and NPH insulin


6/78

Market Opportunity

Diabetes a significant rise in global spending

More than 371 million people have diabetes.

The number of people with diabetes is increasing in everycountry.

Half of people with diabetes are undiagnosed. 4.8 million people died due to diabetes.

More than 471 billion USD were spent on healthcare fordiabetes.

An open market opportunity for a long acting insulin

outperforming existing detemir. Biggest competitive threat, the launch of Tresiba (ultra long

acting insulin degludec), was delayed by FDA.

Market has been growing for all DAD, DPP-IV, GLP-1(injectable) and Insulin (injectable)


7/78

Benchmarking analysis The only direct challenger for Lantus in the US is still insulin detemir

(Levemir), which has a weaker profile. Tresiba (ultra long lasting insulin degludec) was delayed by FDA, but

launched in the EU and Japan. Tresiba shows a better profile than Lantus42 hours of action and lower weight gain in patients the latter being one ofthe much debated side effects of Lantus.

Insulin detemir

Insulin glargine


8/78

Competitive landscape

Brand Company Type Sales bln

Lantus Sanofi long acting analog $6.674

Januvia Merck DPP4 $4.051

NovoRapid Novo Nordisk fast acting analog $2.800

Humalog Eli Lilly fast acting analog $2.438

Victoza Novo Nordisk GLP-1 $1.761

Levemir Novo Nordisk long acting analog $1.758

Janumet Merck combination $1.677

Novo Mix 30 Novo Nordisk combination $1.658

Actos Takeda PPAR $1.518

Global market leader in diabetes Novo Nordisk Best selling diabetes drug Lantus by Sanofi Other major players - Merck and Eli Lilly

Brand Company Type Sales bln


9/78

Burden of Disease direct costs

0

50

100

150

200

250

300

350

400

Europe NorthAmerica

Japan &Oceania

China Rest of theworld

Millions of people2012

Millions of people2030

Direct costs

2012: USD 471 billion2030: USD 595 billion

11% of the totalglobal healthcarespend in 2011 wasattributed to diabetes

Worldwide:2012: 371 million

2030: 552 million


10/78

Burden of Disease indirect costs

Indirect costs - absenteeism due to illness, early retirement due todiabetes, losses in productivity (cost of presenteesm) anddependence on social benefits.

Additional elements of indirect cost relate to premature mortality andcareer costs borne by family members.


11/78

2. PRECLINICAL

Cecilia Padierna Mota



12/78

Preclinical studiesCecilia Padierna Mota


13/78

Preclinical studies content

Product Profile

Mechanism of action

Pre-clinical model data Efficacy

PK data

Toxicity studies

IND package studies Pharmaceutics, dosage forms and route of

administration


14/78

Product profile

LANTUS [insulin glargine injection (rDNAorigin)] is a recombinant human insulinanalogue that is a long-acting, parenteralblood-glucose-lowering agent.


15/78

LANTUS is produced byrecombinant DNA technologyutilizing a non-pathogeniclaboratory strain ofEscherichia coli(K12) as the production organism.

Product profile cont.


16/78

Product profile cont.

Asparagine at position 21 of the A-chain is replaced

by glycine

Two arginines are added to the C-terminus of theB-chain


17/78

Mechanism of actionThe primary activity of insulin,

including insulin glargine, is regulationof glucose metabolism.

IGF-1


18/78

Sustained release mechanism


19/78

Pre-clinical model

Efficacy

In vitro

Human hepatoma HEPG2 cell, humanosteosarcoma cell lines

4-8 higher affinity to IGF-1 receptors than

human insulin products.

Thymidine incorporation assay in osteosarcomacell line

3-5 times higher mitogenic activity than human

insuline products


20/78

Non-clinical model. Efficacy cont.

In vivo Fasted dogs and rabbits. Subcutaneous injection. Different

doses of insuline and different concentrations of zinc.Glucose levels in blood. All the studies were performedcomparing to human insulin products.

The concentration of insuline

glargine and zinc are

relevant to

determine the lastingof the effect.


21/78

PK

Absorbtion and availability. Subcutaneous injection. Radiolabeledinsulins. Mice, rats and dogs.

Lantus is absorbed significantly more slowly thanhuman insuline


22/78

PK cont.

Distribution. Subcutaneous, i.v. injection. Radiolabeledinsulin glargine. Mice, rats, dogs.

High levels of insulin at all time points up to 24 hr after

dosing. Ubiquitous distribution (except CNS).

Acumulation in thyroid, stomach, kidneys, skin, urinarybladder, small intestine.


23/78

Metabolism. Insuline glargine loses arginines to form M1 and

M2 at the carboxy terminus of the B chain.

Insuline glargine (50%), M1 + M2 (50%) wererecovered at the injection-site tissue.

PK cont.


24/78

PK cont.

Elimination. i.v. injection. Rats and

dogs.

Not found in rats urine. Only 1% found indogs urine. Its thought to be excreted asnon-immunereactive compounds orrecycled into endogenous amino acids.

hours Rat dog

Initial half live 0.21 0.18

Terminal halflive

1.2 0.8

Maxconcentration

2 4

Elimination 4.3 5.4

T i it t di


25/78

Toxicity studies

Test Model Outcome

Acute toxicity Mice, rats, I.v. and s.c. LD50 greater to 1000 U/kg

Chronic toxicity Mice, rats, dogs, s.c. Expectedpharmacodynamic results

Carcinogenesis Mice and rats. 2 year No cancer risk to humans

Mutagenesis Ames, HGPRT-tests,cytogenetics V79 cells andChinese hamsters

Not mutagenic norenhances chromosomalaberrations

Reproduction toxicity andimpairment to fertility

Embriotoxicity in rats

Embriotocicity in rabbits

Not maternal nor embriotictoxicity, not teratogenic.Maternal toxicity and

embriofetal toxicity (similarto that observed in humaninsulin).


26/78

IND package studies

Ph ti d f d


27/78

Pharmaceutics, dosage forms androute of administration

LANTUS contains insulin glargine 100 units/mL,glycerol 85%, polysorbate 20 (10 mL vial only), m-cresol, zinc, and water for injection. The pH (4) is

adjusted by addition of aqueous solutions ofhydrochloric acid and sodium hydroxide.

Presentations

10-mL vials 3-mL cartridges in package of 5, for use only withClikSTAR and

Autopen 24.

3-mL SoloSTAR (pre-filled disposable pen), package of 5

Pharmaceutics dosage forms and route of administration


28/78

Administration

LANTUS is administered bysubcutaneous injection. The injectionarea must not be rubbed.

As with all insulins, injection siteswithin an injection area (abdomen,thigh, buttock or deltoid) must be

alternated from one injection to thenext. Patients should be rigorous withsite rotation secondary to prolongeddeposition

Pharmaceutics, dosage forms and route of administrationcont.


29/78

3. EARLY CLINICALDEVELOPMENT

Swati ToppoM.Sc. Clinical Research



30/78

Phase 1 clinical studies


Study N* Subjects Scope1001, 1002 9 Healthy

malevolunteers

Comparison of pharmacodynamics andpharmacokinetics following injection atdifferent injection sites

1003 14 Healthymalevolunteers

Comparison of pharmacodynamics andpharmacokinetics in euglycaemic clamp

1004 Healthyvolunteers

Investigation of absorption rate withformulations not intended to be marketed

1006 14 Healthymalevolunteers

Investigation of the effect of zinc contenton the pharmacodynamics andpharmacokinetics in euglycaemic clamp


31/78

Phase 1 clinical studies Contd..Study N* Subjects Scope

1007 12 Healthy malevolunteers

Comparison between insulin glargine, HOE36H and Ultratard HM

1008 20 Healthysubjects

Determination of the equimolar potency ofinsulin glargine compared with regular insulinfollowing intravenous infusion on glucoselowering effect and pharmacokinetics ineuglycaemic clamp


Study in which the absorption insulin fromdifferent injection sites was compared with theformulation to be marketed

1012 Healthyvolunteers

Assessment of variability in glucose loweringeffect of HOE 901 compared to NPH andUltralong ( human ultralente) human insulinsafter subcutaneous doses of 0.4 IU/Kg usingeuglycaemic clamp technique



32/78

Phase 1 clinical studies Contd..

Study N* Subjects Scope

1013 Healthy male

volunteers

Characterisation of glucose turnover of

HOE 901 with comparison with humaninsulin

1015 20 Type 1 diabeticsubjects

Characterisation of time-action profiles ofinsulin glargine in comparison with NPHinsulin after a single dose


Determination of metabolic degradationproducts

1017 14 Type 2 diabeticsubjects

Comparison of the subcutaneousabsorption of insulin glargine and NPHinsulin


*N is the number of subjects involved in the study

1. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21081_Lantus_biopharmr.pdf

2. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000284/WC500036075.pdf


33/78

Optimizing Phase 1 studies

Combine bioavailibilty studies inphase 1 single dose

Consider patients

Combine trial designs Use positive (Commercial) controls

Ensure large enough sample size to

accomplish the objective



34/78

Phase 2 studies


Study Duration

Number of subjects randomized and treated

Number of

subjects

screened

insulin

glargineNPH insulin Total

Short

Duration

Type 1 diabetes

Study # 2002 4 weeks 315 168 88 256

Study # 2003 4 weeks 372 223 110 333

Subtotal, type 1 687 391 198 589

Type 2 diabetes

Study # 2004 4 weeks 256 136 68 204

Study # 2005 4 weeks 188 108 49 157

Study # 2006 4 weeks 131 57 57 114

Subtotal, type 2 575 301 174 475

Subtotal Short

Duration 1262 692 372 1064


35/78

Phase 2 studies contd..

Short duration studies were used to compare theefficacy and safety of insulin glargine with that ofhuman NPH insulin as well as to select the insulinglargine formulation to be investigated in the longer

duration studies. All studies were multicentre, randomised, open

studies comparing insulin glargine with human NPHinsulin (except study 2006)

The basal insulin dosing regimen for subjectsreceiving insulin glargine was once daily (at bedtime)regardless of their prior regimen.

Primary efficacy parameters were FPG at endpoint(adjusted for baseline) in the intention to treat (ITT)population 7/7/2013

Drug Discovery, Development &Commercialization 2013 35


36/78

Phase 2 studies contd

Secondary efficacy variables in most studies were: hypoglycaemic episodes,

FBG, blood glucose profile,

nocturnal blood glucose,

stability of FPG and FBG,

treatment response, serial overnight plasmaglucose, fasting serum insulin, insulin doses,HbA1c and fructosamine.

Type 1 diabetes studies were conducted in US(2002) and Europe(2003)

Type 2 diabetes studies were conducted in Europeand South Africa (2004), US (2005) and

Europe(2006) 7/7/2013 Drug Discovery, Development &Commercialization 2013 36


37/78


Mean starting dose of HOE901 (insulin glargine)was 21 units.

In study 2002 it was found that patients previouslyon multiple doses of basal insulin developed

nocturnal hypoglycemia when switched to HOE901

This led to a small reduction of dose. In study 2003and phase 3 studies investigators were advised to

reduce the dose of HOE 901 at their descretion.



38/78


39/78

4. LATE CLINICALDEVELOPMENT

Swati ToppoM.Sc. Clinical Research



40/78

Phase 3 clinical studies

Pivotal trials

7/7/2013 40Drug Discovery, Development &Commercialization 2013http://products.sanofi.ca/en/lantus.pdf

Study Duration N* scope

Type 1 diabetes

3001 28weeks

1119 Randomised to basal-bolus treatment withLANTUS (insulin glargine) once daily or withNPH human insulin once or twice daily.Regular human insulin was administeredbefore each meal.

3004 28weeks

3005 16weeks

619 Randomised to basal-bolus treatment withLANTUS (insulin glargine) once daily or withNPH human insulin once or twice daily. Insulin

lispro was used before each meal.Type 2 diabetes

3002 52weeks

570 LANTUS was evaluated as part of a regimenof combination therapy with insulin and oralantidiabetic agents (93.9% sulfonylureas,

51.1%biguanides, 12.3% acarbose, or 2.8% other)
http://products.sanofi.ca/en/lantus.pdfhttp://products.sanofi.ca/en/lantus.pdf


41/78


Primary endpoint: change in c HbA1c from baseline to

endpoint in the ITT population.

Secondary endpoint:

Hypoglycaemia

Other secondary efficacy parameters wereFPG, FBG, variability of FBG, nocturnal

blood glucose, 24-hour average bloodglucose, 24-hour average plasma glucose,fasting serum C-peptide, fasting seruminsulin.



42/78

Quality of life (QoL) was investigatedin studies 3001, 3002, 3004, 3006using the Diabetes Treatment

Satisfaction Questionnaire and theWell-Being Questionnaire.

Studies were planned to provide a

90% power to detect an averagedifference of 0.5% HbA1c betweentreatment groups



43/78

Safety

Safety The safety of insulin glargine was

evaluated on the basis of 10 clinical trials

designed for the evaluation of clinicalefficacy and safety by comparing insulinglargine to NPH insulin



44/78

5. REGULATORYSTRATEGY

Resu Alloza

Pharmacist, Msc, MBA



45/78

Regulatory StrategyINDEX

EMEA filling regulatory strategy Package insert

What indication is the drug approved for?

Is the indication the same in all majormarkets?

What is final indication?

Dosage form? Dosing schedule?

Patient populations?


46/78

Regulatory StrategyEMEA Filling - Product Details

PRODUCT DETAILS LANTUS is a drug marketed by Sanofi

Aventis

The active substance is Insulin Glargine International Non Propietary Name (INN)

is Insulin Glargine

Therapeutic Area: Diabetes Mellitus Agency Product Number:

EMEA/H/C/000284


47/78

Regulatory Strategy EMEA Filling CalendarMarketing Authorisation

STEPS DATE

Aventis Submission for Marketing Authorisation toEMEA

29 March 1999

Second Application for Optisulin 23 April 1999

Assesment of the procedure: Procedure Start 22 July 1999

First Assesment Report to CPMP Members 23 July 1999

Second Assesment Report to CPMP Members 27 July 1999

Draft List of Questions for comments 17 September1999

Consolidated List of Questions to AVENTIS 24 September1999

Responses Submission 28 October 1999

Responses to CPMP Members 22 December1999

Oral Explanation 15-17 Feb 2000

Positive Opinion for Marketing Authorisation 17 February2000


48/78

Regulatory Strategy EMEA Filling ChangesAfter Marketing Authorisation

SCOPE NOTIFICATIONISSUED ON

Change Manufacturing process of active substance 19 October 2000

Additional Presentation: Optiset 19 October 2000

Change Manufacturing process of active substance 1 March 2001

Demonstration of TSE Compliance 26 April 2001Change Insulin glargine production process 27 June 2001

Addition of a new volume of 10 mL 26 July 2001

The indication has been extended for the use of Lantusin children of six years or above

21 November 2001

Change in the dosis schem for Lantus 19 September 2002

Additional presentations: cartridges and Optiset 19 March 2003

Change in the batch size of finished products 25 April 2003

Change in intermediate compound in manufacturing API 19 June 2003

Minor change in the labeling 29 August 2003


49/78

Regulatory StrategyPackage insert - Indications

LANTUS is indicated for use in patientswith type I or type II diabetes mellitus,where treatment with insulin is required

LANTUS can be used in adults,adolescents and children os two years orabove

The indication is the same for all thecountries of the European Union


50/78

Regulatory StrategyPackage Insert Dosage Form

Strength Pharmaceuti

cal Form

RoA Packaging Content Package Size

100units/mL

Solution forinjection

SC Vial (glass) 5 mL 1,2, 5 & 10 vials

100units/mL


SC Cartridge(glass)

3 mL 4, 5 & 10cartridges

100units/mL


SC Optiset 3 mL 3,4, 5 & 10cartridges

100units/mL


SC Vial (glass) 10 mL 1 vial

100units/mL


SC Cartridge(glass)

3 mL 1, 3, 6, 8 & 9cartridges

100units/mL


SC Optiset 3 mL 1, 6, 8 & 9prefilled pens

100units/mL


SC Opticlick 3 mL 1, 3, 4, 5, 6, 8, 9& 10 cartridges

100units/mL


SC Solostar 3 mL 1, 3, 4, 5, 6, 8, 9& 10 prefilled

pens


51/78

Regulatory StrategyPackage insert Dosing Schedule

LANTUS is a sustained release composition thathas a prolonged duration of action and maybeadministerd once daily

It is important to administer at any time but at the

same time every day

The dosage should be adjusted individually bycontrolling blood sugar levels

In patients with Type II Diabetes Mellitus, insulinglargine can also given together with orallyantidiabetic drugs


52/78

6. INTELLECTUALPROPERTYSTRATEGY

Cecilia Padierna Mota



53/78

Content

Patent history and timelineAre there any bio-markers filed as a

companion for that drug that reinforce

the patent?Are there any litigation?

Are there unique strategies that the

companydeveloped to protect their asset?

L t t t hi t d


54/78

Lantus patent history andtimeline

Info needed to understand

Hoechst developed Lantus(Germany)

Hoechst became Aventis in1999

Lantus granted approval on2000 (US and EU)

Sanofi aquired Aventis in 2005

Lantus patent history and time line cont


55/78

Lantus patent history and time line cont.

Approval2000

Trea

tmen

t,su

bs

tance,

pro

duc

t

Pen

injec

tor

1997

2009

2010

2011

2014

Pro

duc

t

Pro

duc

t

1987

1988

2002

2003

P

rocess

Tre

atmen

t,pro

duc

t,formu

lation

Formu

lation

Dosag

eform

2015

Patentexpires

Exp

ira

tion

Lantus patent history and timeline cont.


56/78


Lantus patent history and timeline cont


57/78



58/78

http://www.drugs.com/availability/generic-lantus.html

7/7/2013 Drug Discovery, Development &Commercialization 2013 58
http://www.drugs.com/availability/generic-lantus.htmlhttp://www.drugs.com/availability/generic-lantus.htmlhttp://www.drugs.com/availability/generic-lantus.htmlhttp://www.drugs.com/availability/generic-lantus.htmlhttp://www.drugs.com/availability/generic-lantus.htmlhttp://www.drugs.com/availability/generic-lantus.html


59/78

7. MARKETING

STRATEGY

Tanya Stoyanova


Describe the marketing strategy


60/78

Describe the marketing strategyfor your drug

A lifestyle brand, not just a medical product

Being the first of its kind, Lantus was marketed as a

lifestyle changer. Better quality of life, confidencebooster, self empowerment

A smarter sophisticated drug, superior performance

A new, fresh alternative for the more active patients whofind it challenging to monitor insulin intake around theirbusy schedule


61/78

Lantus: 4Ps and 4Cs


62/78

Market at IND, launch and nowMarket at time of launch and IND: First in class

Market now Tresiba to pose a significant challenge on Lantus in the EU and Japan.

Lantus

AFFREZZAInsulin Human Winthrop

Optisulin (Lantus)

LaunchSubmissionClinical proof of

concept

Phase 3 Regulatory Approval

VIAjectHumalog

Humalog BASAL

Extrawell

Oral-lyn

HDV-I

IN -105Humalog Mix

Capsulin

CPEX

Levemir

Victoza

Tresiba

Ryzodeg

NovoRapid


63/78

SWOT Analysis

- Once a day administration- Better hits targetcompared to Levemir- Heritage of oralmedications for diabetics

S

O

W

T- Tresiba and Ryzodegnot approved by FDA,Expand US business- Lantus successors shinesin Phase 3 possiblelaunch before Tresiba andRyzodeg in the US

- Solid proof of weight gain,while Levemir helpsreducing weight- Proof of peak in somepatients under certaincircumstances

- Some patients still wary ofcancer risks despite proof-Tresiba superior and a

significant challenge in theEU and Japan- Tresiba gains premiumpricing in the UK andDenmark


64/78

Drug Value Proposition

Strong focus on present lifestylerestrictions of insulin therapy beforeLantus

A catalyst that lets you recapturelifestyle for diabetics

You buy Lantus, Lantus buys you time


65/78

Drug Positioning Statement


66/78

Pricing Strategy

Premium pricing First launched in Germany in 2000 and in

the US in 2001, and the UK and Ireland in2002, France and Switzerland followed in2003

Successfully hitting high price targets inWestern Europe contributed to a good roll-

out in India and Russia.


67/78

Reimbursement strategy

An existing code of reimbursement for the US Widely reimbursed throughout Europe and the rest of the world good

value proposition

Sanofi Patient Support - Reimbursement Connection

Insurance benefit verification and prior authorization

Coding and billing guidance

Claims management

Appeals assistance

Patient Assistance Connectionprovides free prescription drugs to patientswho do not have insurance coverage and who meet eligibility criteria.

US insurance companies consider reusable pens to be Durable Medical

Equipment, so insulin pen makers, including Sanofi, offer prefilled pensthat become disposable once fully used. Also the case of Lantus.

Line extensions and novel


68/78

Line extensions and novelindications Extensions: U300, the sucessor of Lantus showed equal ability to

keep blood sugar levels under control as Lantus, meeting the study'smain goal of non-inferiority to the marketed drug.

Focus on night time low blood sugar, or nocturnal hypoglycemia,which can be deadly in severe cases. Sanofi showed positive data

on this score, with fewer cases of low blood sugar at night forpatients on U300 compared with Lantus. During months three to 6 ofthe study, 36.1% of patients on U300 compared with 46% on Lantussuffered from nocturnal hypoglycemia, Sanofi said.

New dosage form - Optisulin: a solution for injection that containsthe active substance insulin glargine. It is available as vials,cartridges and prefilled disposable pens (OptiSet and SoloStar).

Marketing strategy build upon existing awareness, superiorityperformance focus


69/78

8. SALES STRATEGY &

MANAGED MARKETS

Gilbert Atuga



70/78

Sales Strategy and Managed

MarketsInsulin Glargine (Lantus)Name: Gilbert Atuga


71/78

Sales strategy

European Commission, Market authorization, 9th

June, 2000, renewal 9th June 2010.

Market Authorization holder Sanofi AventisDesuschland GmbH, Germany.

Euro sales were predicted to reach 6oo million by2005 and ABN predicted 1999 sales of 75 million in2000 rising to 200 million in 2002.

Lantus ranked as the 17th best selling

pharmaceutical product overall sales Q3 2012($556,147) change of 4.94% Q2. tho patent expiryDec- 2011

Personalized care


72/78

Generic Vs Lantus

Diabetes afflicts 366 million people, killing one every sevenseconds, according to figures released Sept. 13 by theInternational Diabetes Federation. Sanofi said that samemonth it expected sales of Lantus to reach about 4 billioneuros ($5.5 billion) this year (2011).

Sanofi is accelerating the development of a new Lantusformulation, a move designed to help the drugmaker remaincompetitive as Novo Nordisk A/S introduces a rival to its best-selling diabetes medicine.

The profile of Sanofis new insulin glargine formulation will be

only significant if the drug is a longer-acting product thatmay position it well versus Novo Nordisks Degludec andfuture generic versions of Lantus, Bloomberg Industriesanalyst Asthika Goonewardene wrote in e-mailed comments.


73/78

Sales US dollars

2010- Agreement with Agamatrix to develop and saleBlood glucose monitoring device, boost sales of lantus


74/78

To fend off its rival sanofi is testing animproved version of lantus in latestage trials as well as combination of

the product with Lyxumia, a once dailyinjection that controls blood sugarlevels in different way.



75/78

9. FINAL REMARKS



76/78

-A successfully launched best in class drug

-Working on an extension with a high probability ofsuccess (positive results in phase 3 trials)

-Successful marketing strategy, resulting in Lantus

being the best selling diabetes treatment in the world-Good engagement in developing markets



77/78

Timeline Endocrine: Overall it takes around 6.5 yrs in clinical development and 1.2 years

for approval Estimated worldwide sales 2012: $6.12 billion

Lantus leads Sanofi's diabetes stable, with 2011 net sales of3.916 billion ($5.07billion at today's exchange rates), an increase of 12%. So far this year, the drug'sgrowth has only intensified: First-half net sales increased by 16.5% to2.346billion ($3.04 billion).

Lantus owns the long-acting insulin market. It has an 80% share, which is why so

many clinical trials use it as a comparator. Ranked 7 in top best selling drugs in 2012 report

Sanofi announced that it will be advancing a new version of Lantus into phase 3trials in early 2012, which by our estimates would place approval as early as 2014if all goes accordingly before Lantus patents expire in 2015 in the US. Thecompany has disclosed very few details about the new formulation, butemphasized that it will have a different clinical profile than Lantus whether thismeans it will have a longer duration of action, have improved stability or less

hypoglycemia, enable more flexible dosing, or provide some other novel featureremains to be seen.

Read more: Lantus - FiercePharma http://www.fiercepharma.com/special-reports/lantus#ixzz2WkAOwsU0

http://diatribe.us/issues/38/new-now-next/4

http://diatribe.us/issues/38/new-now-next/4http://diatribe.us/issues/38/new-now-next/4http://diatribe.us/issues/38/new-now-next/4http://diatribe.us/issues/38/new-now-next/4http://diatribe.us/issues/38/new-now-next/4http://diatribe.us/issues/38/new-now-next/4


78/78

Thank you

Life Cycle Strategic Plan

Documents

Transcript of Life Cycle Strategic Plan