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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
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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.
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Specific terminology:
NPH insulin: neutral protamineHagedorn (human insulin as isophaneinsulin suspension)
HbA1C: glycosylated haemoglobin FPG: fasting plasma glucose
FBG: fasting blood glucose
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1. THE MARKET
Tanya Stoyanova
7/7/2013 4Drug Discovery, Development &Commercialization 2013
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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
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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)
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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
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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
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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
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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.
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2. PRECLINICAL
Cecilia Padierna Mota
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Preclinical studiesCecilia Padierna Mota
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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
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Product profile
LANTUS [insulin glargine injection (rDNAorigin)] is a recombinant human insulinanalogue that is a long-acting, parenteralblood-glucose-lowering agent.
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LANTUS is produced byrecombinant DNA technologyutilizing a non-pathogeniclaboratory strain ofEscherichia coli(K12) as the production organism.
Product profile cont.
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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
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Mechanism of actionThe primary activity of insulin,
including insulin glargine, is regulationof glucose metabolism.
IGF-1
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Sustained release mechanism
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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
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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.
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PK
Absorbtion and availability. Subcutaneous injection. Radiolabeledinsulins. Mice, rats and dogs.
Lantus is absorbed significantly more slowly thanhuman insuline
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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.
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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.
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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
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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).
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IND package studies
Ph ti d f d
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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
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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.
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3. EARLY CLINICALDEVELOPMENT
Swati ToppoM.Sc. Clinical Research
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Phase 1 clinical studies
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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
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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
1010 12 Healthy malevolunteers
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
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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
1016 5 Healthy malevolunteers
Determination of metabolic degradationproducts
1017 14 Type 2 diabeticsubjects
Comparison of the subcutaneousabsorption of insulin glargine and NPHinsulin
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*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
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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
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Phase 2 studies
7/7/2013 34Drug Discovery, Development &Commercialization 2013
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
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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
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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
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Phase 2 studies contd..
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.
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4. LATE CLINICALDEVELOPMENT
Swati ToppoM.Sc. Clinical Research
7/7/2013 39Drug Discovery, Development &Commercialization 2013
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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)
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Phase 3 studies contd..
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.
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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
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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
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5. REGULATORYSTRATEGY
Resu Alloza
Pharmacist, Msc, MBA
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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?
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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
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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
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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
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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
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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
Solution forinjection
SC Cartridge(glass)
3 mL 4, 5 & 10cartridges
100units/mL
Solution forinjection
SC Optiset 3 mL 3,4, 5 & 10cartridges
100units/mL
Solution forinjection
SC Vial (glass) 10 mL 1 vial
100units/mL
Solution forinjection
SC Cartridge(glass)
3 mL 1, 3, 6, 8 & 9cartridges
100units/mL
Solution forinjection
SC Optiset 3 mL 1, 6, 8 & 9prefilled pens
100units/mL
Solution forinjection
SC Opticlick 3 mL 1, 3, 4, 5, 6, 8, 9& 10 cartridges
100units/mL
Solution forinjection
SC Solostar 3 mL 1, 3, 4, 5, 6, 8, 9& 10 prefilled
pens
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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
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6. INTELLECTUALPROPERTYSTRATEGY
Cecilia Padierna Mota
7/7/2013 52Drug Discovery, Development &Commercialization 2013
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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
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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
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Lantus patent history and time line cont.
Approval2000
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Pen
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tor
1997
2009
2010
2011
2014
Pro
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1987
1988
2002
2003
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rocess
Tre
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lation
Formu
lation
Dosag
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2015
Patentexpires
Exp
ira
tion
Lantus patent history and timeline cont.
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Lantus patent history and timeline cont.
Lantus patent history and timeline cont
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Lantus patent history and timeline cont.
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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.html7/28/2019 Life Cycle Strategic Plan
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7. MARKETING
STRATEGY
Tanya Stoyanova
7/7/2013 59Drug Discovery, Development &Commercialization 2013
Describe the marketing strategy
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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
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Lantus: 4Ps and 4Cs
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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
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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
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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
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Drug Positioning Statement
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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.
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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
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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
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8. SALES STRATEGY &
MANAGED MARKETS
Gilbert Atuga
7/7/2013 69Drug Discovery, Development &Commercialization 2013
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Sales Strategy and Managed
MarketsInsulin Glargine (Lantus)Name: Gilbert Atuga
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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
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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.
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Sales US dollars
2010- Agreement with Agamatrix to develop and saleBlood glucose monitoring device, boost sales of lantus
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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.
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9. FINAL REMARKS
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-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
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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
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Thank you
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