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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

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Drug Discovery, Development & Commercialization 2013

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 in August. 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 basal insulin in newly diagnosed type 1 patients.

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Specific terminology:
NPH insulin: neutral protamine Hagedorn (human insulin as isophane insulin suspension) HbA1C: glycosylated haemoglobin FPG: fasting plasma glucose FBG: fasting blood glucose

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1. THE MARKET
Tanya Stoyanova

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Drug Discovery, Development & Commercialization 2013

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 to patient comfort in cases of active lifestyle and nocturnal hypoclycaemia. Lantus can be prescribed for all types of diabetes. However, it is most commonly prescribed to people with type 1 diabetes. Lantus may be prescribed to people with type 2 diabetes for whom oral hypoglycemic agents have not shown to be sufficiently effective. Longer acting than previously available Insulin Detemir and NPH insulin

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 every country. Half of people with diabetes are undiagnosed. 4.8 million people died due to diabetes. More than 471 billion USD were spent on healthcare for diabetes. 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)

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 Lantus 42 hours of action and lower weight gain in patients the latter being one of the much debated side effects of Lantus. Insulin detemir

Insulin glargine

Competitive landscape
Brand Brand Lantus Januvia NovoRapid Humalog Victoza Levemir Janumet Novo Mix 30 Actos Company Company Sanofi Merck Novo Nordisk Eli Lilly Novo Nordisk Novo Nordisk Merck Novo Nordisk Takeda Type Type long acting analog DPP4 fast acting analog fast acting analog GLP-1 long acting analog combination combination PPAR Sales bln Sales bln $6.674 $4.051 $2.800 $2.438 $1.761 $1.758 $1.677 $1.658 $1.518

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

Burden of Disease direct costs


400 350

300
250 200 150 100 50 0
Europe North America Japan & Oceania China Rest of the world

Millions of people 2012 Millions of people 2030

Worldwide: 2012: 371 million 2030: 552 million 11% of the total global healthcare spend in 2011 was attributed to diabetes

Direct costs 2012: USD 471 billion 2030: USD 595 billion

Burden of Disease indirect costs

Indirect costs - absenteeism due to illness, early retirement due to diabetes, losses in productivity (cost of presenteesm) and dependence on social benefits. Additional elements of indirect cost relate to premature mortality and career costs borne by family members.

2. PRECLINICAL
Cecilia Padierna Mota

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Preclinical studies
Cecilia Padierna Mota

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

Product profile
LANTUS [insulin glargine injection (rDNA origin)] is a recombinant human insulin analogue that is a long-acting, parenteral blood-glucose-lowering agent.

Product profile cont.

LANTUS is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12) as the production organism.

Product profile cont.


Asparagine at position 21 of the A-chain is replaced by glycine Two arginines are added to the C-terminus of the B-chain

Mechanism of action
The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism.

IGF-1

Sustained release mechanism

Pre-clinical model
Efficacy

In vitro Human hepatoma HEPG2 cell, human osteosarcoma cell lines 4-8 higher affinity to IGF-1 receptors than human insulin products. Thymidine incorporation assay in osteosarcoma cell line 3-5 times higher mitogenic activity than human insuline products

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 performed comparing to human insulin products. The concentration of insuline glargine and zinc are relevant to determine the lasting of the effect.

PK

Absorbtion and availability. Subcutaneous injection. Radiolabeled insulins. Mice, rats and dogs. Lantus is absorbed significantly more slowly than human insuline

PK cont.

Distribution. Subcutaneous, i.v. injection. Radiolabeled insulin 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, urinary bladder, small intestine.

PK cont.

Metabolism.
Insuline glargine loses arginines to form M1 and M2 at the carboxy terminus of the B chain.

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

PK cont.

Elimination. i.v. injection. Rats and dogs. hours Rat dog


Initial half live
Terminal half live Max concentration Elimination

0.21
1.2 2 4.3

0.18
0.8 4 5.4

Not found in rats urine. Only 1% found in dogs urine. Its thought to be excreted as non-immunereactive compounds or recycled into endogenous amino acids.

Toxicity studies
Test Acute toxicity Chronic toxicity Model Mice, rats, I.v. and s.c. Mice, rats, dogs, s.c. Outcome LD50 greater to 1000 U/kg Expected pharmacodynamic results

Carcinogenesis Mutagenesis

Mice and rats. 2 year Ames, HGPRT-tests, cytogenetics V79 cells and Chinese hamsters

No cancer risk to humans Not mutagenic nor enhances chromosomal aberrations

Reproduction toxicity and impairment to fertility

Embriotoxicity in rats

Embriotocicity in rabbits

Not maternal nor embriotic toxicity, not teratogenic. Maternal toxicity and embriofetal toxicity (similar to that observed in human insulin).

IND package studies

Pharmaceutics, dosage forms and route of administration

LANTUS contains insulin glargine 100 units/mL, glycerol 85%, polysorbate 20 (10 mL vial only), mcresol, zinc, and water for injection. The pH (4) is adjusted by addition of aqueous solutions of hydrochloric 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 cont.

Administration LANTUS is administered by subcutaneous injection. The injection area must not be rubbed.

As with all insulins, injection sites within an injection area (abdomen, thigh, buttock or deltoid) must be alternated from one injection to the next. Patients should be rigorous with site rotation secondary to prolonged deposition

3. EARLY CLINICAL DEVELOPMENT


Swati Toppo M.Sc. Clinical Research

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Phase 1 clinical studies


Study N* Subjects Healthy male volunteers Healthy male volunteers Healthy volunteers 14 Healthy male volunteers Scope Comparison of pharmacodynamics and pharmacokinetics following injection at different injection sites Comparison of pharmacodynamics and pharmacokinetics in euglycaemic clamp 1001, 1002 9

1003

14

1004

Investigation of absorption rate with formulations not intended to be marketed Investigation of the effect of zinc content on the pharmacodynamics and pharmacokinetics in euglycaemic clamp
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1006

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Phase 1 clinical studies Contd..


Study 1007 N* 12 Subjects Healthy male volunteers Healthy subjects Scope Comparison between insulin glargine, HOE 36H and Ultratard HM Determination of the equimolar potency of insulin glargine compared with regular insulin following intravenous infusion on glucose lowering effect and pharmacokinetics in euglycaemic clamp Study in which the absorption insulin from different injection sites was compared with the formulation to be marketed Assessment of variability in glucose lowering effect of HOE 901 compared to NPH and Ultralong ( human ultralente) human insulins after subcutaneous doses of 0.4 IU/Kg using euglycaemic clamp technique
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1008

20

1010

12

Healthy male volunteers

1012

Healthy volunteers

Phase 1 clinical studies Contd..


Study 1013 N* Subjects Healthy male volunteers 20 Scope Characterisation of glucose turnover of HOE 901 with comparison with human insulin

1015

Type 1 diabetic Characterisation of time-action profiles of subjects insulin glargine in comparison with NPH insulin after a single dose Healthy male volunteers Determination of metabolic degradation products

1016

1017

14

Type 2 diabetic Comparison of the subcutaneous subjects absorption of insulin glargine and NPH insulin

*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 in phase 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
Number of subjects randomized and treated

Study

Duration

Number of subjects screened

insulin glargine

NPH insulin

Total

Short Duration Type 1 diabetes Study # 2002 4 weeks Study # 2003 4 weeks Subtotal, type 1 Type 2 diabetes Study # 2004 4 weeks Study # 2005 4 weeks Study # 2006 4 weeks Subtotal, type 2 Subtotal Short Duration
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315 372 687

168 223 391

88 110 198

256 333 589

256 188 131 575

136 108 57 301

68 49 57 174

204 157 114 475

1262

692

372

1064
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Drug Discovery, Development & Commercialization 2013

Phase 2 studies contd..

Short duration studies were used to compare the efficacy and safety of insulin glargine with that of human NPH insulin as well as to select the insulin glargine formulation to be investigated in the longer duration studies. All studies were multicentre, randomised, open studies comparing insulin glargine with human NPH insulin (except study 2006) The basal insulin dosing regimen for subjects receiving 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) Drug Discovery, Development & 7/7/2013 Commercialization 2013 35 population

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 plasma glucose, 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 Europe and South Africa (2004), US (2005) and Drug Discovery, Development & 7/7/2013 Commercialization 2013 36 Europe(2006)

Phase 2 studies contd..


Mean starting dose of HOE901 (insulin glargine) was 21 units. In study 2002 it was found that patients previously on multiple doses of basal insulin developed nocturnal hypoglycemia when switched to HOE 901 This led to a small reduction of dose. In study 2003 and phase 3 studies investigators were advised to reduce the dose of HOE 901 at their descretion.

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Optimizing phase 2 studies


Use control arm of current popular therapy Multicentre

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4. LATE CLINICAL DEVELOPMENT


Swati Toppo M.Sc. Clinical Research

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Phase 3 clinical studies


Study Duration N* scope

Pivotal trials
Randomised to basal-bolus treatment with LANTUS (insulin glargine) once daily or with NPH human insulin once or twice daily. Regular human insulin was administered before each meal. Randomised to basal-bolus treatment with LANTUS (insulin glargine) once daily or with NPH human insulin once or twice daily. Insulin lispro was used before each meal.

Type 1 diabetes 3001 3004 28 weeks 28 weeks 16 weeks 619 1119

3005

Type 2 diabetes

3002

52 weeks

570

http://products.sanofi.ca/en/lantus.pdf

LANTUS was evaluated as part of a regimen of combination therapy with insulin and oral antidiabetic agents (93.9% sulfonylureas, Drug Discovery, Development & 51.1% 7/7/2013 Commercialization 2013 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 were FPG, FBG, variability of FBG, nocturnal blood glucose, 24-hour average blood glucose, 24-hour average plasma glucose, fasting serum C-peptide, fasting serum insulin.
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Quality of life (QoL) was investigated in studies 3001, 3002, 3004, 3006 using the Diabetes Treatment Satisfaction Questionnaire and the Well-Being Questionnaire. Studies were planned to provide a 90% power to detect an average difference of 0.5% HbA1c between treatment 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 clinical efficacy and safety by comparing insulin glargine to NPH insulin

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5. REGULATORY STRATEGY
Resu Alloza Pharmacist, Msc, MBA

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Regulatory Strategy INDEX

EMEA filling regulatory strategy Package insert


What indication is the drug approved for? Is the indication the same in all major markets? What is final indication? Dosage form? Dosing schedule? Patient populations?

Regulatory Strategy EMEA 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

Regulatory Strategy EMEA Filling Calendar Marketing Authorisation


STEPS Aventis Submission for Marketing Authorisation to EMEA Second Application for Optisulin Assesment of the procedure: Procedure Start DATE 29 March 1999 23 April 1999 22 July 1999

First Assesment Report to CPMP Members


Second Assesment Report to CPMP Members Draft List of Questions for comments

23 July 1999
27 July 1999 17 September 1999

Consolidated List of Questions to AVENTIS


Responses Submission Responses to CPMP Members Oral Explanation Positive Opinion for Marketing Authorisation

24 September 1999
28 October 1999 22 December 1999 15-17 Feb 2000 17 February 2000

Regulatory Strategy EMEA Filling Changes After Marketing Authorisation


SCOPE Change Manufacturing process of active substance
NOTIFICATION ISSUED ON

19 October 2000

Additional Presentation: Optiset


Change Manufacturing process of active substance Demonstration of TSE Compliance Change Insulin glargine production process Addition of a new volume of 10 mL The indication has been extended for the use of Lantus in children of six years or above

19 October 2000
1 March 2001 26 April 2001 27 June 2001 26 July 2001 21 November 2001

Change in the dosis schem for Lantus Additional presentations: cartridges and Optiset
Change in the batch size of finished products Change in intermediate compound in manufacturing API Minor change in the labeling

19 September 2002 19 March 2003


25 April 2003 19 June 2003 29 August 2003

Regulatory Strategy Package insert - Indications

LANTUS is indicated for use in patients with 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 or above

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

Regulatory Strategy Package Insert Dosage Form


Strength Pharmaceuti cal Form RoA Packaging Content Package Size

100 units/mL 100 units/mL 100 units/mL 100 units/mL 100 units/mL 100 units/mL 100 units/mL 100 units/mL

Solution for injection Solution for injection Solution for injection Solution for injection Solution for injection Solution for injection Solution for injection Solution for injection

SC SC SC SC SC SC SC SC

Vial (glass) Cartridge (glass) Optiset Vial (glass) Cartridge (glass) Optiset Opticlick Solostar

5 mL 3 mL 3 mL 10 mL 3 mL 3 mL 3 mL 3 mL

1,2, 5 & 10 vials 4, 5 & 10 cartridges 3,4, 5 & 10 cartridges 1 vial 1, 3, 6, 8 & 9 cartridges 1, 6, 8 & 9 prefilled pens 1, 3, 4, 5, 6, 8, 9 & 10 cartridges 1, 3, 4, 5, 6, 8, 9 & 10 prefilled pens

Regulatory Strategy Package insert Dosing Schedule

LANTUS is a sustained release composition that has a prolonged duration of action and maybe administerd once daily It is important to administer at any time but at the same time every day The dosage should be adjusted individually by controlling blood sugar levels

In patients with Type II Diabetes Mellitus, insulin glargine can also given together with orally antidiabetic drugs

6. INTELLECTUAL PROPERTY STRATEGY


Cecilia Padierna Mota

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Content
Patent history and timeline Are 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 company developed to protect their asset?

Lantus patent history and timeline


Info needed to understand

Hoechst developed Lantus (Germany)


Hoechst became Aventis in 1999 Lantus granted approval on 2000 (US and EU) Sanofi aquired Aventis in 2005

Process
Treatment, product, formulation

1987
1988

1997 Approval 2000

Treatment, substance, product

Formulation Dosage form

2002

2003

2009 2010

Product Product

2011

Pen injector

2014 2015

Expiration

Lantus patent history and time line cont.

Patent expires

Lantus patent history and timeline cont.

Lantus patent history and timeline cont.

http://www.drugs.com/availability/gene ric-lantus.html

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7. MARKETING STRATEGY
Tanya Stoyanova

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Describe the marketing strategy for 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, confidence booster, self empowerment A smarter sophisticated drug, superior performance

A new, fresh alternative for the more active patients who find it challenging to monitor insulin intake around their busy schedule

Lantus: 4Ps and 4Cs

Market at IND, launch and now


Market at time of launch and IND: First in class Market now Tresiba to pose a significant challenge on Lantus in the EU and Japan.

Clinical proof of concept

Submission

Launch
Tresiba Ryzodeg Levemir Lantus

Extrawell

AFFREZZA

Insulin Human Winthrop


Capsulin Optisulin (Lantus) CPEX Oral-lyn VIAject HDV-I IN -105 Humalog Humalog BASAL Humalog Mix NovoRapid Victoza

Phase 3

Regulatory

Approval

SWOT Analysis
- Once a day administration - Better hits target compared to Levemir - Heritage of oral medications for diabetics - Solid proof of weight gain, while Levemir helps reducing weight - Proof of peak in some patients under certain circumstances

W T

- Tresiba and Ryzodeg not approved by FDA, Expand US business - Lantus successors shines in Phase 3 possible launch before Tresiba and Ryzodeg in the US

- Some patients still wary of cancer risks despite proof -Tresiba superior and a significant challenge in the EU and Japan - Tresiba gains premium pricing in the UK and Denmark

Drug Value Proposition


Strong focus on present lifestyle restrictions of insulin therapy before Lantus A catalyst that lets you recapture lifestyle for diabetics You buy Lantus, Lantus buys you time

Drug Positioning Statement

Pricing Strategy
Premium pricing First launched in Germany in 2000 and in the US in 2001, and the UK and Ireland in 2002, France and Switzerland followed in 2003 Successfully hitting high price targets in Western Europe contributed to a good rollout in India and Russia.

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 patients who 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 pens that become disposable once fully used. Also the case of Lantus.

Line extensions and novel indications

Extensions: U300, the sucessor of Lantus showed equal ability to keep blood sugar levels under control as Lantus, meeting the study's main 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 for patients on U300 compared with Lantus. During months three to 6 of the study, 36.1% of patients on U300 compared with 46% on Lantus suffered from nocturnal hypoglycemia, Sanofi said. New dosage form - Optisulin: a solution for injection that contains the active substance insulin glargine. It is available as vials, cartridges and prefilled disposable pens (OptiSet and SoloStar). Marketing strategy build upon existing awareness, superiority performance focus

8. SALES STRATEGY & MANAGED MARKETS

Gilbert Atuga

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Sales Strategy and Managed Markets


Insulin Glargine (Lantus) Name: Gilbert Atuga

Sales strategy

European Commission, Market authorization, 9th June, 2000, renewal 9th June 2010. Market Authorization holder Sanofi Aventis Desuschland GmbH, Germany. Euro sales were predicted to reach 6oo million by 2005 and ABN predicted 1999 sales of 75 million in 2000 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 expiry Dec- 2011 Personalized care

Generic Vs Lantus

Diabetes afflicts 366 million people, killing one every seven seconds, according to figures released Sept. 13 by the International Diabetes Federation. Sanofi said that same month it expected sales of Lantus to reach about 4 billion euros ($5.5 billion) this year (2011). Sanofi is accelerating the development of a new Lantus formulation, a move designed to help the drugmaker remain competitive as Novo Nordisk A/S introduces a rival to its bestselling diabetes medicine. The profile of Sanofis new insulin glargine formulation will be only significant if the drug is a longer-acting product that may position it well versus Novo Nordisks Degludec and future generic versions of Lantus, Bloomberg Industries analyst Asthika Goonewardene wrote in e-mailed comments.

Sales US dollars

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

To fend off its rival sanofi is testing an improved version of lantus in late stage trials as well as combination of the product with Lyxumia, a once daily injection that controls blood sugar levels in different way.

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9. FINAL REMARKS

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-A successfully -Working

launched best in class drug

on an extension with a high probability of success (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 of 3.916 billion ($5.07 billion at today's exchange rates), an increase of 12%. So far this year, the drug's growth has only intensified: First-half net sales increased by 16.5% to 2.346 billion ($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 3 trials in early 2012, which by our estimates would place approval as early as 2014 if all goes accordingly before Lantus patents expire in 2015 in the US. The company has disclosed very few details about the new formulation, but emphasized that it will have a different clinical profile than Lantus whether this means it will have a longer duration of action, have improved stability or less hypoglycemia, enable more flexible dosing, or provide some other novel feature remains to be seen. Read more: Lantus - FiercePharma http://www.fiercepharma.com/specialreports/lantus#ixzz2WkAOwsU0 http://diatribe.us/issues/38/new-now-next/4
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Thank you

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