product portfolio - sanofi

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Long-standing heritage in insulin innovation PCSK9 inhibitor Combination therapy Once-daily, prandial GLP-1 receptor agonist Solid base in oral anti-diabetic treatments REFERENCES: 1. Toujeo SmPC Feb 2018. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000309/WC500047935.pdf [Date accessed: June 2018]. 2. Lantus SmPC Jul 2017. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000284/WC500036082.pdf [Date accessed: June 2018]. 3. Insuman SmPC Mar 2018. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000201/WC500033784.pdf [Date accessed: June 2018]. 4. EMA data on Insuman. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Supply_shortage/2015/03/WC500185164.pdf [Date accessed: June 2018]. 5. Apidra SmPC Jul 2017. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000557/WC500025250.pdf [Date accessed: June 2018]. 6. Lyxumia SmPC Oct 2017. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002445/WC500140401.pdf [Date accessed: June 2018]. 7. Adlyxin PI Jul 2016. Available at: http://products.sanofi.us/adlyxin/adlyxin.pdf [Date accessed: June 2018]. 8. Soliqua 100–33 PI Oct 2017. Available at: http://products.sanofi.us/Soliqua100-33/Soliqua100-33.pdf [Date accessed: June 2018]. 9. Suliqua SmPC Oct 2017. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004243/WC500224673.pdf [Date accessed: June 2018]. 10. Praluent SmPC Jan 2018. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003882/WC500194521.pdf [Date accessed: June 2018]. 11. Amaryl SmPC Apr 2017. Available at: http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1518153414731.pdf [Date accessed: June 2018]. 12. Glibenclamide SmPC Sep 2015. Available at: http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1513315161827.pdf [Date accessed: June 2018]. * Suliqua ® is the brand name in the EU. Within the U.S. it is branded as Soliqua ® 100/33 Lyxumia was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL), http://www.zealandpharma.com. Lyxumia was approved in Europe in 2013 and is currently approved in over 60 countries worldwide for the treatment of adults with type 2 diabetes, with commercial launches in Europe, Japan, Mexico and other markets. Lyxumia is the proprietary name approved by the European Medicines Agency and other health authorities for the GLP-1 RA lixisenatide.[Date accessed: June 2017]. ClikStar, AllStar and JuniorStar pens are reusable; SoloStar and Lyxumia pens are disposable. ** MyStar Plus: App is compatible with GooglePlay and Apple. The Bluetooth ® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Sanofi is under license. Other trademarks and trade names are those of their respective owners. For more information on all products, please consult the Product Information in your country. Not all products and programs are available in all countries. Long-standing heritage in insulin innovation Long-standing heritage in insulin innovation Long-standing heritage in insulin innovation Long-standing heritage in insulin innovation The MyStar ® Portfolio MyStar ® is an integrated portfolio for simpler and more effective diabetes management. The portfolio includes medical devices, solutions and guidance and when combined with our drug offering, aims to meet patients’ needs holistically. * For medical journalists outside the U.S. only PCSK9 inhibitor Long-standing heritage in insulin innovation Intelligent blood glucose monitoring systems Patient-friendly delivery pens Long-standing heritage in insulin innovation Once-daily prandial GLP-1 receptor agonist Combination therapy Solid base in oral anti-diabetic treatments Patient-friendly delivery pens Intelligent blood glucose monitoring system Product About Lyxumia ® Lyxumia ® (lixisenatide) is a once-daily mealtime (prandial) GLP-1 receptor agonist for the treatment of adults with type 2 diabetes mellitus. Lyxumia ® is approved in more than 60 countries worldwide, and lixisenatide is also approved as Adlyxin ® (lixisenatide) in the U.S. 6,7 Lyxumia ® aims to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control. 6,7 Product About the product Toujeo ® Toujeo ® (insulin glargine 300 Units/mL) is a once-daily basal insulin, that is available in more than 60 countries. Toujeo ® is a long-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus. 1 Lantus ® Lantus ® (insulin glargine 100 Units/mL) is a long-acting basal insulin analog that provides a slow, steady release of insulin and helps manage blood sugar between meals, and overnight. 2 The cornerstone of Sanofi’s diabetes portfolio, Lantus has helped more than 10 million people with diabetes over 89 million patient-years since launch, in more than 130 countries. Insuman ® Insuman ® (human insulin 100 IU/mL) includes a range of rapid and intermediate human insulin solutions and suspensions for injections. Insuman is used in patients with diabetes who need treatment with insulin. 3,4 Apidra ® Apidra ® (insulin glulisine injection) is an add-on to basal insulin in basal-bolus regimen. Apidra is indicated for the treatment of adults, adolescents and children, six years or older with diabetes mellitus, where treatment with insulin is required. 5 Product About Soliqua ® Soliqua ® is a once-daily titratable fixed-ratio combination of insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes. It is approved in the U.S. as Soliqua ® 100/33 and in the EU as Suliqua ® . 8,9 Soliqua ® combines two widely-used medicines with complementary modes of action addressing both fasting plasma glucose (FPG) and post-prandial glucose (PPG). This is particularly relevant for people whose type 2 diabetes is uncontrolled, despite using basal insulin. 8,9 Product About Praluent ® Praluent ® (alirocumab) is a PCSK9 inhibitor for the treatment of people who have raised levels of ‘bad’ cholesterol (low-density lipoprotein cholesterol, or LDL-C). 10 Praluent ® is used along with diet and the highest tolerated dose of a statin in adults with heterozygous familial (an inherited condition that causes high levels of LDL cholesterol) and non-familial hypercholesterolemia or mixed dyslipidemia who need additional lowering of LDL cholesterol. 10 Product About Amaryl ® Amaryl ® (glimepiride) is an oral blood glucose-lowering drug of the sulfonylurea class. Amaryl is indicated for the treatment of type 2 diabetes mellitus, when diet, physical exercise and weight reduction alone are not adequate. 11 Daonil ® Daonil ® (glibenclamide) is an oral blood glucose-lowering drug of the sulfonylurea class. Daonil ® is a sulphonylurea hypoglycemic agent, indicated for the oral treatment of patients with non-insulin dependent diabetes who respond inadequately to dietary measures alone. 12 Product About ALLSTAR™ ALLSTAR™ is a high-quality pen for use with Lantus, designed for emerging markets. SoloStar ® /ClikStar ® SoloStar ® and ClikStar ® are Sanofi’s two award-winning delivery devices providing high patient satisfaction. JuniorStar ® JuniorStar ® is an award-winning, half-unit, reusable pen specifically designed for young people with type 1 diabetes by being lightweight and easy-to-use with its large dose display, single-step dial back and easily replaceable cartridges. Lyxumia ® pens The award-winning Lyxumia ® pens have been recognized for design in Europe, North America and Japan and come with pre-set doses. Soliqua ® SoloStar ® pens The Soliqua ® award-winning SoloStar ® pens are pre-filled, disposable and available in two different strengths. Toujeo ® SoloStar ® pen The Toujeo ® pen is available as a re-designed, pre-filled SoloStar ® pen, and has an award-winning design. Toujeo ® Max SoloStar ® The new Max SoloStar ® pen holds 900 Units of Toujeo ® , more than any other long-acting insulin pen in the U.S., and provides up to 160 Units/mL of Toujeo ® in a single injection. Toujeo ® Max SoloStar ® is only authorized in the U.S. Product About Product About MyStar Connect ® MyStar Connect ® is comprehensive data management software that optimizes diabetes therapy. It provides healthcare professionals (HCPs) with the necessary insights and analysis to identify key areas needing attention, and thus supports their clinical decision-making for each individual patient. BGStar ® BGStar ® is an easy-to-use, accurate and reliable blood glucose monitoring device, designed with specific features to help minimize errors and improve confidence in daily glucose management. MyStar Extra ® MyStar Extra ® is the first blood glucose meter that provides an estimated HbA 1C value. It is designed to keep people with diabetes motivated in their diabetes management and engaged to track their therapy progress – even between doctor visits. MyStar DoseCoach ® MyStar DoseCoach ® is an insulin glargine dose helper and integrated blood glucose meter in one single device. MyStar DoseCoach ® helps people with type 2 diabetes on basal therapy to self-adjust their insulin glargine dose in between visits, according to criteria selected by their HCPs. MyStar Plus ® MyStar Plus ® is an advanced blood glucose monitoring system that sends blood glucose data to the MyStar Plus ® App using Bluetooth wireless technology, helping patients manage their diabetes around their lifestyle. ** PRODUCT PORTFOLIO Evidence-based therapies, intuitive diagnostics and easy-to-use pens

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Page 1: PRODUCT PORTFOLIO - Sanofi

Long-standing heritage in insulin innovationPCSK9 inhibitor

Combination therapy

Once-daily, prandial GLP-1 receptor agonist

Solid base in oral anti-diabetic treatments

REFERENCES:

1. Toujeo SmPC Feb 2018. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000309/WC500047935.pdf [Date accessed: June 2018].

2. Lantus SmPC Jul 2017. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000284/WC500036082.pdf [Date accessed: June 2018].

3. Insuman SmPC Mar 2018. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000201/WC500033784.pdf [Date accessed: June 2018].

4. EMA data on Insuman. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Supply_shortage/2015/03/WC500185164.pdf [Date accessed: June 2018].

5. Apidra SmPC Jul 2017. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000557/WC500025250.pdf [Date accessed: June 2018].

6. Lyxumia SmPC Oct 2017. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002445/WC500140401.pdf [Date accessed: June 2018].

7. Adlyxin PI Jul 2016. Available at: http://products.sanofi.us/adlyxin/adlyxin.pdf [Date accessed: June 2018].

8. Soliqua 100–33 PI Oct 2017. Available at: http://products.sanofi.us/Soliqua100-33/Soliqua100-33.pdf [Date accessed: June 2018].

9. Suliqua SmPC Oct 2017. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004243/WC500224673.pdf [Date accessed: June 2018].

10. Praluent SmPC Jan 2018. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003882/WC500194521.pdf [Date accessed: June 2018].

11. Amaryl SmPC Apr 2017. Available at: http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1518153414731.pdf [Date accessed: June 2018].

12. Glibenclamide SmPC Sep 2015. Available at: http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1513315161827.pdf [Date accessed: June 2018].

*Suliqua® is the brand name in the EU. Within the U.S. it is branded as Soliqua® 100/33†Lyxumia was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL), http://www.zealandpharma.com. Lyxumia was approved in Europe in 2013 and is currently approved in over 60 countries worldwide for the treatment of adults with type 2 diabetes, with commercial launches in Europe, Japan, Mexico and other markets. Lyxumia is the proprietary name approved by the European Medicines Agency and other health authorities for the GLP-1 RA lixisenatide.[Date accessed: June 2017].‡ClikStar, AllStar and JuniorStar pens are reusable; SoloStar and Lyxumia pens are disposable. **MyStar Plus: App is compatible with GooglePlay and Apple. The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Sanofi is under license. Other trademarks and trade names are those of their respective owners.For more information on all products, please consult the Product Information in your country. Not all products and programs are available in all countries.

Long-standing heritage in insulin innovation

Long-standing heritage in insulin innovation

Long-standing heritage in insulin innovation

Long-standing heritage in insulin innovation

The MyStar® PortfolioMyStar® is an integrated portfolio for simpler and more effective diabetes management.

The portfolio includes medical devices, solutions and guidance and when combined with our drug offering, aims to meet patients’ needs holistically.

*

For medical journalists outside the U.S. only

PCSK9 inhibitor Long-standing heritage in insulin innovation

Intelligent blood glucose monitoring systems

Patient-friendly delivery pens

Long-standing heritage in insulin innovation

Once-daily prandial GLP-1 receptor agonist

Combination therapy

Solid base in oral anti-diabetic treatments

Patient-friendly delivery pens‡

Intelligent blood glucose monitoring system

Product About

Lyxumia®

Lyxumia® (lixisenatide) is a once-daily mealtime (prandial) GLP-1 receptor agonist for the treatment of adults with type 2 diabetes mellitus. Lyxumia® is approved in more than 60 countries worldwide, and lixisenatide is also approved as Adlyxin® (lixisenatide) in the U.S.†6,7

Lyxumia® aims to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control.6,7

Product About the product

Toujeo®Toujeo® (insulin glargine 300 Units/mL) is a once-daily basal insulin, that is available in more than 60 countries. Toujeo® is a long-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus.1

Lantus®

Lantus® (insulin glargine 100 Units/mL) is a long-acting basal insulin analog that provides a slow, steady release of insulin and helps manage blood sugar between meals, and overnight.2

The cornerstone of Sanofi’s diabetes portfolio, Lantus has helped more than 10 million people with diabetes over 89 million patient-years since launch, in more than 130 countries.

Insuman®Insuman® (human insulin 100 IU/mL) includes a range of rapid and intermediate human insulin solutions and suspensions for injections. Insuman is used in patients with diabetes who need treatment with insulin.3,4

Apidra®

Apidra® (insulin glulisine injection) is an add-on to basal insulin in basal-bolus regimen. Apidra is indicated for the treatment of adults, adolescents and children, six years or older with diabetes mellitus, where treatment with insulin is required.5

Product About

Soliqua®

Soliqua® is a once-daily titratable fixed-ratio combination of insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes. It is approved in the U.S. as Soliqua® 100/33 and in the EU as Suliqua®.8,9

Soliqua® combines two widely-used medicines with complementary modes of action addressing both fasting plasma glucose (FPG) and post-prandial glucose (PPG). This is particularly relevant for people whose type 2 diabetes is uncontrolled, despite using basal insulin.8,9

Product About

Praluent®

Praluent® (alirocumab) is a PCSK9 inhibitor for the treatment of people who have raised levels of ‘bad’ cholesterol (low-density lipoprotein cholesterol, or LDL-C).10

Praluent® is used along with diet and the highest tolerated dose of a statin in adults with heterozygous familial (an inherited condition that causes high levels of LDL cholesterol) and non-familial hypercholesterolemia or mixed dyslipidemia who need additional lowering of LDL cholesterol.10

Product About

Amaryl®Amaryl® (glimepiride) is an oral blood glucose-lowering drug of the sulfonylurea class. Amaryl is indicated for the treatment of type 2 diabetes mellitus, when diet, physical exercise and weight reduction alone are not adequate.11

Daonil®Daonil® (glibenclamide) is an oral blood glucose-lowering drug of the sulfonylurea class. Daonil® is a sulphonylurea hypoglycemic agent, indicated for the oral treatment of patients with non-insulin dependent diabetes who respond inadequately to dietary measures alone.12

Product About

ALLSTAR™ ALLSTAR™ is a high-quality pen for use with Lantus, designed for emerging markets.

SoloStar®/ClikStar® SoloStar® and ClikStar® are Sanofi’s two award-winning delivery devices providing high patient satisfaction.

JuniorStar®

JuniorStar® is an award-winning, half-unit, reusable pen specifically designed for young people with type 1 diabetes by being lightweight and easy-to-use with its large dose display, single-step dial back and easily replaceable cartridges.

Lyxumia® pens The award-winning Lyxumia® pens have been recognized for design in Europe, North America and Japan and come with pre-set doses.

Soliqua® SoloStar® pens The Soliqua® award-winning SoloStar® pens are pre-filled, disposable and available in two different strengths.

Toujeo® SoloStar® pen The Toujeo® pen is available as a re-designed, pre-filled SoloStar® pen, and has an award-winning design.

Toujeo® Max SoloStar®The new Max SoloStar® pen holds 900 Units of Toujeo®, more than any other long-acting insulin pen in the U.S., and provides up to 160 Units/mL of Toujeo® in a single injection. Toujeo® Max SoloStar® is only authorized in the U.S.

Product About Product About

MyStar Connect®

MyStar Connect® is comprehensive data management software that optimizes diabetes therapy. It provides healthcare professionals (HCPs) with the necessary insights and analysis to identify key areas needing attention, and thus supports their clinical decision-making for each individual patient.

BGStar®

BGStar® is an easy-to-use, accurate and reliable blood glucose monitoring device, designed with specific features to help minimize errors and improve confidence in daily glucose management.

MyStar Extra®

MyStar Extra® is the first blood glucose meter that provides an estimated HbA1C value. It is designed to keep people with diabetes motivated in their diabetes management and engaged to track their therapy progress – even between doctor visits.

MyStar DoseCoach®

MyStar DoseCoach® is an insulin glargine dose helper and integrated blood glucose meter in one single device. MyStar DoseCoach® helps people with type 2 diabetes on basal therapy to self-adjust their insulin glargine dose in between visits, according to criteria selected by their HCPs.

MyStar Plus®

MyStar Plus® is an advanced blood glucose monitoring system that sends blood glucose data to the MyStar Plus® App using Bluetooth wireless technology, helping patients manage their diabetes around their lifestyle.**

PRODUCT PORTFOLIO

Evidence-based therapies, intuitive diagnostics and easy-to-use pens