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About Navitas Life SciencesNavitas Life Sciences delivers platform-driven full-service Clinical, Regulatory and Safety solutions and services. As the dedicated life sciences brand of TAKE Solutions, Navitas Life Sciences operates across North America, Europe, Asia pacific and Latin America. Navitas Life Sciences combines the knowledge and experience of three legacy brands - Ecron Acunova, Navitas, DataCeutics, KAI Research and Intelent. Thus, Navitas brings together the capabilities of a full-service CRO, a technology-led life sciences services provider, and expertise in analytics and data sciences to address critical challenges and drive outcomes for life sciences. Navitas Life Sciences has over 30 years of rich experience across 400+ phase I-IV clinical trials, 20+ therapeutic areas, and 40+ successful GCP/non-GCP audits. Our trial expertise is augmented by OneClinical, a platform thatdelivers trial oversight, analytics, and insights to drive successful study outcomes.

For more informationAmericas +1 609 720 1002 Europe +49 69 668 0300 APAC +91 44 4590 9000 contact@navitaslifesciences.com www.navitaslifesciences.com /company/navitas-life-sciences

Diabetes Drugs Coming off Patent

Levemir (Insulin Detemir Recombinant) Afrezza (Insulin

Recombinant Human)

Actoplus Met XR (Metformin Hydrochloride; Pioglitazone Hydrochloride)

Apidra (Insulin Glulisine Recombinant)

Janumet (Metformin Hydrochloride; Sitagliptin Phosphate)

Janumet XR (Metformin Hydrochloride; Sitagliptin Phosphate)

Kombiglyze XR (Metformin Hydrochloride; Saxagliptin Hydrochloride)

Synjardy XR (Empagliflozin; Metformin Hydrochloride)

Jentadueto (Linagliptin; Metformin Hydrochloride)

Jardiance (Empagliflozin)

Glumetza (Metformin Hydrochloride)

Synjardy (Empagliflozin; Metformin Hydrochloride)

Glyxambi (Empagliflozin; Linagliptin)

Insulin - LC/MS/MS 0.2-20 ng/mL - Injection

C-Peptide - ECLIA 0.188-7.050ng/mL

Metformin - LC/MS/MS 3-2000 ng/mL & 20-2000 ng/mL - PlasmaInsulin - LC/MS/MS 0.2-20 ng/mLC-Peptide - ECLIA 0.188-7.050ng/mLPioglitazone Method can be developed and validated upon request

Metformin - LC/MS/MS 3-2000 ng/mL & 20-2000 ng/mL - Plasma

Metformin - LC/MS/MS 3-2000 ng/mL & 20-2000 ng/mL - Plasma

Saxagliptin Method can be developed and validated upon request

Empagliflozin - LC/MS/MS 5-1000 ng/mL Plasma

Metformin - LC/MS/MS 3-2000 ng/mL & 20-2000 ng/mL - Plasma

Linagliptin Method can be developed and validated upon request

Other Diabetic Methods (Analyte and Method):

2019

2021 2023

2022 2025

Brand N

ame and M

oleculeN

avitas Life Sciences’ C

urrently Available Methods

Navitas Life Sciences has the capabilities and resources to enable biosimilars companies to bring effective

ANTI-DIABETIC THERAPIESto the market quickly and safely

Navitas Life Sciences Capabilities

OUR STUDYEXPERIENCE

INCLUDES

Experienced expert Physicians from the tertiary care hospital

In-house expertise in designand conduct

Trained investigators and nursing staff

Qualified, 21CFR Part11 Compliant analyzer with redundancy

Study Conduct

BioanalysisHigh sensitivity methods

Expertise in handling peptides

LC/MS/MS Method for insulin and other peptides

ECLIA methods for Insulin and C-Peptide

With our extensive experience, we understand and have mastered the challenges of deploying the appropriate study design to effectively and scientifically demonstrate the biosimilarity of your product.

We have invested in and built up the necessary expertise and infrastructure to ensure that your

Euglycemic Glucose Clamp

BIOSIMILAR INSULIN PRODUCT is launched quickly.

Adjust Glucose Infusion to “Clamp”

Blood Glucose Levels

Frequent Blood Sampling. Heating pad to arterialise

venous blood

20% Glucose infusion through infusion pump

At “Steady-State”, Glucose Infusion = Net Glucose Utilisation

Insulin infusion if required

YSI Glucose Analyzer

Facts on Diabetes

Insulin is a hormone secreted by the

PANCREASand is responsible for modulating the use of sugars by the body.

Type 2 Diabetesis the most common type of diabetes, which occurs

when the body either becomes resistant to insulin or does not produce enough insulin, resulting in elevated

blood glucose levels.

105The WHO predicts diabetes will be the 7th leading cause of death

by 2030

Over 451 million people across the globe suffer from diabetes

In 2016,

over 5 millionpeople died due to diabetes

Hear

tBlood

vessels

Eyes

Kidn

eys NervesDiabetes

can Affect Many Parts of the Body

Diabetes is a chronic condition that is characterized by elevated levels of blood glucose

Lifestyle choices, such as diet and exercise, play a major role in causing type 2 diabetes

• Canagliflozin LC/MS/MS 25-6000 ng/mL Plasma• Glimepiride LC/MS/MS 1-200 ng/mL & 2-600 ng/mL Plasma• Glipizide LC/MS/MS 2-2000 ng/mL Plasma• Insulin & C-Peptide Antidiabetic ECLIA 0.16-7.214 ng/mL

and 0.188-7.050 ng/mL Plasma

• Insulin Glargine and M1, M2 metabolites LC/MS/MS0.2-12 ng/mL, 0.2-12 ng/mL 0.2-12 ng/mL Plasma

• Metformin & Glimepiride LC/MS/MS 10-3000 ng/mL& 2-300 ng/mL Plasma

Type 2 Diabetes68%

12%Diabeticfoot ulcer

Others*

20%

Navitas Life Sciences Diabetes Clinical Trial Experience

Soluble Insulin

Injection R 40 Iu/Ml

Insulin Aspart

Regular Insulin Human, 30 Iu per

Ml / Isophane Suspension70 Iu per Ml

Subcutaneous Doses of

Insulin Glargine Injection

Bring YourDIABETES PRODUCTto the Market Quickly and Effectively

Biphasic Isophane Insulin 30/70 Injection

200 Iu

*Includes Obesity, Prediabetes,Type 1 Diabetes

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Over 20Studies

Over 4,500patients enrolled for Studies

Over 450Sites

Glob

al

Site

Patients Enro

lled

Diab

etes

Experience Experience

Phase I

17%

Phase II

22%

Phase III

52%

Phase IV

9%

Perc

enta

ge o

f Stu

dies

Clinical Drug Development Phase Experience

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