IQ4I Research & Consultancy Pvt. Ltd. Chronic Kidney Disease Pipeline Analysis

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1 IQ4I Research & Consultancy Pvt. Ltd. Chronic Kidney Disease Pipeline Analysis

2 CONTENTS REPORT DESCRIPTION INTRODUCTION Causes & Symptoms Diagnosis Classification Epidemiology HOT TARGETS, MECHANISMS & THERAPIES Associated targets DNA vaccination Gene therapy Tissue engineering MARKET DATA Forecasting model Market dynamics Market sizing Cost burden PIPELINE ANALYSIS Development stage Modalities Leading players Innovative approaches SMALL MOLECULES Pipeline Competitive Analysis LARGE MOLECULE Pipeline Competitive Analysis MONOCLONAL ABs Pipeline Competitive Analysis STEMCELL THERAPY Pipeline Competitive Analysis RNA-BASED THERAPY Pipeline Competitive Analysis MAJOR PLAYERS Company Profiles REFERENCES Overview, Pipeline & Deals Confidential

3 REPORT DESCRIPTION Chronic Kidney Disease (CKD) Pipeline Analysis gives comprehensive insight on the various drugs being developed for the treatment of CKD. The report covers all the drugs being developed in various phases (Discovery, Preclinical, Clinical & Marketing). The pipeline focuses on novel pharmacologic drugs & regenerative medicines covering small molecules, monoclonal antibodies, stem cell therapies and RNA-based therapeutics, but excludes symptom relief drugs. The report also covers some of the hot targets in research for CKD treatments. This report enables Pharmaceutical /Biotech companies, Academic institutes, Individual researchers, Investors, Medical technology companies, Service providers and other associated stake holders to identify and analyze the available licensing/collaborative commercial opportunities in the CKD Drug market. The report also provide strategic insights on medicines that are likely to have an impact on CKD treatment space and potentially alter standards of care in CKD in the foreseeable future. Current therapies are not effective and more than half of patients gradually face severe renal and cardiovascular complications, hence it provides a tremendous opportunity for upcoming therapies specific to CKD such as MAbs, stem cell-based and RNA-based therapies, which reverses disease course or slow down kidney deterioration.

4 CHRONIC KIDNEY DISEASE INTRODUCTION

5 CHRONIC KIDNEY DISEASE (CKD) CKDis a progressive & persistent kidney disease accompanied by reduction in Glomerular Filtration Rate (GFR) i.e; less than 60 ml/min/1.73m^2 for a period of more than 3 months and is manifested by abnormal albumin secretion. Major Causes (2014) STAGE 1 No symptoms Signs of symptoms People at major risk Stages of CKD STAGE 3 Mild symptoms Low kidney function STAGE 2 STAGE 4 CKD Reality STAGE 5 Kidney damage Others XX% High blood pressure XX% Prevalence Diabetes XX% Comparitiveto Whites risk of: African Americans 4 times high Americans 1.6 times high Asians 1.4 times high Hispanics high 31 million people in U.S. adults have kidney disease 1 in 3 American adults are prone to CKD CKD in women is more common than men. But 50% men with CKD will progress to kidney failure. Currently out of 120,000 Americans are waiting for organ transplant and more than 100,000 need a kidney. ~ 25.8 million people in U.S. have diabetes and 40% of people with diabetes will develop CKD. U.S. XX% Mexico XX% Argentina XX% Europe XX% India -XX% China XX% Indonesia XX% Global CKD prevalence is approximately XX XX% Taiwan XX%

6 DIAGNOSIS OF CHRONIC KIDNEY DISEASE BLOOD TEST ULTRAS OUND SCAN DIAGNOSIS URINE TEST KIDNEY BIOPSY IMAGING TEST

7 STAGES OF CHRONIC KIDNEY DISEASE According to KDOQI Clinical Practice Guidelines CKD is classified into 5 stages. STAGE STAGE 1 STAGE 2 STAGE 3 STAGE 4 STAGE 5 GFR GFR 90 ml/min/1.73m^2 GFR ml/min/1.73m^2 GFR ml/min/1.73m^2 GFR ml/min/1.73m^2 GFR less than 15 ml/min/1.73m^2 SYMPTOM No symptoms observed No symptoms observed Early symptoms observed Tiredness, itching, poor appetite observed Poor sleeping, vomiting, breathing difficulty DIAGNOSIS Normal urea & creatinine level Mildly elevated urea & creatinine level Excess urea & creatinine level Excess urea & creatinine level Excess urea & creatinine level FUNCTION Normal kidney function Evidence of kidney damage Signs of kidney damage Reduced kidney function Damage of kidney system KDOQI Kidney Disease Outcomes Quality Initiative

8 CHRONIC KIDNEY DISEASE MARKET DATA

9 CKD MARKET: FORECASTING MODEL Fig 4 Historical Data and trends of CKD Market Pipeline Evolution Evolution Market Share CKD Costs of Burden Company Developments Hospitalization Pattern Epidemiology Pattern Applications Download Pattern Readmission Regulatory Landscape Pattern Geographical Usage Factors Influencing Market Growth Market Drivers Increasing individuals suffering from diabetes and BP Increasing incidence and prevalence of chronic kidney diseases Increasing aged population Market Penetration Innovative drug discovery platforms Market Opportunities Acquisitions/collaborations of companies and research institutes Demand for novel drugs to increase revenue of pharma industry Market Restraints High cost of innovative therapies including stem cell and gene therapies Changing reimbursement scenario in major markets like U.S. and U.K. Investments In September 2014, Covance and Frenova Renal Research established a collaboration designed to find more effective treatment for patients living with CKD and ESRD. Market Trends and Forecasting Historical Market Data Impact Analysis of Market Trends Market Size & Forecast by Region Major Players Profiling and Strategies Global CKD Market Size 2013 and Forecast to Confidential

The market growth is attributed to technological advancements, which led to emergence of novel therapeutics,

10 CKD - MARKET SIZING Fig 6 Fig 7 Global CKD Drugs Market Global CKD Drugs Market by Region The global CKD market is estimated to be $XX billion in 2013 and is expected to reach $XX billion by 2020 with a CAGR of XX%( ). The market growth is attributed to technological advancements, which led to emergence of novel therapeutics, expansion in number of kidney transplantation, increasing incidence of kidney diseases, and high unmet needs. Confidential

11 GLOBAL CKD DRUG MARKET BY THERAPEUTIC SEGMENTATION Fig 8 Anemia associated CKD SHPT + Hyperphosphatemia Others Diabetic Nephropathy Confidential

12 CHRONIC KIDNEY DISEASE PIPELINE ANALYSIS

CKD PIPELINE BY PHASES Fig 10 Pipeline analysis reveals that there are XX molecules in various stages of pipeline (focused on Discovery, Pre-clinical,

13 CKD PIPELINE BY PHASES Fig 10 Pipeline analysis reveals that there are XX molecules in various stages of pipeline (focused on Discovery, Pre-clinical, Phase I, II, III and Marketed candidates) The phase II stage commanded the pipeline analysis with XX molecules, followed by preclinical with around XX molecules.

14 CKD PIPELINE BY LEADING PLAYERS Fig 11 molecules No. of m

15 GLOBAL CKD DRUG MARKET BY THERAPEUTIC SEGMENTATION Fig 12 Small molecules Large molecules Monoclonal antibodies Stem cell therapy RNA based therapy Others The CKD pipeline is commanded by pharmacological drugs, accounting for XX molecules. Large molecules accounting for XX molecules followed by Monoclonal antibodies, Stem cell therapy, RNA base therapy and others. Confidential

16 CHRONIC KIDNEY DISEASE SMALL MOLECULES

17 SMALLMOLECULES MOLECULE PHASE MOA COMPANY SUMMARY STNM310 Discovery Glycan inhibitor Stelic Institute & Co. For small molecule glycan inhibitor, the company is seeking a strategic business partner with expertise in developing and optimizing the candidates to launching the drug into the market. XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX Confidential

18 SMALL MOLECULES-SEGMENTATION BY PHASES Fig 13 Pre-Clinical Marketed Discovery Clinical Phase I Phase II Phase III In the small molecule segment are clinical phase dominated with XX molecules among them phase II is the largest with XX molecules, followed by preclinical with XX molecules Confidential

19 CHRONIC KIDNEY DISEASE LARGE MOLECULES

20 LARGE MOLECULES MOLECULE PHASE MOA COMPANY SUMMARY BLR-103 Discovery Not Available BLR-Bio Blr-103 is a peptide mimetic, BLR Bio is advancing its product candidates with a focus on chronic kidney disease and the complications of diabetes. However, our drug target is causal in many forms of fibrosis as well as certain cancers. XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX Confidential

21 LARGE MOLECULES-SEGMENTATION BY PHASES Fig 14 Pre-Clinical Discovery Marketed Clinical Phase II Phase I Phase III In the large molecule segment are clinical phase dominated with XX molecules among them phase II is the largest with XX molecules, followed by preclinical with XX molecules Confidential

22 CHRONIC KIDNEY DISEASE MONOCLONAL ANTIBODIES

23 MONOCLONAL ANTIBODIES MOLECULE PHASE MOA COMPANY SUMMARY XX XX XX XX XX XX XX XX XX XX XX XX XX XX XX Confidential

24 CHRONIC KIDNEY DISEASE STEM CELL-BASED THERAPY

25 STEM CELL THERAPY MOLECULE PHASE MOA COMPANY SUMMARY XX XX XX XX XX Confidential

26 RNA-BASED THERAPY MOLECULE PHASE MOA COMPANY SUMMARY RG-012 Pre- Clinical anti-mir- 21 Regulus mir-21 is a 22-mer non-coding RNA that negatively regulates gene/networks and has been reported to be up-regulated in fibrotic kidney diseases in both animal models and human patients.preclinical studies have demonstrated that treatment with an anti-mir-21 significantly attenuates chronic kidney disease progression. In July 2014, RG-012 received orphan drug designation from the U.S. Food & Drug Administration as a therapeutic for the treatment of Alport syndrome. In September 2014, Regulus initiated ATHENA, a natural history of disease study to gather greater information about the CHRONIC KIDNEY DISEASE OTHER MOLECULES progression of Alport syndrome, particularly the rate of decline in renal function in Alport syndrome patients over time. In the first half of 2015, Regulus expects to initiate a Phase I clinical study of RG-012 and a Phase II proof-ofconcept study thereafter. Confidential

27 OTHER MOLECULES MOLECULE PHASE MOA COMPANY SUMMARY CureNephron Discovery Not Applicable Evotec Ag In January 2012, Evotec AG, Harvard University, Brigham and Women's Hospital, University of South California and AstraZeneca collaboratively started the programme "CureNephron", designed to deliver and exploit novel therapeutic targets as well as biomarkers that allow more accurate diagnosis, monitoring and treatment of chronic and acute kidney disease. As per the company presentation the next milestone is pharma collaboration. XX XX XX XX XX XX XX XX XX XX Confidential

28 CHRONIC KIDNEY DISEASE MAJOR PLAYERS

29 CKD KEY PLAYERS - HEADQUARTERS Vidasym AstraZeneca Astellas Pfizer Eli lilly Johnson & Johnson Regulus BLR bio Angion biomedica Opko health Fig 15 Confidential

COMPANY-ASTELLAS PHARMA HEADQUARTERS ILLIONIS OVERVIEW Astellas pharma is a U.S. affiliate of Tokyo-based pharmaceutical company founded in the year 2005 and is headquartered in United States.

30 COMPANY-ASTELLAS PHARMA HEADQUARTERS ILLIONIS OVERVIEW Astellas pharma is a U.S. affiliate of Tokyo-based pharmaceutical company founded in the year 2005 and is headquartered in United States. The company aims to maintain and strengthen their position as global leader in transplantation and urology areas. It also focus in other applications like oncology, urology, cardiology, infectious disease, immunology and dermatology. Astellas sustained commitment to research and development within the urology scientific community which continues in 2015/2016 as a collaborative effort with the Canadian Urological Association (CUA). The CUA Astellas Research Grant Program has been established to support investigator sponsored research in urology. PIPELINE Discovery Preclinical Phase I Phase II Phase III Marketed ASP-6858 XXX XXX XXX XXX XXX Confidential

31 DISCLAIMER IQ4I strategic analysis services are limited publications containing valuable market information provided to a select group of customers in response to orders. Our customers acknowledge, when ordering, that IQ4I strategic analysis services are for our customers internal use and not for general publication or disclosure to third parties. Quantitative market information is based primarily on interviews and therefore, is subject to fluctuation. IQ4I does not endorse any vendor, product or service depicted in its research publications. IQ4I strategic analysis publications consist of the opinions of IQ4I' research and should not be construed as statements of fact. IQ4I disclaims all warranties, expressed or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose. IQ4I takes no responsibility for any incorrect information supplied to us by manufacturers or users. All trademarks, copyrights and other forms of intellectual property belong to their respective owners and may be protected by copyright. Under no circumstance may any of these be reproduced in any form without the prior written agreement of their owner. No part of this strategic analysis service may be given, lent, resold or disclosed to noncustomers without written permission. Reproduction and/or transmission in any form and by any means including photocopying, mechanical, electronic, recording or otherwise, without the permission of the publisher is prohibited. For information regarding permission, contact: Tel: satish.birudukota@iq4i.com Confidential

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