REFERENCE CODE GDHC334DFR PUBLICAT ION DATE J ANU ARY 2014 ENGERIX-B (PROPHYLACTIC HEPATITIS B VIRUS VACCINES) - FORECAST AND MARKET ANALYSIS TO 2022

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1 REFERENCE CODE GDHC334DFR PUBLICAT ION DATE J ANU ARY 2014 ENGERIX-B (PROPHYLACTIC HEPATITIS B VIRUS VACCINES) - FORECAST AND MARKET ANALYSIS TO 2022

2 Executive Summary The table below provides a summary of the key metrics for Engerix-B in the 8MM Prophylactic Hepatitis B Virus (HBV) Vaccines markets during the forecast period from Engerix-B: Key Metrics in the 8MM Prophylactic HBV Vaccines Markets, Market Sales US 5EU Japan Canada Total Key Events ( ) Engerix-B faces stiff competition from combination vaccines in the pediatric market, most notably GSK s Infanrix Hexa in the 5EU Market Sales US 5EU Japan Canada Global* Source: GlobalData 8MM= US, France, Germany, Italy, Spain, UK, Japan and Canada 5EU = France, Germany, Italy, Spain and UK N/A: not available $15.9m $14.8m N/A $1.6m $32.3m Level of Impact $12.5m $5.3m N/A $1.1m $18.9m Sales of Engerix-B in the Prophylactic HBV Vaccines Market The combined sales of Engerix-B were estimated at $32.3 million in By 2022, we project Engerix-B sales to fall to $18.9 million, with a negative Compound Annual Growth Rate (CAGR) of 5.2% over the course of the decade. These estimates cover the sales in the eight countries included in this report: the US, France, Germany, Italy, Spain, the UK, Japan, and Canada. Key factors contributing to sales of Engerix-B will include: The yeast-derived, recombinant HBsAg antigen makes accidental infection impossible and thus eliminates the HIV transmission concerns associated with the plasma-derived, first-generation HBV vaccines. Physicians are comfortable with Engerix-B s strong safety profile and clinical performance. Unlike the combination vaccines, Engerix-B can be given to infants at birth. This expanded indication gives Engerix-B an advantage over its competitors in markets that encourage the administration of the first dose of HBV vaccine shortly after birth. Amidst unwarranted public skepticism towards the ability of the infant immune system to tolerate combination vaccines, Engerix-B is seen as a viable option for alternative vaccination schedules and immunization skeptics. 2

3 Executive Summary Despite these drivers, the major barrier affecting the sales of Engerix-B will include: The figure below illustrates the global Engerix-B sales by region during the forecast period. Engerix-B only protects against HBV, which puts this vaccine at a competitive disadvantage. Pediatric combination vaccines, such as GSK s Infanrix Hexa, are seen as more cost-effective and reduce the infant shot burden because they protect against multiple diseases. Sales for Engerix-B by Region, Total: $32.3m 4.9% US Engerix-B does not effectively protect all patients against HBV, and its effectiveness is especially diminished in adults with renal insufficiency. Because there is little differentiation between Engerix-B and Merck s Recombivax HB, GSK 45.8% 28% 2022 Total: $18.9m 6.1% 49.3% 5EU Japan must compete for sales in a highly mature market. Despite Engerix-B s record as a reliable vaccine, it fails to differentiate itself enough from competitors to dominate the 65.9% market. Source: GlobalData 3

4 Executive Summary What Do Physicians Think? The KOLs interviewed for this report shared their expert insight into the HBV vaccines market. These KOLs revealed that, while physicians are relatively happy with the performance of the currently marketed vaccines, they realize that there are still glaring weaknesses in the treatment algorithm that must be addressed. They cite increased vaccine immunogenicity in adults as the most important clinical unmet need, and also reveal the need for improved dosing regimens, physician education, and adult immunization strategies. According to the KOLs, combination vaccines are also advantageous for improving vaccination coverage in the pediatric market. Ultimately, KOLs thought that open dialogue between vaccine manufacturers and policymakers is necessary for a vaccine s commercial success in the HBV vaccine market. Yes, I m sure that physicians need to be better educated on how to advise their patients about immunization. OUS key opinion leader, November 2013 A pediatric combination vaccine is more likely to increase vaccine uptake than several vaccines administered separately. OUS key opinion leader, November 2013 I think an ongoing dialogue between policymakers and manufacturers, before vaccines are actually launched, would be beneficial. There is a lack of compliance in adults because the series is extended over six months, so it may be difficult to get patients to follow up...the lack of compliance originates from the fact that we cannot get an immune response in less than three doses. US key opinion leader, November 2013 Selectively targeting subgroups within the population has been shown repeatedly for different vaccines to be a very ineffective [immunization] strategy. Doctors and their office staff seemingly have a very hard time in doing that. I mean that s just a fact that s been demonstrated time and time again. US key opinion leader, November 2013 I think there will be a growing trend towards the use of combination vaccines. US key opinion leader, September 2013 A key barrier to increasing vaccine coverage in the adult population is lack of awareness on the part of patients and physicians. US key opinion leader, November 2013 The available hepatitis B vaccines are incredibly safe vaccines, and they are very effective. They are not ideal, there are improvements that we would like to make, and there are also substantial enhancements of hepatitis B immunization programs that are waiting to be undertaken. US key opinion leader, November 2013 OUS key opinion leader, October

5 Executive Summary The currently available hepatitis B vaccines require three doses. It would be great to have a vaccine that only requires two doses. I guess it s unreasonable to hope for a vaccine that only requires one [dose], but two doses would be better. US key opinion leader, November 2013 I think the number one unmet need is the seroconversion problem I would really like a vaccine that induces seroconversion in nearly everybody, if possible everyone I would like a vaccine that would induce in everyone more than 100mIU/mL HBs antibodies. OUS key opinion leader, October 2013 To exploit opportunities, vaccine manufacturers should produce better vaccines, vaccines that have few side effects and are able to raise antibodies levels higher Companies should also be investigating more efficient and cheaper vaccines for development. OUS key opinion leader, November

6 Table of Contents 1 Table of Contents 1 Table of Contents List of Tables List of Figures Introduction Catalyst Related Reports Upcoming Related Reports Disease Overview Overview Etiology and Pathophysiology Etiology Pathophysiology Symptoms Prognosis Vaccination Recommendations and Coverage Rates Overview Competitive Assessment Overview Strategic Competitor Assessment Engerix-B Overview

7 Table of Contents 6.2 Immunogenicity Safety SWOT Analysis Forecast Appendix Bibliography Abbreviations Methodology Forecasting Methodology Patient Populations Targeted for Vaccination Vaccination Coverage Rates Vaccinated Patients Regulatory Approval vs. Advisory Committee Recommendation General Pricing Assumptions Individual Vaccine Assumptions Physicians and Specialists Included in this Study Interviews of Key Opinion Leaders (KOLs) Online Survey of High-Prescribing Physicians (non-kols) About the Authors Analyst Therapy Area Director Global Head of Healthcare About GlobalData

8 Table of Contents 7.8 Disclaimer List of Tables Table 1: Modes of HBV Transmission Table 2: HBV Serological Markers and Test Interpretations Table 3: Symptoms of HBV Infection Table 4: HBV Vaccination Advisory Committees by Country Table 5: HBV Immunization Recommendations by Country Table 6: Targeted Age Group(s) for Routine Immunization and Most Administered HBV Vaccines by Country in the Global Markets, Table 7: Leading Vaccines for HBV, Table 8: Product Profile Engerix-B Table 9: Immunogenicity Profile Engerix-B Table 10: Safety Profile Engerix-B Table 11: Engerix-B SWOT Analysis, Table 12: Global Sales Forecasts ($m) for Engerix-B, Table 13: Patient Population(s) Targeted for HBV Vaccination in the Pediatric Market, by Country Table 14: Patient Population(s) Targeted for HBV Vaccination in the Adult Market, by Country Table 15: High-Prescribing Physicians (non-kols) Surveyed, by Country List of Figures Figure 1: HBV Structure and the Recombinant Vaccine Development Process

9 Introduction 2 Introduction 2.1 Catalyst The global (7MM and Canada) prophylactic hepatitis B virus (HBV) vaccine market has seen moderate growth over the last several years, primarily due to the effectiveness of routine childhood immunization programs and the strong clinical performance of currently marketed vaccines, such as GSK s Engerix-B, Pediarix/Infanrix Hexa, and Merck s Recombivax HB, in these targeted populations. Despite this success, opportunities still exist for improving the treatment algorithm. The growing popularity of combination vaccines, along with the push for vaccines that achieve higher seroconversion in non-responders, will serve to stimulate modest growth in the marketplace over the forecast period from GlobalData expects the following key factors to contribute to the evolution of the prophylactic HBV vaccine market over the next decade: The maintenance and/or increase of routine HBV vaccination coverage rates in the 7MM and Canada will be essential to the commercial success of these vaccines, as widespread uptake outside of official recommendations is unlikely. GlobalData believes that country-specific immunization recommendations and policy implementation will be an essential metric for determining future vaccine uptake. Our report provides a detailed, primary research-driven analysis of immunization policy at the country level. Vaccines that more effectively protect traditional non-responders, such as patients with chronic kidney disease (CKD) and diabetes mellitus, have the potential to address an area of high unmet need while simultaneously exploiting a largely untapped segment of the HBV vaccine market. For example, Dynavax s Heplisav has showed encouraging results in Phase III clinical studies in the US. Key opinion leaders (KOLs) have indicated to GlobalData that, despite superior clinical performance, the success of vaccines targeting these specific adult populations will depend upon a drastic improvement in current coverage rates. A growing preference for pediatric combination vaccines, particularly in the 5EU, is expected to drive stiff competition between GSK s Infanrix Hexa and Sanofi Pasteur MSD s Hexyon. Vaccine manufacturers will focus much effort on emphasizing the convenience and costeffectiveness of combination vaccines, but their eventual use will depend heavily on how well they fit into country-specific vaccination schedules. Our report includes a thorough competitive 9

10 Introduction assessment of marketed and late-stage pipeline vaccines in the 7MM and Canada, which takes into account both clinical and commercial positioning. GlobalData anticipates that vaccine manufacturers will face an uphill battle in countries that do not currently recommend routine vaccination against HBV, such as the UK and Japan. Despite pressure from patient advocacy and pro-immunization groups, KOLs have indicated that shortterm change to immunization policy appears unlikely. Firms interested in accessing these markets may only target specific at-risk patient populations for the foreseeable future. 2.2 Related Reports GlobalData (2013). PharmaPoint: HIV Therapeutics Global Drug Forecast and Market Analysis to 2022: Event-Driven Update, March, 2013, GDHC41PIDR GlobalData (2013). PharmaFocus: Vaccine Adjuvants in Infectious Disease, March, 2013, GDHC001PFR GlobalData (2013). PharmaPoint: Pediatric Respiratory Syncytial Virus Prophylactics United States Drug Forecast and Market Analysis to 2022, April, 2013, GDHC102PIDR GlobalData (2013). PharmaPoint: HCV Therapeutics Global Drug Forecast and Market Analysis to 2022, May, 2013, GDHC42PIDR GlobalData (2013). PharmaPoint: Dermatophytic Onychomycosis United States Drug Forecast and Market Analysis to 2022, June, 2013, GDHC101PIDR GlobalData (2013). PharmaPoint: Meningococcal Vaccines Global Drug Forecast and Market Analysis to 2022, June 2013, GDHC51PIDR GlobalData (2013). PharmaFocus: Market Access Strategies for Antibiotics Targeting Multidrug-Resistant Gram-Negative Bacteria, August 2013, GDHC004PFR GlobalData (2013). PharmaFocus: HIV R&D Strategies Towards Cure and Prevention, August 2013, GDHC003PFR GlobalData (2013). PharmaPoint: Meningococcal Vaccines Global Drug Forecast and Market Analysis to 2022: Event-Driven Update, August 2013, GDHC61PIDR GlobalData (2013). PharmaPoint: Seasonal Influenza Vaccines Global Drug Forecast and Market Analysis to 2022: Event-Driven Update, September 2013, GDHC67PIDR 10

11 Introduction GlobalData (2014). PharmaPoint: Prophylactic Hepatitis B Virus Vaccines Global Drug Forecast and Market Analysis to 2022: January 2014, GDHC68PIDR GlobalData (2014). Ambirix (Prophylactic Hepatitis B Virus Vaccines) Forecast and Market Analysis to 2022, January 2014, GDHC331DFR GlobalData (2014). Bimmugen (Prophylactic Hepatitis B Virus Vaccines) Forecast and Market Analysis to 2022, January 2014, GDHC332DFR GlobalData (2014). Comvax (Prophylactic Hepatitis B Virus Vaccines) Forecast and Market Analysis to 2022, January 2014, GDHC333DFR GlobalData (2014). Fendrix (Prophylactic Hepatitis B Virus Vaccines) - Forecast and Market Analysis to 2022, January 2014, GDHC335DFR GlobalData (2014). Hexyon (Prophylactic Hepatitis B Virus Vaccines) - Forecast and Market Analysis to 2022, January 2014, GDHC337DFR GlobalData (2014). Infanrix Hexa (Prophylactic Hepatitis B Virus Vaccines) - Forecast and Market Analysis to 2022, January 2014, GDHC338DFR GlobalData (2014). Pediarix (Prophylactic Hepatitis B Virus Vaccines) - Forecast and Market Analysis to 2022, January 2014, GDHC339DFR GlobalData (2014). Recombivax HB (Prophylactic Hepatitis B Virus Vaccines) - Forecast and Market Analysis to 2022, January 2014, GDHC340DFR GlobalData (2014). Twinrix (Prophylactic Hepatitis B Virus Vaccines) - Forecast and Market Analysis to 2022, January 2014, GDHC341DFR GlobalData (2014). Heplisav (Prophylactic Hepatitis B Virus Vaccines) - Forecast and Market Analysis to 2022, January 2014, GDHC336DFR GlobalData (2014). Prophylactic Hepatitis B Virus Vaccines - US Drug Forecast and Market Analysis to 2022, January 2014, GDHC214CFR GlobalData (2014). Prophylactic Hepatitis B Virus Vaccines 5EU Drug Forecast and Market Analysis to 2022, January 2014, GDHC215CFR 11

12 Introduction GlobalData (2014). Prophylactic Hepatitis B Virus Vaccines - Japan Drug Forecast and Market Analysis to 2022, January 2014, GDHC216CFR GlobalData (2014). Prophylactic Hepatitis B Virus Vaccines - Canada Drug Forecast and Market Analysis to 2022, January 2014, GDHC217CFR GlobalData (2014). Prophylactic Hepatitis B Virus Vaccines - Current and Future Players, January 2014, GDHC1028FPR 2.3 Upcoming Related Reports GlobalData (2014). PharmaPoint: Asthma Therapeutics Global Drug Forecast and Market Analysis to 2022, April 2014, GDHC75PIDR. GlobalData (2014). PharmaPoint: Prophylactic HPV Vaccines Global Drug Forecast and Market Analysis to 2022, March 2014, GDHC84PIDR. 12

13 Appendix 7.7 About GlobalData GlobalData is a leading global provider of business intelligence in the Healthcare industry. GlobalData provides its clients with up-to-date information and analysis on the latest developments in drug research, disease analysis, and clinical research and development. Our integrated business intelligence solutions include a range of interactive online databases, analytical tools, reports and forecasts. Our analysis is supported by a 24/7 client support and analyst team. GlobalData has offices in New York, Boston, San Francisco, London, India and Singapore. 7.8 Disclaimer All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GlobalData. 66