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REFERENCE CODE GDHC015POA | PUBLICAT ION DATE DECEMBER 2013

ENDOMETRIOSIS - OPPORTUNITY ANALYSIS AND FORECASTS TO 2017

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ENDOMETRIOSIS – OPPORTUNITY ANALYSIS AND FORECASTS TO 2017

Executive Summary

The table below presents the key metrics for

endometriosis therapeutics in the six major

pharmaceutical markets covered in this report (US,

France, Germany, Italy, Spain, and UK) during the

forecast period from 2012–2017. For the purposes

of this report, the endometriosis market consists of

drugs commonly prescribed to patients with a

diagnosis of endometriosis confirmed by

laparoscopy. While certain classes of drugs

commonly used off label — namely, combined oral

contraceptives (COCs) — which contain both an

estrogen and a progestin — are included in this

forecast, others are not. For example, non-

steroidal anti-inflammatory drugs (NSAIDs) and

other analgesics are deliberately omitted from this

analysis.

Endometriosis Therapeutics: Key Metrics in Six Major Markets (6MM), 2012–2017

2012 Patient Population 6MM

Prevalent population (ages 15–19 Years) 5.8 million

Prevalent population (ages 20–49 Years) 8.3 million

Treated population*

2012 Market Sales

US 1.64 billion

5EU 71.1 million

Total 1.71 billion

Key Events (2012–2017) Level of Impact

Lupron (leuprolide acetate) patent expiry in the US and EU 2014 ↓↓

Elagolix launch in the US and EU – 2016 ↑↑

2017 Market Sales

US $1.67 billion

5EU $68.48 million

Total $1.74 billion Source: GlobalData *Excludes patients managed only via NSAIDs or surgery alone. 6MM = US and 5EU (France, Germany, Italy, Spain, and UK)

Global Endometriosis Therapeutics Market Expected to Decrease at a Compound Annual Growth Rate of 0.19% During 2012–2017

GlobalData estimates that the global endometriosis

therapeutics market in the 6MM was valued at

$1.88 billion in 2012. The market was largely

dominated by the US, with sales of $1.1 billion.

Combined sales in the 5EU were estimated at

$137.6m. By 2017, GlobalData forecasts that

global sales of endometriosis therapeutics will

decrease slowly to $1.66 billion at a Compound

Annual Growth Rate (CAGR) of 0.19%.

By the end of the forecast period in 2017,

GlobalData foresees that market growth will remain

driven by the US, with marginal changes in the

5EU share by 2017. The patent expiry of Lupron

(leuprolide acetate) in 2014 is expected to have a

negative effect on this market. However, since it is

a sterile injectable drug, GlobalData has tempered

the potential effect of this event, as manufacturers

may face barriers when attempting to create

generic equivalents.

The figure below illustrates the global sales for

endometriosis therapeutics by region during the

forecast period.

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ENDOMETRIOSIS – OPPORTUNITY ANALYSIS AND FORECASTS TO 2017

Executive Summary

Global Sales for Endometriosis Therapeutics by Region, 2012–2017

96%

4%2012 Total:$1.71bn

US

5EU

96%

4% 2017 Total:$1.75bn

US

5EU

Source: GlobalData

Nonetheless, this waning market will regain

momentum upon the expected launch of elagolix, a

first-in-class oral gonadotropin-releasing hormone

(GnRH) antagonist, in the US and 5EU in 2016.

Since price is a primary attribute driving therapy

choice in this market, new entrants such as

elagolix will have little potential to steal share from

low-cost therapies such as OCs, NSAIDs, and

progestins.

Endometriosis Market Plagued by High Unmet Need

Patients with endometriosis have significant unmet

needs due to the lack of approved treatment

options that have both continuous efficacy and a

favorable long-term safety profiles. Laparoscopic

surgery, either alone or in combination with

hormone therapy (HT), is typically the first

treatment choice for physicians. However, the

methods of treating the condition, have been

largely haphazard. As a result, women often

undergo numerous rounds of surgery and try

several medical approaches before finding relief.

Even after finding a suitable solution, patients can

expect a high rate of recurrence. The current

approved treatment options for endometriosis

include GnRH agonists, progestins, and

androgens, each of which has its own safety and

efficacy limitations. Although the use of GnRH

agonists has increased in the past decade, the

duration of therapy is typically limited to six months

due to hypoestrogenic side effects, such as hot

flashes, and significant bone mineral density

(BMD) loss. Moreover, these drugs come with

hefty price tags, which further stifles their appeal

for long-term use. NSAIDs and COCs are

commonly prescribed off label for confirmed and

suspected cases of endometriosis, although their

efficacy in this indication has not been validated via

randomized clinical trials. Because of the intrinsic

limitations of the currently available therapies,

innovative drugs with novel mechanisms of action

are required in order to address the unmet needs

of endometriosis patients.

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ENDOMETRIOSIS – OPPORTUNITY ANALYSIS AND FORECASTS TO 2017

Executive Summary

GnRH Antagonists will Replace GnRH Agonists, but Their High Price Will Limit Further Adoption

GnRH antagonists dominate the late-stage pipeline

for endometriosis therapeutics, with three agents

being in Phase II or Phase III (Abott’s elagolix,

Takeda’s relugolix, and Astellas’ ASP-1707).

Elagolix, which is in Phase III, promises to be the

first oral GnRH antagonist approved for

endometriosis. This class of therapies has several

key advantages over the currently marketed GnRH

agonists. In terms of safety and tolerability, elagolix

avoids the detrimental hypoestrogenic side effects

seen with GnRH agonists such as Lupron and

Zoladex (goserelin acetate). According to key

opinion leaders (KOLs) interviewed by GlobalData,

an oral formulation will be a welcome addition to

the field because it provides doctors with increased

control over dosing and allows for the immediate

cessation of therapy, if necessary. Therefore,

GlobalData believes that GnRH antagonists will

rapidly replace the GnRH agonist market segment.

Based on their improved efficacy and safety profile,

GnRH antagonists like elagolix are likely to be

priced at a premium over GnRH agonists such as

Lupron. Due to the low cost of progestins, COC’s,

and NSAIDs, GlobalData believes that the GnRH

antagonists are unlikely to take substantial market

share away from these drugs. Like GnRH agonists,

GnRH antagonists can only be administered for a

short period of time, which will restrict their use to

late-line therapy and sicker patients. Until more

long-term safety data are gathered, and there is

evidence that GnRH agonists can be used safely

for a longer treatment duration, GlobalData

believes that GnRH antagonists will only serve as

follow-up drugs to GnRH agonists.

The figure below provides a competitive

assessment of the marketed and late-stage

pipeline agents in endometriosis therapeutics

during the forecast period.

Competitive Assessment of Marketed and Late-Stage Pipeline Agents in Endometriosis Therapeutics, 2012–2017

Lupron

Elagolix

TAK-385

ASP-1707

Depo Sub-Q Provera

COC's

2

4

2 4

Com

mer

cial

Sco

re

Clinical Score

Source: GlobalData

Opportunity Remains High for Innovative Therapies

Since none of the late-stage drug candidates are

meant to address the high unmet need in the

endometriosis therapeutics market, the

management of the disease is not likely to evolve

during the forecast period, and opportunities in the

market will remain particularly high. Whether it is

for safer drugs or drugs that demonstrate efficacy

in mild or severe patients through robust clinical

trials, the market is crying for new therapies.

Ultimately, since all of the marketed, off-label, and

pipeline drugs have little impact in curbing the

disease progression, a high rate of recurrence is

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ENDOMETRIOSIS – OPPORTUNITY ANALYSIS AND FORECASTS TO 2017

Executive Summary

expected upon cessation of therapy. Therefore,

large opportunities will remain for safe, efficacious

therapies that target the root cause of the

condition. Non-hormonal strategies, in particular,

are promising, including immune modulators,

peroxisome proliferator-activated receptor (PPAR)

agonists, tumor necrosis factor-alpha (TNF-alpha)

inhibitors, and antiangiogenic agents. In

conclusion, a much better understanding of the

underlying pathology of this condition will be

required in order for a novel therapy to achieve

considerable success in the endometriosis market.

What Do Physicians Think?

The consensus among the KOLs interviewed for

this report is that endometriosis patients have

significant unmet needs due to the lack of safe,

efficacious, long-term therapies. Furthermore,

significant gaps in the current understanding of the

underlying disease pathology were flagged as a

hurdle plaguing endometriosis therapy

development. Although the KOLs are optimistic

about the potential approval of first-in-class

therapy, elagolix, they still foresee that unmet

needs will persist. One common concern about

GnRH antagonist therapy is that it continues to

approach the treatment of endometriosis via

hormonal pathways. A key limitation is that these

drugs do not target the underlying cause of the

disease, which means that recurrence is expected

to occur once a woman stops therapy. Since

endometriosis starts as early as adolescence and

can be expected to persist until menopause, any

drug that only addresses the symptoms of

endometriosis will translate into decades of

disease management, rather than resolution of the

condition.

One key weakness of the hormonal regimens used

to treat endometriosis is that they prevent

conception. Given the fact that the majority of

women who suffer from endometriosis are of

childbearing age, there is a considerable unmet

need for a novel therapy that allows for

continuation of the normal menstrual cycle and

provides for the possibility of pregnancy during

treatment. Given the estrogen-dependent nature of

endometriosis, the current therapies target the

condition by disrupting hormonal pathways which

play a key role in fertility. Although some novel

therapeutic classes that are under development

have shown promising efficacy data, many of these

approaches have side effects that would

contraindicate their use in women looking to

conceive.

“I am sure that GnRH antagonists will be effective.

The problem is that women will have recurrences

[of endometriosis] once they will discontinue the

drug.”

EU KOL, October 2013

“Approaching the disease from an inflammatory

standpoint would be an innovative approach that I

would be interested in seeing.”

EU KOL, October 2013

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ENDOMETRIOSIS – OPPORTUNITY ANALYSIS AND FORECASTS TO 2017

Executive Summary

“We don’t know very much about the real

mechanism underlying the generation of pain in

endometriosis.”

US KOL, October 2013

“I believe GnRH antagonists will be yet another

class [of drugs] that would be useful in the

management of endometriosis.”

US KOL, October 2013

“The oral formulation of GnRH antagonists will

certainly provide advantages over the injectable

GnRH agonists.”

US KOL, October 2013

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Table of Contents

ENDOMETRIOSIS – OPPORTUNITY ANALYSIS AND FORECASTS TO 2017

1 Table of Contents

1 Table of Contents ....................................................................................................................... 7

1.1 List of Tables .................................................................................................................... 12

1.2 List of Figures ................................................................................................................... 14

2 Introduction ............................................................................................................................... 15

2.1 Catalyst ............................................................................................................................. 15

2.2 Related Reports ................................................................................................................ 15

3 Disease Overview ..................................................................................................................... 16

3.1 Etiology and Pathophysiology ........................................................................................... 16

3.2 Etiology ............................................................................................................................. 18

3.3 Pathophysiology ................................................................................................................ 18

3.4 Clinical Prognosis ............................................................................................................. 21

3.5 Quality of Life .................................................................................................................... 21

3.6 Symptoms and Diagnosis ................................................................................................. 22

4 Epidemiology ............................................................................................................................ 23

4.1 Risk Factors and Comorbidities ........................................................................................ 23

4.1.1 Family history is a strong predictor for the risk of endometriosis .................................... 23

Late age at menarche protects women from developing endometriosis. ....................................... 24

4.1.2 Higher parity decreases the risk for endometriosis ........................................................ 25

4.2 Global Trends ................................................................................................................... 27

4.2.1 US ................................................................................................................................. 28

4.2.2 5EU ............................................................................................................................... 28

4.2.3 Forecast Methodology ................................................................................................... 29

4.2.4 Sources Used................................................................................................................ 31

4.2.5 Sources Not Used ......................................................................................................... 33

4.2.6 Forecast Assumptions and Methods ............................................................................. 33

4.3 Epidemiological Forecast for Endometriosis (2012–2022) ................................................. 36

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4.3.1 Diagnosed Prevalent Cases of Endometriosis ............................................................... 36

4.3.2 Age-Specific Prevalent Cases of Endometriosis ............................................................ 37

4.3.3 Age-Standardized Diagnosed Prevalence of Endometriosis .......................................... 39

4.3.4 Diagnosed Prevalent Cases of Endometriosis by Stage ................................................ 40

4.4 Discussion ........................................................................................................................ 42

4.4.1 Epidemiological Forecast Insight ................................................................................... 42

4.4.2 Limitations of the Analysis ............................................................................................. 43

4.4.3 Strengths of the Analysis ............................................................................................... 44

5 Current Treatment Options ....................................................................................................... 46

5.1 Overview ........................................................................................................................... 46

5.2 Product Profiles – Major Brands ........................................................................................ 49

5.2.1 Zoladex (goserelin acetate) ........................................................................................... 49

5.2.2 Lupron (leuprolide acetate depot) .................................................................................. 52

5.2.3 Synarel (nafarelin nasal spray) ...................................................................................... 54

5.2.4 Visanne (dienogest) ...................................................................................................... 57

5.2.5 Depo-SubQ Provera 104 (medroxyprogesterone injection) ........................................... 60

5.2.6 Danazol (Danocrine) ..................................................................................................... 62

5.2.7 Off-Label Treatment: Combined Oral Contraceptives, Progestins, and NSAIDs ............ 64

6 Unmet Needs Assessment and Opportunity Analysis ............................................................... 68

6.1 Overview ........................................................................................................................... 68

6.2 Unmet Needs Analysis ...................................................................................................... 69

6.2.1 Unmet Need: Non-Invasive Diagnostics ........................................................................ 69

6.2.2 Unmet Need: Non-Hormonal Therapies ........................................................................ 70

6.2.3 Unmet Need: Better Pain Management ......................................................................... 70

6.2.4 Unmet Need: Better Understanding of the Disease Pathology to Prevent Recurrence .. 71

6.2.5 Unmet Need: Identification of Biomarkers ..................................................................... 72

6.2.6 Unmet Need: Transparency in Clinical Trials ................................................................. 72

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ENDOMETRIOSIS – OPPORTUNITY ANALYSIS AND FORECASTS TO 2017

6.3 Opportunity Analysis ......................................................................................................... 73

6.3.1 Opportunity: Biomarkers Identification ........................................................................... 73

6.3.2 Opportunity: Treatment Options for Adolescents ........................................................... 74

6.3.3 Opportunity: Drugs Targeting Pain Pathways ................................................................ 74

6.3.4 Opportunity: Novel Targets............................................................................................ 75

6.3.5 Opportunity: Efficacious Treatments Suitable for Long-Term Use ................................. 75

6.4 Research and Development Strategies ............................................................................. 76

6.4.1 Overview ....................................................................................................................... 76

6.4.2 The Race for the Development of GnRH Antagonists.................................................... 77

6.4.3 Alliances and In-Licensing Strategies ............................................................................ 77

6.4.4 Maximizing Return-on-Investment by Targeting Secondary indications ......................... 78

6.5 Clinical Trial Design .......................................................................................................... 79

6.5.1 Overview ....................................................................................................................... 79

6.5.2 Defining Efficacy in Endometriosis Clinical Trials .......................................................... 79

6.5.3 Future Trends in Endometriosis Clinical Trial Design .................................................... 84

7 Pipeline Assessment................................................................................................................. 85

7.1 Overview ........................................................................................................................... 85

7.2 Promising Drugs in Development ...................................................................................... 86

7.2.1 Elagolix (ABT-602) ........................................................................................................ 87

7.2.2 Relugolix (TAK-385) ...................................................................................................... 91

7.2.3 ASP-1707 ...................................................................................................................... 93

7.3 Innovative Early-Stage Approaches .................................................................................. 95

7.3.1 Overview ....................................................................................................................... 95

7.3.2 Anti-Inflammatory Approaches ...................................................................................... 97

7.3.3 Cellular Adhesion .......................................................................................................... 98

7.3.4 Angiogenesis Endometriotic Implants ............................................................................ 98

7.3.5 Selective Progesterone Receptor Modulators................................................................ 99

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7.3.6 Aromatase Inhibitors ................................................................................................... 100

8 Pipeline Valuation Analysis ..................................................................................................... 101

8.1 Overview ......................................................................................................................... 101

8.2 Clinical Benchmarking of Key Pipeline Drugs .................................................................. 101

8.3 Commercial Benchmarking of Key Pipeline Drugs .......................................................... 105

8.4 Competitive Assessment ................................................................................................. 106

8.5 Top-Line, Five-Year Forecasts ........................................................................................ 107

8.5.1 Overview ..................................................................................................................... 107

8.5.2 US ............................................................................................................................... 110

8.5.3 5EU ............................................................................................................................. 111

9 Appendix................................................................................................................................. 113

9.1 Bibliography .................................................................................................................... 113

9.2 Abbreviations .................................................................................................................. 124

9.3 Methodology ................................................................................................................... 127

9.4 Forecasting Methodology ................................................................................................ 127

9.4.1 Diagnosed Endometriosis Patients .............................................................................. 128

9.4.2 Percent Drug Treated Patients .................................................................................... 129

9.4.3 Drugs Included in Each Therapeutic Class .................................................................. 130

9.4.4 Launch and Patent Expiry Dates ................................................................................. 130

9.4.5 General Pricing Assumptions ...................................................................................... 131

9.4.6 Individual Drug Assumptions ....................................................................................... 131

9.4.7 Generic Erosion .......................................................................................................... 134

9.4.8 Pricing of Pipeline Agents............................................................................................ 134

9.5 Physicians and Specialists Included in This Study .......................................................... 135

9.6 About the Authors ........................................................................................................... 136

9.6.1 Author ......................................................................................................................... 136

9.6.2 Epidemiologist ............................................................................................................. 136

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9.6.3 Global Director of Epidemiology and Health Policy ...................................................... 137

9.6.4 Global Head of Healthcare .......................................................................................... 137

9.7 About GlobalData ............................................................................................................ 138

9.8 Disclaimer ....................................................................................................................... 138

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ENDOMETRIOSIS – OPPORTUNITY ANALYSIS AND FORECASTS TO 2017

1.1 List of Tables

Table 1: ICD-9-CM Codes for Endometriosis and Pelvic Pain .................................................................... 17

Table 2: Stages of Endometriosis .............................................................................................................. 19

Table 3: Symptoms of Endometriosis ........................................................................................................ 22

Table 4: Risk Factors for Endometriosis .................................................................................................... 23

Table 5: Epidemiological Sources for the Diagnosed Prevalence and Stages of Endometriosis ................. 30

Table 6: 6MM, Diagnosed Prevalent Cases of Endometriosis, Ages 15–49 Years, N, 2012–2022.............. 36

Table 7: 6MM, Diagnosed Prevalent Cases of Endometriosis, by Age, N, Row (%), 2012 .......................... 38

Table 8: Leading Branded Treatments for Endometriosis .......................................................................... 48

Table 9: Product Profile – Zoladex ............................................................................................................ 50

Table 10: SWOT Analysis – Zoladex ........................................................................................................... 51

Table 11: Product Profile – Lupron .............................................................................................................. 52

Table 12: SWOT Analysis – Lupron ............................................................................................................ 54

Table 13: Product Profile – Synarel ............................................................................................................. 55

Table 14: SWOT Analysis – Synarel ........................................................................................................... 56

Table 15: Product Profile – Visanne ............................................................................................................ 57

Table 16: SWOT Analysis – Visanne........................................................................................................... 59

Table 17: Product Profile – Depo-SubQ Provera 104 .................................................................................. 60

Table 18: SWOT Analysis – Depo-SubQ Provera 104 ................................................................................. 62

Table 19: Product Profile – Danazol ............................................................................................................ 63

Table 20: SWOT Analysis – Danazol .......................................................................................................... 64

Table 21: Branded Hormonal Contraceptives Commonly Used Off Label for Endometriosis ........................ 65

Table 22: Progestins Commonly Used Off Label for Endometriosis ............................................................. 66

Table 23: Overall Unmet Needs – Current Level of Attainment .................................................................... 69

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Table 24: Common Primary and Secondary Outcome Measures in Endometriosis Clinical Trials ................ 80

Table 25: Design of the Most Relevant Current Phase II and III Clinical Trials in Endometriosis................... 82

Table 26: Endometriosis – Late-Stage Pipeline, 2012 ................................................................................. 86

Table 27: Product Profile – Elagolix............................................................................................................. 88

Table 28: SWOT Analysis – Elagolix ........................................................................................................... 90

Table 29: Product Profile – Relugolix .......................................................................................................... 92

Table 30: SWOT Analysis – Relugolix ......................................................................................................... 93

Table 31: Product Profile – ASP-1707 ......................................................................................................... 94

Table 32: SWOT Analysis – ASP-1017 ....................................................................................................... 95

Table 33: Early-Stage Pipeline Products for Endometriosis ......................................................................... 96

Table 34: Clinical Benchmarking of Key Pipeline Drugs for Endometriosis ................................................. 102

Table 35: Commercial Benchmarking of Key Pipeline Drugs for Endometriosis ......................................... 105

Table 36: Top Line Sales Forecasts ($) for Endometriosis, 2012–2017 ..................................................... 108

Table 37: Endometriosis Therapeutics Market – Drivers and Barriers, 2012 – 2017 .................................. 110

Table 38: Key Events Influencing Sales for Endometriosis, 2012–2017 ..................................................... 110

Table 39: Key Launch Dates ..................................................................................................................... 130

Table 40: Key Patent Expiries ................................................................................................................... 130

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ENDOMETRIOSIS – OPPORTUNITY ANALYSIS AND FORECASTS TO 2017

1.2 List of Figures

Figure 1: 6MM, Diagnosed Prevalent Cases of Endometriosis, Ages 15–49 Years, N, 2012–2022.............. 37

Figure 2: 6MM, Diagnosed Prevalent Cases of Endometriosis, by Age, N, 2012 ......................................... 38

Figure 3: 6MM, Age-Standardized Diagnosed Prevalence (%) of Endometriosis, Ages 15–49 Years, 2012 . 40

Figure 4: 6MM, Diagnosed Prevalent Cases of Endometriosis by Stage, Ages 15–49 Years, 2012 ............. 41

Figure 5: Endometriosis Pipeline by Phase, 2012–2017 ............................................................................. 86

Figure 6: Advantages of GnRH Antagonists Over GnRH Agonists .............................................................. 87

Figure 7: Competitive Assessment of Late-Stage Pipeline Agents in Endometriosis Therapeutics, 2012–

2017.......................................................................................................................................... 107

Figure 8: Global Sales for Endometriosis Therapeutics by Region, 2012–2017 ......................................... 109

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ENDOMETRIOSIS – OPPORTUNITY ANALYSIS AND FORECASTS TO 2017

Introduction

2 Introduction

2.1 Catalyst

The endometriosis therapeutics market has been in need of innovative therapies for quite a while.

Competition in this market has historically been weak due to the lack of approved products.

Hormonal therapies have dominated this market, yet the currently approved drugs leave much to

be desired in terms of their risk-benefit profiles and long-term efficacy. The endometriosis

therapeutics market is expected to experience a flurry of changes over the next five years.

Although the market-leading gonadotropin-releasing hormone (GnRH) agonist, Lupron (leuprolide

acetate), will lose patent protection in 2014, this change will be offset by the launch of AbbVie and

Neurocrine’s first-in-class oral GnRH antagonist, elagolix. The entry of elagolix will provide a much-

needed jolt to this market. In fact, this product will be the first major innovation in this indication in

many years. Being orally active is a major benefit of elagolix, which will potentially offer several

advantages over the incumbent injectable GnRH agonists. The GnRH antagonist mechanism of

action allows for the rapid onset of estrogen suppression, without the hormonal flare effect seen

with the GnRH agonists. Furthermore, the deleterious BMD loss seen with the injectable GnRH

agonists is not seen with the GnRH antagonists. Ultimately, elagolix’s oral route of administration

will be a welcome addition to the therapeutic paradigm that will give doctors more control over

dosing and will allow for the titration of circulating estrogen levels. By allowing for modulation of the

level of ovarian suppression, elagolix will be a customizable solution, with increased safety over the

currently approved drugs. Elagolix’s major commercial attribute will be its potential to tap into a

larger patient pool than drugs such as the GnRH agonists, Lupron and Zoladex (gosarelin acetate).

2.2 Related Reports

GlobalData (2013). EpiCast Report: Endometriosis – Epidemiology Forecast to 2022,

PHARMAEPIA35167.

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9.6.3 Global Director of Epidemiology and Health Policy

Franka des Vignes, PhD, currently serves as the Global Director of Epidemiology and Health

Policy at GlobalData in New York City, where her primary responsibilities include managing the

production and quality of the epidemiology reports and forecast models, improving the

epidemiology database, liaising with clients to identify their satisfaction with the existing

epidemiology offerings, prioritizing critical unmet needs, and supporting GlobalData teams with

consulting opportunities. Prior to joining GlobalData, Franka worked for several years in the public

sector to implement and manage several large projects leading to successful disease surveillance

programs in the United States. Her experience includes analyzing epidemiological trends,

assessing clinical trials, and performing pharmaceutical market forecasting in the private sector. In

the nonprofit sector, she served as the Deputy Director of a Washington DC-based organization

focused on health policy regarding HIV/AIDS. In the international arena, she has advised national

Ministries of Health and has worked for international health organizations such as

CAREC/PAHO/WHO to provide technical assistance to governments with health systems’

strengthening, patient population databases, and the assessment of surveillance systems in more

than 20 countries in the Caribbean and Latin America. Franka holds a Master of Science in

Microbiology and a PhD in Epidemiology and Public Health from Yale University.

9.6.4 Global Head of Healthcare

Bonnie Bain, PhD, is Global Head of Healthcare for GlobalData in Boston, managing the Medical

and Pharmaceutical arms of the business. Prior to this role, she was Vice President and Global

Research & Analysis Director for Informa, where she oversaw the global strategy and operations

for Datamonitor Healthcare’s syndicated business. Bonnie has over 15 years of experience in the

healthcare sector and a proven track record of developing innovative solutions on both the client

and vendor sides of the business. Prior to joining Informa, she was Director of Product

Development at Wood Mackenzie, where she oversaw the development and management of two

product lines. Bonnie also worked for several years at Decision Resources as an Analyst and

Project Manager. On the client side of the industry, she worked for several years as a Senior

Manager in Marketing Strategy and Analytics at Boston Scientific, where her work contributed to

the successful commercialization of the first-ever Access and Visualization Platform at the

company. She has a PhD in Biochemistry and Molecular Biology from Purdue University, and was

a postdoctoral fellow in molecular pharmacology at the University of Miami School of Medicine.

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9.7 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, London, India, and Singapore.

9.8 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.