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Cobicistat (HIV) – Forecast and Market Analysis to 2022
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Cobicistat (HIV) – Forecast and Market Analysis to 2022

Summary

GlobalData has released its new PharmaPoint Drug Evaluation report, “Cobicistat (HIV) – Forecast and Market Analysis to 2022”. Human Immunodeficiency Virus (HIV), the causative agent of AIDS, has claimed millions of lives since its emergence. However, the advent of antiretroviral therapy (ART) has transformed the face of HIV/AIDS from a deadly disease to a manageable chronic condition for most infected individuals. Antiretroviral treatment not only reduces the viral load and reconstitutes immune function, but also decreases infection incidence rates by limiting viral transmission. The treatment algorithm in HIV has characteristically involved multiple drug regimens designed to tackle the virus on different levels. In the recent past, simplified dosing regimens through the emergence of single tablet regimens (STRs) or fixed dose combination (FDC) therapies have become increasingly popular amongst physicians and patients alike by increasing clinical efficacy thresholds and enabling patient compliance.

Gilead has developed a novel pharmacokinetic booster, cobicistat (previously known as GS-9350), which acts as an inhibitor of human cytochrome P450 3A (CYP3A) isoforms. The drug increases the systemic exposure of co-administered medications that are metabolized by CYP3A enzymes, such as protease inhibitors. This increases the co-administered drug’s bioavailability, thereby enabling less frequent dosing of the co-administered medications (PIs or elvitegravir). Cobicistat’s mechanism is similar to AbbVie’s Norvir (ritonavir), but cobicistat lacks intrinsic antiretroviral activity. When dosed as a booster, the antiretroviral activity of Norvir is minimal, which positions cobicistat as a threat to Norvir as a PK booster, since neither can claim antiviral activity. Studies that compared cobicistat with Norvir used a CYP3A substrate, midazolam for clearance. Both Norvir and cobicistat potently inhibit midazolam from being cleared. That means that a drug that would be metabolized by CYP3A can have sustained antiviral activity in the presence of cobicistat (Mathias et al., 2010). Cobicistat is already approved for use in the US as a component of Gilead’s Stribild (Sax et al., 2012). Gilead also filed for EMA approval in the EU, and Japan Tobacco filed an application with the Pharmaceuticals and Medical Devices (PMDA) in Japan for a drug with Stribild’s formulation in November of 2012. In June 2012, Gilead Sciences also filed a New Drug Application (NDA) with the FDA for approval as a standalone booster to be used with pre-existing PIs that are currently used with AbbVie’s Norvir (Gilead Sciences, press release, July 24, 2012). GlobalData estimates that cobicistat will be launched in the US and EU in 2013, and in Japan by 2014.

Scope

– Overview of HIV, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
– Detailed information on Cobicistat including product description, safety and efficacy profiles as well as a SWOT analysis.
– Sales forecast for Cobicistat for the top nine countries from 2012 to 2022.
– Sales information covered for the US, France, Germany, Italy, Spain, the UK, Japan, Brazil and China

Reasons to buy

– Understand and capitalize by identifying products that are most likely to ensure a robust return
– Stay ahead of the competition by understanding the changing competitive landscape for HIV
– Effectively plan your MA and partnership strategies by identifying drugs with the most promising sales potential
– Make more informed business decisions from insightful and in-depth analysis of Cobicistat performance
– Obtain sales forecast for Cobicistat from 2012-2022 in top nine countries (the US, France, Germany, Italy, Spain, the UK, Japan, Brazil and China)

Table of Contents

1 Table of Contents 4
1.1 List of Tables 7
1.2 List of Figures 7
2 Introduction 8
2.1 Catalyst 8
2.2 Related Reports 8
3 Disease Overview 10
3.1 Etiology and Pathophysiology 10
3.1.1 Etiology 10
3.1.2 Pathophysiology 13
3.1.3 Prognosis 13
3.1.4 Quality of Life 14
3.2 Symptoms 14
3.2.1 Primary or Acute Infection 14
3.2.2 Chronic Infection 14
3.2.3 Advanced Infection/AIDS 15
4 Disease Management 16
4.1 Treatment Overview 16
5 Competitive Assessment 20
5.1 Overview 20
5.2 Strategic Competitor Assessment 20
6 Opportunity and Unmet Need 23
6.1 Overview 23
6.1.1 Simplified regimens and dosing frequency 23
6.1.2 Side effects and toxicities 24
6.1.3 Drug resistance 24
6.1.4 Prophylaxis 25
6.1.5 Lack of functional cure 25
6.1.6 Patient awareness 26
6.1.7 Treatment availability 26
6.1.8 Treatment affordability 27
6.2 Unmet Needs Gap Analysis 27
6.3 Opportunities 29
6.3.1 Development of treatments to counter drug resistance 29
6.3.2 Collaborations to develop newer STRs 29
6.3.3 Development of new injectable formulations 29
6.3.4 Development of new prophylactics 30
6.3.5 Development of drugs that use a novel mechanism of action 30
6.3.6 Public-Private Partnerships 30
7 Pipeline Assessment 31
7.1 Overview 31
7.2 Promising Drugs in Clinical Development 32
8 Cobicistat 34
8.1 Overview 34
8.2 Efficacy 36
8.3 Safety 37
8.4 Dosing and Formulation 37
8.5 Potential Clinical Positioning 37
8.6 Potential Commercial Positioning 38
8.7 Pricing and Reimbursement 38
8.8 SWOT Analysis 39
8.9 Forecast 40
9 Appendix 42
9.1 Bibliography 42
9.2 Abbreviations 46
9.3 Methodology 48
9.4 Forecasting Methodology 48
9.4.1 HIV Prevalence 48
9.4.2 Percent Drug-Treated Patients 48
9.4.3 General Pricing Assumptions 49
9.4.4 Generic Erosion 50
9.4.5 Pricing of Pipeline agents 50
9.5 Physicians and Specialists Included in this Study 51
9.5.1 Survery of Prescribing Physicians 52
9.6 About the Authors 53
9.6.1 Authors 53
9.6.2 Global Head of Healthcare 54
9.7 About GlobalData 55
9.8 Contact Us 55
9.9 Disclaimer 55

List of Tables

Table 1: Symptoms HIV 15
Table 2: Treatment Guidelines for HIV 17
Table 3: Most Prescribed Drugs for HIV by Class in the Global Markets, 2012 18
Table 4: Leading Treatments for HIV, 2012 22
Table 5: Overall Unmet Needs – Current Level of Attainment 23
Table 6: Clinical Unmet Needs – Gap Analysis, 2012 28
Table 7: HIV – Promising Drugs in Clinical Development, 2012 32
Table 8: Comparison of Therapeutic Classes in Development for HIV, 2012 33
Table 9: Product Profile – Cobicistat 36
Table 10: Cobicistat SWOT Analysis, 2012 40
Table 11: Global Sales Forecasts ($m) for cobicistat, 2012–2022 41
Table 12: Physicians Surveyed, By Country 52

List of Figures

Figure 1: HIV Lifecycle 11
Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in HIV, 2012–2022 33

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Cobicistat (HIV) – Forecast and Market Analysis to 2022

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