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Cobicistat (HIV) - Forecast And Market Analysis To 2022

NEW YORK, April 10, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Cobicistat (HIV) - Forecast and Market Analysis to 2022 http://www.reportlinker.com/p01158420/Cobicistat-HIV---Forecast-and-Market-Analysis-to-2022.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Pathology

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 M&A 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 41.1 List of Tables 71.2 List of Figures 72 Introduction 82.1 Catalyst 82.2 Related Reports 83 Disease Overview 103.1 Etiology and Pathophysiology 103.1.1 Etiology 103.1.2 Pathophysiology 133.1.3 Prognosis 133.1.4 Quality of Life 143.2 Symptoms 143.2.1 Primary or Acute Infection 143.2.2 Chronic Infection 143.2.3 Advanced Infection/AIDS 154 Disease Management 164.1 Treatment Overview 165 Competitive Assessment 205.1 Overview 205.2 Strategic Competitor Assessment 206 Opportunity and Unmet Need 236.1 Overview 236.1.1 Simplified regimens and dosing frequency 236.1.2 Side effects and toxicities 246.1.3 Drug resistance 246.1.4 Prophylaxis 256.1.5 Lack of functional cure 256.1.6 Patient awareness 266.1.7 Treatment availability 266.1.8 Treatment affordability 276.2 Unmet Needs Gap Analysis 276.3 Opportunities 296.3.1 Development of treatments to counter drug resistance 296.3.2 Collaborations to develop newer STRs 296.3.3 Development of new injectable formulations 296.3.4 Development of new prophylactics 306.3.5 Development of drugs that use a novel mechanism of action 306.3.6 Public-Private Partnerships 307 Pipeline Assessment 317.1 Overview 317.2 Promising Drugs in Clinical Development 328 Cobicistat 348.1 Overview 348.2 Efficacy 368.3 Safety 378.4 Dosing and Formulation 378.5 Potential Clinical Positioning 378.6 Potential Commercial Positioning 388.7 Pricing and Reimbursement 388.8 SWOT Analysis 398.9 Forecast 409 Appendix 429.1 Bibliography 429.2 Abbreviations 469.3 Methodology 489.4 Forecasting Methodology 489.4.1 HIV Prevalence 489.4.2 Percent Drug-Treated Patients 489.4.3 General Pricing Assumptions 499.4.4 Generic Erosion 509.4.5 Pricing of Pipeline agents 509.5 Physicians and Specialists Included in this Study 519.5.1 Survery of Prescribing Physicians 529.6 About the Authors 539.6.1 Authors 539.6.2 Global Head of Healthcare 549.7 About GlobalData 559.8 Contact Us 559.9 Disclaimer 55

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