Market Report Source

Overview

Introduction

Novel oral anticoagulants and antiplatelet agents will have a profound impact on the antithrombotics market. Datamonitor expects Bayer’s rivaroxaban and Sankyo/Eli Lilly’s prasugrel to achieve blockbuster status. Parenteral anticoagulants are not expected to be large revenue generators, due to low clinical unmet need in this market segment and strong competition from current gold standard agents.

Scope

• Event-driven sales projections for 2007-16 for key late-stage developmental antithrombotics in the seven major markets
• Commercial analysis of late-stage developmental compounds in terms of their ability to satisfy unmet clinical needs
• An overview of the antithrombotics R&D pipeline with a comprehensive assessment of all classes in development
• Analysis of the potential for developmental antithrombotics with respect to the patient populations for which they are indicated

Highlights

Following the abrupt withdrawal of AstraZeneca’s Exanta in February 2006, Bayer Healthcare’s rivaroxaban and Boehringer Ingelheim’s Rendix are well positioned to profit from patients switching from warfarin, and market growth obtained by recruiting the previously untreated population. The highest selling brands in the antidiabetics market are Lovenox (enoxaparin) and Plavix (clopidogrel), but these agents will be genericized within our forecast period. Consequently, pipeline agents are expected to become significant drivers in the market. Acute Coronary Syndrome is usually the first indication for which novel anticoagulants are approved; this is a quick route to market, while drug companies then prepare to launch their products in more lucrative, chronic treatment markets.

Reasons to Purchase

• Understand the factors that will drive the success of next-generation antithrombotics
• Overcome the barriers to entry generated by lifecycle strategies of key players in the market
• Assess the remaining market opportunity, where established therapies and other developmental compounds fail to address key unmet clinical needs

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the Disease pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Datamonitor insight into the antithrombotics market

Key metrics

Datamonitor pipeline assessment summary

Anticoagulants

Antiplatelet Agents

CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS

Pipeline overview

Antithrombotics segmented by mechanism of action

Redesigning heparin: the race for ideal coagulation cascade target is still open

Antiplatelet agents by drug class

Antithrombotics segmented by developing company

Japanese companies in the antithrombotics market

Key companies involved in the antithrombotics pipeline

Overview

AstraZeneca

Sanofi-Aventis

CHAPTER 3 PATIENT POTENTIAL

Definition of antithrombotic market

Antithrombotic launch indications

Venous thrombosis

VTE prophylaxis in patients undergoing major orthopedic surgery

Treatment and secondary prevention of acute venous thromboembolism

Arterial thrombosis

Coronary thrombosis

Acute coronary syndromes

Incidence of STEMI

Incidence of UA and NSTEMI

Cerebrovascular thrombosis

Stroke treatment

Stroke prevention in atrial fibrillation patients (SPAF)

Peripheral thrombosis

Peripheral arterial disease (PAD)

Marketing considerations: unmet needs, barriers to market entry and uptake

Anticoagulants

Unmet needs: parenteral anticoagulants

Unmet needs: oral anticoagulants

Unmet need: increased physician awareness of VTE

Points of consideration: factors influencing market entry and uptake

Unmet needs summary

Antiplatelets

Unmet needs

Unmet need for rapid onset of action in interventional cardiology

Unmet need: increased physician awareness for the need of therapy for PAD

Points of consideration: factors influencing market entry and uptake

Unmet needs summary

CHAPTER 4 R&D APPROACH

Classification of pipeline products

Anticoagulants

Hemostasis and the coagulation cascade

Indirect thrombin inhibitors

Unfractionated heparin (UFH)

Low molecular weight heparin (LMWH)

Direct thrombin inhibitors (DTIs)

Factor IXa inhibitors

Factor Xa inhibitors

Factor VIIa inhibitors/tissue factor pathway inhibitors

Anticoagulant activity

Antiplatelet Agents

Cyclo-oxygenase (COX) inhibitors: aspirin

ADP antagonists

GPIIb/IIIa inhibitors

PGE-1 antagonists

PI3-kinase antagonists

PGH2/TXA2 (TP) receptor antagonists

Clinical trial design for antithrombotics

Phase III sample size

Choice of control drug

Patient exclusion

Patient exclusion from efficacy analysis

Duration of drug intervention

Pre-operative or post-operative initiation of prophylaxis?

Dosing interval

Dose timing

Clinical trial endpoints for antithrombotics

Efficacy endpoints

VTE incidence

Diagnosis of VTE events

Central versus local adjudication

Safety endpoints

CHAPTER 5 ANTICOAGULANTS LATE-STAGE DRUG ANALYSIS AND FORECASTS

Overview of the key anticoagulants in late-stage development

Pipeline summary

Datamonitor drug assessment summary

Comparative forecasts

Rivaroxaban (BAY-59-7939)

Drug overview

Clinical data

Patient potential

Marketing factors

Forecasts to 2016

Dabigatran etexilate (BIBR-1048) – Rendix

Drug overview

Clinical data

Pharmacokinetics of dabigatran etexilate

Phase II clinical trial of Dabigatran etexilate in MOS versus enoxaparin: BISTRO II

Patient potential

SPAF – greatest potential for dabigatran etexilate

Potential device competitor for SPAF indication for high-risk patients?

Marketing factors

Forecast to 2016

Idraparinux

Drug overview

Clinical data

PERSIST trial

No significant effect on liver enzymes

Phase III VAN GOGH trial in PE patients

Phase III AMADEUS trial

Patient potential

Marketing factors

Strong presence and experience in the AF market

High price may pose a barrier to uptake

Lack of antidote raises concerns

Forecast to 2016

ART-123

Drug overview

Clinical data

Phase III trials

Phase I trials

Prevention of VTE after total hip replacement

Patient potential

Marketing factors

Forecast to 2016

CHAPTER 6 OTHER ANTICOAGULANTS

Antithrombin aptamers – NU-172 and ARC1779

Drug overview

Preclinical data

Clinical data

Apixaban (BMS-562247)

Drug overview

Clinical data

AVE-5026

Drug overview

Clinical data

AZD-0837

Drug overview

Clinical data

AZD-9684

Drug overview

Preclinical data

Biotinylated Idraparinux (SSR-126517)

Drug overview

Clinical data

DU-176b

Drug overview

Clinical data

E-5555

Drug overview

Preclinical data

Clinical data

Elaprin (Oral heparin) and Oral LMWH

Drug overview

Clinical data

Datamonitor comment

Flovagatran (TGN-255)

Drug overview

Clinical data

Datamonitor comments

GSK-813893

Drug overview

LY-517717

Drug overview

Clinical data

Odiparcil (SB-424323)

Drug overview

Clinical data

Otamixaban (XRP-0673)

Drug overview

Clinical data

PD-348292

Drug overview

Pegmusirudin (SPP-200; LU-57291)

Drug overview

Clinical data

PRT-54021

Drug overview

Clinical data

REG-1

Drug overview

Clinical data

SCH-530348

Drug overview

Preclinical data

Clinical data

Sofigatran (MCC-977)

Drug overview

SR-123781

Drug overview

Preclinical data

Clinical data

Tanogitran (BIBT-986)

Drug overview

Clinical data

TGN-167

Drug overview

Clinical data

TTP-889

Drug overview

Clinical data

Datamonitor comment

YM-150

Drug overview

Clinical data

CHAPTER 7 ANTIPLATELET AGENTS: LATE-STAGE ANALYSIS AND FORECASTS

Overview of the key antiplatelets in late-stage development

Pipeline summary

Datamonitor drug assessment summary

Comparative forecasts

Prasugrel (CS-747)

Drug overview

Clinical data

Phase IIa: Randomized two-way cross-over, open-label study in healthy subjects

Phase IIa : Randomized, partially blind, parallel group dose-ranging study

Patient potential

Marketing factors

Forecast to 2016

Cangrelor (AR-C69931)

Drug overview

Clinical Data

Patient potential

Marketing factors

Forecast to 2016

Ticagrelor (AZD-6140)

Drug overview

Clinical data

Patient Potential

Marketing Factors

Forecast to 2016

CHAPTER 8 OTHER ANTIPLATELET AGENTS

DA-697b

Drug overview

Preclinical data

DG-041

Drug overview

Preclinical data

Clinical data

Ecraprost

Drug overview

Clinical data

Datamonitor comment

Liprostin

Drug overview

Clinical data

Parogrelil (NM-702)

Drug overview

Clinical data

PR-15

Drug overview

Preclinical data

Clinical data

Datamonitor comment