Printer Friendly Printed from http://www.researchandmarkets.com/reports/223048 Commercial and Pipeline Perspectives: Lower GI Disorders - Remicade Leads Growth as Novel Biologics Compete for Market Share in Inflammatory Bowel Disease Description: Introduction IBD pipeline products are set to challenge Remicade and other existing therapies in the management of the disease. Competition will intensify as CDP870, Antegren, and Humira provide new alternatives in the severe Crohns disease market, and mode of administration will be a key element of product differentiation. In ulcerative colitis, drugs with novel mechanisms will compete for patient share. Scope Assessment of epidemiological data and patient potential Analysis of IBD product pipeline with emphasis on Phase III, including trial results and opinion leader insight Seven country sales forecasts to 2014 Transcripts of interviews with key IBD opinion leaders in the US, UK, and Japan Highlights Antegren has been filed early for multiple sclerosis on the basis of one year data from Phase III studies. Strong uptake of Antegren in multiple sclerosis, followed by approval for Crohns disease in 2006, will put pressure on Biogen Idecs manufacturing capabilities, making swift completion of a new production plant in San Diego crucial. Patients who received a limited course of induction therapy with Remicade in effect were "immunized" against the product, and sometimes have not been able to benefit from maintenance therapy when this indication has been approved. This has shrunk the potential patient population for Remicade in Crohns disease, reducing revenues. A desire to stay with "tried and trusted" Remicade means that in Crohns disease, switching from Remicade caused by Medicare drug coverage in 2006 will be limited. Uptake of CDP870, Antegren, and Humira in Crohns disease will be boosted by Medicare reform, but probably not at Remicades expense. Reasons to Purchase Understand the impact of Medicare reform in the biologics for IBD market and how companies are positioning products for maximum benefit In a sector heavily dependent on licensing deals, appreciate why big pharma needs to worry about alienating potential partners Explore IBD clinical trial design and recruitment strategies to understand how to maximize chances for success Contents: TABLE OF CONTENTS CHAPTER 1 EXECUTIVE SUMMARY 3 Objective of the analysis 3 insight into the IBD market 3 CHAPTER 2 PATIENT POTENTIAL 11 Definition of IBD 12 CD 12 UC 13 Segmentation of the IBD population 15 CD 15 Mild to moderate 15 Moderate to severe 15 Severe fulminant disease 15 Remission 16 UC 16 Mild 16 Moderate 16 Severe 16 Epidemiology of the IBD population 17 Unmet needs in IBD 19 Efficacy 19 Side effects 20 Convenience 20 Products covered in this analysis 21 CHAPTER 3 R&D APPROACH 23 Classification of pipeline products 24 Clinical trial design and endpoints in IBD 25 Practical challenges in IBD trial design 25 CD trial design: a work in progress 25 Measuring efficacy in CD: indexes and beyond 26 CDAI for beginners 26 CDAI issues and debates 28 Additional endpoints 29 Improvements possible to CDAI gold standard 31 Using the CDAI: continuous index, or proportions of patients? 31 Placebo response in CD: trial design challenges and solutions for biologics 32 Efficacy endpoints in CD: how high is the bar? 33 Measuring efficacy in UC: indexes and beyond 34 DAI for beginners 34 DAI issues and debates 35 Placebo as active intervention in UC? 36 Diary keeping in UC: another active intervention? 37 CHAPTER 4 COMMERCIAL ANALYSIS 38 Remicade: localized strategies deliver outstanding growth in a tale of three companies 39 Profile 39 Drug overview 43 Marketing partners deliver global growth 49 Johnson & Johnson: relentless investment sustains growth 51 Schering-Plough: Remicade provides relief in troubled times 55 Tanabe: physician education to drive sales as epidemiology and market gaps define Remicade’s niche 59 Forecast assumptions 65 CHAPTER 5 LATE-STAGE DRUG ANALYSIS AND FORECASTS 70 Overview 71 Pipeline summary 71 Product assessment methodology 71 Prograf 77 Profile 77 Drug overview 77 Clinical trial data 80 Patient potential 82 Marketing factors 82 Satisfaction of unmet needs 83 Forecast assumptions 83 Humira 86 Profile 86 Drug overview 86 Clinical trial data 94 Patient potential 95 Marketing factors 95 Satisfaction of unmet needs 95 Forecast assumptions 97 Alicaforsen sodium 102 Profile 102 Drug overview 104 Clinical trial data 108 Patient potential 120 Marketing factors 120 Satisfaction of unmet needs 121 Forecast assumptions 122 CDP870 124 Profile 124 Drug overview 126 Clinical trial data 132 Patient potential 134 Marketing factors 134 Satisfaction of unmet needs 134 Forecast assumptions 136 OPC-6535 139 Profile 139 Drug overview 141 Clinical trial data 141 Patient potential 142 Marketing factors 142 Satisfaction of unmet needs 143 Forecast assumptions 144 Antegren 146 Profile 146 Drug overview 148 Clinical trial data 154 Patient potential 156 Marketing factors 157 Satisfaction of unmet needs 157 Forecast assumptions 158 COLAL-PRED 162 Profile 162 Drug overview 164 Clinical trial data 168 Patient potential 170 Marketing factors 170 Satisfaction of unmet needs 171 Forecast assumptions 172 Other drugs in IBD 175 CHAPTER 6 OPINION LEADER TRANSCRIPTS 177 Opinion leader interviews: methodology 177 Opinion leader interviews: biographies 177 Professor Anthony Axon (ATR Axon, Anthony Thomas Roger Axon, Tony Axon) 177 Professor Danial Baker 178 Professor Subrata Ghosh 178 Professor Tetsuya Mine 179 Opinion leader interviews: questions 180 Opinion leader interviews: answers 182 CHAPTER 7 APPENDIX 211 Report methodology 211 Japanese market data 211 Standard units 211 Pricing forecasts 211 Exchange rates and calendrical notes 212 Bibliography 213 Disclaimer 217 Ordering: Order Online - visit http://www.researchandmarkets.com/reports/223048 Order by Fax - using the order form below Order By Post - print the order form below and send to Research and Markets, Guinness Centre, Taylors Lane, Dublin 8, Ireland. Page 1 of 2 Printed 29/08/2008 02:25:33 Fax Order Form To place an order via fax simply print this form, fill in the information below and fax the completed form to the number at the bottom of this page. If you have any questions please email help@researchandmarkets.com Order information Please verify that the product information is correct and select the format you require. Product Name: Commercial and Pipeline Perspectives: Lower GI Disorders - Remicade Leads Growth as Novel Biologics Compete for Market Share in Inflammatory Bowel Disease Web Address: http://www.researchandmarkets.com/reports/223048 Office Code: OCHGLKLRMOV Report formats Please enter the quantity of the report format you require. Format Quantity Price Electronic €16,264.00 Contact information Please enter all the information below in BLOCK CAPITALS. First Name:   Last Name:   Email Address: Job Title: Organisation: Address: City: Postal/Zip Code: Country: Phone Number: Fax Number: Please fax this form to: (646)607-1907 or (646)964-6609 - From USA +353-1-481-1716 or +353-1-653-1571 - From Rest of World Page 2 of 2 Printed 29/08/2008 02:25:33 Payment information Please indicate the payment method you would like to use by selecting the appropriate box.  Pay by Credit Card: American Express Diners Club Master Card Visa Cardholder Name: Expiry Date: / Card Number: CVV Security Code: Issue Date: /   (Diners Club only)  Pay by Check: Please post the check, accompanied by this form, to: Research and Markets, Guinness Centre, Taylors Lane, Dublin 8, Ireland.  Pay by Wire Transfer: Please transfer funds to: Account number: 83313083 Sort code: 98-53-30 Swift code: ULSBIE2D IBAN number: IE78ULSB98533083313083 Bank Address: Ulster Bank, 27-35 Main St, Blackrock, Co. Dublin, Ireland. If you have a Marketing Code please enter it below: Marketing Code: Please note that by ordering from Research and Markets you are agreeing to our Terms and Conditions at http://www.researchandmarkets.com/info/terms.asp Please fax this form to: (646)607-1907 or (646)964-6609 - From USA +353-1-481-1716 or +353-1-653-1571 - From Rest of World