Pipeline Insight: Multiple Sclerosis - The oral revolution : Market Research Report

Pipeline Insight: Multiple Sclerosis - The oral revolution

Published by: Datamonitor

Published: Mar. 30, 2007 - 250 Pages

ABOUT DATAMONITOR HEALTHCARE
CHAPTER 1 EXECUTIVE SUMMARY: Scope of the analysis; Datamonitor insight into the multiple sclerosis market; Key metrics; Datamonitor Pipeline Assessment Summary
CHAPTER 2 MULTIPLE SCLEROSIS PIPELINE OVERVIEW AND DYNAMICS: Pipeline overview; Oral disease-modifying drugs feature heavily in the late-stage MS pipeline; The majority of products are in development for RRMS; Oral formulations aiming to succeed in a solely injectable market; Key companies involved in the multiple sclerosis pipeline; Current MS players look to offset mass competition with follow-up products; Biogen Idec committed to maintaining MS market leader status; Avonex and Tysabri provide Biogen Idec with leader status in MS market; Rituxan and BG-12 Phase III MS developments lead the way; Early-stage development products add depth to Biogen Idec's MS pipeline; Biogen Idec's MS pipeline products are split by class and delivery mechanism; In-licensing and collaborations essential to Biogen Idec's future MS advancements; Teva looks to supplement its Copaxone franchise; Copaxone represents Teva's first branded product and now boasts blockbuster status; Oral Copaxone is still many years away from market; Laquinimod replaces oral Copaxone developments as Teva's front-running oral MS focus; Teva licenses Vaccinex's VX-15 to strengthen its long-term MS developments; Key R&D company strategies; Combination of oral administration with novel mechanism provides major competitive edge; Targeting SPMS and PPMS can reduce competition but will increase R&D challenge; In-licensing is increasingly important to secure long-term franchise growth
CHAPTER 3 MULTIPLE SCLEROSIS DISEASE OVERVIEW AND MARKET POTENTIAL: Definition of multiple sclerosis; There is no universal course for multiple sclerosis; Segmentation of multiple sclerosis; Researchers have attempted to classify multiple sclerosis according to the clinical course of the disease; Epidemiology of multiple sclerosis; Young female adults are most at risk of developing MS; Genetic and environmental factors appear to play a role in the onset of MS; Over 800,000 individuals in the US, Japan and 5EU markets are estimated to suffer from MS; US; Japan; 5EU; The majority of patients suffer from relapse remitting multiple sclerosis; Unmet needs in multiple sclerosis; Prevention and discovery of a cure are the ultimate goals in MS; Unmet need 1: improved efficacy; Improved disease modifying efficacy is the top unmet need in MS; The need for improved symptomatic efficacy remains an issue; Unmet need 2: improved side-effect profile; Improved side-effect profile is in joint second place as the highest unmet need below improved efficacy.; Unmet need 3: approval for a wider range of MS disease severities; Approval for a wider range of MS disease severities is regarded as a high unmet need; Unmet need 4: improved delivery method; The MS market is a solely injectable domain in need of a more less-invasive and user-friendly delivery method; Unmet need 5: fewer drug interactions; The ability to combine treatments depends on the drug-drug interactions
CHAPTER 4 R&D APPROACH: Current treatment options; Current treatment options; There are only six disease-modifying agents currently on the market; Across all stages of MS, 45% of total diagnosed patients do not receive disease-modifying therapy; RRMS and SPMS patients are most likely to recieve disease-modifying therapy; Classification of pipeline products; Novel drug classes look to capitalize in a largely undifferentiated market; Cytokines; Interferons; Interleukin antibodies; Other cytokines; Immunomodulators; Myelin basic protein modulators; Dehydrogenase inhibitors; Human immunoglobulins; Therapeutic vaccines; Others; Clinical trial design in multiple sclerosis; Approved MS disease-modifying drugs set the standard for future trial design; The revised McDonald criteria allows trials to include patients earlier in the course of their disease; Placebo-controlled MS trials might be considered unethical; A placebo control arm is essential in Phase III trials but less of an issue in Phase II trials; The SENTINEL and BEYOND trials provide alternative trial design; Clinical trial endpoints in multiple sclerosis; Relapse rate; Disability/progression measures; Fatigue; Expanded disability status scale; Multiple Sclerosis Functional Composite; Health-related quality-of-life assessments; The Multiple Sclerosis Quality of Life-54 instrument; Multiple Sclerosis Impact Scale; Multiple Sclerosis Symptom and Impact Diary; MRI measures; Conventional MRI techniques to assess lesions; Advanced MRI techniques; Brain atrophy
CHAPTER 5 CYTOKINE LATE-STAGE DRUG ANALYSIS & FORECASTS: Cytokine pipeline Overview; Pipeline summary; Definition of current comparator therapy; MS disease-modifier 'gold-standard' is Avonex; Two key studies evaluated the clinical effectiveness of Avonex in MS; Contraindications and adverse reactions reported with the use of Avonex; Avonex's major competitors and key strengths and weaknesses; Interferon pipeline overview; Pipeline summary; There are two interferon drugs in the late-stage R&D pipeline for MS in 2007; Alferon N injection (interferon alfa-n3); Drug overview; Clinical trial data; Alferon N under Hemispherx; Retrospective, uncontrolled study; Drug evaluation; Tauferon; Drug overview; Clinical trial data; Pre-clinical and Phase I; Phase II trial initiated; Drug evaluation; Interleukin antibodies pipeline overview; Pipeline summary; There are three interleukin antibodies in the late-stage R&D pipeline for MS in 2007; Daclizumab; Drug overview; Clinical trial data; Phase II open-label clinical studies; Phase II CHOICE study assessing daclizumab added to ongoing interferon-beta treatment; CHOICE study meets primary endpoint; Drug evaluation; CNTO-1275; Drug overview; Clinical trial data; Phase I data show subcutaneous injection of CNT0-1275 is well tolerated; Patient recruitment completed in safety and efficacy Phase II trial; Drug evaluation; ABT-874; Drug overview; Clinical trial data; Drug evaluation; Other cytokines pipeline overview; Pipeline summary; There are four other cytokine drugs in the late-stage R&D pipeline for multiple sclerosis in 2007; Rituxan (rituximab); Drug overview; Rituxan was first approved for non-Hodgkin's lymphoma in 1997; Ongoing developments of Rituxan in multiple indications; Clinical trial data; Positive 24-week 'HERMES' Phase II RRMS data; Results from Phase II/III PPMS OLYMPUS trial expected in H1-2007; Additional PPMS study in four patients shows Rituxan suppresses B-cells; Patient potential; Marketing potential; Satisfaction of unmet needs; Unmet need 1: improved efficacy; Unmet need 2: improved side-effect profile; Unmet need 3: approval for a wider range of MS severities; Unmet need 4: improved delivery method; Unmet need 5: fewer drug interactions; Forecasts to 2016; Datamonitor drug assessment summary; Campath (alemtuzumab); Drug overview; Clinical trial data; Early pilot MS studies; Suspension of Phase II RRMS CAMPATH MS 223 trial due to safety concerns; Drug evaluation; ATL-1102 (ISIS-107248); Drug overview; Clinical trial data; ATL-1102 proved well-tolerated through Phase I studies; Phase II ATL-1102 study in RRMS patients restarts after one-year suspension; Recent animal study supports the use of ATL-1102 in MS; Drug evaluation; MLN1202; Drug overview; Clinical trial data; Results from Phase II trial in 40 RRMS patients set for H1-2007; Drug evaluation
CHAPTER 6 IMMUNOMODULATOR LATE-STAGE DRUG ANALYSIS AND FORECASTS: Comparative forecasts; Comparative Datamonitor drug assessment summaries; Overview; Pipeline summary; There are four key immunomodulator drugs in the late-stage R&D pipeline for multiple sclerosis in 2007; BG-12; Drug overview; Clinical trial data; BG-12 achieves primary endpoint in a 257- patient Phase II RRMS study; Phase III BG-12 MS clinical program includes the DEFINE and CONFIRM international trials that plan to enroll more than 2,000 patients; Patient potential; Marketing potential; Satisfaction of unmet needs; Unmet need 1: improved efficacy; Unmet need 2: improved side-effect profile; Unmet need 3: approval for a wider range of MS severities; Unmet need 4: improved delivery method; Unmet need 5: fewer drug interactions; Forecasts to 2016; Datamonitor drug assessment summary; Laquinimod (SAIK-MS); Drug overview; Clinical trial data; Phase I dose escalation study meets primary endpoint and identifies 1.2mg as being the maximum-tolerated daily dose.; Phase II trial primary endpoint met with laquinimod 0.3mg/day; 77% of patients remained relapse-free during Phase II investigation trial of laquinimod at a higher dose; Teva discusses Phase III Laquinimod clinical program plan with regulatory authorities on back of positive Phase IIb safety and efficacy results; Patient potential; Marketing potential; Satisfaction of unmet needs; Unmet need 1: improved efficacy; Unmet need 2: improved side-effect profile; Unmet need 3: approval for a wider range of MS severities; Unmet need 4: improved delivery method; Unmet need 5: fewer drug interactions; Forecasts to 2016; Datamonitor drug assessment summary; Cpn10 (XToll); Drug overview; Clinical trial data; Phase I studies demonstrate tolerability of Cpn10 IV infusion and SC injection; Undisclosed Phase IIa trial results meet set objectives; Drug evaluation; GEM-SP; Drug overview; Clinical trial data; Drug evaluation; TV-5010; Drug overview; Drug evaluation
CHAPTER 7 MYELIN BASIC PROTEIN MODULATOR LATE-STAGE DRUG ANALYSIS AND FORECASTS: Overview; Pipeline summary; There are two myelin basic protein modulator drugs in the late-stage R&D pipeline for MS in 2007; MBP-8298; Drug overview; The design of MBP-8298 includes MBP residues 85-96 plus amino acid extension at both ends; MBP-8298 apparently induces immunological tolerance to autoimmune targeting of MBP; The University of Alberta has been granted 88 worldwide patents concerning MBP-8298; Clinical trial data; An in-depth development program of MBP-8298 sees it currently progressing through three MS clinical trials; MBP-8298 showed a reduction of MBP autoantibody in the CSF in chronic progressive MS sufferers during Phase I studies; Positive Phase II chronic progressive MS study results paved the way for Phase III SPMS trials; The MAESTRO-01 & MAESTRO-03 Phase II/III clinical trials in SPMS patients; Commencement of MINDSET-01 Phase II RRMS trial as BioMS aims to advance MBP-8298 into a second indication; Patient potential; Marketing potential; Satisfaction of unmet needs; Unmet need 1: improved efficacy; Unmet need 2: improved side-effect profile; Unmet need 3: approval for a wider range of MS severities; Unmet need 4: improved delivery method; Unmet need 5: fewer drug interactions; Forecasts to 2016; Datamonitor drug assessment summary; BHT-3009; Drug overview; Clinical trial data; Phase I MS trial of BHT-3009 as monotherapy or in combination with atorvastatin; Phase II RRMS trial initiated in February 2006; Drug evaluation
CHAPTER 8 DEHYDROGENASE INHIBITOR LATE-STAGE DRUG ANALYSIS AND FORECASTS: Overview; Pipeline summary; There are two dehydrogenase inhibitor drugs in the late-stage R&D pipeline for MS in 2007; Teriflunomide (HMR-1726); Drug overview; Clinical trial data; Phase II proof-of-concept study with 179 MS patients; Pivotal Phase III study EFC6049 continues to recruit two years after initiation; Sanofi-Aventis discloses long-term Teriflunomide development plans and look to initiate combination studies and studies in early MS; Patient potential; Marketing potential; Satisfaction of unmet needs; Unmet need 1: improved efficacy; Unmet need 2: improved side-effect profile; Unmet need 3: approval for a wider range of MS severities; Unmet need 4: improved delivery method; Unmet need 5: fewer drug interactions; Forecasts to 2016; Datamonitor drug assessment summary; CellCept (mycophenolate mofetil); Drug overview; Clinical trial data; Phase III RRMS trial of CellCept as monotherapy or in combination with Avonex; Drug evaluation
CHAPTER 9 HUMAN IMMUNOGLOBULIN LATE-STAGE DRUG ANALYSIS AND FORECASTS: Overview; Pipeline summary; There are two human immunoglobulin drugs in the late-stage R&D pipeline for MS in 2007; Venilon; Drug overview; Drug evaluation; Gamunex (IGIV); Drug overview; Clinical trial data; Phase II trial in RRMS patients was started in 2002 and is now complete; Drug evaluation
CHAPTER 10 THERAPEUTIC VACCINE LATE-STAGE DRUG ANALYSIS AND FORECASTS: Overview; Pipeline summary; There are two therapeutic vaccine drugs in the late-stage R&D pipeline for MS in 2007; NeuroVax; Drug overview; Clinical trial data; Phase I data presented in the late 1990s showed potential for the TCR peptide vaccine; NeuroVax remains in Phase II trials, six years after studies began; Drug evaluation; Tovaxin; Drug overview; Clinical trial data; Positive interim results from two Phase I/II clinical trials released in 2005; TERMS 150 patient Phase IIb trial initiated in August 2006; Drug evaluation
CHAPTER 11 OTHER LATE-STAGE DRUG ANALYSIS AND FORECASTS: Comparative forecasts; Comparative Datamonitor drug assessment summaries; Overview; Pipeline summary; There are six drugs classified as other in the late-stage R&D pipeline for MS in 2007; Mylinax (oral cladribine); Drug overview; Mylinax awarded Fast Track status by FDA for relapsing forms of MS; Clinical trial data; Previous studies of injectable cladribine support the use of the drug in MS; Achievement of therapeutic drug blood levels led the way for Mylinax Phase III studies; Phase III CLARITY study recruits over 1,300 RRMS patients; Initiation of ONWARD study of Mylinax & new formulation of Rebif add-on treatment; Patient potential; Marketing potential; Satisfaction of unmet needs; Unmet need 1: improved efficacy; Unmet need 2: improved side-effect profile; Unmet need 3: approval for a wider range of MS severities; Unmet need 4: improved delivery method; Unmet need 5: fewer drug interactions; Forecasts to 2016; Datamonitor drug assessment summary; Fingolimod (FTY720); Drug overview; Clinical trial data; Positive Phase II trial data reported by Novartis in January 2005; Six-month Phase II trial data presented in June 2005 at the 15th European Neurological Society meeting in Vienna, Austria; 12-month Phase II data show sustained benefits and good tolerability of fingolimod; Positive 18-month and two-year data presented; Phase III FREEDOMS program and FTY720D2309 trial evaluating the daily dosing of FTY720 have been initiated; TRANSFORMS study; Patient potential; Marketing potential; Satisfaction of unmet needs; Unmet need 1: improved efficacy; Unmet need 2: improved side-effect profile; Unmet need 3: approval for a wider range of MS severities; Unmet need 4: improved delivery method; Unmet need 5: fewer drug interactions; Forecasts to 2016; Datamonitor drug assessment summary; MN-166 (ibudilast); Drug overview; Clinical trial data; One year Phase II efficacy data expected in Q107 217; Drug evaluation; Firategrast (SB-683699; T-0047); Drug overview; Clinical trial data; Phase II trials of SB-683699 suspended because of safety concerns; Phase II MS trial resumed in January 2007; Drug evaluation; Oral E3 (Trimesta); Drug overview; Clinical trial data; Drug evaluation; E2007; Drug overview
CHAPTER 12 INNOVATIVE EARLY-STAGE PROJECTS: Key Phase I and preclinical compounds in multiple sclerosis; BalanCell; Nanocort
CHAPTER 13 SYMPTOMATIC MULTIPLE SCLEROSIS PIPELINE: Overview; Pipeline summary; Fampridine-SR; Drug overview; Clinical trial data; MCT-125; Drug overview; Erythropoietin; Drug overview
BIBLIOGRAPHY: Journals; Websites; Posters
APPENDIX A: Methodology; Definition of the MS market; Datamonitor forecast methodology; Estimated 2006 sales revenue; Product forecasts; Definition of a standard unit; Estimation of launch dates; Patent expiry and generic assumptions; Japanese market data; Additional information; Datamonitor drug assessment summary; Contributing experts; Report methodology
APPENDIX B: About Datamonitor; Datamonitor Healthcare's therapy area capabilities; About the CNS analysis team; Disclaimer
List of Tables: Table 1: Forecast key pipeline products for multiple sclerosis in the seven major markets ($), 2006-2016; Table 2: Disease-modifying pipeline drugs in Phase III development for multiple sclerosis, 2007; Table 3: Disease-modifying pipeline drugs in Phase II development for multiple sclerosis, 2007; Table 4: Biogen Idec's pipeline multiple sclerosis drugs, 2007; Table 5: Teva's pipeline multiple sclerosis drugs, 2007; Table 6: Prevalence of multiple sclerosis in the seven major markets, 2006; Table 7: The average rating of the clinical unmet needs in multiple sclerosis; Table 8: Key facts for marketed disease-modifying drugs for multiple sclerosis in the seven major markets, 2007; Table 9: Percentage of patients diagnosed with each stage of MS who receive disease-modifying drug therapy, 2006; Table 10: Expanded Disability Status Scale (EDSS) for multiple sclerosis; Table 11: Key interferon drugs in late-stage R&D pipeline for MS, 2007; Table 12: Biogen Idec's Avonex: key facts; Table 13: Comparisons of the four leading MS disease-modifiers; Table 14: Key interferon drugs in late-stage R&D pipeline for multiple sclerosis, 2007; Table 15: Key interleukin antibody drugs in late-stage R&D pipeline for multiple sclerosis, 2007; Table 16: Key other cytokine drugs in late-stage R&D pipeline for multiple sclerosis, 2007; Table 17: Key events, approval and launch dates impacting Rituxan revenue forecasts for multiple sclerosis in the seven major markets, 2007-2016; Table 18: Key immunomodulator drugs in late-stage R&D pipeline for multiple sclerosis, 2007; Table 19: Key events and launch dates impacting BG-12 revenue forecasts in the seven major markets, 2007-2016; Table 20: Key events and launch dates impacting Laquinimod revenue forecasts for multiple sclerosis in the seven major markets, 2007-2016; Table 21: Key myelin basic protein modulator drugs in late-stage R&D pipeline for MS, 2007; Table 22: Key events, approval and launch dates impacting MBP-8298 revenue forecast for multiple sclerosis in the seven major markets, 2007-2016; Table 23: Key dehydrogenase inhibitor drugs in late-stage R&D pipeline for multiple sclerosis, 2007; Table 24: Key events and launch dates impacting Teriflunomide revenue forecasts for multiple sclerosis in the seven major markets, 2007-2016; Table 25: Key human immunoglobulin drugs in late-stage R&D pipeline for multiple sclerosis, 2007; Table 26: Key therapeutic vaccine drugs in late-stage R&D pipeline for multiple sclerosis, 2007; Table 27: Key other drugs in late-stage R&D pipeline for multiple sclerosis, 2007; Table 28: Key events and launch dates impacting Mylinax revenue forecast for multiple sclerosis in the seven major markets, 2007-2016; Table 29: Key events and launch dates impacting Fingolimod revenue forecast for multiple sclerosis in the seven major markets, 2007-2016; Table 30: Drugs in Phase I development for multiple sclerosis, 2007; Table 31: Drugs in clinical and pre-clinical development for multiple sclerosis, 2007; Table 32: Key drugs in late-stage R&D pipeline for symptomatic treatment of multiple sclerosis, 2007; Table 33: Estimation of launch dates by phase of development; Table 34: Estimated generic discounts by country, 2006; Table 35: Estimation of brand erosion by following patent expiry by country; Table 36: Datamonitor's pipeline drug assessment weighting scale
List of Figures: Figure 1: Datamonitor's multiple sclerosis drug assessment summary for the seven major markets ($m), 2007-2016; Figure 2: Breakdown of the late stage pipeline by form of multiple sclerosis, 2007; Figure 3: Delivery method of multiple sclerosis pipeline drugs, 2007; Figure 4: Injection method of the 15 injectable multiple sclerosis pipeline drugs, 2007; Figure 5: Segmentation of multiple sclerosis; Figure 6: World distribution of multiple sclerosis; Figure 7: Percentage of diagnosed MS patients who suffer from each type of MS, 2006; Figure 8: Clinical unmet needs in multiple sclerosis according to KOLs, 2007; Figure 9: Percentage of patients diagnosed with each stage of MS who receive disease-modifying drug therapy, 2006; Figure 10: Breakdown of the late-stage multiple sclerosis pipeline by class, 2007; Figure 11: Datamonitor's forecast of sales for Rituxan for multiple sclerosis across the seven major markets ($m), 2007-2016; Figure 12: Datamonitor's competitive positioning analysis for Rituxan in the seven major markets, 2007-2016; Figure 13: Datamonitor's comparative forecast of sales for late-stage immunomodulator products across the seven major markets ($m), 2007-2016; Figure 14: Datamonitor's competitive positioning analysis for BG-12 and Laquinimod in the seven major markets, 2007-2016; Figure 15: Datamonitor's forecast of sales for BG-12 across the seven major markets ($m), 2007-2016; Figure 16: Datamonitor's competitive positioning analysis for BG-12 in the seven major markets, 2007-2016; Figure 17: Datamonitor's forecast of sales for Laquinimod across the seven major markets ($m), 2007-2016; Figure 18: Datamonitor's competitive positioning analysis for Laquinimod in the seven major markets, 2007-2016; Figure 19: MBP-8298 stage of development; Figure 20: Datamonitor's forecast of sales for MBP-8298 across the seven major markets for multiple sclerosis ($m), 2007-2016; Figure 21: Datamonitor's competitive positioning analysis for MBP-8298 in the seven major markets, 2007-2016; Figure 22: The patient flow for the study population.; Figure 23: Datamonitor's forecast of sales for Teriflunomide in multiple sclerosis across the seven major markets ($m), 2007-2016; Figure 24: Datamonitor's competitive positioning analysis for Teriflunomide in the seven major markets, 2007-2016; Figure 25: Datamonitor's comparative forecast of sales for the other late-stage products across the seven major markets ($m), 2007-2016; Figure 26: Datamonitor's competitive positioning analysis for Mylinax and Fingolimod in the seven major markets, 2007-2016; Figure 27: Datamonitor's forecast of sales for Mylinax across the seven major markets for multiple sclerosis ($m), 2007-2016; Figure 28: Datamonitor's competitive positioning analysis for Mylinax in the seven major markets, 2007-2016; Figure 29: Datamonitor's forecast of sales for Fingolimod in multiple sclerosis across the seven major markets ($m), 2007-2016; Figure 30: Datamonitor's competitive positioning analysis for Fingolimod in the seven major markets, 2007-2016

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Pipeline Insight: Multiple Sclerosis - The oral revolution

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Abstract