Pipeline Insight: Schizophrenia Asenapine; A future market leader?

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1 A Datamonitor report Pipeline Insight: Schizophrenia Asenapine; A future market leader? Published: Jul-06 Product Code: DMHC2186 Providing you with: Detailed pipeline analysis for key products in development for schizophrenia, plus drug sales forecasts to 2015 Overview of patient potential, segmentation by indication and unmet needs in schizophrenia across the US, EU and Japan Use this report to... Assess the global sales forecasts of late-stage pipeline drugs for schizophrenia and examine their clinical and commercial potential Benchmarking of key product and company attractiveness of late-phase pipeline products Detailed clinical trial information and opinions from key thought leaders

2 Pipeline Insight: Schizophrenia Asenapine; A future market leader? DMHC2186 Introduction The global schizophrenia market will continue to grow until 2010, when revenues will reach $3.8 billion. However, despite the launch of numerous pipeline schizophrenia drugs, the market will begin to decline thereafter owing to the US launch of generic risperidone in 2007, followed by generic versions of olanzapine, quetiapine and ziprasidone from 2011 onwards. The challenge for manufacturers will be to convince physicians to prescribe novel schizophrenia drugs over the existing branded market players and the ever increasing number of generics. Such a move can only provide healthy competition for the development of superior drugs, benefiting the development of the industry as a whole, and patients alike. Key findings and highlights By 2015, prospective players can expect to face stiff competition from numerous generic atypical antipsychotics. Product differentiation through improved treatment of negative or cognitive symptoms, partial responders, as well as improved tolerability, and demonstration of cost-effectiveness are essential. Current schizophrenia drug manufacturers are taking measures to buffer the erosion of their products by generics over the forecast period. Of the current players, Datamonitor forecasts that only Pfizer will maintain a strong schizophrenia franchise after the genericization of its marketed drug, with the remaining franchises expected to decline. The potential of Organon/Pfizer's asenapine in treating negative symptoms will be a key therapeutic and commercial advantage, with the drug forecast to be the leading market entrant in terms of value by Lundbeck/Solvay/Wyeth's bifeprunox's will become the second highest new entrant in terms of value by Reasons to buy Understand unmet needs in the schizophrenia market based on key opinion leader comments regarding both currently marketed and pipeline products Benchmark key late-stage schizophrenia compounds against current market leaders Assess the global sales forecasts of late-stage pipeline drugs for schizophrenia and examine their clinical and commercial potential For more information... Contact Emma Travis, CNS Analysis Team tel: fax:

3 Sample pages from the report...the drugs that we have now have much more of an impact on positive symptoms than they do on negative symptoms or cognitive dysfunction, so those are the domains that really remain to be very important targets... Key Opinion Leader, Pipeline Insight: Schizophrenia Asenapine; A future market leader?

4 Pipeline Insight: Schizophrenia Asenapine; A future market leader? DMHC2186 Table of contents ABOUT DATAMONITOR HEALTHCARE About the CNS pharmaceutical analysis team EXECUTIVE SUMMARY Scope of the analysis Datamonitor insight into the schizophrenia market Key metrics PATIENT POTENTIAL Etiology of schizophrenia - DSM-IV defined symptoms of schizophrenia Classification of schizophrenia Epidemiology of schizophrenia - Schizophrenia affects 1per cent of the population - Comorbidities of schizophrenia - Diagnosis rates of schizophrenia Unmet needs in schizophrenia - Improving patient compliance is key R&D APPROACH Classification of marketed and pipeline products - Serotonergic and dopaminergic receptor antipsychotics - Dopaminergic antipsychotics - Serotonergic antipsychotics - Novel antipsychotics Clinical trials and drug development - Clinical trial endpoints and schizophrenia rating scales - A number of other tests are used in the diagnosis and monitoring of patients during general treatment management and for the duration of clinical trials - Clinical trial design guidance - Key research recommendations PIPELINE DRUG ANALYSIS Pipeline overview - Approved drugs yet to be launched - Drugs in pre-registration - Pipeline drugs in Phase III - Pipeline drugs in Phase II - Pipeline drugs in Phase I - Key companies involved in the development of novel schizophrenia therapeutics Methodology of Datamonitor's competitive positioning analysis - Gold standard antipsychotic - The market value is calculated using IMS diagnosis value - Forecast caveats LATE-STAGE PIPELINE DRUG ANALYSIS AND FORECASTS Paliperidone - Physicians not overly impressed with paliperidone therapeutic profile - Paliperidone IM - an improvement over Risperdal Consta? - Risperdal patent expiry and switch to paliperidone over generic risperidone - How will J&J price paliperidone IM compared to Risperdal Consta - Paliperidone ER will be the next entrant to the US market in H Intramuscular Zyprexa - Zyprexa's undesirable side-effect profile will limit the uptake of the long-acting IM formulation Intramuscular Abilify - Abilify IM may lead to increased use of Abilify as a first-line maintenance therapy - Abilify needs to demonstrate strong efficacy in a head-to-head study - Multiple IM doses within a 24-hour period may limit use of Abilify IM compared to other IM formulations - How will Abilify IM be priced? - BMS/Otsuka should consider a long-acting IM version of Abilify Sertindole - Physicians not impressed with sertindole's tolerability despite new data - Sertindole will be the next entrant to the EU market in H Asenapine (Org-5222) - Asenapine's potential in treating negative symptoms will be a key therapeutic and commercial advantage For more information... Contact Emma Travis, CNS Analysis Team tel: fax:

5 - Twice daily dosing of asenapine may limit uptake - Asenapine will be the leading market entrant in terms of revenue value by 2015 Bifeprunox - Bifeprunox's tolerability is a key therapeutic and commercial attribute - Bifeprunox unlikely to be used for acute psychosis, but may have a niche in first episode psychosis - Bifeprunox's pharmacokinetic profile is suitable for once-daily dosing, with a potential for numerous reformulation strategies - Solvay and Wyeth's experience in psychiatry and Lundbeck's launch of sertindole will provide a strong base for the commercialization of bifeprunox - Bifeprunox will be the second-highest new entrant in terms of cash value to the schizophrenia market by 2015 Blonanserin - Blonanserin demonstrates no clear advantages over marketed or pipeline schizophrenia drugs - Almirall's limited commercial presence in the EU, and lack of presence in the US will limit uptake of blonanserin outside of Japan - Blonanserin will receive its strongest uptake in the Japanese market Seroquel SR - Seroquel SR unlikely to provide significant differentiation from Seroquel - Seroquel will retain patent protection until 2011, safeguarding the initial uptake of Seroquel SR from generic quetiapine - Will US health insurers pay the increased costs for the SR formulation? - Seroquel SR is not expected to receive a strong uptake, and revenues will decline from 2012 onwards Iloperidone - If approved, QT will limit iloperidone uptake as a first-line therapy - Iloperidone offers no therapeutic advantage over marketed or pipeline schizophrenia drugs - Iloperidone will receive limited uptake in the US PHASE II PIPELINE DRUG ANALYSIS Introduction ABT Nicotinic agonists which improve cognitive functioning and smoking cessation would be valuable in the management of schizophrenia ACP-103/ACP ACP-103 clinical trial data - There is little need for an adjunct to improve positive symptoms, as marketed drugs already treat this domain of schizophrenia - ACP-104 clinical trial data - ACP-104 would be a significant treatment advance if it can demonstrate cognitive enhancement without the side effects of clozapine AVE-1625 Dihydrexidine Idazoxan - Idazoxan is unlikely to be a standalone therapy, but may have a niche in treatment-resistant schizophrenia Lurasidone - Lurasidone - another me-too atypical, and therefore of limited therapeutic and commercial potential LY Ocaperidone - J&J may choose to relicense ocaperidone from Neuro3d if ocaperidone performs well in Phase II trials Org Org may have potential in treating cognitive functioning RG The subcutaneous formulation is unlikely be well received by patients Sabcomeline (SB A) SCA-136 SGS518 - Commercial and patient potential Talnetant - Pharmacokinetic profile may hamper talnetant's clinical development...most patients don't like to take the drugs, so non-compliance is a major issue which is sometimes related to side-effects or to reduced tolerability... Key Opinion Leader, Pipeline Insight: Schizophrenia Asenapine; A future market leader?

6 Pipeline Insight: Schizophrenia Asenapine; A future market leader? DMHC2186 FUTURE TREATMENT OF SCHIZOPHRENIA Key opinion leaders discuss how they believe the schizophrenia market will change over the forecast period APPENDIX A Forecast revenues Competitive positioning analysis of pipeline schizophrenia drugs Bibliography - Websites - Journal articles and conference abstracts TABLES Table 1: Diagnostic criteria for schizophrenia and its subtypes Table 2: Prevalence of patients with schizophrenia exhibiting comorbid psychiatric disorders across the US, EU and Japan (%), 2005 Table 3: Risk factors for non-compliance to follow-up appointments and/or antipsychotics in patients with schizophrenia Table 4: Potential strategies for improving compliance in patients with schizophrenia Table 5: Novel antipsychotic drug classes in development for the treatment of schizophrenia,2006 Table 6: Approved drugs yet to be launched in the US, EU and Japan for the treatment of psychosis and schizophrenia, 2006 Table 7: Pipeline drugs in pre-registration for the treatment of psychosis and schizophrenia, 2006 Table 8: Pipeline drugs in Phase III development for psychosis and schizophrenia, 2006 Table 9: Pipeline drugs in Phase II development for psychosis and schizophrenia, 2006 Table 10: Pipeline drugs in Phase I development for psychosis and schizophrenia, 2006 Table 11: J&J's pipeline schizophrenia drugs, 2006 Table 12: Lundbeck's pipeline schizophrenia drugs, 2006 Table 13: Organon's pipeline schizophrenia drugs, 2006 Table 14: Pfizer's pipeline schizophrenia drugs, 2006 Table 15: Dainippon-Sumitomo's pipeline schizophrenia drugs, 2006 Table 16: GSK's pipeline schizophrenia drugs, 2006 Table 17: Commercial strength/weakness factors - weightings and scoring definitions Table 18: Product-specific strength/weakness factors - weightings and scoring definitions Table 19: Proportion of total molecule volume (SU and sales) of antipsychotics, accounted for by schizophrenia diagnoses in the US, EU and Japan, 2005 Table 20: Comparison of paliperidone IM versus Risperdal Consta Table 21: Price of different formulations of Risperdal ($), Table 22: Revenues of the rapid-acting atypical antipsychotic IMs ($m), Table 23: Price points for the rapid-acting atypical antipsychotic IMs ($), Table 24: Asenapine can address most of the unmet needs for the treatment of schizophrenia Table 25: Datamonitor's forecast schizophrenia revenues of marketed and pipeline schizophrenia drugs across the US, EU and Japan ($m), Table 26: Datamonitor's competitive positioning analysis of pipeline schizophrenia drugs according to product-specific strength/weakness factors, 2006 Table 27: Datamonitor's competitive positioning analysis of pipeline schizophrenia drugs according to commercial strength/weakness factors, 2006 Table 28: Schizophrenia market definition by ICD10 code FIGURES Figure 1: Forecast schizophrenia revenues of marketed and pipeline schizophrenia drugs across the US, EU and Japan, Figure 2: Datamonitor's competitive positioning analysis of pipeline schizophrenia drugs compared to marketed comparators, 2006 Figure 3: Reasons for non-compliance among schizophrenia patients receiving antipsychotic therapy Figure 4: Drug classes in development for the treatment of schizophrenia, 2006 Figure 5: NICE measurement of cost-effectiveness of drug treatment Figure 6: Forecast revenues for J&J's schizophrenia franchise (Risperdal and paliperidone), Figure 7: Datamonitor's competitive positioning analysis of J&J's marketed and pipeline schizophrenia drugs, 2006 Figure 8: Datamonitor's competitive positioning analysis of Lundbeck's pipeline schizophrenia drugs, 2006 For more information... Contact Emma Travis, CNS Analysis Team tel: fax:

7 Figure 9: Forecast revenues of Lundbeck's schizophrenia franchise(serdolect and bifeprunox (Lundbeck's share - EU only), Figure 10: Datamonitor's competitive positioning analysis of Pfizer's marketed and pipeline schizophrenia drugs, 2006 Figure 11: Forecast revenues of Organon's schizophrenia franchise (asenapine), Figure 12: Datamonitor's competitive positioning analysis of Pfizer's marketed and pipeline schizophrenia drugs, 2006 Figure 13: Forecast revenues of Pfizer's schizophrenia franchise (Geodon and asenapine), Figure 14: Paliperidone ER only meets one of the criteria for a therapeutically and commercially successful drug reformulation Figure 15: Datamonitor's competitive positioning analysis of paliperidone ER and IM, 2006 Figure 16: Datamonitor's forecast of paliperidone's revenues across the US, EU and Japan ($m), Figure 17: Zyprexa's declining US revenues, and plateauing EU revenues Figure 18: Datamonitor's competitive positioning analysis of Zyprexa IM, 2006 Figure 19: Datamonitor's competitive positioning analysis of Abilify IM, 2006 Figure 20: Datamonitor's competitive positioning analysis of sertindole, 2006 Figure 21: Datamonitor's forecast of sertindole's revenues across the five major EU markets ($m), Figure 22: Datamonitor's competitive positioning analysis of asenapine, 2006 Figure 23: Datamonitor's forecast of asenapine's revenues across the US, EU and Japan ($m), Figure 24: Datamonitor's competitive positioning analysis of bifeprunox, 2006 Figure 25: Datamonitor's forecast of bifeprunox's revenues across the US, EU and Japan ($m), Figure 26: Datamonitor's competitive positioning analysis of blonanserin, 2006 Figure 27: Datamonitor's forecast of blonanserin's revenues across the US, EU and Japan, Figure 28: Seroquel SR meets two out of three criteria for a therapeutically and commercially successful drug reformulation Figure 29: Datamonitor's competitive positioning analysis of Seroquel SR, 2006 Figure 30: Datamonitor's forecast of Seroquel SR's revenues across the US, EU and Japan, Figure 31: Datamonitor's competitive positioning analysis of iloperidone, 2006 Figure 32: Datamonitor's forecast of iloperidone's revenues across the US, EU and Japan, Figure 33: Polypharmacology affinity of atypical antipsychotics for serotonergic, dopaminergic, adrenergic, muscarinic and histaminergic receptors For more information... Contact Emma Travis, CNS Analysis Team tel: fax:

8 Pipeline Insight: Schizophrenia Asenapine; A future market leader? DMHC2186 Datamonitor: Your total information solution Datamonitor is a premium business information company helping 5,000 of the world's leading companies across the Automotive, Consumer Markets, Energy, Financial Services, Healthcare and Technology sectors. Our products and services are specifically designed to support our clients key business processes from corporate strategy to competitive intelligence. We provide an independent and trustworthy source of data, analysis and forecasts to improve these processes and ultimately, to help grow your business. Corporate Strategy & Business Planning Quality Data Make more effective strategic and business decisions Product Development & Commercialization Targeting & Influencing the Market Expert Analysis Accelerate delivery of commercial success Assess and influence your commercial and market environment HELPING TO GROW YOUR BUSINESS Market & Competitive Intelligence Future Forecasts Maintain or obtain critical competitive advantage Nothing speaks louder than our clients 3M Abbott Accenture Alcon Labs Allergan Almirall-Prodesfarma Altana Pharma AG Amersham Amgen Amrad Angelini Acraf Astellas AstraZeneca AT Kearney Baxter Bayer Healthcare AG Beaufour Ipsen Biochemie Biogen Idec Boehringer Ingelheim Boots Bristol-Myers Squibb Cantab Caremark International Chiesi Chiron Chugai CMC Co Daiichi Deutsche Morgan Grenfell Elan Eli Lilly Esteve Flamel Fournier Gehe Genzyme Gilead Gist Brocades GlaxoSmithKline IBM Immuno AG Johnson & Johnson Jouveinal LEK Lipha Lundbeck Merck KGaA Merck & Co Millennium Pharmaceuticals Nabi Biopharmaceuticals Novartis Novo Nordisk Pfizer Pharmachemie Pierre Fabre Pliva Procter & Gamble Ranbaxy Recordati Sankyo sanofi-aventis Schering AG Schering-Plough Schwarz Pharma AG Serono Shire Pharmaceuticals Solvay Pharmaceuticals Takeda TAP Pharmaceutical Teva UCB Uriach Vernalis Viatris Wyeth...89% of our clients use Datamonitor research to develop competitive intelligence... Source: Datamonitor Customer Research

9 Interested in this topic? Datamonitor s Central Nervous System portfolio features detailed analysis of development pipelines, current and future market dynamics, patient potential, treatment patterns, and strategic issues, to highlight latest market trends and new commercial opportunities. Other reports available in this series Stakeholder Insight: Cognitive impairment in schizoaffective disorder Inevitable or treatable? Detailed analysis of prescribing trends in cognitive impairment in schizophrenia (CIS) across the seven major pharmaceutical markets. Identifies stakeholder relationships and key unmet needs in diagnosis and treatment, and patient management. Published: Oct-05 Product code: DMHC2094 Commercial Insight: Antipsychotics - From blockbuster brands to billion dollar generics An in-depth analysis of the antipsychotics market with forecasts of all leading products on a country-by-country basis for the seven major pharmaceutical markets until Published: Dec-04 Product code: DMHC2057 Stakeholder Insight: Patient compliance in psychiatry From patient acquisition to patient retention Analysis of patient compliance in psychiatry based on an international survey of 192 therapists and leading experts conducted across the seven major pharmaceutical markets. Published: Dec-04 Product code: DMHC2054 Commercial Insight: Neuropathic Pain - A Plethora of Patient Segmentation and Product Differentiation Opportunities Detailed analysis of the neuropathic pain market, including an assessment of country specific events and company strategies. Includes an indication specific ten-year forecast for key products. Published: Jul-06 Product code: DMHC2221 Stakeholder Opinions: Parkinson's Disease - Review of Key Commercial Opportunities in the Symptomatic Treatment Market A case study analysis based on recent events in the Parkinson's disease drug market and key opinion leader interviews. Published: Jul-06 Product code: DMHC2184 For more information about our products visit Subscribe to Healthcare Monitor A monthly update of the latest Healthcare products, events, news and special offers from Datamonitor delivered to you by . To subscribe your contact details to with subscribe in the subject line.

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