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Japan Pharma Outlook 2015: 2015 Year to Watch out for Authorized Generics (AGs), Biosimilars and Overseas Strategic Initiatives

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The new pricing system adopted in Japan from April -2014 (Annexure 1) is a game changer initiative. It pains most of the companies - whether generic or innovator. The most of the companies are revalidating their domestic (and thus overseas) strategies to adopt with new regulations. For the innovators testing Authorized Generics (AGs) phenomenon for protecting their long-listed sales against generic could be one of new choice in Japan. The format and regulations for AGs are still not clear in Japan, however with the largest Japanese product Blopress AGs launched recently and generic companies in queue to compete with their generic versions will make the things lucid for the fate of AGs in Japan.

For most of the generic companies focusing on reducing manufacturing costs, and for many of them to venture in biosimilars space as a new growth avenue would be focus. The trends suggest that Japanese companies may need to set up or alliance with companies overseas for manufacturing. In this note of Outlook-15, we look deeper into these trends to anticipate likely near term changes of Japanese pharma industry.

In innovation space, after Oncology, regenerative medicine and Orphan disease are the areas where Japanese innovator companies are focusing its R & D efforts. While from late stage pipeline/new launch, Edoxaban, Lenvatinib, Entyvio, Brintellix, and Ixazomib are the few important NCEs, uptake of which will decide Japanese Innovator growth in Global market. In this report- We analyzed pipeline, strategies and key growth drivers of 13 major Japanese biopharma companies (Pure play innovators/ Innovators+ Generics/Pure play generics) and detailed our view on these growth drivers along with their interest for inlicensing external innovation from the globe for increasing R&D productivity.
~Astellas : Table 2: Pipeline Early stage Androgen Receptor antagonist

Table 3: Competitive landscape for Antifungals
Table 4: Competitive landscapes for OAB drugs
Table 5: Pipeline HIF alpha stabilizer- AKEBIA AKB-6548 is closest competitor
Table 6: Competitive landscape- Anti PCSK9 MAB- ALIROCUMAB vs. EVOLOCUMAB
~Chugai: Table 1: Deals Done By Chugai Pharma in 2013-2014
Table 2: Ongoing Important Clinical Studies of Kadcyla in Late Stage Her 2 Positive Cancers
Table 3: Actemra - Ongoing Global Trials
~Daiichi Sankyo : Table 1: Edoxaban Possible Scenario Analysis and Peak Sales Estimate
Table 2: % Patients Crcl<95% In Key Pivotal Studies Of Noac In Nvaf
Table 3: Launched Noac- Efficacy And Safety Comparision In Renally Imparied Patients
Table 4: Launched Noac- Ww Reported Sales
Table 5: Competitive Landscape Select Late And Mid Stage Drug Targeting Aml
Table 6: Select Jak 2/1 Inhibitors: Mid- To LateStage Pipeline
Annexure 1: 5-Year Business Plan: Numerical Targets For Fy2017
Annexure 2: Core Strategies Of 5-Year Business Plan
Annexure-3: New Generation Oral Anticoagulants Market Dynamics
~Dainippon Sumitomo : o Table 1: Pipeline Of Drugs Targeting Cancer Stem Cell
o Table 2: Pipeline Of Boston Biomedical
o Table 3: Psychiatrists See High Unmet Need
o Table 4: Latuda Swot Analysis
Table 5: Dainippon Sumitomo-Key Pipeline Candidates- Japan
Table 6: Dainippon Sumitomo-Key Pipeline Candidates- Us
Table 7: Deals Done By Dainippon In 2013-2014
~Eaisai: Table 1: Sales outlook for major lung cancer drugs vs. Lenvatinib expectation
Table 2: Indications Prospects For Halaven
Annexure 1; EISAI R&D Pipeline (Ph II and III Only)
~Kyowa Hakko Kirin : Table 1: Competitive Landscape Of Biologics In Severe Asthma
Table 2: Parkinsons disease competitive landscape of recently launched PD Drugs in Japan
Table 3: Global Pipeline And Our Comments
Table 4: Deals Done By Khk In 2013-2014
Table 5: Potelligent Technology
~Meiji Seika : Table 1: Pharma contribution on sales
Table 2: High Profitability of Pharma Segment
Table 3: R & D pipeline
Table 4: Meiji Seika overseas R & D activity
~Mitsubishi Tanabe : Table 1:Clinical data comparison of CT-P13 (Celtrion/NK Remicade biosimilar) vs. INX. In RA (54 week, PLANETRA study) in EU study
Table 2: Top Ten Most Expensive Drugs Procured By Tokyo
Medical Hospital
Table 3: SGLT -2 Inhibitors And Dppiv Players In Japan
~Shionogi: Table 1: Single Trial Data- Triumeq vs. Atripla
Table 2: Dolutegravir Phiii Trials
Table 3: Treatment Of Thrombocytopenia - Recently Approved Drugs + Late Stage Pipeline
Table 4: Global Clinical Data Comparison Of Late Stage Oral Tpo Mimetics For Treatment OF Thrombocytopenia Associated With Chronic Liver Disease
Table 5: Shionogi- Late Stage Pipeline Analysis Of Global Candidates
Table 6: Shionogi- Early Stage Pipeline Analysis Out Licensing Opportunities
Table 7: Shionogi- Early Stage Pipeline Analysis Out Licensing Opportunities
Table 8: Deals Done By Shionogi In 2013-2014
SymBio Pharma : Table 1: RR/2nd line HR MDS- Select late-to mid stag e pipeline
~Takeda : Table 2: Key Late Stage Pipeline Global Candidates- Takeda
Table 3: Pipeline Leukocyte Traffic Inhibitor (Integrin Inhibitor)
Chart 1: Mln9708 -Trial Design Of Tourmaline-Mm1 Rrmm
Table 4: competitive landscape mln 0002/vedolizumab vs. marketed mab in ulcerative colitis
Table 5: Takeda Competitive Landscape mln 0002/vedolizumab vs. marketed mab in crohns disease
Table 6: Takeda Mln 0002/Vedolizumab Clinical Trial Program
Table 7: Vortioxetine - Major Depressive Disorder
Table 8: Vortioxetine - Major Depressive Disorder - Drugs Discontinued In The Recent Past
Table 9: Vortioxetine - Major Depressive Disorder Competitive Landscape
Table 10: Data Comparison - Newly Diagnosed Multiple Myeloma (Ndmm)
Chart 2: MLN-9708 Trial design
Chart 3: Reported adverse events in clinical trials- MLN9708
Table 11: Data Comparison - Relapsed And Refractory Multiple Myeloma (Rrmm)
Table 12: Data Comparison - Relapsed And Refractory Multiple Myeloma (Rrmm)
~Nippon chemiphar : Table 1: Nippon Chemiphar Sales break up
Annexure 1- Key Features of New NHI Pricing System
Sawai : o Table 1: Gradually Improving Wholesaler Base

List Of Tables

Astellas : Chart: 1, 2 Current and Future use of anti androgens in treatment of Prostate Cancer Chugai - Alectinib, ACE910 Global Success Next Growth Driver!
~Dainippon Sumitomo : Chart 1: Atypical antipsychotics market
~Shionogi: Chart 1: Tivicay Prescription Trend vs. Isentress VS. Stribild
Chart 2: TIVICAY VS. ISENTRESS VS. STRIBILD- MARKET SHARE
Chart 3: Current HIV treatment paradigm
~SymBio : Chart 1: Symbio- Pipeline
Takeda :Chart 1: Mln9708 -Trial Design Of Tourmaline-Mm1 Rrmm
Chart 2: MLN-9708 Trial design
Chart 3: Reported adverse events in clinical trials- MLN9708

List Of Figures

~Astellas : Table 2: Pipeline Early stage Androgen Receptor antagonist

Table 3: Competitive landscape for Antifungals
Table 4: Competitive landscapes for OAB drugs
Table 5: Pipeline HIF alpha stabilizer- AKEBIA AKB-6548 is closest competitor
Table 6: Competitive landscape- Anti PCSK9 MAB- ALIROCUMAB vs. EVOLOCUMAB
~Chugai: Table 1: Deals Done By Chugai Pharma in 2013-2014
Table 2: Ongoing Important Clinical Studies of Kadcyla in Late Stage Her 2 Positive Cancers
Table 3: Actemra - Ongoing Global Trials
~Daiichi Sankyo : Table 1: Edoxaban Possible Scenario Analysis and Peak Sales Estimate
Table 2: % Patients Crcl<95% In Key Pivotal Studies Of Noac In Nvaf
Table 3: Launched Noac- Efficacy And Safety Comparision In Renally Imparied Patients
Table 4: Launched Noac- Ww Reported Sales
Table 5: Competitive Landscape Select Late And Mid Stage Drug Targeting Aml
Table 6: Select Jak 2/1 Inhibitors: Mid- To LateStage Pipeline
Annexure 1: 5-Year Business Plan: Numerical Targets For Fy2017
Annexure 2: Core Strategies Of 5-Year Business Plan
Annexure-3: New Generation Oral Anticoagulants Market Dynamics
~Dainippon Sumitomo : o Table 1: Pipeline Of Drugs Targeting Cancer Stem Cell
o Table 2: Pipeline Of Boston Biomedical
o Table 3: Psychiatrists See High Unmet Need
o Table 4: Latuda Swot Analysis
Table 5: Dainippon Sumitomo-Key Pipeline Candidates- Japan
Table 6: Dainippon Sumitomo-Key Pipeline Candidates- Us
Table 7: Deals Done By Dainippon In 2013-2014
~Eaisai: Table 1: Sales outlook for major lung cancer drugs vs. Lenvatinib expectation
Table 2: Indications Prospects For Halaven
Annexure 1; EISAI R&D Pipeline (Ph II and III Only)
~Kyowa Hakko Kirin : Table 1: Competitive Landscape Of Biologics In Severe Asthma
Table 2: Parkinsons disease competitive landscape of recently launched PD Drugs in Japan
Table 3: Global Pipeline And Our Comments
Table 4: Deals Done By Khk In 2013-2014
Table 5: Potelligent Technology
~Meiji Seika : Table 1: Pharma contribution on sales
Table 2: High Profitability of Pharma Segment
Table 3: R & D pipeline
Table 4: Meiji Seika overseas R & D activity
~Mitsubishi Tanabe : Table 1:Clinical data comparison of CT-P13 (Celtrion/NK Remicade biosimilar) vs. INX. In RA (54 week, PLANETRA study) in EU study
Table 2: Top Ten Most Expensive Drugs Procured By Tokyo
Medical Hospital
Table 3: SGLT -2 Inhibitors And Dppiv Players In Japan
~Shionogi: Table 1: Single Trial Data- Triumeq vs. Atripla
Table 2: Dolutegravir Phiii Trials
Table 3: Treatment Of Thrombocytopenia - Recently Approved Drugs + Late Stage Pipeline
Table 4: Global Clinical Data Comparison Of Late Stage Oral Tpo Mimetics For Treatment OF Thrombocytopenia Associated With Chronic Liver Disease
Table 5: Shionogi- Late Stage Pipeline Analysis Of Global Candidates
Table 6: Shionogi- Early Stage Pipeline Analysis Out Licensing Opportunities
Table 7: Shionogi- Early Stage Pipeline Analysis Out Licensing Opportunities
Table 8: Deals Done By Shionogi In 2013-2014
SymBio Pharma : Table 1: RR/2nd line HR MDS- Select late-to mid stag e pipeline
~Takeda : Table 2: Key Late Stage Pipeline Global Candidates- Takeda
Table 3: Pipeline Leukocyte Traffic Inhibitor (Integrin Inhibitor)
Chart 1: Mln9708 -Trial Design Of Tourmaline-Mm1 Rrmm
Table 4: competitive landscape mln 0002/vedolizumab vs. marketed mab in ulcerative colitis
Table 5: Takeda Competitive Landscape mln 0002/vedolizumab vs. marketed mab in crohns disease
Table 6: Takeda Mln 0002/Vedolizumab Clinical Trial Program
Table 7: Vortioxetine - Major Depressive Disorder
Table 8: Vortioxetine - Major Depressive Disorder - Drugs Discontinued In The Recent Past
Table 9: Vortioxetine - Major Depressive Disorder Competitive Landscape
Table 10: Data Comparison - Newly Diagnosed Multiple Myeloma (Ndmm)
Chart 2: MLN-9708 Trial design
Chart 3: Reported adverse events in clinical trials- MLN9708
Table 11: Data Comparison - Relapsed And Refractory Multiple Myeloma (Rrmm)
Table 12: Data Comparison - Relapsed And Refractory Multiple Myeloma (Rrmm)
~Nippon chemiphar : Table 1: Nippon Chemiphar Sales break up
Annexure 1- Key Features of New NHI Pricing System
Sawai : o Table 1: Gradually Improving Wholesaler Base

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Reports Details

Published Date : Jan 2015
No. of Pages :153
Country :Japan
Category :Healthcare
Publisher :MP Advisors
Report Delivery By :Email
Report Delivery Time :12 to 24 hours after placing the order.

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