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

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 AG’s are still not clear in Japan, however with the largest Japanese product Blopress AG’s launched recently and generic companies in queue to compete with their generic versions will make the things lucid for the fate of AG’s 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.

Table Of Contents

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

Company Analysis:
Astellas - Xtandi uptake in Pre-chemo PC, Isavuconazole US approval and Uptake will provide cushion to Next batch of innovation (Roxadustat, CMV vaccine, ASP8273)!
- Xtandi- Xtandi's early stage clinical data in HER2 positive, HR+ve, AR +ve Breast cancer and Data from TERRAIN/STRIVE study in early PC will drive Xtandi momentum in 2015, while PhIII data read out of ARN-509 from SPARTAN study is the key near term threat
- Isavuconazole: Our view on US approval and Uptake
- Myrbetriq: Myrbetriq uptake in OAB market - a blockbuster potential likely- EB178 (FDC/combo of Solifenacin+ Mirabegron) combination - Next Batch of Innovation
- Roxadustat- Can change the current treatment paradigm mainly in CKD-NDPatients- AKB-6548 is the key competitor
o Key advantage over current EPO
o Biosimilar EPO is not a threat
o Pipeline HIF inhibitors and clinical data comparison
- ASP-8273 (Ph 1, Irreversible mutant selective EGFR inhibitor)
- Evolocumab
Table 1: Deals done by Astellas in 2013, 2014
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
Chart: 1, 2 - Current and Future use of anti androgens in treatment of Prostate Cancer Chugai - Alectinib, ACE910 Global Success - Next Growth Driver!

Chugai's - Breast Cancer Franchisee: Breast Cancer Franchise-
o Perjeta will be the key growth driver for the franchisee-not Kadcyla -
o In long term, Perjeta + Herceptin + Chemo will be the standard of care vs. currently Herceptin + chemo. Kadcyla will cater 2nd line market, while data from APHINITY trial in 2016 will decide Perjeta + Herceptin use for adjuvant setting in Breast cancer
o Failure of MARIANNE Study further increases threat of Herceptin biosimilar
- Chugai's NSCLC franchisee:
o MPDL3280A (anti-PDL1 mAB, PhIII, NSCLC, Melanoma) - It is in PhIII in Japan and for NSCLC indication- Nivolumab is the closest competitor.
- April 2014 price cut to Long listed products resulted in sales decline of Suvenyl, Sigmart and Alfarol ….
- MPDL3280A - Anti PD1 from Roche- competitive landscape and status in Japan
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 -Edoxaban uptake + Ranbaxy/Sun Closure will provide Momentum in 2015!
- Ranbaxy +Sun= Sun = 9% equity stake in New Sun- Exit or hold???-
- Vision 2017 Revision is expected around FY03/15 results:
- Edoxaban: A blockbuster potential likely despite restricted US launch and will be 4th Entrant in NOAC market
- Acquisition of Ambit bioscience
- Quizaritinib
- Other Assets from Ambit
- Other Assets in Pipeline- CL 108 and Etanercept biosimilar
- JP domestic market - Long listed products sales decline…..
- Daiichi Sankyo Espha (DSE) - New pricing policy make difficult road ahead
Table 1: Edoxaban - Possible Scenario Analysis and Peak Sales Estimate
Table 2: % Patients CrclTable 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 Late-Stage 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 Pharma - Latuda growth is the Key to support Regenerative/Cell therapy Innovation!
BBI-608 - Post failure in PhIII CRC (Colorectal cancer) study, focus now shifts to PhIII clinical data
- Pipeline CSC Inhibitors
BBI-503- Clinical data from PhI/II study in 2015 will decide its future potential-BBI-503
Regenerative medicine/Cell therapy medicine - A long way to go!!!-SB623

Other Pipeline candidates:
o EPI-743
o AS-3201 (Ranirestat)
o DSP-1747
o Dasotraline
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
Chart 1: Atypical antipsychotics market

Eisai - Success in RandD is the Only Hope!
- LENVATINIB
- Thyroid cancer
- Hepatocellular carcinoma
- Lung Cancer
- Table 1: Sales outlook for major lung cancer drugs vs. Lenvatinib expectation
- Halaven - Eisai's Flagship Product After Aricept and Aciphex
Table 2: Indications Prospects For Halaven
- Fycompa to maintain presences into CNS space
- E2006 is another candidate strengthening base of CNS franchise
- Annexure 1; EISAI RandD Pipeline (Ph II and III Only)

Kyowa Hakko Kirin - Poteligeo Combination Trial With IO Therapy Will Drive The Story
- KHK's Potelligent technology
- Biosimilar JV
Our view on its global late stage pipeline candidates
o KW-0761
o KW-6002
o KRN-23
o MEDI-563/Benralizumab/KHK4563
Archimedes acquisition Strengthen Prostakan Product portfolio + EU presence
Newly launched products in Domestic Market (Japan) Poteligeo, Nouriast, Onglyza - Very slow
uptake does not allow KHK to withstand pricing pressure /biosimilar competition in domestic
market - G-Lasta may change the picture

Table 1: Competitive Landscape Of Biologics In Severe Asthma
Table 2: Parkinson's 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- : Strengthening CNS Foothold and Gx Fusion Strategy to Drive Growth
- The core focus on antidepressant market is going to strengthen further:
- Medreich Acquisition - a bold step to venture into overseas markets
- Success in Generic business likely to continue
Table 1: Pharma contribution on sales
Table 2: High Profitability of Pharma Segment
Table 3: R and D pipeline
Table 4: Meiji Seika overseas R and D activity

Mitsubishi Tanabe - Overseas Efforts to be intensified in Coming Years!
- Growth drivers vs. long listed exposure
- Our view on MT's acquisition strategy
- Remicade: biosimilars are unlikely to generate massive loss in near term
- Invokana- to play important role in Japan SGLT-2 inhibitor market
o Invokana US prescription vs. newly launched products in type 2 diabetes space
- Gilenya: Gilenya sales well on track, no impact of negative data from PPMS
- Our view on Gilenya growth going forward and upcoming competition
- Key reasons why Gilenya will continue to Maintain its market share in the new competitive landscape
- Venture into Vaccine Business to unfold soon
- 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 - Tivicay + Triumeq- Cushion for Shionogi's Next Batch of Innovation!
- Tivicay- Tivicay (Dolutegravir) best in class profile has already set the stage for Triumeq use in first line setting, and helps Triumeq to take the market share from Atripla/ Stribild, Post 2018, FDC with Truvada is a free call option
o Pipeline HIV drugs competing with Triumeq- No near term threat- TAF- Stribild has its own disadvantage
- Shionogi- Late stage pipeline analysis of the global candidates (Table 5)
o S-297995
o S-888711 (Lusutrombopag)
- Shionogi- Early stage pipeline analysis
o S-222611
o S-010887
- Shionogi- Japan- late stage pipeline analysis (Table 7)
o S-556971
o S-877489 9
Chart 1: Tivicay Prescription Trend vs. Isentress VS. Stribild
Chart 2: TIVICAY VS. ISENTRESS VS. STRIBILD- MARKET SHARE
Chart 3: Current HIV treatment paradigm
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 Pharmaceuticals: All Eyes Are On Label Expansion Of Treakisym
- Rigosertib - Catering Niche despite Negative ONTIME data- Ph II data read out by
- YE2014/1H2015 will decide First line potential
o In 2nd-line Higher Risk MDS patients (IV Rigosertib)
o In 1st line lower risk MDS pts (Oral Rigosertib)
- TREAKISYM
o CLL
o Front line NHL
o RR aggressive NHL
o Upcoming Milestones
Chart 1: Symbio- Pipeline
Table 1: RR/2nd line HR MDS- Select late-to mid stage pipeline

Takeda -Will the New Launches (Entyvio, Takecab, and Brintellix) Set The Stage For Next Growth Cycle???
- Key milestones to watch for in 2015 are
- EU portfolio becoming strong post ENTYVIO and Natura alpha launch - Nycomed's strong GI market presence will boost this franchise
- Entyvio (Vedolizumab/MLN0002, approved US/EU, vedolizumab, ?4?7 integrin inhibitor, Ulcerative colitis / Crohn's disease): Strong uptake confirms differentiated profile- blockbuster potential likely
- Competition from Pipeline drugs:
- Brintellix (Vortioxetine) - Cognition data will differentiate Brintellix in genericized depression market-
o Vortioxetine vs. Currently Available Drugs
- MLN-9708 (PhIII, Multiple Myeloma) interim PhIII data in RRMM in combination with Revlimid in 2015 will decide its potential in crowded Multiple Myeloma market:
- Expected competition to Velcade in Second/third line setting and upcoming milestones before patent expiry (2017)
Table 1: Deals Done By Takeda In 2013-2014
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 crohn's 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) -

JAPAN GENERICS:

Nippon Chemiphar - Less Vulnerability to New Pricing System is Advantageous!
o Relatively Modest Margins Profile Compared to Peers
o Impact of April 14 NHI price revision
o A balanced portfolio provides flexibility in adopting favorable market strategies:
Table 1: Nippon Chemiphar Sales break up
Annexure 1- Key Features of New NHI Pricing System

Sawai - Poised Well To Sail Through Tough Times!
- Gradually improving wholesaler base is advantageous
o Table 1: Gradually Improving Wholesaler Base
- Primary Care Focused Product Mix- Not Highly Profitable yet less Risky
Table 2: Balanced Primary Care Products-Mix
Table 3: Better Performance by New products
Table 4: Value To/Of Products Going Off Patent In Next 5 Years
Table 5: Newly Listed Products In 2014
Figure 1: Sawai- Medium to long term vision

Towa - Tough Time In Adapting To New Pricing Regulations!
- Need of decreasing dependence on direct sales channel under changed scenarios:
- A solid foundation of organic growth is in place through years of constant Capex and RandD investments
- GP Market Focus is Moving to DP Markets; HP Needs Improvement
- Japan Generic Industry Outlook
Table 1: Direct Sales On Rise
Chart 1: Constantly Increasing Capex
Table 2: Key Launches Of 2014
Table 3: Steady Performance Of Key Products
Table 4: GP Market Focus Switching To DP Market

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