Japan Pharma Outlook 2016

  • ID: 3638082
  • Report
  • Region: Japan
  • 91 Pages
  • MP Advisors
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JP Giants Leaning in to Become a Speciality Global Pharma

FEATURED COMPANIES

  • Chugai
  • Kyowa Hakko Kirin
  • Mitsubishi Tanabe
  • Nippon Kayaku
  • Shionogi
  • Takeda
  • MORE
The ongoing decline in long listed products sales, as well as a few successes in R&D in the last decade, had put JP giants under pressure to refocus on innovation with specialty therapy areas to strengthen their global presence. Eisai Ajinomoto JV, Teva-Takeda partners for Speciality Generics, is the area they have targeted. Fast track approval is expected on “Sakigake”, which is the first step by PMDA/MHLW to encourage JP Pharmas research specialised in the area of the high unmet medical need/orphan disease, where US biotech companies have taken a successful leap in last decade.

In the area of innovation, Nivolumab, Alectinib, Dolutegravir have had global success again, demonstrating the ability of JP pharma/university research houses to contribute significant pharma Innovation. From the late stages of their pipeline/new launch, Mirogabalin gained approval for their Neuropathic Pain Brintellix Cognition label expansion. Edoxaban now has taken off in the EU, while Alectinib uptake in the US and ACE-910 approval for hemophilia will demonstrate the global Japanese Innovator success. The biennial price cut scheduled in April-2016 will balance the Innovation premium with the long listed price cut (Z2 rule) to increase R&D productivity.

In the next 3 years, ¥950b worth of drugs will go off patent in Japan- and, as happened in 2015, a substantial volume of growth due to new patent expiry opportunities will help Japanese generic companies to withstand NHI pricing pressure. Consolidation activities like Teva-Takeda JV –will make this growing domestic generic market more competitive and companies with “direct sales model” may fetch the upper hand due to having less dependence on wholesale distribution channel. Challenging Alimta patent and Evista patent against Lilly in Japan, and Livalo ANDA filing in US by JP Generic companies is indicative of the changing dimensions of the JP generic giants, who are launching generics in Japan to becoming a patent challenger- Intellectual property rights challenging generic company. This is a step towards finding its place amongst the world generic players in the coming years. The successful launch of Blopress AG, Plavix AG in the last few years marked out Authorized Generics as one of the most attractive opportunites for Generic players in Japan. Encouraging Uptake of Filgrastim BS and Lantus BS in Japan is indicative of how Japan will be the next important market after the EU in the next five years for growth of Biosimilar players. In contrast, there is a very slow uptake post launch of Remicade biosimilar (~1% volume share).

This report analyzes therapy focus, changing Strategies, pipeline and key growth drivers of 12 major Japanese biopharma companies (Pure play innovators/ Innovators+ Generics/Pure play generics) and detailed our view on their strategic action to withstand in domestic market and expand globally with their interest for inlicensing external innovation from the globe for increasing R&D productivity and priorities on M & A side.
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Note: Product cover images may vary from those shown
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FEATURED COMPANIES

  • Chugai
  • Kyowa Hakko Kirin
  • Mitsubishi Tanabe
  • Nippon Kayaku
  • Shionogi
  • Takeda
  • MORE
1. CHUGAI : Sustainable Growth from Oncology Franchisee is Evident
- Kadcyla Superiority over Tykerb will increase the market size of 2nd/3rd line breast cancer beyond current levels
- Change in Chugai Roche business agreement- For pipeline drug Global development- and to be the first in Class
Table 1 : DEALS DONE BY CHUGAI PHARMA IN 2013-2014-2015
- Chugai :KEY MILESTONES
DAIICHI SANKYO : Upcoming Olmetec Patent Cliff – A Definite Need for Swift R & D Strategy!
- Japan Olmetec patent cliff (2019) manageable through growth from Memary, Nexium and Lixiana
Chart 1: Daiichi Sankyo
- Efficacy Results of Mirogabalin vs. Lyrica/Pregabalin
Chart 2: Daiichi Sankyo
- Efficacy comparison of Quizartinib vs. ASP-2215
Chart 3: Daiichi Sankyo
- US TRX of each NOAC since launch
Chart 4 :Daiichi Sankyo
- New NOAC share vs. Warfarin- Warfarin still holds >60% share in US
- Daiichi Sankyo :KEY MILESTONES
- KYOWA HAKKO KIRIN : News flow from Pipeline – KW6002, KRN-23…will decide Global Expansion!
- KHK in Biosimilar- Gearing up for a Bigger Pie- AZN JV is the first step
Table 1 KHK-Outlook 2016
- Competitive landscape of Biologics in Severe Asthma
Table 2 KHK-Outlook 2016
- PARKINSON’S DISEASE-COMPETITIVE LANDSCAPE OF RECENTLY LAUNCHED
- PD DRUGS IN JAPAN
Table 3 Kyowa Hakko Kirin
- GLOBAL PIPELINE AND OUR COMMENTS
Table 4 Kyowa Hakko Kirin
- DEALS DONE BY KHK IN 2013-2014-2015
Table 5 Kyowa Hakko Kirin
- POTELLIGENT TECHNOLOGY
- KHK: KEY MILESTONES

2. MEIJI SEIKA : Post “TAKE OFF”- Will Easily Achieve “STEP UP” Due to Pharma !
- Pharma business growth - a key to achieve Next medium term plan-STEP up 15-17:
- Antidepressant and Anti Infectives- Innovation wheels of Meiji Seika Pharma- Market share expansion in Japan will sustain near term growth, while outlicensing of pipeline assets for overseas market may provide surprises in 2016-2017
- Medreich Acquisition – Global revenue base growth expected by expanding CMO and CDMO business
Table 1: Meiji Seika
- PHARMA -GROWING ARM OF MEIJI- CONTRIBUTION ON SALES
Table 2 Meiji Seika
- R&D PIPELINE
Table 3 Meiji Seika
- MEIJI SEIKA OVERSEAS R&D ACTIVITY

3. MITSUBISHI TANABE : Ambiguous Mid Term Plan‘20 Targets for US market will drive Mid size M & A!
- M& A for strengthening its US business and uptake & approval of Radicut in ALS in US
- Gilenya- Steady growth helps it to achieve $3.5b peak sales WW by 2018/2019
Chart 1 :Mitsubishi TanabeUS- Prescription Trend of Gilenya
Chart 2 :Mitsubishi Tanabe US- Prescription Trend of SGLT2 inhibitors
Chart 3: Mitsubishi Tanabe US-Prescription Trend of SGLT2 inhibitors
Table 1 : Mitsubishi Tanabe SGLT -2 INHIBITORS AND DPPIV PLAYERS IN JAPAN
- KEY MILESTONE

4. NIPPON KAYAKU : Filgrastim, Remicade and then Herceptin- Biosimilar Leader in the making!
- Pioneering ‘New Age’ of Biosimilars by First launching Remicade biosimilar in Japan- A slow start but situation will change
- Nippon Kayaku- An Oncology specialist- Equipped well enough for succeeding in biosimilar market
Table 1:Nippon Kayaku - BUSINESS SEGMENTS : SALES BREAK UP
Table 2:Nippon Kayaku - Operating Income by segment
Table 3 :Nippon Kayaku
- NIPPON KAYAKU:PIPELINE CANDIDATES OTHER THAN BIOSIMILAR
Table 4 Nippon Kayaku
- BIOGENERICS STATUS
Table 5 Nippon Kayaku
- FILGRASTIM: COMPETITIVE LANDSCAPE
Table 6:Nippon Kayaku
- TOP TEN MOST EXPENSIVE DRUGS PROCURED BY TOKYO MEDICAL HOSPITAL
- SHIONOGI : SMART MANAGEMENT SET TO MANAGE CRESTOR CLIFF SMOOTHLY!
Chart 1 Shionogi
- US TRX trend of Triumeq/Stribild- June 5th 2015
Chart 2:Shionogi
- US NRX trend of Triumeq/Stribild
Chart 3 :Shionogi

5. US TRX trend of Integrase inhibitors
Table 1 :Shionogi
SINGLE TRIAL DATA- Triumeq vs. Atripla
- Shionogi- Late stage pipeline analysis of the global candidates
Table 3 Shionogi
- Global competitive landscape for Treatment of Thrombocytopenia- Recently approved drugs + Late stage pipeline
Table 4 Shionogi
- Global Clinical data comparison of late stage oral TPO mimetics for treatment of Thrombocytopenia associated with chronic liver disease
Table 5 Shionogi
- Shionogi - Late stage Pipeline Analysis of Global Candidates
Table 6 :Shionogi
- Shionogi - Early stage Pipeline Analysis – Out licensing Opportunities
Table 7 :Shionogi
- Shionogi - Late stage Pipeline Analysis – Japan Near term Opportunities
Table 8 :Shionogi
- DEALS DONE BY SHIONOGI IN 2013-14-15

6. TAKEDA : LEANING TOWARDS BEING A GLOBAL SPECIALTY
Chart 1 :Takeda
- Long listed Product JV with TEVA in Japan
Table 1 :Takeda
- VORTIOXETINE - MAJOR DEPRESSIVE DISORDER – LATE STAGE PIPELINE DRUGS- PhIII
Table 2 : Takeda
- VORTIOXETINE - MAJOR DEPRESSIVE DISORDER - DRUGS DISCONTINUED IN THE RECENT PAST
Table 3 : Takeda
- VORTIOXETINE - MAJOR DEPRESSIVE DISORDER – COMPETITIVE LANDSCAPE
- Key advantages of Vedolizumab (MLN0002) are
Table 4 Takeda
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
- Takeda MLN 0002/Vedolizumab Clinical trial Program
- Ninlaro (MLN-9708, PhIII, Multiple Myeloma) –Uptake in US is key to watch in 2016
Table 7 : Takeda
- Ninlaro - Tentative Filing and approval timeline
- For Each Indication- Multiple Myeloma
- KEY MILESTONES

7. NIPPON CHEMIPHAR : Margin improvement – Key to lift up!
Table 1 : Nippon Chemiphar SALES BREAK UP
Table 2 : Nippon Chemiphar
- INNOVATORS WITH SIGNIFICANT PRESENCE IN GENERIC BUSINESS
Annexure 1 Expected Key Changes of New NHI Pricing System- April 2016
- SAWAI : Para-IV/505b(2) challenger of Japan in the making!
Table 1 : Sawai
- GRADUALLY IMPROVING WHOLESALER BASE
Table 2 : Sawai - BALANCED PRIMARY CARE PRODUCTS-MIX
Table 3 : Sawai
- BETTER PERFORMANCE BY NEW PRODUCTS
Table 4 : Sawai
- VALUE OF PRODUCTS GOING OFF PATENT IN NEXT 3 YEARS
Table 4 : Sawai
- VALUE OF PRODUCTS GOING OFF PATENT IN NEXT 3 YEARS Figure 1:
Sawai : MEDIUM TO LONG TERM VISION
Figure 2 : Sawai
- Generic Market Size (Volume Basis)
Annexure 1 : Expected Key Changes of New NHI Pricing System- April 2016

8. TOWA : “Direct Sales Model”- A better way to withstand Teva-Takeda Generic Giant?
Table 1 : Towa
- DIRECT SALES ON RISE
Chart 1 : Towa
- CONSTANTLY INCREASING CAPEX
Table 2 : Towa
- KEY LAUNCHES OF 2015 AND MAJOR LAUNCHES EXPECTED IN THE NEXT TWO YEARS
Table 3 : Towa
- STEADY PERFORMANCE OF KEY PRODUCTS IN LAST THREE YEARS –
- SALES ¥b
Annexure 1 Key Features of April-14 NHI Pricing System
Annexure 2 Expected Key Changes of New NHI Pricing System- April 2016
Annexure 3 MARKET SURVEY 2015 - DIFFERENCE BETWEEN NHI PRICE vs. MARKET PRICE OF GENERICS IN JAPAN
Note: Product cover images may vary from those shown
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- Chugai
- Daiichi Sankyo
- Kyowa Hakko Kirin
- Meiji Seika
- Mitsubishi Tanabe
- Nippon Chemiphar
- Nippon Kayaku
- Sawai
- Shionogi
- Symbio
- Takeda
- Towa
Note: Product cover images may vary from those shown
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Note: Product cover images may vary from those shown
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