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Japan Pharma Outlook 2016 : JP Giants leaning in for becoming a Speciality Global Pharma

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Date: 10-Mar-2016
No. of pages: 91
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Sakigake designation - A Push from government to "Innovate"!

"Essential drugs" exemption from Z2 rule- Balancing long listed pricing pressure!

Authorized Generics, Biosimilars, and Patent Litigations - Avenues to grow in JP Generic market!

Increasing decline in long listed products sales, and a few success in R & D in the last decade had put JP giants under pressure to refocus on Innovation with specialty therapy area to strengthen their global presence. Eisai Ajinomoto JV, Teva-Takeda partnership for Speciality Generics is the actions in this direction. Fast track approval based on "Sakigake" designation is the step by PMDA/MHLW to encourage JP Pharmas to research in the area of high unmet medical need/orphan disease where US biotech has taken a successful leap in last decade.

In innovation space, Nivolumab, Alectinib, Dolutegravir global success again demonstrate ability of JP pharma/university research house to contribute Pharma Innovation, while encouraging regulatory environment for "Regenerative Medicine Drug Development" and "Drug Repurposing" will make Japan front runner in this space. From late stage pipeline/new launch, Mirogabalin approval in Neuropathic Pain, Brintellix Cognition label expansion, Edoxaban uptake in EU, Alectinib uptake in US and ACE-910 approval for hemophilia will decide Japanese Innovator growth in Global market. The biennial price cut scheduled in April-2016 will balance Innovation premium with long listed price cut (Z2 rule) to increase R & D productivity.

In next 3 years, ¥950b drugs will go off patent in Japan- and as happened in 2015, substantial volume 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 upper hand due to 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 breadth of the JP generic giants from launching generics in Japan to becoming a patent challenger- Intellectual property rights challenging generic company. This is a step towards finding its place against the world generic players in the coming time. Successful launch of Blopress AG, Plavix AG in last few years stamps Authorized Generics as one of the attractive opportunity for Generic players in Japan. Encouraging Uptake of Filgrastim BS and Lantus BS in Japan is indicative of Japan to be the next important market after 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).

In this report- we analyzed 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.

Companies Mentioned

Takeda, Chugai, Daiichi Sankyo, Kyowa Hakko Kirin, Meiji Seika, Mitsubishi Tanabe, Shionogi, Symbio, Takeda, Towa, Sawai, Nippon Chemiphar, Nippon Kayaku

Japan Pharma Outlook 2016 : JP Giants leaning in for becoming a Speciality Global Pharma

Table of Contents

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

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

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

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
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

TAKEDA : LEANING TOWARDS BEING A GLOBAL SPECIALTY PChart 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

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
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

List of Tables

Table 1
Chugai
DEALS DONE BY CHUGAI PHARMA IN 2013-2014-2015
Chugai - Key Milestone Table
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
KEY MILESTONES (4568)
KEY MILESTONES (4151)
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
Table 1:Mitsubishi Tanabe SGLT -2 INHIBITORS AND DPPIV PLAYERS IN JAPAN
Key Milestone : Mitsubishi Tanabe
Table 1: Nippon Kayaku BUSINESS SEGMENTS : SALES BREAK UP
(Million yen)
Table 2
Nippon Kayaku rating Income by Segment
(Million yen)
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 Table 1 : Shionogi SINGLE TRIAL DATA- Triumeq vs. Atripla
Table 2 :Shionogi
Global competitive landscape for Treatment of Thrombocytopenia- Recently approved drugs + Late stage pipeline
Table 3 :Shionogi
Global Clinical data comparison of late stage oral TPO mimetics for treatment of
Thrombocytopenia associated with chronic liver disease
Table 4 :Shionogi
Shionogi- Late stage Pipeline Analysis of Global Candidates
Table 5 :Shionogi
Shionogi- Early stage Pipeline Analysis - Out licensing pportunities
Table 6 :Shionogi
Shionogi- Late stage Pipeline Analysis - Japan Near term Opportunities
Table 7 :Shionogi
DEALS DONE BY SHIONOGI IN 2013-14-15
KEY MILESTONES (4507)Table 1 :SymBio
SymBio - PIPELINE
Table 2 :SymBio
RR / 2ND-LINE HR-MDS - SELECT LATE - TO MID - STAGE PIPELINE
KEY MILESTONES (4582)
Table 1 :Sawai
GRADUALLY PROVING WHOLESALER BASE
Table 2 :Sawai
BALANCED PRIMARY CARE PRODUCTS-MIX
Table 3:Sawai BTTER PERFORMANCE BY NEW PRODUCTS
Table 4 :Sawai
VALUE OF RODUCTS GOING OFF PATENT IN NEXT 3 YEARS
Table 5 :Sawai
NEWLY LISTED PRODUCTS IN FY 03/16 (YE March-2016)
Table 1 :Towa
DIRECT SALES ON RISE
Table 2 :Towa
KEY LAUNCHES OF 2015 AND MAJOR LAUNCHES EXPECTED IN THE NEXT TWO YEARS
Table 3 :Towa
STEADY RFORMANCE OF KEY PRODUCTS IN LAST THREE YEARS -
SALES ¥b
Annexure 3 :MARKET SURVEY 2015 -
DIFFERENCE BETWEEN NHI PRICE vs. MARKET PRICE OF GENERICS IN
JAPAN
Table 1 :Nippon Chemiphar NIPPON CHEMIPHAR SALES BREAK UP
Table 2 :Nippon Chemiphar
INNOVATORS WITH SIGNIFICANT PRESENCE IN GENERIC BUSINESS

List of Figures

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
Chart 1
Mitsubishi Tanabe
US- Prescription Trend of Gilenya
Chart 2
Mitsubishi Tanabe
US- Prescription Trend of SGLT2 inhibitors
Chart 3
Mitsubishi Tanabe
US- Prescription Trend of SGLT2 inhibitors
Chart 1 :Shionogi
US TRX trend of Triumeq/Stribild- June 5th 2015
Chart 2:Shionogi
US NRX trend of Triumeq/Stribild
Chart 3 :Shionogi
US TRX trend of Integrase inhibitors
Figure 1 :Sawai
MEDIUM TO LONG TERM VISION
Figure 2:Sawai
Generic Market Size
Chart 1 :Towa
CONSTANTLY INCREASING CAPEX

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