$2500 |

JP Giants leaning in for becoming a Speciality Global Pharma
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!
[Lowest Price Guaranteed: $2,500]

Published by MP Advisors: 10 Mar 2016 | 20127 | In Stock
Related Topics: Biosimilars , Drug , Lantus , Lilly , Pain , Plavix , Regenerative Medicine

Introduction

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.

Table of Contents
for JP Giants leaning in for becoming a Speciality Global Pharma 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!

  • 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 .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

Additional Details

Publisher

MP Advisors

Publisher Information

Reference

20127 | 4488

Number of Pages

91

Report Format

PDF

MP Advisors Reports

This report is published by MP Advisors

Download Free Report Summary PDF

JP Giants leaning in for becoming a Speciality Global Pharma
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! | Download PDF Summary

Download our FREE report summary PDF. It contains all the information on these web pages, plus a Proforma Invoice request form, should you need it to satisfy your company's internal order procedures.

Ordering Information

Orders are processed immediately and you will be notified of the despatch date on confirmation of your order.

Accepted Card Types

Payment

Buy now using our secure payment system.

We Stock...