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2014 will be marked as a transition year for the Japanese Pharma industry - the year is bound to be painful both for innovators and generic companies due to the new regulations. We find these regulations to be 'decisive' in spurring generic penetration significantly, with the main beneficiary being the Japanese government (or society) and not the generic companies. The implications of new price-reversions are going to have many facets and will change conventional business models. We expect many support services industries - CMOs, CROs and other allied services industries to benefit from these structural changes, while API importers will suffer. We also expect consolidation and M&A activities to spur in Japan.

Innovation Takes the Driver's Seat: While the new regulations will change the current business philosophy of doing business in patent expired space (>45% to total Japan market), the policy makers also discourage 'me too' innovations at the same time. The regulators however tend to support the 'first time in the world' level innovations by providing 'innovation premiums'. Japanese innovators will now become more serious and selective in their R&D approach. Previous year the Japanese innovators have focused on acquiring assets in - autoimmune, orphan diseases and oncology fields (Annexure 5). We expect this trend to prevail in the coming years. We find some of the candidates to remain in the limelight in 2014 along with some new additions - Edoxaban (Daiichi Sankyo), Invokana (Mitsubishi Tanabe), Dolutegravir (Shionogi), BBI-608 (Dainippon Sumitomo), Vedolizumab (Takeda), Xtandi (Astellas), Nivolumab (Ono) to hand-pick a few of them. The reports explain detail analysis on these key candidates.

The 138 pages report contains the detailed discussion of Japan biopharmaceutical market – which includes- Our view on the impact of 2014 price cuts on generic companies and innovator companies and detailed discussion on key attributes (consolidation activities, potential of R & D pipeline candidates, generic threat in domestic Japan market etc…) of leading Japanese innovator companies- Astellas, Chugai, Daiichi Sankyo, Dainippon Sumitomo, Eisai, Kyorin, Kyowa hakko Kirin, Mitsubishi Tanabe, Shionogi, Takeda and leading Japanese generic companies- Nippon Chemiphar, Sawai and Towa.

Table Of Contents

Global Pharmaceutical and Biotechnology Outlook 2014 - Japan Pharma
GLOBAL PHARMACEUTICAL AND BIOTECHNOLOGY OUTLOOK 2014

JAPAN PHARMA

Table of contents

MACRO ANALYSIS: Price-cuts will bring pain to many in 2014! Innovators tremble while generics look witless!

INNOVATORS:
• New Price-Cuts - A Double Punch To The Innovators!
o Table 1- NEW SLABS FOR NHI PRICE CUTS FOR LONG-LISTED DRUGS
o Table 2 - EXPENSE VS. PROFITABILITY OF JAPANESE INNOVATORS
• Another Blow For Innovators In Not Institutionalizing The ‘Innovation Premium'

GENERICS:
• Pressure To Generic Discount Further Increased
• Upcoming New Generics
• Existing Generics
o Table 3 - NEW DRUG PRICES FOR EXISTING GE DRUGS
• Listing Of GE Drugs by Both GE Name And Brand To Promote Discounting

IMPLICATIONS:
o Finding New Avenues Of Cost Saving Are Inevitable For GE Cos
o Innovators Need To Redefine Long-Listed Products Strategies
o Consolidation Activities To Will Witness A Boost
o Table 4 -OTHER REGULATION UNDER APRIL-14 REFORMS*
o Table 5 -Profitably Structure Of Select Generic Companies


Annexure 1 JAPAN GENERICS MARKET MODEL

Annexure 2 JAPANESE INNOVATORS: LONG LISTED EXPOSURE

Annexure 3 PATENT EXPIRY THROUGH 2016


JAPAN INNOVATORS

ASTELLAS: Successful Global Launch of Xtandi And Myrbetriq To Overcome Domestic worries!

Prograf Generics Launch in Japan
Xtandi
• JP Approval ahead than Zytiga
• What to watch out for in Detailed PREVAIL data in Late Feb at ASCO GU-14?
• Prevail top line data of Xtandi - rPFS advantage and ease of use compensate absolute OS disappointment for urologist
• Recent US prescription trends of Xtandi are encouraging
Isavuconazole: Isavuconazole QIDP designation and our expectation
• Competitive landscape of Antifungals
Myrbetriq
• Early prescription trend
• Target market
• Competitive landscape for OAB drugs

Table 1: Deals done by Astellas in 2013
Table 2: Clinical data Comparison Xtandi vs. Zytiga
Table 3: Pipeline early stage Androgen receptor antagonist
Table 4: Competitive landscapes for Antifungals
Table 5: Competitive landscape for OAB drugs
Table 6: Key Milestones


Chugai: New Wave of Products Will Help Maintain Leadership Of Japan's Biotech!!!

Long listed product exposure vs. Sales growth of newly launched products
Actemra in 2014
• Penetration of Actemra in first line setting
• Actemra Japan Uptake of SC formulation
• Actemra ongoing clinical trials
• Japan RA market
Chugai's Breast Cancer Franchisee:
• Slower uptake expected than Global market for Perjeta in Japan, While for Kadcyla price listing in April is key for timely launch
• In long term, Perjeta and Kadcyla franchisee in Japan will reduce threat of Herceptin Biosimilar
• Further indication expansion of Perjeta in Global Market
• Japan dynamics would be different than global market for Perjeta
• Kadcyla vs. Tykerb in 2nd/3rd line breast cancer

Chugai's NSCLC franchisee:
• Launch of “Made in Japan ALK inhibitor” from Chugai's in house pipeline
• Tarceva indication expansion
MPDL3280A - Anti PD1 from Roche- status in Japan
2014 Price cut least impact amongst peers
• Tamiflu, Mircera, Boniva

Table 1: Actemra Ongoing Global trials
Table 2: Japan RA market
Table 3: Efficacy and Safety Comparision of Kadcyla vs. Trastuzumab + Docetaxel in FL BC
Table 4: Ongoing Clinical studies of Kadcyla in late stage HER2 positive Cancers
Table 5: Deals done by Chugai Pharma in 2013
Table 6: Key Milestones

Annexure 1: Possibility of Roche increasing its stake in Chugai is real and high
Annexure 2: Roche Chugai Maturing Relationship timeline
Annexure 3a: Potential benefits to Roche by increasing stake in Chugai
Annexure 3b: Chugai- Widening prospects of Actemra


Daiichi Sankyo: More Gain, Less Pain in 2014!

Vision 2017 is achievable
ENGAGE AF outcome did not disappoint, focus now shifts to launch and global partnering:
• Rx trends Suggest OD daily dosing matters in Oral anticoagulants:
• ENGAGE AF Data does not disappoint
• Japanese filing in VTE is encouraging
Chart 1: ORAL ANTICOAGULANTS: TRX TREND
Daiichi Sankyo Espha (DSE) - can unfold as a game changer in Japan generic market:
Table 1: PATENT EXPIRY THROUGH 2016
Table 2: DAIICHI SANKYO ESPHA APPROVALS UNTIL 2012
Table 3: DAIICHI SANKYO ESPHA APPROVALS IN 2013

Daiichi Sankyo Enjoys Greater Geographic Diversity And Revenue Sustainability Than Its Peers:
• High geographical diversity support in long run on multiple fronts:
Table 4: SALES - REGIONWISE
• KEY PRODUCTS REVENUE BASE RELATIVELY SUSTAINABLE COMPARED TO PEERS
Table 5: SALES TRAJECTORY IN JAPAN OF KEY PRODUCTS - THRU 2017
Table 6: EXPOSURE TO LONG LISTED PRODUCTS

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 - Expectation from BBI-608 to Achieve FY2017 MTP Target looks Unachievable

Summary of the company's ongoing activities and strategy

BBI-608 Optimism is too high
• Lead indication mCRC opportunity limited- Efficacy advantage in PhII study with standard of care needs to justify dual agent cost
• Pipeline Cancer Stem Cell inhibitors
• Conceptually targeting cancer stem cell approach is revolutionary, but it is still not validated in the clinic
o Failure of Imetelstat raises some questions on the approach
o Probable MOA of BBI-608 specific or not in mCRC
• A success fee partnering model demands high peak sales to translate meaningfully on bottom lines for DSP

Latuda- US blockbuster potential likely while opportunities in bipolar maintenance and IM depo formulation are limited
• Latuda prescription trend post bipolar disorder approval
• Latuda EU/JP approval

STEDESA/Aptiom US approval and uptake

Other Pipeline candidates
• DS-3025
• AS-3201
• SMP-986

Chart 1: Presence of stem cell in colon tissue
Table 1: Markers to identify colon stem cells and colon cancer stem cells
Table 2: Competitive landscape Metastatic colorectal cancer
Table 3: Early stage data Comparision of Cancer stem cell inhibitors targeting colon cancer
Table 4: Pipeline of drugs targeting cancer stem cell
Table 5: Pipeline of Boston Biomedical
Table 6: Psychiatrists see high unmet need
Chart 2: Atypical antipsychotics market
Table 7: PEARL 3 clinical study data of Latuda vs. Seroquel
Table 8: Latuda SWOT analysis
Table 9: Latuda extension study data
Table 10: Dianippon Sumitomo- Key pipeline candidates and expected filing
Table 11: Deals done by Dainippon in 2013 and our view
Table 12: Key events expected in next two years and our expectation on it


Eisai- Multiple Challenges, Little Hope!
Eisai Key Thesis
Table 1: KEY PIPELINE CANDIDATES
Table 2: DEPENDENCE ON LONG LISTED DOMESTIC PRODUCTS
Halaven - Promising In Triple Negative Breast Cancer, Many New Indications Underway And May Succeed:
Table 3: HALAVEN -INDICATIONS UNDERWAY
Table 4: HALAVEN : UPCOMING COMPETITION
Fycompa approved in US as adjuvant therapy for refractory partial seizure, but potential will be limited due to genericization of the market
Table 5: FYCOMPA CLINICAL DATA
Table 6: DATA PRESENTED AT IEC ANNUAL MEETING 2011
High Expectations from Belviq are not justifiable - Label Restrictions Will confine Peak-Sales from reaching $500m. Agreement terms with Arena leave little for Eisai on bottom line:
Featured Late Stage Pipeline - High Risk Candidates Await More Clarity On Data
Levantine Progressing Well
Table 7: LEVANTINE - WIDE INDICATION RANGE
Farletuzumab has lost attractiveness
E-5501 Looks Interesting So Far, Data Awaited for a Long
Chart 1: E-5501 - SHORT AND LONG TERM PLATELET RESPONSES
Eritoran (E5564) Looks Dormant in Pipeline


Kyorin- Time to display its Respiratory Strength in Japan

Kyorin Key summary
• Teijin group acquires a stake in Kyorin- What next???
KRP-AB1102/KRP-AB1102F
• JP status
• US sales trend
• Our view
KRP-108
• Our view on its expected uptake in Japan
• Its uptake in EU is very slow- but why it will not be the same case for Japan
• Asthma market dynamics in Japan
• Kyorin- Skyepharma agreement on KRP-108
Kipres and Uritos: Growing steadily but will face competition
Mucodyne sales trend and Pentasa line extension
Other pipeline candidates in early stage development
• KRP-203
• KRP-209
• KRP-EPA605
• KRP-AM1977X and KRP-AM1977Y
Chart 1: US prescription tend of recently launched drugs in respiratory therapy class
Chart 2: Flutiform vs. Seretide (Advair) - Head to head efficacy comparison
Table 1: Flutiform competition in Japan
Table 2: Flutiform: Key pipeline candidates in JP asthma market
Table 3: Key events expected in next two years and our expectation on it


Kyowa hakko Kirin - A long way to go to become a Global Speciality Pharma

Kyowa Hakko Kirin - Key summary
• KHK's Potelligent technology
• Biosimilar JV
Our view on its global late stage pipeline candidates
• KW-0761
• KW-6002
• KRN-23
• MEDI-563/Benralizumab/KHK4563
Newly launched products in domestic market
• Poteligeo- First Potelligent based antibody in market
• KW-6002
• Onglyza

Table 1: KHK: Global Pipeline - expected launch, peak sales estimates and upcoming milestones
Table 2: Parkinson's disease competitive landscape of recently launched PD Drugs in Japan
Table 3: Deals done by KHK in 2013
Table 4: KHK- Potelligent technology
Table 5: Key events expected in next three years and our expectation on it

Mitsubishi Tanabe - Near term growth dependent on the competiton faced by Gilenya and Invokana

Mitsubishi Tanabe - Key summary
• Growth drivers vs. long listed exposure
• Our view on MT's acquisition strategy
Invokana- US prescription trend is encouraging but warrant a caution
• Invokana US prescription vs. newly launched products in type 2 diabetes space
• Invokana cost vs. Victoza cost
• EU uptake of Forxiga
• Japan market dynamics for SGLT2 inhibitors
• Our expectation on market share for Invokana vs. Empagliflozin vs. dapagliflozin
• What to watch in SGLT2 class globally next??- LX4211, Empagliflozin ….
Tenelia prospects post Invokana launch
Gilenya: 2013 A year of Gilenya: BG-12 US launch has not impacted yet what next…
• 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
Remicade Growth in Japan - Biosimilar Remicade entry in Japan and our view on its impact
• Simponi
• Simponi ARIA
STENDRA (Avanafil) would not add much
Telavic growth is dampen in Japan
MT-4666
MT's early stage global pipeline - Peak sales estimates, our view and upcoming milestones
• MT-3995, MT-9938, MP-157, MP-124, T-0047/SB-683699, MN-305
• MT-1303, MT-210, STU-199, TT-138, Wf-516


Chart 1: US prescription trend of Invokana
Chart 2: US prescription trend of Invokana vs. Victoza
Table 1: Five post marketing studies required by FDA on Invokana
Table 2: SGLT2 inhibitors- Efficacy Comparision
Table 3: SGLT2 inhibitors - Safety Comparision
Table 4: SGLT2 pipeline - Japan and Global status
Table 5: Marketed DPP-IV inhibitors in Japan, FY12 sales and Patent expiry
Table 6: Multiple Sclerosis: Oral drugs data Comparision
Table 7: Co-Pay difference to patients if biosimilar replace original Mab in Japan
Table 8: Clinical data Comparision of CT-P13 (Remicade biosimilar) vs. Remicade in RA
Table 9: Pipeline Remicade biosimilar in Japan
Table 10: Available biosimilar in Japan
Table 11: Avanafil Relative positioning
Table 12: MT- Pipeline analysis of early stage global candidates
Table 13: Deals done by MT in 2013
Table 14: Key events expected in 2014 and our expectation on it


Shionogi - Tivicay uptake is the key until next batch of Innovation

Shionogi- Key summary
Tivicay-
• US early prescription trend
• Market dynamics one all three integrase inhibitors on market
• Approval of Trii-FDC combination
• Tivicay- a huge potential beyond integrase inhibitor space
• What next to look for in the integrase inhibitor space?
Crestor: NRx/TRx show better resilience / Impact of IMPROVE- IT study
Low margin Domestic business not going to change soon
Pipeline has potential but unlikely to give breakthroughs in near term
US business: Nothing left for further downside

Chart 1: Tivicay Early prescription trend
Chart 2: Current HIV treatment Paradigm
Table 1: Competitive landscape - Integrase inhibitors
Table 2: Dolutegravir PhIII trials
Table 3: Tivicay- SINGLE Trial data
Table 4: SPRING-2 Trial data
Table 5: Deals done by Shionogi in 2013
Table 6: Key events expected in 2014 and our expectation on it



Takeda - Challenges Ahead for its New European President

Takeda - Key summary
EU New products launch in near term get modest help from Nycomed presence while in long term expected launch of vedolizumab and Natura alpha in IBD market will get big boost

Vortioxetine- US launch for MDD likely in Early 2014, Competitive enough against genericized MDD market
• Edivoxetine failure a moderate positive
• Brexpriprazole clinical development needs a close watch
• Vortioxetine vs. currently available drugs
• Pipeline drugs ready to unfold in 2014 in major depressive disorder market

Vedolizumab approval and our expectation
• Vedolizumab different mechanism of action
• Vedolizumab does not carry the risk of developing PML as Tysabri although follows the same pathway
• Efficacy comparable to currently available second line options
• Safety data looks impressive vs. currently approved drugs
• Competition from pipeline drugs
• Upcoming near term milestones in UC/CD indication

MLN-9708/Velcade- Our view on Takeda's multiple myeloma franchise
• MLN-9708 in NDMM and RRMM
• Competitive landscape
• PhIII trial design
• Update post EHA and ASCO 2013
• Current treatment options NDMM and RRMM
• Velcade post launch of Kyprolis and Pomalyst
• Expected competition to Velcade in second/third line setting and upcoming milestones before patent expiry (2017)
• Recent approvals of Kyprolis and Pomalyst in RRMM have set a new bar for efficacy

TAK-700 - Unable to demonstrate OS benefit in chemo experienced patients- What to expect in chemo naïve pool and in earlier setting???
• Xtandi - the real bar in earlier setting
• Key Milestones to watch out for TAK-700 in 2014
• TAK-700 vs. Zytiga

Our view on Takeda's other important growth drivers in 2014
• SYR-322 - Japan and US sales trend
• EDARBI- Outlicensing deal with Arbor pharma - a smart move
• Adcetris


Table 1: Deals done by Takeda in 2013
Table 2: Key late stage pipeline candidates- Expected launch and peak sales estimate
Table 3: Vortioxetine- Major depressive disorder- late stage pipeline
Chart 1: Anti-depressants - WW Competitive landscape
Table 4: Vortioxetine- Major depressive disorder- Early stage pipeline
Table 5: Vortioxetine- MDD - Drugs discontinued in the recent past
Table 6: Vortioxetine- Major Depressive disorder- Competitive landscape
Table 7: Vedolizumab- Pipeline leukocyte Traffic inhibitor (Integrin inhibitor)
Table 8: Vedolizumab vs. Marketed Mab in Ulcerative colitis
Table 9: Vedolizumab vs. Marketed MAB in Crohn's disease
Table 10: Vedolizumab Clinical trial Programme
Chart 2: MLN-9708 Trial design
Chart 3: Reported adverse events in clinical trials- MLN9708
Table 11: MLN 9708- Data Comparision- Newly diagnosed Multiple Myeloma
Table 12: MLN 9708- Data Comparision- Relapsed and refractory Multiple Myeloma
Table 13: TAK-700 Comparision of CY17 inhibitors pipeline drugs action on Androgen synthesis
Chart 4: TAK-700- Drugs acting through androgen pathway in Prostate cancer
Table 14: Key candidates of Antiandrogen therapy in Prostate Cancer
Chart 5: Nesina US prescription trend
Table 15: Key events expected in next year and our expectation on it

JAPAN GENERICS

Nippon Chemiphar - Overseas Expansion - An attempt to improve thin margins, Wavering Profitability outlook

Nippon Chemiphar- Different from pure play generic player

Impact of April 14 NHI price revision
Table 1: Nippon Chemiphar: Generic Sales Break up

Lowest profitability structure in not going to change soon
Table 2: Generic companies with NCE research focus- FY 2013 sales estimate and growth rate


Sawai - Growth Story Continues!

A Balanced Therapy Focus, Warrants Sustainable Base
Table 1: BALANCED THERAPY FOCUS
Wider Distribution Base to Exploit All Markets
Table 2: BALANCED DISTRIBUTION FOCUS
Constantly growing manpower base
Table 3: CONSTANTLY GROWING MANPOWER BASE
Japan Generic Macro Thesis
• Likely Consolidation Activities
• NHI Price Cuts and GE Friendly Reforms in April-14
• Changing Market Dynamics With the Debut of Foreign Players in Japan GE Space
• Price War' Does not Work Well in Japan
• Market Opportunity is Large Enough to ‘Feed' Everyone

Table 4: FOREIGN COMPANIES ENTRY IN JAPAN GENERIC MARKET
Table 5: SAWAI VS. KEY COMPETITORS SALES BREAK UP
Chart 1: JAPAN GENERIC MARKET: POTENTIAL VS. PENETRATION


Towa - 2014 - Testing Year for ‘Premium Pricing' Strategy!
Direct sales model likely to maintain high margin business
Recent Investments Will Start Yielding Returns Soon
Conventional Business Model is Sustainable
Likely Consolidation Activities
NHI Price Cuts and GE Friendly Reforms in April-14
Table 1: DISTRIBUTION TREND
Chart 1: CAPEX TO MEET FUTURE DEMAND
Table 2: TOWA VS. KEY COMPETITORS SALES BREAK UP
Table 3: FOREIGN COMPANIES ENTRY IN JAPAN GENERIC MARKET
Chart 2: Japan Generic Market: Potential vs. Penetration


Japan Pharma Industry Tables

Annexure 4: Key late stage pipeline/Newly launched drugs potential through 2018

Annexure 5: Therapy Area wise Deals done by Japan Innovators in 2013 161-166

Annexure 6: Expected Drug Clinical Milestones

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