Global Pharmaceutical and Biotechnology Outlook 2012 - MP Advisors

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Table of Contents
Global Pharmaceutical and Biotechnology
Outlook 2012
Table of Contents
• Therapeutic Class Reports
B/203,Alkapuri Arcade, R.C.Dutt Road,Vadodara-390007,INDIA.
Phone: +1.480.263.9400,+91|265|232-7096,E-mail: mp@mpadvisor.com
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04
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Chapter 1:
Global Pharma
Chapter 2:
Rising Stars
Chapter 3:
Japan Pharma
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14
14
Chapter 4:
Mature Biotech
Chapter 5:
India Pharma
Chapter 6:
Macro Tables Of Pharma Industry
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Alzheimer’s Disease
Cancer Vaccine
Hepatitis C Virus
(HCV)
Metastatic Melanoma
(mMelanoma)
Multiple Sclerosis
(MS)
GLP-1 agonist
Oral Anticoagulants
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CHAPTER 1:GLOBAL PHARMA
Roche: Gaining Traction
The key milestones for 2012 that would improve Roche’s long term growth
Zelboraf should have an accelerated uptake and should ramp up to $700m in 2012
Vismodegib Approval in Inoperable basal cell carcinoma
Approval of Pertuzumab in first line HER2+ metastatic breast cancer, based on
PhIII CLEOPATRA data
PhIII Interim data from dal- OUTCOME Study
Key Milestones to Watch out for in the HDL raising Therapy Space
Head to head study – Actemra Vs. Humira in DMARD refractory patients
MARIANNE,EMILIA AND APHINITY trial will lend sustainable growth to breast cancer franchise
Tarceva –EURTAC Data positive: Threat to Iressa in Firstline NSCLC
Threat to Lucentis, but the market is large enough for Lucentis to sustain current level of sales
Avastin outlook - 2012 onwards
Patent expiry impact in 2011
Ocrelizumab: Long term safety and efficacy –Gaining confidence in positive PhIII readout
RG1678 in Schizophrenia
MetMab
GA101
in NSCLC
GlaxoSmithKline: 2012 – Pipeline News flow Will Reshape Growth Outlook
Stock Price Catalysts for 2012
PhIII study exploring Adjuvant Tykerb in combination with Trastuzumab in Breast cancer
PhIII data on Melanoma pipeline (BRAF and MEK inhibitor, MAGE-A3)
PhIII data on the LABA/LAMA Fixed Dose combination (Umeclidinium/Vilanterol) in COPD
Multiple PhIII studies to report data on Relovair in 2012
Darapladib – Outcome data from STABILITY - Interim analysis expected by YE 2012/1H 2013
Multiple studies on Syncria will unveil data
PhIII study exploring Tykerb in Adjuvant High risk Head and Neck cancer
Head to Head Clinical data on IPX-066 vs. Stalevo, and EU approval
PhIII data on Rare disease pipeline (migalastat- Fabry, GSK2402968-Muscular
Dystrophy)
GSK2402968- Duchenne muscular dystrophy
Bristol-Myers Squibb: Valuations and Patent Expiry Pressure Towering
Reasons for restricted potential for Eliquis
Assessment of Yervoy growth going forward
Risk to our Thesis
Eliquis potential in stroke prevention in atrial fibrillation
Competitive Threats - Clinical data from Edoxaban and approval of Watchman Device are the key
threats
Dapagliflozin- will extend regulatory timelines or translate into restricted label and competitive
landscape
Brivanib in Hepatocellular carcinoma
HCV Franchise – NS5A replication complex inhibitor – Daclatasvir
Elotuzumab in Multiple Myeloma
Growth from marketed drugs
Impact of generization in topline revenues
MP Advisors
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Global
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AstraZeneca: Brilinta ramp up slow, while patent expiry pressures at their peak
Series of pipeline failures – TC-5214, Olaparib and Zibotenten
Brilinta – Current Prescription Trends Disappointing
Crestor is also likely to be threatened by interim data from IMPROVE IT trials
Lipitor Genericization impact on Crestor
Dapagliflozin – Restricted potential even if approved
Threat to marketed drugs
Generic exposures through 2016
Key milestones
Eli Lilly: Fortune Depends On Solanezumab Success
Solanezumab PhIII data from EXPEDITION 1 and EXPEDITION 2 study in
moderate to severe Alzheimer Disease Patients – A key binary event
Effient - TRIOLOGY ACS study is the next important milestone
Key pipeline candidates review: Empagliflozin, Dulaglutide and LY2063016
Oncology Late stage pipeline candidates will still take time to mature
Necitumumab in Squamous NSCLC
Key growth driver and patent expiry impact
Key milestones
Merck: 2012- IMPROVE-IT Interim Analysis Can Swing the Stock Back in Flavor
Vytorin/Zetia fate beyond Lipitor Patent expiry - Approval in CKD patients based on SHARP data
Interim Analysis from IMPROVE-IT Trial
MK-0653C launch is a growth driver beyond 2013
Victrelis uptake against competition and MRK’s early stage HCV assets
Januvia/Janumet will continue to grow due to expansion of DPP-IV inhibitor market
Isentress will face competition from Quadpill launch
View on key late stage pipelines: Ridaforolimus, Tredaptive, V5036, Suvorexant and Odanacatib
Key milestones
Novartis: A Fundamental Buy, But Near Term Pressures Will Weigh On the Stock Price
Most important events to watch out in 2012
Gilenya Ramp up in Multiple Sclerosis
Afinitor Shaping Up As a Blockbuster
Tasigna Penetration in 1st Line Chronic Myelogenous Leukemia
Respiratory Franchise (Indacaterol, NVA237 and QVA149)
NVA237 filing delayed in US and QVA149 to be filed in International market (Ex- US) by 2012
MenB –EU Approval
SOM230 (Pasireotide LAR) – PhIII head to head study comparing SOM230 with
Sandostatin LAR in active acromegaly
Key milestones
Novo Nordisk:Fully Valued for Now – Degludec Thrice Weekly Is The Key to Further Upside
Competitive Pressures for Victoza in diabetes, potential in obesity for non-diabetics
Insulin Degludec – We forecast incremental sales of $1.5b by 2018
Haemostasis Franchise
NN1841 in FXIII deficiency
NN7008 in Haemophilia A
Key milestones
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Global
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Pfizer: In Search Of New Cash-Cow- Eliquis /Tofacitinib/….?
Tofacitinib Efficacy is impressive – Need to keep a watch on the Follow up pipeline
candidates in ORAL RA and market potential
Axitinib (Inlyta) – Positive advisory committee vote and potential
Prevnar 13 US growth will be driven by outcome of the CAPITA study data is the key, while in Ex-
US market, geographic expansion and increase in penetration will drive the growth
Eliquis Potential In Stroke Prevention In Atrial Fibrillation
Competitive Threats - Clinical data from Edoxaban and approval of Watchman device
Long term growth opportunities
Key milestones
Sanofi: Business Performance to Bottom Out In 2012
Important clinical data and regulatory events expected in 2012
Risk to our thesis
Lemtrada Approval YE – 2012
Lixisenatide – PhIII data from GETGOAL program
Approval of Teriflunomide in Multiple Sclerosis
Aflibercept – PhIII data in 2nd line colorectal cancer
Mipomersen in familial hypercholesterolemia
New Lantus formulation
Semuloparin in Onco patients VTE prevention
Growth from recently launched products and generic impact
R&D Pipeline: Upside limited due to Strong Competition; but orphan indication approval to improve
the top-line growth
Key milestones
Annexure 1: Drugs Losing Patent Protection by 2016
Annexure 2: Impact of Patent Expiry In W.R.T. 2011 Total Revenue
Annexure 3: Global Pharma PhII and PhIII - Pipeline Potential
Annexure 4: Global Pharma High Impact Milestone - 2012
Global Sector Industry Tables US & EU
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Global
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Market Perform Recommendations – Company Analyses
Amarin
AVEO Pharma
Galapagos
ISIS Pharma
Medivir
Rigel Pharma
Not Rated – Company Analyses
Ablynx
Allos Therapeutics
Alnylam Pharma
Intercell
Protalix
Rising Stars Sector Industry Tables
Annexure 1: Drug Clinical Milestones
Annexure 2: Drug Launch Table - 2012
Annexure 3: Npv Valuation
CHAPTER 2: RISING STARS (UNPROFITABLE INNOVATORS)
Macro Analysis
• Top Picks for 2012
• MP’s Performance for 2011
• Paradigm shift in investing pattern: Tap Them Young
• Innovation Rewarded- Drug approvals in 2011 and Expected Drug Launch in 2012

Many Up For Garage Sale but Technology Platforms will Continue to Attract
Top Picks - Company Analyses
Anthera Pharma
Incyte
Micromet
Other Outperform Recommendations - Company Analyses
Ardea Biosciences
ArQule
Immunomedics
MorphoSys
Regeneron
Vertex
Rising Stars
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CHAPTER 3: JAPAN PHARMA
Chugai: 2012 - Going to Be A Happening Year!
Actemra to gradually increase its patient base
Ongoing head-to-head trials vs. Humira (adalimumab)
Subcutaneous vs. Intravenous study (SUMMACTA trial)
Table 1 Ongoing Global trials on Actemra
Table 2 Japan RA market
Pertuzumab will secure approval in Japan followed by overseas markets
TDM1 approaching milestones expected to turn positive
Table 3 Efficacy and safety of comparison: TDM1 vs. Trastuzumab+Docetaxel
Table 4 TDM1: Ongoing important clinical studies
Safe domestic business and sales ramp up of newly launched products in Japan
Table 5 Chugai-sales break up
Table 6 Key products of Roche & their contribution
Table 7 Lowest exposure to long listed product compared to peers
Roche may increase its stake in Chugai after Sept-12
Annexure 1 Chugai’s EPS CAGR and attractive Div. yield
Annexure 2 Domestic Japan pharma sales
Daiichi Sankyo: ‘Hybrid Tree’ Is Ready to Give Fruits!
Table 1 Key pipeline candidates
Edoxaban - positioned well in late stage factor Xa inhibitors
Table 2 Indication wise market opportunity of late stage oral anticoagulants
Table 3 Factor-Xa candidates: Global development timeline
Table 4 Factor-Xa candidates: development in Japan
Table 5 Anticoagulants market in Japan
ARQ-197: first c-Met inhibitor is on its way
Denosumab promises safe cash flow stream beyond 2020
RBXY’s solid growth prospects beyond near term concerns
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Japan
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Table 6 Ranbaxy FTF opportunity
Table 7 Ranbaxy key Para IV milestones
Daiichi Sankyo Espha - A game changer in Japan generics market
Table 8 DSE approvals
Geographic diversity and revenue sustainability
High geographical diversity support in long run on multiple fronts
Table 9 sales break up region-wise
Key products revenue base relatively sustainable compared to peers
Table 10 sales trajectory of key products in Japan – thru 2017
Table 11 DS vs Peers exposure to long listed products
Table 12 Sales forecast of important products
Recently approved drug will maintain sustainability
Approval of Zelboraf establishes foothold in oncology
Slow but constant sales ramp up of Efient
Laninamivir will change the competitive landscape of the Japanese influenza market
Annexure 1 PHII clinical data cross comparison of Betrixaban, Edoxaban and Pradaxa for
stroke prevention in AF
Annexure 2 Competitive landscape: non-small cell lung cancer
Annexure 3 Patent expiry through 2014
Annexure 4 DS income statement
Annexure 5 Domestic Japan pharma sales
Torii Pharma: A Bet That Offers Only Upside!
Table 1 NPV valuation
Factors suggesting Dalcetrapib success
Dalcetrapib data - so far good and clean
Role of pre-beta HDL is Key for reverse cholesterol transport
CETP modulation – More safe than CETP inhibition
Table 2 Difference between CETP inhibitor/modulator
Dalcetrapib action on reverse cholesterol transport system is unique
Merck is the closest competitor, but lags in timeline by about ~3 years
Elvitegravir – partnered with HIV leader Gilead and US filing expected by 2Q12 for mono-therapy
Table 3 Dalcetrapib development program
Annexure 1 Pipeline of Japan Tobacco
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Japan
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Annexure 2 Competitive landscape of CETP inhibitors
Annexure 3 Ongoing PhIII trials on Dalcetrapib and Anacetrapib
Towa: Performance Will Outcast New ‘Mid Term Plan’
Bearish assumptions about ’major reforms’ in Towa MTP
MTP assumes no fundamental reform on NHI pricing system
Investment plans
Towa has always exceeded its MTP
Attractiveness as an Acquisition target
Relative standing vs. Peers on valuation
Healthcare reforms in April-12
Emerging threats to domestic generic companies
Generics market - total pie is huge, growth from untapped market is more likely
Table 1 Proposed healthcare reforms for 2012
Table 2 Conservative Mid Term Plan VS. MPE
Table 3 Revenue growth of generic Cos in price cut years
Table 4 Previous MTP of Towa vs. Actual
Table 5 Entry of foreign companies in the Japan generic market
Table 6 Towa vs. peer generic Cos - valuation summary
Chart 1 Japan: long listed drugs and generic penetration (2011)
Annexure 1 Sales break up in various segments of generic companies
Annexure 2 Financial summary of generic companies
Annexure 3 Capex efficiency: Towa vs Sawai
Dainippon Sumitomo: Latuda Story Is Not Over Yet!
Latuda Position In The Highly Competitive & Genericized Anti-Psychiatric Market
Addressing High Unmet Need in Anti-Psychotics Market
Latuda: Ongoing/Planned Clinical Studies Will Continue To Drive Growth
Table 1 Psychiatrist See High Unmet Need
Table 2 Latuda - ongoing/planned clinical studies
Chart 1 Monthly TRx trend- US
Chart 2 Atypical anti-psychotics market
Table 3 Latuda PEARL 2 data
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Japan
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Table 4 PEARL 3 vs. Seroquel: overall a good risk/benefit ratio
Table 5 Latuda SWOT analysis
Table 6 PEARL 3 extension study data- non inferior to Seroquel XR
Other pipeline potential is modest
Annexure 1 DSP pipeline candidates
Annexure 2 Atypical anti-psychotics – competitive landscape
Annexure 3 Domestic pharma sales
Eisai: ‘HAYABUSHA’ Difficult to Achieve!
Pipeline potential overly built
Domestic challenges surface soon
Biomarker’s upside falls ‘beyond Hayabusha timeline’
Table 1 Key pipeline candidates
Aricept Lifecycle Management Programs Unlikely to Meet Management’s Target
Table 2 Aricept WW sales projections
Table 3 Aricept sales in Japan: strength wise
Halaven Approval is Good but Delayed; Competition is growing in the class
Table 4 Halaven – a number of indications underway
Table 5 Upcoming competitors for Halaven
Late Stage Pipeline – Clarity On Data Awaited
Perampanel Expected US Filing By Year End
Table 6 Data presented at AAN annual meeting 2011
Table 7 Data presented at IEC annual meeting 2011
E-7080/ lenvatinib: VEGF receptor for thyroid cancer
MORAb-003/ farletuzumab : humanized IgG1 monoclonal antibody for Ovarian Cancer
Eritoran (E5564) Filing Has Been Delayed
Table 8 Eritoran vs. Xigris: comparative efficacy
E-5501: thrombopoietin agonist for 2nd/3rd line treatment of ITP
Chart 1 E-5501 - short and long term platelet responses
E5555: thrombin receptor antagonist for ACS
Annexure 1 Consolidated income statement: MPE vs. HAYABUSHA
Annexure 2 Domestic pharma sales
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Japan
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ASTELLAS: Defensive Agreements Dilute Catalysts’ Value!
Table 1 Major deals structure leaves little room for investors
MDV 3100: Data shows promise to reach market; partnership agreement dilutes bottom line upside
AFFIRM Trial Data Is Impressive
Previous Data Also Give Positive Signals
Less lucrative Commercialization Agreement
Table 2 Long-term Ph I/II follow-up results
Mirabegron will reach market in time; will strengthen Astellas urinary franchise
Mirabegron target patients targets
Mirabegron Data Is Good and Glaucoma Concerns Does Not Hamper Its Potential
We Do not See Incidence of Glaucoma Threat to Mirabegron Fate
Table 3 Overactive bladder syndrome: key drugs
Table 4 Mirabegron results from European and Australian patients
Table 5 Mirabegron efficacy and tolerability results from American patients
ASP-1941 remains competitive in SGLT-2 inhibitors class
Table 6 SGLT2/SGLT1 inhibitors: preliminary efficacy comparison
Rest of pipeline has good candidates, but carry certain concerns
Vibativ Still Lingers: Has Proven To Be a Pricey Deal For Astellas
Table 7 MRSA agents: competitive landscape
Aacotiamide can emerge as ‘new generation’ treatment for functional dyspepsia
Becoming A Global Category Leader In Oncology
ASP4130/ Tivozanib–‘Me Too’ drug will not bring much positive
Annexure 1 Late stage overseas pipeline
Annexure 2 NPV shrinks due to commercialization agreement
Annexure 3 Competitive landscape of VEGF inhibitors in renal cell carcinoma
Annexure 4 Domestic pharma sales

Kyorin: Stable Base Business Lacks Drivers
Key catalyst has lost the ‘Race’
Kyorin Remains as One of The Most Viable Acquisition Target in Japan
Kipres Continues To Drive Growth In Anti-Asthmatic Market
Uritos Sales Ramping Up Well
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Japan
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Rapport with GPs Keeps Mucodyne Sales Stable
Nothing Much Exciting in Pipeline; Key Catalyst Look For Partners
Table 1 Kipres: competitive landscape in Japan
Table 2 Japanese OBS market

Kyowa Hakko Kirin: Divestment Of Chemicals Business Starts Improving Bottom Lines
Margins are on an improvement track
Addition of ProStakan group boosts Pharma sales
Unfolding the value of Potelligent technology is still a couple of years away
Table 1 Segment classification
Table 2 Income statement
Table 3 3Q FY 2011 results
Table 4 Pharma sales trend
Table 5 Potelligent technology

Mitsubishi Tanabe: Key Drivers Played Out Well!
Royalty income from Gilenya sales remains key
Table 1 FCF from Gilenya royalty
Table 2 MS - Marketed Products
Table 3 Select oral drugs in late stage development
Remicade and Telavic will continue to grow, but most of other products face generic threat
Table 4 Key products sales
Table 5 Japan RA market
Table 6 HCV pipeline in Japan
No Major Catalyst Coming Out From Late Stage Pipeline
Canagliflozin is showing promise of better safety and efficacy, among pipeline SGLT2 inhibitors
Table 7 SGLT2 pipeline (Japan and Global status)
Table 8 Domestic pipeline candidates
Annexure 1 Domestic pharma sales
Nippon Chemiphar: Size Matters!
Lowest profitability structure is not going to change soon
Increase in the number of DPC hospitals is a major catalyst for NP’s generic business growth
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Japan

Table 1 Financial summary of generic companies
Table 2 Entry of foreign companies in the Japan generic market
Chart 1 Japan: long listed drugs and generic penetration (2011)
Sawai: Relying on ‘Bond Theory’ Is Not Safe!
Favorable reforms will be implemented from April-12
Cautious over the ‘bond theory’ prevailing in the street
High revenue generation from dispensing pharma is a plus
Untapped opportunity from DPC hospital market is huge
No clarity on its investment into bio-similar
Premium to peers will be maintained
Table 1 Proposed healthcare reforms for 2012
Table 2 Sawai’s presence in major market segments
Table 3 Sawai vs. peer generic Cos - valuation summary
Table 4 Entry of foreign companies in the Japan generic market
Chart 1 Japan: long listed drugs and generic penetration (2011)
Annexure 1 Financial summary of generic companies
Annexure 2 Sales break up in various segments of generic companies
Shionogi: Little On Horizon While Crestor Approaches Climax!
Crestor – efforts to ‘Differentiate’ did not play out well; therapeutic substitution is likely post Lipitor generics

‘Low Margin Domestic Business’ is not going to change soon
Pipeline has potential but unlikely to give breakthroughs in near term
US Business – nothing left for further downside
Table 1 Japan pipeline and global status
KEY R&D PROJECTS
S/GSK-349572 / dolutegravir entered PhIII following positive outcome in two PhIIb studies
Rapidly Changing HIV Market Dynamics and Strategic Rationale of Integrase Inhibitors
Table 2 HIV market : Competitive landscape
Ospemifene - Clinical data suggests likely success in the market
PSD502 (US/EU PhIII, lidocaine and prilocaine, spray, premature ejaculation)
Annexure 1 Domestic pharma sales
Annexure 2 valuation
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Japan
Takeda: Nycomed to Give More Setbacks!
Nycomed product & pipeline will not be able to deliver for what Takeda has paid for
Table1 Nycomed: Proforma sales statement
Table 2 Nycomed: carrying value of G/w and intangible assets
Table 3 Nycomed: R&D pipeline
Safety related issues with Actos affect prospects of ‘alogliptin+actos’ combination
Table 4 DPPIV key products sales
EDARBI –‘Me Too’ ARB Will Allevi ate Pain of Atacand Revenue Loss
Table 5 ARBs: Competitive landscape in US
Pipeline is full with good high-risk-high-return candidates
Peginesatide is likely to secure FDA approval for CRF patients on dialysis
Adcetris/SGN-35/brentuximab vedotin
TAK 700 (PhIII US/EU, non-steroidal androgen synthesis inhibitor, Prostate cancer)
AMG706/ motesanib (PhIII US/EU/JP, VEGFR1-3, non squamous NSCLC)
Lu AA21004 (PhIII US/JP, Bis-aryl-sulphanyl amine, major depressive disorder)
MLN0002 (PhIII US/EU, vedolizumab, α4β7 integrin inhibitor, Ulcerative colitis / Crohn’s
disease)
TAK – 875 (PhIII US/EU/JP, GPR-40 agonist, diabetes)
Chart 1 Phase 2 data at ADA 2011
Annexure 1 Key pipeline candidates
Annexure 2 Takeda: proforma consolidated income statement
Annexure 3 EDARBI superiority over key marketed ARBs
Annexure 4 Domestic pharma sales
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Japan
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CHAPTER 4: MATURE BIOTECH
Macro Analysis
• Top Picks for 2012
• MP’s Performance in 2011
• Boosting R&D Productivity Through Smart Acquisitions
• Key Milestones Through 2012-13

Relative Valuation amidst Modest Generic Challenges
Top Picks - Company Analyses
Biogen Idec
Gilead
Other Outperform Recommendations - Company Analyses
Alexion
Amgen
Celgene
Market Perform Recommendation – Company Analysis
Onyx Pharma
Mature Biotech Sector Industry Tables
Annexure 1: Valuation Snapshot
Annexure 2: Expected Drug Clinical Milestones
Annexure 3: MB Sector Selected Companies M&A Activities
Annexure 4: Marketed Products' Potential
Annexure 5: Pipeline Potential Thru 2015
Mature Biotech
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MP Advisors
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CHAPTER 5: INDIA PHARMA
CY12 Investment Drivers & Criteria
Domestic Formulations: Reforms & Consolidation continue
Recent reforms (GMP+GLP) drive market growth by improving manufacturing practices
Draft of drug pricing policy- Neutral to positive for the industry
Para IV led growth- Indian companies poised to make the most
Company Recommendations
Aurobindo; Biocon; Cadila; Cipla; Dishman; Dr Reddy’s; Sun Pharma
Ipca; Lupin; Ranbaxy
CHAPTER 6: MACRO TABLES OF PHARMA INDUSTRY
Table 1: Report Card – Top Picks in 2011
Table 2: Report Card – Bottom Picks In 2011
Table 3:Top Picks – CY 2012
Table 4: Bottom Picks – CY2012
Annexure 1: Broad Index VS. Healthcare Index
Annexure 2: Biopharma Segment Shares
Annexure 3: Top 30 Historical Market Value Companies: 1999 - Present
Annexure 4: Market Share Correlates Well With Market Value
Annexure 5: Pharma Sales: Past, Present and Futre
Annexure 6: The Many Faces Of Profitability – 2012 Income Statement Matrix
Investment Conclusions

Macro Analysis
India
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Therapeutic Class Table of Contents
Therapy Class Reports
ANTI-INFECTIVE
1.HCV- NEXT WAVE: IFN-FREE DRUGS AND NOVEL FORMULATIONS
1.Investment conclusions
2.Key Pipeline Products
3.An All Oral Option in the Future! – Combination of Antiviral Agents
4.IFN-Free Combination Pipeline
5.Key Milestones through 2013
6.Data Analysis of IFN-Free Combination Drugs
7.Interferon Combinations – With Better Safety And Dosing Advantage
8.Market Analysis (Historic and Future)
9.Data Analysis of Combination Drugs with IFNs
10.Unmet need in Chronic Hepatitis C
11.Portfolio Of Best-In-Class HCV Drugs and Possible “Take-Out” Candidates
12.Background
13.Appendix
AUTOIMMUNE DISEASES
2.ALZHEIMER’S DISEASE: IS THERE MERIT IN PURSUING “AMYLOID-ISM” OR “TAU-
ISM”?
1.Unmet Need Persists = Investment Opportunity?
2.Failures Have Not Been the Pillars of Success
3.Pipeline and Key Milestones-2012-2015
4.Disease Overview and Current Treatment Paradigm
5.Market Share of Approved Therapies
6.Treatment Approaches:
o Immunotherapy
o Combination Therapies
o Anti-Oxidation / Anti-Aggregation
o Serotonin Modulators
o Others
3.MULTIPLE SCLEROSIS: ORAL DRUGS MAKING A WAVE- PILL VS. SHOT
1.Investment conclusions
2.Future trends
3.Generic Threats
4.Marketed Products – Unit & Sales Growth (2008-10)
5.Pipeline Analysis
6.Select Oral Therapies’ Analysis
7.Injectable Drugs Offer Efficacy – but Come with Risks!
8.Key Milestones
9.Disease Overview and Current Treatment Paradigm
10.Competitive Analysis of Oral and Injectable MS drugs
Global Pharmaceutical and Biotechnology
Outlook 2012
Table of Contents
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Therapeutic Class
Therapeutic Class Table of Contents
CARDIOVASCULAR
4.NEXT GENERATION ORAL ANTICOAGULANTS
1.Anticoagulants Market
• Market size and Segmentation – By Drugs and Indications
• Goals (Duration) of Current anticoagulant therapy in different indications
• New generation anticoagulants pipeline
• Major Upcoming Milestones
• Estimated launch timelines for new generation anticoagulants– Indication wise
• Characteristics of Ideal anticoagulants
• Factor Xa vs. Direct Thrombin inhibitor
2.Stroke Prevention in Atrial Fibrillation
• The Current Market Dynamics- Geography wise prevalence of SPAF and treatment paradigm of
anticoagulation therapy in SPAF
• The need for new generation anticoagulants
• Does higher unmet need prevail in high risk (CHADS2 score) patients or low risk patients?
• Experts view on the hurdles to the adoption of new generation anticoagulants in SPAF
• Factors that will influence the choice of anticoagulation therapy in Atrial Fibrillation – Regulatory
and Clinical
o Patient’s history of stroke and bleeding risk factors impacting treatment decision
o Impact of dosing frequency on treatment practice in SPAF
o Warfarin discontinuers
o Concomitant Medicines- Donut hole and drug-drug interaction
o Regulatory Scenario – Medicare Shared Saving program to be implemented in 2012
o Reimbursement status of PT/INR monitoring for warfarin in major countries
o Physician’s Experience and cost effectiveness
o Warfarin Genotype testing, its regulatory approval and reimbursement
o Use of Device for Stroke Prevention in Atrial Fibrillation
• Warfarin continues to hold itself strong against Pradaxa – Will the entry of Xarelto / Eliquis /
Edoxaban change the scenario?
• Clinical data comparison of ARISTOTLE, AVERROES, RELY and ROCKET AF Studies and
our analysis on each clinical data
o Baseline and Clinical Trial Design comparisons – RELY, ROCKET AF AND ARISTOTLE
o Overall Efficacy and Safety comparisons – ROCKET, RELY, ARISTOTLE AND
AVERROES
o Efficacy and safety comparison in high risk patient population
o Clinical data analysis from ROCKET- AF detailed data
o Clinical data analysis from ARISTOTLE detailed data
o AVERROES trial rationale and results – No commercial implications
• FDA approval of Xarelto in SPAF
• Universal antidote for novel oral anticoagulants
• The Future Mainstay Treatment In SPAF - Xarelto or Pradaxa or Eliquis or Edoxaban
3.Role of New Generation Oral Anticoagulants in VTE Prevention in Orthopedic Surgery
• Prevalence of VTE after Total Hip Replacement Surgery / Total Knee Replacement Surgery
• The need and importance for extended prophylaxis and current limitations
Therapeutic Class Table of Contents / 16
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Therapeutic Class
Therapeutic Class Table of Contents
• Clinical data comparison – Xarelto, Eliquis and Pradaxa
4.Role of New Generation Oral Anticoagulants in VTE Prevention in Medically-ill Patients
• Market segmentation based on Illness
• Risk/Incidence of DVT and Fatal PE in different categories of Medically ill Patients
• Incidence of DVT In Orthopedic Surgery vs. Acute Medically ill Patients
• VTE Prevention in Cancer Patients – VTE incidence rates in different types of cancer
• Ongoing clinical studies
• Xarelto – Review of MAGELLAN study
• Semuloparin - Clinical data comparison of VTE prophylaxis in cancer Patients
5.Role of New Generation Oral Anticoagulants -VTE Treatment
• New Generation anticoagulants will expand the DVT treatment opportunity manifold
• Pradaxa - RECOVER study
• Eliquis - BOTTICELLI Study and AMPLIFY study
• Xarelto – EINSTEIN DVT study
• Xarelto – EINSTEIN EXT study
• Xarelto – Other ongoing studies
• Edoxaban – HOKUSAI study
• Clinical data comparison from DVT treatment studies
6.Factor Xa Inhibitors - Do They Have Potential to be an Ideal Anticoagulant for Secondary
Prevention of ACS?
• Historically, Anticoagulants have failed to show a positive risk-reward profile in ACS – Xarelto
succeeded in ATLAS TMI 58
• Clinical data comparison of Anticoagulant as add on to current ACS treatment vs. Newer
Antiplatelet agent

Upcoming clinical data news flow which has potential to change market dynamics
7.Is Anyone Competent enough in The Early Stage Factor Xa Inhibitors? –
• LY517717
• Eribaxaban
• Betrixaban
• TAK-442
• YM150
8.How Will the Next Generation Oral Anticoagulants Stack Up?
ENDOCRINOLOGY & METABOLISM
5.GLP-1 AGONIST
1.Executive Summary
• GLP-1’s best positioned to leverage the diabetes market growth
• Forecast for Late Stage GLP-1 Drugs
• GLP-1 Pipeline - Late Stage and Early Stage
o Key Traits
o Launch Timelines
o Upcoming Milestones
• Clinical data comparison of Late stage GLP-1 analogues
2.Post DPP-IV, GLP-1 analogue to become the next growth driver for type 2 diabetes market
• GLP-1 analogues to become multi-billion market in Type 2 diabetes space
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o GLP-1 class – Growth Drivers
o Key Opinion Leaders Insights (Endocrinologist)
o Clinical data comparison between different class of anti-diabetics
o Growing Evidence on Long term safety should allow GLP-1 uptake to accelerate
o Currently available therapy and Current treatment algorithm by Joint ADA and EASD and
NICE guidelines
• Emerging late stage newer mechanism to treat type 2 diabetes vis-à-vis GLP-1 class
3.Pipeline GLP-1 candidates are targeted to overcome the key hurdles limiting the uptake of
approved GLP-1’s
• How do the newer pipeline candidates address the limitations of current GLP-1’s?
• Beyond compliance-pipeline longer acting versions also brings a better clinical profile
4.Key Catalysts that will gradually transform the treatment paradigm in diabetes space
• Our view on Bydureon launch in US
• Estimated launch milestones of pipeline GLP-1 agonists
5.Our view on the late stage GLP-1 analogues
• Clinical data comparison of late stage GLP-1 analogues
• Bydureon will lead the growth of the GLP-1 class in near to mid term
o DURATION 6 Results–Bydureon once weekly advantage outweighs moderate efficacy
difference against Victoza
o Efficacy difference is inconsistent: Victoza and Bydureon against Byetta and Lantus
o Duration-6 head to head comparison Bydureon vs. Victoza
o Clinical profile of Bydureon studies (DURATION Programme)
o Bydureon – once weekly advantage outweighs injection site nodules
• Albiglutide
• Lixinetide
• Dulaglutide
• Semaglutide / once weekly Liraglutide Depot
• Fixed dose combination of GLP-1 analogue + Insulin
• Lixinetide and basal Insulin
• Victoza and Insulin Degludec
6.Market Size Forecast of GLP-1 analogues
• GLP-1 analogues current market size – to 2020
• GLP-1 current market share in comparison to other therapy class
• GLP-1 market growth against total prescription and diabetes care (past, current and future)
• Current share of Victoza in overall GLP-1 market
• GLP-1 analogues are expected to take market share from which anti-diabetic class
• Market share forecast of each GLP-1 analogue pipeline candidate
7.Early stage Pipeline of GLP-1 analogues and upcoming rising star from the space
• Novel Exenatide formulation
o Clinical profile for Exenatide once monthly (PhII)
o Preclinical and PhI data and advantages of HM11260C (PhI)
o Benefits of XTEN Technology in VRS-859 (Versatis)
• Review on Oral GLP-1 analogue
o NN9924-GIPET Technology
o ZTGK1
o ORMD 0901
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• PhI/Preclinical GLP-1 analogue
• Insulin + GLP-1 analogue combination
8.Comprehensive Review on Novel Delivery Technology on pipeline GLP-1 agonists
• Implants
o ITCA 650 – DUROS Technology for 3 m , 6 m and 12 m delivery
o Mechanism of delivery of drug
o Efficacy and safety data
• Hydrogel Technology
o ACP-03 – Transcon Linker and Hydrogel Technology
• Inhalation Powder
o Advantages of MKC 253
• Transdermal patch
o VioDor – RF-Microchannel technology
• Our view on the different formulations of pipeline GLP-1 analogues
9.GLP-1’s - Geography wise difference in prescribing habits
• US vs. EU- Probable reason for difference in prescribing habits
• Label difference of the approved GLP-1’s
• Percentage share of prescription by PCP and Endocrinologist for GLP-1 agonist
• Anti-diabetics Prescription pattern in major EU countries
• Mean HbA1c in Type 2 diabetes in various countries
• Geography wise difference in Type 2 diabetic patient’s profile
• Current market share difference of each anti-diabetics
10.Future of GLP-1 analogues as anti-obese drugs
• Obesity trends and diabetes prevalence in the US
• Relationship between Diabetes and Obesity
• Overweight and obesity prevalence in selected countries
• Liraglutide is ahead in the race
11.Appendix
• Chart 1 – Diabetes prevalence
• Chart 2 – Physiological correlation between glucose, insulin and glucagon excursions
• Chart 3 – Currently US is the major contributor of GLP-1 value market
• Chart 4 – 2006-10 global diabetes care market by treatment class
• Chart 5 – Victoza prescription in EU – Germany
• Chart 6 – Victoza prescription in EU – France
• Chart 7 – Victoza source of patients in Europe
• Chart 8 – Development of victoza in key European GLP-1 market
• Chart 9 – EU Victoza prescription
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ONCOLOGY
6.PERSONALIZED MEDICINE – CANCER VACCINES: HOPE OR JUST HYPE?
1.Investment conclusions
2.Cancer Vaccines: Is So much Caution Warranted?
3.Triggers for Transformation
4.Select Cancer Vaccine Milestones – 2012-13
5.Select Cancer Vaccine Pipeline – Late-stage and Mid-stage
6.Clinical Trial Design – Challenges for Cancer Vaccines
7.Mechanism of Action and Clinical Data of Cancer Vaccines in:
• Metastatic Melanoma
• Non-Small Cell Lung Cancer (NSCLC)
• Prostate Cancer
• Other Cancers (Follicular Lymphoma, Colorectal Cancer, Glioblastoma multiforme - GBM, Breast
Cancer)
7.METASTATIC MELANOMA
1.Prevalence, Market Size in Different Geography
• Current Market and Potential
2.Target Product Profile vs. Current Level of Attainment
3.Worldwide Melanoma Market Forecast
• US and
• Ex-US Melanoma
4.Recently Approved Therapies:
• Yervoy And Zelboraf - How Will the Ongoing Trials Impact Their Potential
• USFDA is unlikely to approve 10mg/kg ipilimumab dose as toxicity is likely to play spoilsport
• Durability of Response vs. Overall response Rate
• Ongoing Ipilimumab Clinical Study In Metastatic Melanoma
• Zelboraf (Vemurafenib, Roche) – Spectacular benefits, managing resistance is the key
5.B-RAF resistance: How to Overcome?
• Combination Therapy to reduce B-RAF resistance!!
• GSK 436 +GSK 212 ahead in the race than Vemurafenib
• Safety data –GSK 436+ GSK 212
• Vemurafenib + MEK inhibitor
• Vemurafenib with PI3K/AKT/mTOR inhibitors and Immunotherapy
• Earl
y research for reducing Resistance to BRAF inhibitors
• Ongoing clinical studies with Vemurafenib
6.Melanoma Pipeline – New Approaches Underway
• Targeted Chemotherapy
• Targeted Immunotherapy
• Targeted MAP Kinase therapy
• Vaccines
• Anti-angiogenesis Therapy
7.Key Pathways and Biomarkers for Metastatic Melanoma
8.Extensive review of Metastatic Melanoma pipeline candidates
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9.B-RAF inhibitors – Specificity to B-RAF is the key for efficacy
• B-RAF inhibitors: Late stage and Early stage pipeline compounds
• PhI/II clinical data of GSK 436 in the treatment of metastatic melanoma
10.MEK Inhibitors
• GSK 212
• AZD 6244
• MEK 162
• GDC 0973
• PD0325901
• TAK-733
• BAY 86-9766
• RO 5126766
11.C-KIT mutation and C-KIT inhibitors in the pipeline
12.Pipeline Assessment of Immunotherapeutics: Ipilimumab
13.Early stage Immunotherapy approaches to treat Melanoma
• PD1 blocking agents
• CD-40 activation
14.Chemo or chemo+targeted therapy
• Nab-Paclitaxel
• Abraxane + Avastin
• Abraxane + carboplatin
• Avastin + Dacarbazine
• Vaccine pipeline assessment
• Allovectin – 7
• Talimogene laherparepvec (formerly OncoVEX
GM-CSF
)
• MAGE-A3 ASCI
15.Others
• PV 10 (Rose Bengal)
• Genasense
16.Trial design and Clinical data comparison of Launched and pipeline candidates in First line,
Second line settings of Metastatic Melanoma
• Clinical trial data comparison for metastatic melanoma- first line setting
• Clinical trial data comparison for metastatic melanoma- second line setting
• Clinical trial data comparison for metastatic melanoma- unresectable stage IV & adjuvant setting
17.Upcoming Milestones and Launch Timelines of Late Stage Pipeline Candidates
18.Key Milestones in Metastatic Melanoma Therapy Class
19.Annexure
• Etiology and Survival of Melanoma
• Stages of Melanoma and Treatment Options Overview
• Survival of Melanoma Patients
• FDA requirement for new drug approval in Melanoma (Oncology)
• RESIST evaluation criteria for the assessment of drugs’ efficacy in cancer
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