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Global Biopharma Outlook 2011 Product Image

Global Biopharma Outlook 2011

  • ID: 1849778
  • January 2011
  • Region: Global
  • 391 Pages
  • MP Advisors

FEATURED COMPANIES

  • Ablynx
  • AstraZeneca
  • Cadila
  • Gilead
  • LifeCycle
  • Pfizer
  • MORE

Global Pharmaceutical and Biotechnology Outlook 2011 is an extensive, yet conclusive research work that encompasses a comprehensive, historical and forward looking analysis of 80 small and large cap US, EU, Japan and ROW companies – formulated with an aim to facilitate strategic and long term investment decision making of senior management. Outlook-11' has been tailored to deliver more meaningfully in the current economic scenario.

MP Advisors integrated top-bottom and bottom-up research methodology spots business models which are valued to a lesser extent as compared to some of the 'popular' business models. The company capsules' of over 80 bio-pharmaceuticals elucidate the financial and strategic model they follow, the pros and cons about existing and new products, growth strategies for the future, and their key milestones.

The Global Pharmaceutical Model is changing. Major pharmaceutical companies continue to under-perform in a market constrained by patent expiry, generic competition and a lack of new blockbuster drugs. There are signs of improvement, with the outcome of new clinical trials and new launches expected to reshape market dynamics.

MP Advisor READ MORE >

FEATURED COMPANIES

  • Ablynx
  • AstraZeneca
  • Cadila
  • Gilead
  • LifeCycle
  • Pfizer
  • MORE

Global Bio-Pharma Outlook 2011

India Pharma: Macro View

Para IV - The New India Advantage

Table 2: Indian Cos. Presence in Para IV of Top 20 Products

Table 3: Snapshot of Indian Cos. Para IV Presence

Table 4: Important Para IV Milestones of Indian Cos.

Table 5: Comprehensive List of Para IVs of Indian Cos.

Domestic Formulations - Regulatory Scenario Guarantees Further Growth

- Chart 1: India Market Growth Analysis

- Strict Implementation of GMP Norms Helped Consolidation

- Mandatory GLP Norms - Fresh Salvo

- Table 6: Indian Cos. Continue To Invest In Sales Force Expansion

Acquisition - Can it Be another Stock Driver?

Manufacturing Alliances - Generics to Gain The Most

- Why We Do Not Expect Pure Play Contract Manufacturers To Gain Significantly?

- Table 7: Manufacturing Alliances with Generic Companies

Industry Capsules

Sun Pharma

Domestic Formulations - Robust Growth Taro Business Overview

- Current Position of Taro

- Taro's Business - Mix of Branded and Generic Dermatology

- Taro's Manufacturing Facilities

- What Does Taro Mean For Sun?

Export Formulations - Leaving Protonix Behind

Launch of Effexor XR with 180-Day Exclusivity

Upcoming Para IV / Low Competition Opportunities

- Prandin
- Stalevo
- Strattera
- Gemzar
- Taxotere

Appendix 1: Para IV Valuation
Appendix 2: Para IV Milestones
Appendix 3: Sales Breakup

Ipca
Domestic Formulations - Robust Growth Even Without Anti Malarials

- Table 1: Increased Sales Force Breakup

Generic Formulations - Growth From All the Geographies

- US Generics
- UK Generics
- Generic Coartem Sales to WHO nations

Branded Formulations - Russia Still Proving a Drag

Financial Highlights

Appendix 1: Sales Breakup

Cadila Healthcare

Domestic Formulations - Robust Growth Continues

Export Formulations - Growth From All the Geographies

Gemzar Generics Enter US - Cadila To Benefit

Update on Abbott Deal Update on JVs - Hospira & Nycomed

Appendix 1: Para IV Valuation

Appendix 2: Para IV Milestones

Appendix 3: Sales Breakup

Lupin

US Formulations - Growth Continues Without Major Launches

Table 1: Lupin's US Launches in Last 2 Years

Near Term Para IV Opportunities

- Geodon

- Ambien CR

Branded Sales - Suprax Declines

Table 2: US Sales Analysis

Oral Contraceptive - Gaining Market Share Remains A Question

Appendix 1: Para IV Valuation

Appendix 2: Para IV Milestones

Appendix 3: Sales Breakup

Biocon

R&D Expenses To Pressurize Margins

Biopharma Sales Analysis

Update on Contract Research and NCE pipeline

Analysis of Insulin Deal With Biocon - A Zero Sum Game In the Near Term!

- Highlights of the Deal With Pfizer

- Table 1: Biocon-Pfizer Deal: Details of Products

- Table 2: Inflow and Outflow For Biocon

Appendix 1: Sales Breakup

Aurobindo Pharma

ARV Formulations - Benefiting from Increased Capacity

API Segment to Continue With Low Growth

Topline May Grow, But Margins To Remain Under Pressure

Deal With AstraZeneca - Details

ECB of $125m Raised To Finance Repayment of FCCBs

Table 1: Gross Debt Breakup

Appendix 1: Para IV Valuation

Appendix 2: Para IV Milestones

Appendix 3: Sales Breakup

Dishman

Contract Manufacturing - Business Challenges Continues

Hi Potency Facility to Contribute from H2FY11

Increase in Debt and Capex Continues Despite Pressure on Business

Appendix 1: Sales Breakup

Cipla - Zyprexa - A Niche Upcoming Opportunity

Domestic Formulations - Mix of Branded and Non Branded Sales

Technology Licensing Income - Further Decline

APIs Down Due To Captive Consumption

Zyprexa - An Upcoming Opportunity

Table 1: Upside From Zyprexa Exclusivity

Indore Facility - Sales Ramp Up to Take Time

HFA Inhaler Opportunity - Significant Only After 2 Years

Financial Highlights

Appendix 1: Sales Breakup

Dr Reddy's Lab

Domestic Segment - Robust Growth

Russia - Focusing on OTC Portfolio

Betapharm - Challenges Continue

PSAI Segment - Continues

To Decline US Generics - The Game Changer

- Launch of Accolate

- Allegra D12 - Commoditized Launch
-

- Allegra D24 - Regulatory Challenges Persist

- Tacrolimus - Sales Plateauing

- Fondaparinux - Lucrative But Shared Opportunity

- Omeprazole OTC - Expects Faster Ramp up

- Prevacid - Competition from OTC Remains a Key Hangover

- Zyprexa - High Impact

- Fosamax Plus D - A Big Launch, But Timelines Uncertain

Appendix 1: Para IV Valuation

Appendix 2: Para IV Milestones

Appendix 3: Sales Breakup

Piramal Healthcare

Deal With Abbott - Reflects Strength of Indian Pharma Market

Table 1: Relative Valuaion of Similar Acquisitions

Table 2: Market Share of MNCs and Indian Cos.

Table 3: Calculation of Net Cash Value

Table 4: Combined Revenues From Abbott and Piramal

Piramal Sells Off Diagnostics Arm

Acquired Anesthetic Products From Bharat Serums and Vaccines

Appendix 1: Sales Breakup

Ranbaxy

USFDA Issues - Management Remains Non-committal

US Generics Business - Managing Exclusivities

Aricept - Launched on Day One

Valcyte - To Be Launched in March 2013

Lipitor - Apotex Trying To Trigger Early Exclusivity

Base Business Margin Still Under Pressure Despite Topline Growth

Appendix 1: Para IV Valuation

Appendix 2: Para IV Milestones

Appendix 3: Sales Breakup

Wockhardt

European Business Can Prove To Be a Burden

US Generics - Low Competition Opportunities

Toprol XL - High Value, Low Competition and Long Term

Stalevo - Wockhardt's first 180-day opportunity

Comtan - Niche Opportunity

Debt Restructuring Now Seems Visible

Appendix 1: Para IV Valuation

Appendix 2: Para IV Milestones

Appendix 3: Total Liabilities - Secured Loans, FCCBs and Derivatives

Appendix 4: CDR Package

Appendix 5: Discounted Free Cash flow

Appendix 6: Weighted Average Cost of Capital

Appendix 7: Sales Breakup

India Pharma Tables

- Sales Force Expansion by Indian Companies

- Du Pont Analyses of Indian Companies

- FIIs Holdings - Change in Shareholding

- NCE and Biologic pipeline of Indian Companies
Global Pharma: Macro View

2010 Performance

- 2010 - A Year of Underperformance for the Sector
- Our View on the potential of Major NME/BLA approvals that happened in 2010
- A Retrospective analysis of our 2010 recommendations on Product approval, Clinical data and stock price

Growth Drivers for Global Pharma

A. Innovation
- Outcome from Major Clinical studies/events expected to reshape the competitive dynamics in different therapy areas
- Forecast for NME & NCE Approvals and their peak sales potential
- Important Clinical, Regulatory and Marketing Milestones in 2011 with important implications

B. The emerging market opportunity and how Global pharma's are shaping up

- Emerging market opportunity size through 2014

C. Health Care reform in US: Doughnut hole discount to be implemented from 1st Jan 2011 in US and its implication on Innovation

- Share of Part D Enrollees Who reached doughnut hole and Catastrophic Coverage

- Changes in drug use by Part D enrollees after reaching the coverage Gap in 2017

- Donut hole change due to HC reform- 2020 A: Branded drugs B: Generic Drugs

- Medicare Part D enrollees who reach the Coverage Gap

Company Analysis

AstraZeneca: More disappointments in store

- Ongoing litigation over Nexium in US

- Lipitor Patent Expiry and SATURN Trial - Implications

- Dapagliflozin - Clinical Data and Regulatory Analysis

- SGLT2/SGLT1 inhibitors: Preliminary Efficacy comparison

- SGLT2 inhibitors: Efficacy comparison vs. Januvia as first line therapy

- Generic Exposure Through 2014

Bristol-Myers Squibb: 2011- To decide the prospects of BMY beyond

Apixaban- Success highly dependent on ARISTOTLE and Not AVEEROES

- Is AVEEROES patient population Unique?

- Xarelto vs. Apixaban- Who will win in the Race of an ideal anticoagulant post Pradaxa launch

- Trial design comparison- ROCKET AF study has set itself higher hurdles compared to competitors

- Stroke prevention in Atrial fibrillation market, PhIII pipeline expected launch and peak sales estimates

Ipilimumab- Approval likely in second line melanoma but we are cautious
about prospects in first line melanoma

- Competitive landscape in second line metastatic melanoma

Belatacept

- Timely Belatacept approval in mid 2011 is highly dependent on the resolution of GMP issues at its Manati facility and 3 years long term survival data

Sprycel
- Difficult to beat Tasigna for treatment of first line CML

- DASSION, ENESTnd and BELA data comparison in first line CML

Dapagliflozin
- Our view on First in class SGLT2 inhibitor

Brivanib

- Clinical data in Hepatocellular Carcinoma

- Competitive landscape in Hepatocellular Carcinoma

- KEY Growth drivers

Eli Lilly: Few Near Term Avenues for Success

- Key growth driver AND Para IV Challenges

- Effient ramp up - Post Brilinta launch and Plavix patent expiry - Where it stands?

- Brilinta vs. Effient - Efficacy comparison in different sub groups

- Outcome study data from GeCCO study in Plavix non responders

- Effient vs. Brilinta in Plavix non responders

- Axiron approval - Matches well with product portfolio

- Generic Testosterone Market

GlaxoSmithKline: Evolution of Back up: Breath Easy

- Our view on Relovair, Tykerb, Benlysta, Syncria and Otelixizumab

- Syncria Efficacy data

- Pipeline GLP-1 compared to Byetta

Merck: Ripen late stage pipeline

Remicade - JNJ arbitration

Vytorin Zetia - Positive SHARP data should reinstate lost glory of Vytorin and raises hope from IMPROVE-IT

- CV outcome Benefit in Renally impaired population- Vytorin vs. Crestor

Boceprevir regulatory pathway and launch

Vorapaxar (Thrombin Receptor antagonist) in ACS

- TRIOLOGY ACS and TRA 2P Outcome data will decide its future

Anacetrapib- Could it be a safe CETP inhibition?

- Clinical data comparison of CETP inhibitor / CETP modulator

Betrixaban - Safety established but efficacy continues to baffle

- PhII clinical data comparison of Betrixaban vs. DU- 176b vs. Pradaxa for stroke prevention in Atrial fibrillation

Novartis: To clock positive growth for next five years on back of:

- Tasigna sales to double driven by strong penetration in first line CML

- Competitive landscape in first line CML (Tasigna vs. Sprycel vs. Bosutinib)

- Gilenya - quick ramp up expected as first line oral Multiple Sclerosis treatment

- QAB 149 (indacaterol) approval expected in 1H 2011 for COPD indication

- Comparison of QAB 149 vs. Spiriva

- Ilaris: Impressive efficacy in refractory Gout through IL beta 1 inhibition

- Competitive landscape - For prophylaxis and treatment of acute gout flares and pain relief

- Clinical data news flow in 2011

- Sales Trends of Newly launched products

- Approval expected in 2011 and peak sales potential

Novo Nordisk : Degludec thrice weekly version to drive growth of Insulin leader

- Insulin degludec- Anything beyond better tolerability?

- Important trials to report Data in 2011

Pfizer: Will Austerity Measures rejuvenate the giant?

- ARISTOTLE data on apixaban in stroke prevention in Atrial Fibrillation

- Approval of Taliglucerase alfa for Gaucher's Disease

- Tasocitinib- Our view on PhIII head to head data vs. Humira and its potential for treatment of RA

- Efficacy of Tasocitinib in Oral Solo Study

- Axitinib - PhIII data comparing Axitinib with Nexavar in Second line RCC

- Prevnar 13 vaccine approval in adults- Key growth drives for prevnar franchise

- Can the late stage pipeline nullify the impact of patent expiry?

Roche : BRAF inhibitor, dalcetrapib, pertuzumab and T-DM1- key late stage pipeline assets to report clinical data in 2011

- Our view on Ph III data on its BRAF inhibitor- RG7204 in first line metastatic melanoma

- Changing landscape of first line metastatic breast cancer

- Dalcetrapib: A CETP modulator will report interim outcome data for reducing CV risk in ACS patients in 2011

- RG 7128 - A nucleoside polymerase inhibitor for Treatment of Hepatitis C

- Wet Age AMD: Who wins? Avastin or Lucentis

- Major Pipeline molecules with expected Filing

Sanofi Aventis: Will take longer to deliver

- R & D pipeline- Strong competition provide limited potential

- Terflunomide in multiple sclerosis BSI-201 in triple negative Breast cancer

- AVE0010- PhIII data from GETGOAL program

- Aflibercept in Colorectal cancer and NSCLC

- Allegra OTC switch

Global Bio-Pharma Outlook 2011 - Japanese Pharma

Industry Capsules

Astellas : Drivers of oncology yet to be proven

Oncology Pipeline

Pipeline has good candidates, but carries certain concerns

- Mirabegron safety issues raise concernsover maintaining leadership in urinary franchise

- Acotiamide market potential is limited to Japan only

- Darexaban is filed in Japan for VTE, but growing competition limits expectations

- Vibativ keeps on lingering; a pricey deal for Astellas

- ASP-1941 appearing as strong candidate in SGLT-2 Inhibitors

China to get the highest attention among BRIC countries

Key Milestones

Appendix 1 MDV3100 early data has shown good results

Appendix 2 Monthly Sales Trend

Chugai

- Dependence on long listed products

- Actemra sales is ramping up well in US/ EU

- Key Milestones

Appendix 1 Monthly Sales Trend

Daiichi Sankyo

Geographic diversity and platform leverage of emerging markets

- Table 1 Geographical Presence

- Table 2 Presence In Emerging Markets

- Table 3 Sales - Region wise

- Revenue base relatively sustainable compared to peers

Domestic Business

OTC Business

- Table 4 Key product sales-Through 2017

- Table 5 Patent expiry calendar in Japan thru 2017

- Table 6 Exposure to long listed products

Global Business

- Ability to exploit Japanese generic opportunity

- Daiichi Sankyo Espha (DSE) - A Game Changer in Japan Generics Market

- Table 8 Low hanging fruits for Daiichi Sankyo Espha

Ranbaxy Para IV opportunity

- Aricept, Valcyte, Lipitor, Diovan Recently approved drug

Laninamivir, Effient

Key Pipeline Candidates

- Edoxaban, ARQ-197, Denosuma

Key Milestones

Appendix 1 Monthly Sales Trend

Appendix 2 Patent expiry through 2013

Appendix 3 Ranbaxy DMF list

Dainippon Sumitomo

Latuda addressing high unmet need in Antipsychotics Market

Anti-Psychotics Market and Competitive Landscape

Latuda Swot Analysis

Next pipeline attraction after Latuda

Key Milestones

Appendix 1 Monthly Sales Trend

Eisai

Aricept Lifecycle Management Programs

Halaven Approved But Has Narrow Target Population

Late stage pipeline candidates

- Eritoran

Appendix 1 Monthly Sales Trend

Kyorin

Sales Growth from its mainstream products

Late stage pipeline is weak Key Milestones

Appendix 1 Monthly Sales Trend

Kyowa Hakko Kirin

Pharma business remains sluggish

Non-pharma business growth offsets Pharma sales decline to some extent

Table 1 Segment Classification

Kyowa Hakko Kirin's antibody pipeline

Table 2 Potelligent Technology

Key Milestones

Appendix 1 Monthly Sales Trend

Mitsubishi Tanabe

Gilenya addresses a huge unmet need in the MS market

Table 1 MS Marketed Products

Existing products to withstand the generic threat

Late stage pipeline is good

- MP-146 (uremic toxin absorbent)

- MCI-196 (phosphate binder)

- TA-1790 (PDEs inhibitor)

- Roflumilast (PDE4 inhibitor)

- Golimumab (anti-TNF mAb)

- Telaprevir (protease inhibitor)

Key Milestones

Appendix 1 Monthly Sales Trend

Shionogi

Crestor sales

The domestic business is safe compared to peer group

US Subsidiary sales deterioration concerns are over

Table 1 Near term patent threats are over

Late stage R&D projects

- S/GSK-1349572 (Integrase inhibitor, HIV infection)

- Ospemifene

- Velneperit/S-3367

- PSD 502

Key Milestones Appendix 1 Monthly Sales Trend

Takeda

Growth from existing products like Actos and Velcade

Actos Patent litigation

Rich late stage pipeline and expected approval through 2012

- Contrave

- Azilsartan

- Hematide

- Alogliptine

World's most cash rich pharmaceutical company

Expected acquisition in emerging market

Key Milestones

Appendix 1 Monthly Sales Trend

Appendix 2 Para IV list

Nippon Chemiphar

- Lowest Profitability Structure Is Not Going To Change Soon

Sawai

- Generic Penetration Has Reached Upper Level For Near Term

- Strong position among generics will be maintained

- Ambitions beyond conventional generic business

- No visibility on utilization of raised debt

- Competition from Big Players

Towa

- Modest Sales sustainability from Dispensing Pharma

- Current capacity can sustain the growth

- Capex can negatively impact its Margins

Torii Pharma

- Driving factors for dalcetrapib success

- Difference between CETP inhibitor/modulator

- Dalcetrapib development programme

- Competitive landscape of CETP inhibitors

- Managing Dyslipidemia with CETP inhibition

- Key Milestones

Mature Biotech: Macro View
Positive clinical data and new drug approvals
- Table 1: Drug Approvals 2011-12
- Table 2: Key Events in R&D, Clinical and Regulatory in 2011 & 12

Healthcare Reforms' impact:
- Biologics Exclusivity, Substitutability / Interchangeability, and Patent Challenges

Promising PhIII molecules

- Table 1: Late Phase Unpartnered Compounds - Idea Bank For Business Development
- Table 2: M & A Ideas Which Can Enhance Value/ Change Rules of The Game

Industry Capsules

- Amgen - Denosumab Uptake - The Next Driver
- Denosumab approval in HALT - the next key driver
- Dawn of Biosimilar Era
- Near term Milestones assessment
- Maturing Pipeline

Appendix 1: Sales Projection thru 2013

Biogen - Modest Growth Story Even After a New 'Avatar'

Does restructuring framework help BIIB to sustain its top-line?

- MS franchise competitive threats remain
- Avonex growth: Pricing game only!!

What Can the Pipeline Deliver by 2014/15?
Near term Milestones assessment
Appendix 1: Sales Projection thru 2013
Appendix 2: Multiple Sclerosis: Marketed Products' Comparison

Celgene - Good Products Ultimately Call the Shots
- Revlimid - Robust Growth
- Diversifying Beyond Oncology
- Abraxis - Smart Acquisitions
- Strong Pipeline
- Recent Data from Revlimid in Multiple Myeloma

Appendix 1: Sales Projection thru 2013
Appendix 2: Multiple Myeloma: Competitive Landscape

Onyx - Not a One-Pony Trick Anymore
Carfilzomib is the star
Opportunity for Nexavar in New Indications:
Competitive Landscape: Multiple Myeloma
Appendix 1: Sales Projection thru 2013
Appendix 2: Multiple Myeloma: Competitive Landscape

Rising Stars Companies

Rising Star Companies: Macro View
3Bs - Biologics, Bio-Generics, and Better-biologics to Drive M&A

- Outlook 2011-13: Second-Generation targeted therapies - mAbs
- Biologics Exclusivity, Substitutability / Interchangeability, and Patent Challenges

Table 1: Targeted Therapies - mAbs To Drive Future Growth
Table 2: Marketed Biologics Launch And Patent Expiry Years
Table 3A: Biologics Focused Rising Stars Table 3B: Key Attributes Of The mAb Technologies Of Select Companies
Table 4: Select M&A Activities Of mAb Companies

Anti-Infectives : Protease inhibitors will sweep the HCV market, as they did in the case of AIDS. At least two compounds will be approved (telaprevir, boceprevir) before 2012.

- Alnylam
- Intercell
- Pharmasset
- Vertex

Auto-immune/ Inflammation diseases have seen the best outcome –
both in targeting unmet needs and better patient friendly treatment options.
Oral drug (INCB28050, R788, RDEA594, Gilenya) options are likely to make way for many diseases, such as, RA, MS;

- Ablynx
- Ardea
- Biosciences
- Galapagos
- ImmunoMedics
- Incyte
- MorphoSys
- Regeneron
- Rigel

Cardio/ Pulmonary - first-in-class and second-generation antibodies' PoC awaited

- Ablynx
- Anthera therapeutics
- ISIS Pharma

Metabolic Endocrine
- Alnylam
- ISIS Pharma

Oncology - In coming years, we see clinical data and approvals of pipeline
compounds which could bring a paradigm shift in treatment options

- Allos Therapeutics
- ArQule
- AVEO Pharma
- Immunomedics
- Incyte
- ISIS Pharma
- MorphoSys

Rare and Genetic - Orphan diseases continue to be pursued as a preferred area by Innovators - premium pricing, low regulatory bar, etc. are incentives. Besides ERT (Enzyme Replacement Therapy), drugs for MPN Myeloproliferative Neoplasms), IPF and HoFH (Homo)
- Auxilium Pharma
- ISIS Pharma
- Vertex

Others indications , such as, wet-AMD, Asthma/ COPD, Macular Edema to be pursued where it warrants more detail studies to validate the novel mechanism/ targets

- Auxilium
- ISIS Pharma
- Regeneron

Global Pharma - Company Analyses
- AstraZeneca
- Bristol-Myers
- Eli Lilly
- GlaxoSmithkline
- Merck
- Novartis
- Novo Nordisk
- Pfizer
- Roche
- Sanofi Aventis

Rising Stars - Company Analyses
- Ablynx
- Allos
- Alnylam Pharma
- Anthera Pharma
- Ardea Bioscience
- Arqule Inc
- Auxilium Pharma
- Aveo Pharma
- Galapagos
- Immunomedics
- Incyte
- Intercell AG
- Isis Pharma
- LifeCycle
- Morphosys AG
- Pharmasset
- Regeneron Pharma
- Rigel Pharma
- Vertex

India Pharma - Company Analyses
- Aurobindo
- Biocon
- Cadila
- Cipla
- Dishman
- Dr Reddy's
- Ipca
- Lupin
- Piramal Healthcare
- Ranbaxy
- Sun Pharma
- Wockhardt

Mature Biotech - Company Analyses
- Amgen
- Biogen
- Celgene
- Gilead
- Onyx

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