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Global Biopharma Outlook 2011: Major US and EU
MP Advisors, February 2011, Pages: 90
The year 2011 and 2012 will be a bonanza for generic companies, as large innovator companies will lose patent exclusivity on prescription drugs worth over $70b in sales. It is imperative to understand how global companies are adapting to this difficult situation, as the challenge is mammoth. There are only two avenues of growth for global pharma companies - Innovation and Emerging markets.
As far as emerging markets are concerned, not all global companies have been able to execute as well as others. There are only a select few companies, that have been able to adapt their product/marketing/pricing strategies to the needs of emerging market and is reflected by their existing market penetration and on-going growth. China, which so far has been the darling for global pharma companies, is facing policy pressures and we expect lacklustre growth at least for the next 12 months. This report expects more price cuts from National drug Reimbursement list (NDRL) drugs in China and this report also views the on-going hospital reform with caution. India is growing well and global pharma companies are pursuing different strategies to extract their fair share of the growing market.
On the Innovation front, over the last two years, this research has seen approval of a host of new molecular entities (NME) with blockbuster potential (Gilenya, Victoza, Linagliptin, Pradaxa, denosumab, telaprevir, boceprevir, Brilinta, Bydureon). A majority of these drugs are first in class and have game changing potential in their respective therapy areas. The implication of approval of these drugs is wide ranging.
There are late stage compounds in the pipeline of global pharma companies, which have the potential to take away the pain of patent expiries for these companies. We are excited about the potential of few of them like Xarelto (Atrial Fibrillation), RG7204 (Metastatic Melanoma), T-DM1 (Breast Cancer), QVA149 (COPD), Anacetrapib (Dyslipidemia), Alovectin (Metastatic Melanoma), MAGE-A3 (Metastatic Melanoma), TC-5214 (Depression), CP690550 (Rheumatoid Arthritis), Canagliflozin (Diabetes), Lemtrada (Multiple Sclerosis), Aleglitazaar (Diabetes) and Solanezumab (Alzheimer Disease). The cumulative sales potential of these drugs is expected to be $40b and should help the global pharma companies take care of their patent expiry woes. In 2011 alone we expect 15 new drug approvals for the large cap innovator companies.
This report gives a thorough analysis of the large cap companies - Novartis, Pfizer, Merck, AstraZeneca, Eli Lilly, Bristol Myers Squibb, Novo Nordisk, Sanofi, Glaxo Smithkline and Roche in terms of:
(1) The key R&D success and news flow in various therapy areas expected over the next 3 years.
(2) Impact of healthcare reforms and patent expires in the major therapeutic classes and companies.
(3) The companies that are best poised to grow despite the challenges facing the sector.
(4) The companies that are best poised to grab emerging market opportunity.
Each company analysis includes a detailed drug-by-drug pipeline analysis with explanations of how a drug will perform in its therapy area and why. And there is an in-depth look at the current portfolio with generic exposure analysis and sales projections to 2015.
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
- AstraZeneca
- Bristol-Myers Squibb
- Eli Lilly
- GlaxoSmithKline
- Merck
- Novartis
- Novo Nordisk
- Pfizer
- Roche
- Sanofi Aventis
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