Large Cap Pharma Us & Eu Outlook 2016 - Maximizing Their Strength On Fewer Therapy Class

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Large Cap Pharma Us & Eu Outlook 2016: Maximizing Their Strength
On Fewer Therapy Class, Personalized Medicine, Novel Target And
Biosimilars For Future Growth
Major pharma companies are continue to improve the productivity by taking different approaches like
focusing on selected therapy area and markets, merger and acquisition, divestment of non-core
brands/segments and consolidation in animal health, vaccines and consumer health care business.
Oncology segment has been the key areas of interest for large cap Pharma companies in 2014/2015. The
field of immuno-oncology is currently one of the most explosive fields in biotechnology. Bristol-Myers’ s
with more concentrated effort in Immuno-Oncology has gain the leadership with its Anti-PD-1 drug.
Along with Bristol, there's Merck (MRK), Roche (RHHBY), and AstraZeneca (AZN) as well chasing the
field.
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The global estimates of Immuno-oncology drug is expected at >$40 billion in next ten years. AntiInfective remains a big attraction for large pharm. Merck acquisition of Cubist for $9 billion and Roche’
in-licensing deal for $1billion was the key highlight. Biosimilar development from Large ad Biotech
companies are progressing well with many reaching to regulatory space and in lates stage of clinical
trials. Biogen Idec streamlined its focus to develop drugs for specialty medicine (Multiple Sclerosis,
Inflammatory Bowel Disease), Neurodegeneration (Alzheimer’ s disease, Parkinson’ s, ALS, Neuroimmunology) and rare diseases (Hemophilia, Spinal Muscular Atrophy and Neuropathic Pain). Celgene
(CELG) keeps capitalizing on its strength in hematology and operational excellence to build global
standards of care in the segments of Oncology and Inflammation & Immunology (I&I). Gilead, a
prominent player in Hepatitis C therapy areas is looking to expand its learning in Liver disease
for another high unmet need of Nonalcoholic Steatohepatitis (NASH), while its Oncolgy segment failed
to make any major impact other than approved drug Zydelig. First – in-class mechanisms like anti-PD1,
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anti-PCSK9 and CDK inhibitors continue to get attraction by large cap pharma companies. Biotech and
pharmaceutical companies pursue targeted and specialized therapies – more than 25% (45 new drugs
approval vs. 44 in 2014) of drugs approved by FDA in 2015 are Personalized Medicines. Global
Biopharmaceutical Outlook 2016-Global Pharma, released by MP Advisors provides analyses of
individual large cap companies, promising drug candidates in their late stage pipelines, competitive
landscape, and important therapy areas where new innovation will create leadership, forecast for major
marketed drugs where competition/ regulatory scenario will change the dynamics, and the potential
impact of several important upcoming milestones on the industry.
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Table of Content
AMGEN : Focus On New Biologics For Larger Market And Biosimilar to Offset Own Losses!
-Figure 1
Amgen
IMPACT OF BLINATUMOMAB TREATMENT IN MRD+ ALL PTS
-Key Pipeline Products and Development
-Key Acquisitions and Partnership in 2015
- AMGN’ s Commercial Strategy
-KEY MILESTONES
Biogen Idec :Growth from Tecfidera and Newly Launched Products!
-MARKETED PRODUCTS – TO GAIN STRENGTH BASED ON NEW DATA
-PIPELINE TO WATCH IN 2016/2017
-KEY MILESTONES
-Annexure I : Biogen Idec
MULTIPLE SCLEROSIS – INJECTABLE DRUGS DATA COMPARISON
Annexure II : Biogen Idec
MULTIPLE SCLEROSIS – ORAL DRUGS DATA COMPARISON
CELGENE : Innovative Strategies for Long Term Gains
KEY MILESTONES
-Development In Multiple Myeloma Franchise: Strengthening Pipeline and Sales
-Inflammation – Pipeline maturing beyond OTEZLA
-Other Products in Mid stage for Long Term Growth
Celegene: Table 1
RELAPSED AND REFRACTORY MULTIPLE MYELOMA (RRMM): RECENTLY APPROVED – DATA
COMPARISON
GILEAD SCIENCES Poised to Emerge as a Leader in HCV Treatment!
Table 1
Gilead Sciences
DEVELOPMENT PIPELINE
Table 2
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Gilead Sciences
DATA FROM ASTRAL -1 STUDY
Table 3
Gilead Sciences
DATA FROM ASTRAL-4 STUDY
- GILD has multiple programs running in late stage PhII/PhIII chronic HBV pts
-Liver Disease – Non-alcoholic Hepatosteatosis (NASH)
- Inflammation/Respiratory Pipeline
- ACQUISITIONS IN THE LAST ONE YEAR
KEY MILESTONES
AstraZeneca: Late Stage Pipeline maturing; Focused development on Respiratory, Psoriasis and anti-PD1
will support long term growth
-Table 1
AstraZeneca
COMPETITIVE LANDSCAPE OF BIOLOGICS IN SEVERE ASTHMA
- Table 2
AstraZeneca
ORR BY IFN? AND PD-L1 STATUS
TABLE 3
AstraZeneca
DURVALUMAB CLINICAL DEVELOPMENT PROGRAMS
-COMMERCIAL ADVANCEMENT- KEY MILESTONES TABLE
GlaxoSmithKline : Reliance On Low Margin Consumer Health And Vaccines; Unable To Revive
Respiratory Franchise
-PIPELINE ANALYSIS – HIV/INFECTIOUS DISEASE
- HCV AND HBV PIPELINE – TOO EARLY TO COMMENT
- PIPELINE ANALYSIS: RESPIRATORYPIPELINE ANALYSIS – RESPIRATORY
-Other Biologics in Asthma Pipeline:
- RESPIRATORY DISEASE - COPD
-RESPIRATORY R&D BEYOND ASTHMA AND COPD
- PIPELINE ANALYSIS – VACCINES
- PIPELINE ANALYSIS – IMMUNO-INFLAMMATION
- PIPELINE ANALYSIS – RARE DISEASE
- PIPELINE ANALYSIS – ONCOLOGY
- KEY MILESTONES
Merck & Co : Anti-PD1 and HCV will remain growth drivers - going forward!
KEY POTENTIAL CATALYSTS FOR 2016
-Table 1
Merck
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