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  4. > 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. The global estimates of Immuno-oncology drug is expected at >$40 billion in next ten years. Anti-Infective 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, Neuro-immunology) 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, 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.

Table Of Contents

LARGE CAP PHARMA US and EU OUTLOOK 2016: MAXIMIZING THEIR STRENGTH ON FEWER THERAPY CLASS, PERSONALIZED MEDICINE, NOVEL TARGET AND BIOSIMILARS FOR FUTURE GROWTH
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
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 RandD BEYOND ASTHMA AND COPD
- PIPELINE ANALYSIS - VACCINES
- PIPELINE ANALYSIS - IMMUNO-INFLAMMATION
- PIPELINE ANALYSIS - RARE DISEASE
- PIPELINE ANALYSIS - ONCOLOGY
- KEY MILESTONES
Merck and Co : Anti-PD1 and HCV will remain growth drivers - going forward!
KEY POTENTIAL CATALYSTS FOR 2016
-Table 1
Merck
KEYTRUDA: LIST OF ON-GOING COMBINATION STUDIES
- Table 2
Merck
DATA FROM C-CREST 1 and 2 PART A STUDY
- 5. Januvia (sitagliptin): Positive TECOS data should help DPP-IV expand their share in a fast growing but highly genericized diabetes market
- 6. Bezlotoxumab (mAb, R, antitoxin for prevention of Clostridium difficile; C. difficile infection recurrence
- 7. Biosimilar Advancement
- OTHER LATE STAGE DRUGS - TO ADD VALUE IN 2017 AND BEYOND
- OTHER LATE STAGE DRUGS - TO ADD VALUE IN 2017 AND BEYOND
- KEY MILESTONES
MERCK KGaA : Emerging markets and anti-PD1 to lift outlook; Acquisition of Sigma-Aldrich to Stabilize Business Growth
- HEALTHCARE SEGMENT: NEXT TWO YEARS ARE MAINLY AN INVESTMENT PHASE
- HEALTHCARE SEGMENT - PIPELINE TO WATCH FOR
KEY MILESTONE TABLE
NOVARTIS:Strengthening Position In Oncology: Heart Failure And Psoriasis Therapy Will Find New Blockbusters
- NEWLY LAUNCHED DRUGS AND LATE STAGE PIPELINE- KEY PIPELINE ADVANCEMENT - FILING EXPECTED IN 2016
- Table 1
Novartis
DATA FROM PHIII STUDY OF BUPARLISIB IN BREAST CANCER (BELLE-2)
- Table 2
Novartis
EFFICACY DATA OF LCZ696 IN PARADIGM-HF
- OTHER MARKETED DRUG - STILL SHOWING HEALTHY GROWTH
- Table 3
Novartis
SANDOZ BIOSIMILAR PIPELINE STATUS
KEY MILESTONES
NOVO NORDISK: Growth is limited by pricing competitive pressures in Diabetes and
-OBESITY: A LARGE MARKRT BUT VALUE REMAINS LOW - NOVO-B PIPELINE IS EXPANDING
Figure 1
Novo Nordisk
KEY FEATURES OF COMPOUNDS IN PHASE 1 DEVELOPME FOR OBESITY

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