Mature Biotech Outlook 2015: New Therapy Ventures Pave the Way for Success
Table of Contents
In-depth Company Analysis and Reports on
1. Acorda Therapeutics - Neurological Pipeline Getting Bigger
Key Pipeline Drugs
a. CVT -301 (PhIII, OFF episodes of Parkinson's disease)
b. Dalfampridine (PhIII, post-stroke walking deficits)
c. rHIgM22 (Remyelinating mAb, PhI)
d. Glial Growth Factor 2 (neuregulin, PhI, GGF2)
Other Programs in the Pipeline - Future Uncertain
2. Alexion Pharma - Pipeline Maturity will witness a Strong 2015 for ALXN
Asfotase alfa (hypophosphatasia, HPP, R) on Track
Soliris in PNH and aHUS: Growth to Continue
SOLIRIS BEYOND PNH AND aHUS
Beyond Soliris
Other PhII Programs
Messenger RNA Therapeutics platform from Moderna
3. Amgen - Focus On New Biologics For Larger Market And Exploiting Biologics' Manufacturing Experience For Biosimilars Gain Newly Marketed Product: Future Growth
a. Kyprolis
b. BLINCYTO
Key Pipeline Products and Development
a. Evolocumab (R, PCSK9 Inhibitor, CVD, SC)
b. Ivabradine (R, Chronic Heart Failure):
c. Talimogene laherparepvec
d. Brodalumab (PhIII, moderate-to-severe plaque psoriasis and psoriatic arthritis, PhII, Asthma)
e. Omecamtiv mecarbil (PhIIb, Heartfailure, licensed from Cytokinetics)
f. Romosozumab (PhIII, co-developed with UCB, Postmenopausal Osteoporosis, PMO)
g. AMG 334 (PhIIb, CGRP receptor mAb)
h. Trebananib (PhIII, Ovarian Cancer):
i. AMG 416 (PhIII, secondary hyperparathyroidism in pt with CKD, velcalcetide)
Failed in Clinical studies
Biosimilars in Development
AMGN's Commercial Strategy
4. Biogen Idec - Growth from Newly Launched Products + Clinical Milestones of Novel Pipeline
Near-Term Key Pipeline Candidates to Watch
Hemophilia Franchise Offers Long-Term Opportunity
Anti-CD20 franchise Continues to Grow through Label Expansion of Gazyva Neurology: Leadership In Ms And Portfolio Expansion
5. Celgene - Innovative Strategies for Long Term Gains
Development In Multiple Myeloma Franchise: Strengthening Pipeline
Other Oncology Drugs
Inflammation - Pipeline to start contributing to sales by 2015
Other Products in Early stage for Long Term Growth
6. Gilead Sciences - Poised to Emerge as a Leader in HCV Treatment
Sovaldi has made the way, Harvoni to take Lead
Pipeline: Anti-viral Franchise ? HCV
Antiviral Franchise ? HIV
Cardiovascular Program
Beyond Anti-Virals- Oncology
Acquisitions In Last Two Years
7. Regeneron - Late-Stage Pipeline Potential - Accelerator for Further Growth
Label expansion of E ylea in DME, BRVO, and Myopic CNV indication
Late-Stage Pipeline
REGN-Sanofi Collaboration
8. Vertex Pharma - From Large Volume Market to Niche Indications - Transformation has Paid
Cystic Fibrosis: Success in G551D mutation to Repeat in Larger Population of del508 Mutation
Small But Meaningful Addition in Other Mutations for KALYDECO monotherapy Cf Background
Beyond CF Not a Priority
List of Tables
Amgen : Table 1 : Competitive Landscape: Anti-Pcsk9 Mab - Alirocumab Vs. Evlocumab
Biogen Idec : Annexure 1 : Multiple Sclerosis - Injectable Drugs Data Comparison
Celgene : Table 1: Hematological Malignancies - Multiple Myeloma (MM)
Data Comparison - Newly Diagnosed Multiple Myeloma (Ndmm)
Table 2 : Hematological Malignancies - Multiple Myeloma (MM) Data Comparison - Relapsed / Refractory Multiple Myeloma (RRMM)
Gilead : Table 1 : Development Pipeline
Key Pipeline Product :
Table 2: Key Pipeline Products: Ifn-Free Combination
Regeneron : Tale 1: Branch Retinal Vein Occlusion (Brvo): Clinical Data Analysis
Table 2A: Clinical Data: Anti-Pcsk9 Mab, Alirocumab At American Heart Association 2014
Table 2B: Competitive Landscape: Anti-Pcsk9 Mab - Alirocumab Vs. Evolocumab
Vertex : Table 1: Phiib Data Of Ivacaftor In Residual Cftr Function
Table 2 : Phiib Data Of Ivacaftor In Residual Cftr Function
Table 3: Phiii Primary Efficacy Data From Ivacaftor/ Lumacaftor Combination
Table 4 :Phiii Secondary Efficacy Data From Ivacaftor/ Lumacaftor Combination
Table 5 : Phiii Pooled Primary Efficacy Data From Ivacaftor/ Lumacaftor Combination
Table 6: Phiii Pooled Secondary Efficacy Data From Ivacaftor/ Lumacaftor Combination
List of Figures
Gilead Sciences: Figure 1: Macrogenics: Dart Technology
Regeneron : Figure 1 : SAR236553/REGN727: Phase III Clinical Program
Vertex: Figure 1 : Mutations And Drugs Target
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