Global Pharmaceutical & Biotechnology Outlook 2014: Mature Biotech
Positive sentiments for the biotech sector have prevailed in the last two to three years, and we expect this trend to continue for the next year too. Our optimism is based on the continuity in the flow of innovative products from their pipeline, implementation of strategic decisions to improve cost efficiency, strengthen therapeutic leadership, and hedge against generic threats – which all lend stability to the business model of the company. Focus and interest in Orphan diseases remains and Alexion kept everyone guessing on the possible acquisition. BMRN, Alexion are likely candidates to be acquired in this space.
In the next five years the distinction between some mature biotech companies and large global pharma may become blurred esp. if there is consolidation within the sector. AMGN was the first amongst the peers to declare a dividend and this has raised the bar/expectations from others too. First mAb Biosimilar (Hospira’s infliximab – Inflectra) was approved in EU and the pipeline, competition intensifies despite no firm regulatory pathway is defined in US.
The detailed 72 pages report contains the detailed discussion of the key attributes of leading biotech companies’ Acorda, Alexion, Amgen, Biogen Idec, Celgene, Gilead, Regeneron and Vertex.
Key Words : Tags: Acorda, Alexion, Amgen, Biogen Idec, Celgene, Gilead, Regeneron, Vertex, ACOR, ALXN, AMGN, BIIB, CELG, GILD, REGN, VRTX, Soliris, Eculizumab, Asfotase alfa, Onyx, Kyprolis, RRMM, Denosumab, Prolia, XGEVA, Enbrel, Neupogen/ Neulasta, Biosimilar, Ampyra, Multiple Sclerosis, TECFIDERA, BG-12, PLEGRIDY, Gazyva, obinutuzumab, GA-101, ELOCTATE, ALPROLIX, Hemophilia A, Hemophilia B, Factor VIIIFc, Factor IXFc, Pomalidomide, POMALYST, Carfilzomib, ABRAXANE, Sotatercept, ACE-536, CC-292, MOR202, Stribild, Complera, Idelalisib, DART, Sovaldi, Sovaldi, Interferon-free treatment, Sofosbuvir/ Ledispavir, Eylea, Aflibercept, VEGF-Trap Eye, wet-AMD, Arcalyst, ZALTRAP, Alirocumab, INCIVEK, KALYDECO, KAKALYDECO/VX-809, VX-509, VX-787, VX-767, Cystic Fibrosis, G551D mutation, del508 Mutation
In the next five years the distinction between some mature biotech companies and large global pharma may become blurred esp. if there is consolidation within the sector. AMGN was the first amongst the peers to declare a dividend and this has raised the bar/expectations from others too. First mAb Biosimilar (Hospira’s infliximab – Inflectra) was approved in EU and the pipeline, competition intensifies despite no firm regulatory pathway is defined in US.
The detailed 72 pages report contains the detailed discussion of the key attributes of leading biotech companies’ Acorda, Alexion, Amgen, Biogen Idec, Celgene, Gilead, Regeneron and Vertex.
Key Words : Tags: Acorda, Alexion, Amgen, Biogen Idec, Celgene, Gilead, Regeneron, Vertex, ACOR, ALXN, AMGN, BIIB, CELG, GILD, REGN, VRTX, Soliris, Eculizumab, Asfotase alfa, Onyx, Kyprolis, RRMM, Denosumab, Prolia, XGEVA, Enbrel, Neupogen/ Neulasta, Biosimilar, Ampyra, Multiple Sclerosis, TECFIDERA, BG-12, PLEGRIDY, Gazyva, obinutuzumab, GA-101, ELOCTATE, ALPROLIX, Hemophilia A, Hemophilia B, Factor VIIIFc, Factor IXFc, Pomalidomide, POMALYST, Carfilzomib, ABRAXANE, Sotatercept, ACE-536, CC-292, MOR202, Stribild, Complera, Idelalisib, DART, Sovaldi, Sovaldi, Interferon-free treatment, Sofosbuvir/ Ledispavir, Eylea, Aflibercept, VEGF-Trap Eye, wet-AMD, Arcalyst, ZALTRAP, Alirocumab, INCIVEK, KALYDECO, KAKALYDECO/VX-809, VX-509, VX-787, VX-767, Cystic Fibrosis, G551D mutation, del508 Mutation
MACRO ANALYSIS
Key Attributes of Leading Biotech Companies
New Drug Approval in 2013-16
Key Milestones during 2014/15
Merger and Acquisitions
Biosimilars in developments
IN-DEPTH COMPANY ANALYSIS AND REPORTS ON
1. ACORDA THERAPEUTICS – PIPELINE OF NDDS DRUGS TARGETING NICHE INDICATIONS
Marketed Products - Ampyra and Qutenza
Label expansion of Ampyra
Pipeline beyond Ampyra
2. ALEXION PHARMA – FOCUS ON INNOVATIVE DRUGS FOR ORPHAN/ ULTRA-RARE DISEASES WITH NO COMPETITION VISIBLE!
Product Pipeline – Future Potential
Soliris in PNH and aHUS: Growth to Continue
Soliris beyond PNH and aHUS
Diversifying Beyond Soliris - Asfotase alfa
Early stage programs – Cyclic Pyranopterin Monophosphate, ALXN1007, ALXN1102
3. AMGEN – LATE-STAGE PIPELINE CARRIES POTENTIAL TO COUNTERACT EXPECTED HEADWINDS
Late-Stage Pipeline
Biosimilar Opportunity & Competition
Partnership and Acquisitions
Competitive Landscape: Anti-PCSK9 mAb – Hyperlipidemia
4. BIOGEN IDEC – NEAR-TERM GROWTH PROSPECTS DRIVEN BY CORE BUSINESS + NEW PRODUCT LAUNCHES
TECFIDERA
Long-Acting Hemophilia Drugs – ELOCTATE and ALPROLIX
Detailed data from long-lasting recombinant FVIII and FIX
Superiority of Gazyva against Rituxan in CLL
BIIB’s MS Franchise – Strengthening its Leadership
MULTIPLE SCLEROSIS – INJEC Table DRUGS DATA COMPARISON
MULTIPLE SCLEROSIS – ORAL DRUGS DATA COMPARISON
5. CELGENE – INNOVATIVE STRATEGIES FOR LONG TERM GAINS
Growth from marketed products and label expansion of Revlimid, ABRAXANE, POMALYST/IMNOVID, Vidaza
Novel Early Stage Products - Sotatercept, ACE-536, CC-292, MOR202, CC-223, EPZ5676, CC-220
Collaborations
6. GILEAD SCIENCES – POISED TO EMERGE AS A LEADER IN HCV TREATMENT
Sofosbuvir/ Ledispavir FDC
Development Pipeline
HIV Life cycle management
Beyond Anti-Virals – Idelalisib, Momelotinib, Simtuzumab, GS-9973
Acquisitions
Technology platform – Dual-Afnity Re-Targeting (DART)
7. REGENERON – LABEL EXPANSION SUSTAINS EYLEA’S GROWTH MOMENTUM + LATE STAGE PIPELINE
Potential Poised For Further Contribution
Marketed Products – Eylea, Arcalyst, ZALTRAP
Label expansion of Eylea in DME and BRVO indication
Late-Stage Pipeline - Alirocumab, Sarilumab, Dupilumab
REGN-Sano Collaboration
BRANCH RETINAL VEIN OCCLUSION (BRVO): CLINICAL DATA ANALYSIS
COMPETITIVE LANDSCAPE: ANTI-PCSK9 MAB – HYPERLIPIDEMIA
8. VERTEX PHARMA – FOCUS SHIFT TO CYSTIC FIBROSIS AND NICHE INDICATIONS
Cystic Fibrosis: Success in G551D mutation to Repeat in Larger Population of del508
Mutation
Small But Meaningful Addition in Other Mutations for KALYDECO
PhII data from KALYDECO / VX-809
PHIII studies for KALYDECO and VX- 809/KALYDECO in homozygous CF pts
HCV Glory Faded Very Soon
Beyond CF and HCV – VX-509, VX-787, VX-767
KEY Pipeline Products: IFN-Free Combinations for HCV
1. Pipeline Potential Thru 2018
2. Marketed Products’ Potential
3. Sector Selected Companies M&A Activities
4. Expected Drug Clinical Milestones
Key Attributes of Leading Biotech Companies
New Drug Approval in 2013-16
Key Milestones during 2014/15
Merger and Acquisitions
Biosimilars in developments
IN-DEPTH COMPANY ANALYSIS AND REPORTS ON
1. ACORDA THERAPEUTICS – PIPELINE OF NDDS DRUGS TARGETING NICHE INDICATIONS
Marketed Products - Ampyra and Qutenza
Label expansion of Ampyra
Pipeline beyond Ampyra
2. ALEXION PHARMA – FOCUS ON INNOVATIVE DRUGS FOR ORPHAN/ ULTRA-RARE DISEASES WITH NO COMPETITION VISIBLE!
Product Pipeline – Future Potential
Soliris in PNH and aHUS: Growth to Continue
Soliris beyond PNH and aHUS
Diversifying Beyond Soliris - Asfotase alfa
Early stage programs – Cyclic Pyranopterin Monophosphate, ALXN1007, ALXN1102
3. AMGEN – LATE-STAGE PIPELINE CARRIES POTENTIAL TO COUNTERACT EXPECTED HEADWINDS
Late-Stage Pipeline
Biosimilar Opportunity & Competition
Partnership and Acquisitions
Competitive Landscape: Anti-PCSK9 mAb – Hyperlipidemia
4. BIOGEN IDEC – NEAR-TERM GROWTH PROSPECTS DRIVEN BY CORE BUSINESS + NEW PRODUCT LAUNCHES
TECFIDERA
Long-Acting Hemophilia Drugs – ELOCTATE and ALPROLIX
Detailed data from long-lasting recombinant FVIII and FIX
Superiority of Gazyva against Rituxan in CLL
BIIB’s MS Franchise – Strengthening its Leadership
MULTIPLE SCLEROSIS – INJEC Table DRUGS DATA COMPARISON
MULTIPLE SCLEROSIS – ORAL DRUGS DATA COMPARISON
5. CELGENE – INNOVATIVE STRATEGIES FOR LONG TERM GAINS
Growth from marketed products and label expansion of Revlimid, ABRAXANE, POMALYST/IMNOVID, Vidaza
Novel Early Stage Products - Sotatercept, ACE-536, CC-292, MOR202, CC-223, EPZ5676, CC-220
Collaborations
6. GILEAD SCIENCES – POISED TO EMERGE AS A LEADER IN HCV TREATMENT
Sofosbuvir/ Ledispavir FDC
Development Pipeline
HIV Life cycle management
Beyond Anti-Virals – Idelalisib, Momelotinib, Simtuzumab, GS-9973
Acquisitions
Technology platform – Dual-Afnity Re-Targeting (DART)
7. REGENERON – LABEL EXPANSION SUSTAINS EYLEA’S GROWTH MOMENTUM + LATE STAGE PIPELINE
Potential Poised For Further Contribution
Marketed Products – Eylea, Arcalyst, ZALTRAP
Label expansion of Eylea in DME and BRVO indication
Late-Stage Pipeline - Alirocumab, Sarilumab, Dupilumab
REGN-Sano Collaboration
BRANCH RETINAL VEIN OCCLUSION (BRVO): CLINICAL DATA ANALYSIS
COMPETITIVE LANDSCAPE: ANTI-PCSK9 MAB – HYPERLIPIDEMIA
8. VERTEX PHARMA – FOCUS SHIFT TO CYSTIC FIBROSIS AND NICHE INDICATIONS
Cystic Fibrosis: Success in G551D mutation to Repeat in Larger Population of del508
Mutation
Small But Meaningful Addition in Other Mutations for KALYDECO
PhII data from KALYDECO / VX-809
PHIII studies for KALYDECO and VX- 809/KALYDECO in homozygous CF pts
HCV Glory Faded Very Soon
Beyond CF and HCV – VX-509, VX-787, VX-767
KEY Pipeline Products: IFN-Free Combinations for HCV
1. Pipeline Potential Thru 2018
2. Marketed Products’ Potential
3. Sector Selected Companies M&A Activities
4. Expected Drug Clinical Milestones
