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Global Pharmaceutical & Biotechnology Outlook 2014: Mature Biotech Product Image Special Offer Sale Banner

Global Pharmaceutical & Biotechnology Outlook 2014: Mature Biotech

  • Published: January 2014
  • Region: Global
  • 145 Pages
  • MP Advisors
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FEATURED COMPANIES

  • Acorada
  • Alexion
  • Amgen
  • Biogen Idec
  • Celgene
  • Gilead Sciences
  • MORE

Positive sentiments for the biotech sector have prevailed in the last two to three years, and the authors expect this trend to continue for the next year too. The optimism is based on the continuity in the flow of innovative products from the biotech 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.

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 especially 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 being defined in the US. This report contains the detailed discussion of the key attributes of leading biotech companies' Acorda, Alexion, Amgen, Biogen Idec, Celgene, Gilead, Regeneron and Vertex.

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 – INJECTABLE 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

TOC:

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-Af?nity 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

Industry Tables

1. Pipeline Potential Thru 2018
2. Marketed Products' Potential
3. Sector Selected Companies M&A Activities
4. Expected Drug Clinical Milestones

- Acorada
- Alexion
- Amgen
- Biogen Idec
- Celgene
- Gilead Sciences
- Regeneron
- Vertex Pharma

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