PCSK9 Inhibitors - The hot new approach to lower cholesterol

DUBLIN, November 25, 2013 /PRNewswire/ --

Research and Markets (http://www.researchandmarkets.com/research/559pr8/pcsk9_inhibitors) has announced the addition of the "PCSK9 Inhibitors - The hot new approach to lower cholesterol" report to their offering.

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Several companies are actively pursuing a new strategy to lower cholesterol: the inhibition of the PCSK9 gene/enzyme. This enzyme speeds the degradation of LDL receptors. Thus its inhibition should preserve receptor function and enhance the clearance of LDL-C, thereby lowering plasma levels. Sponsor efforts have focused on three technology platforms as a means to accomplish this antibodies that target PCSK9, RNA silencing, and antisense oligonucleotides. This report explores the underlying rationale for PCSK9 inhibition and those three technology platforms. Additionally, it looks at the strength of available data, the regulatory paths ahead, and the market opportunities for the two most advanced candidates Regeneron/Sanofi's REGN727 and Amgen's AMG 145.

Key Topics Covered:

INTRODUCTION

1. Lipid metabolism-an overview
2. The role of LDL cholesterol (LDL-C)
3. LDL-C, current therapies, and cardiovascular risk
4. The role of PCSK9 in cardiovascular disease
5. Companies have used three technologies to target PCSK9

CLINICAL DATA

1. Regeneron and Sanofi's REGN727/SAR236553
2. Amgen's AMG 145
3. Pfizer's RN316 (PF-04950615)
4. Novartis' LGT209
5. Alnylam's ALN-PCS02
6. Bristol Myers Squibb/ISIS Pharmaceutical's BMS-844421/ISIS 394814 and Santaris Pharma A/S' SPC5001
7. Preclinical programs

CLINICAL AND REGULATORY DISCUSSION

1. PCSK9 inhibitors lower LDL-C dramaticallyso what are the questions?
2. Which segments of the population would be best served by PCSK9 inhibitors and does that match with the indications that the sponsors are seeking?
3. Can one expect these agents to lower cardiovascular risk even further?
4. PCSK9 inhibition seems safe but, as always, caveats remain
5. Antibody therapeutics are associated with certain risks
6. Antisense and siRNA technologies are newer and untried
7. Are there theoretical concerns related to PCSK9 inhibition itself?
8. The regulatory path forward

MARKET ANALYSIS

1. Market overview
2. Competitive issues
3. Pipeline competitor analysis

SUMMARY OPINION


Companies Mentioned

- Regeneron
- Sanofi
- Amgen
- Pfizer
- Novartis
- Alnylam
- Isis Pharmaceuticals
- Bristol Myers Squibb
- Santaris
- Adnexus
- Alder Biopharmaceuticals
- AFFiRiS
- Serometrix
- Shifa
- Idera
- Merck

For more information visit http://www.researchandmarkets.com/research/559pr8/pcsk9_inhibitors

Research and Markets
Laura Wood, Senior Manager.
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Sector: Pharmaceuticals